Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs (Hearing, 2021)
Summary
Record of the virtual hearing "Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs" before the Subcommittee on Health of the Committee on Energy and Commerce, May 4, 2021, Serial No. 117-27. Opening statements came from Anna G. Eshoo, Brett Guthrie, Frank Pallone, Jr. and Cathy McMorris Rodgers. Witnesses were patient Therese Ball, Michael A. Carrier of Rutgers Law School, Gaurav Gupta of Ascendent BioCapital, Khrystal K. Davis of Texas Rare Alliance and Rachel E. Sachs of Washington University in St. Louis. Bills submitted by Ms. Eshoo include H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act, and H.R. 19, the Lower Costs, More Cures Act of 2021. Ms. Davis did not answer submitted questions for the record by the time of publication.
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“Negotiating a Better Deal: Legislation to Lower the Cost of Prescription Drugs (Hearing, 2021).”
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[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
NEGOTIATING A BETTER DEAL: LEGISLATION TO LOWER THE COST OF
PRESCRIPTION DRUGS
=======================================================================
VIRTUAL HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
__________
MAY 4, 2021
__________
Serial No. 117-27
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Published for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
47-719 PDF WASHINGTON : 2022
COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois CATHY McMORRIS RODGERS, Washington
ANNA G. ESHOO, California Ranking Member
DIANA DeGETTE, Colorado FRED UPTON, Michigan
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California BRETT GUTHRIE, Kentucky
KATHY CASTOR, Florida DAVID B. McKINLEY, West Virginia
JOHN P. SARBANES, Maryland ADAM KINZINGER, Illinois
JERRY McNERNEY, California H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
PAUL TONKO, New York BILL JOHNSON, Ohio
YVETTE D. CLARKE, New York BILLY LONG, Missouri
KURT SCHRADER, Oregon LARRY BUCSHON, Indiana
TONY CARDENAS, California MARKWAYNE MULLIN, Oklahoma
RAUL RUIZ, California RICHARD HUDSON, North Carolina
SCOTT H. PETERS, California TIM WALBERG, Michigan
DEBBIE DINGELL, Michigan EARL L. ``BUDDY'' CARTER, Georgia
MARC A. VEASEY, Texas JEFF DUNCAN, South Carolina
ANN M. KUSTER, New Hampshire GARY J. PALMER, Alabama
ROBIN L. KELLY, Illinois, Vice NEAL P. DUNN, Florida
Chair JOHN R. CURTIS, Utah
NANETTE DIAZ BARRAGAN, California DEBBBIE LESKO, Arizona
A. DONALD McEACHIN, Virginia GREG PENCE, Indiana
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
DARREN SOTO, Florida JOHN JOYCE, Pennsylvania
TOM O'HALLERAN, Arizona KELLY ARMSTRONG, North Dakota
KATHLEEN M. RICE, New York
ANGIE CRAIG, Minnesota
KIM SCHRIER, Washington
LORI TRAHAN, Massachusetts
LIZZIE FLETCHER, Texas
------
Professional Staff
JEFFREY C. CARROLL, Staff Director
TIFFANY GUARASCIO, Deputy Staff Director
NATE HODSON, Minority Staff Director
Subcommittee on Health
ANNA G. ESHOO, California
Chairwoman
G. K. BUTTERFIELD, North Carolina BRETT GUTHRIE, Kentucky
DORIS O. MATSUI, California Ranking Member
KATHY CASTOR, Florida FRED UPTON, Michigan
JOHN P. SARBANES, Maryland, Vice MICHAEL C. BURGESS, Texas
Chair H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon BILLY LONG, Missouri
TONY CARDENAS, California LARRY BUCSHON, Indiana
RAUL RUIZ, California MARKWAYNE MULLIN, Oklahoma
DEBBIE DINGELL, Michigan RICHARD HUDSON, North Carolina
ANN M. KUSTER, New Hampshire EARL L. ``BUDDY'' CARTER, Georgia
ROBIN L. KELLY, Illinois NEAL P. DUNN, Florida
NANETTE DIAZ BARRAGAN, California JOHN R. CURTIS, Utah
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
ANGIE CRAIG, Minnesota JOHN JOYCE, Pennsylvania
KIM SCHRIER, Washington CATHY McMORRIS RODGERS, Washington
LORI TRAHAN, Massachusetts (ex officio)
LIZZIE FLETCHER, Texas
FRANK PALLONE, Jr., New Jersey (ex
officio)
C O N T E N T S
----------
Page
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 2
Prepared statement........................................... 3
Hon. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 4
Prepared statement........................................... 5
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 6
Prepared statement........................................... 8
Hon. Cathy McMorris Rodgers, a Representative in Congress from
the State of Washington, opening statement..................... 9
Prepared statement........................................... 10
Witnesses
Therese Ball, Patient............................................ 12
Prepared statement........................................... 15
Michael A. Carrier, Distinguished Professor, Rutgers Law School.. 22
Prepared statement........................................... 24
Answers to submitted questions............................... 123
Gaurav Gupta, M.D., Founder, Ascendent BioCapital................ 28
Prepared statement........................................... 30
Submitted questions for the record \1\....................... 126
Khrystal K. Davis, Founding President, Texas Rare Alliance....... 38
Prepared statement........................................... 40
Submitted questions for the record \1\....................... 129
Rachel E. Sachs, Associate Professor, School of Law, Washington
University in St. Louis........................................ 50
Prepared statement........................................... 52
Submitted Material \2\
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act,
submitted by Ms. Eshoo
H.R. 19, the Lower Costs, More Cures Act of 2021, submitted by
Ms. Eshoo
H.R. 153, the Protecting Consumer Access to Generic Drugs Act of
2021, submitted by Ms. Eshoo
H.R. 2815, the Bolstering Innovative Options to Save Immediately
on Medicines Act, submitted by Ms. Eshoo
H.R. 2831, the Prompt Approval of Safe Generic Drugs Act,
submitted by Ms. Eshoo
H.R. 2843, the Stop The Overuse of 3 Petitions and Get Affordable
Medicines to Enter Soon Act of 2021, submitted by Ms. Eshoo
H.R. 2846, the Ensuring Access to Lower-Cost Medicines for
Seniors Act of 2021, submitted by Ms. Eshoo
H.R. 2853, the Bringing Low-cost Options and Competition while
Keeping Incentives for New Generics Act of 2021, submitted by
Ms. Eshoo
----------
\1\ Dr. Gupta and Ms. Davis did not answer submitted questions for the
record by the time of publication.
\2\ All documents have been retained in committee files and are
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=112551.
Statement from the National Community Pharmacists Association,
submitted by Ms. Eshoo
Statement from the ERISA Industry Committee, submitted by Ms.
Eshoo
Letter from the American Federation of State County and Municipal
Employees, submitted by Ms. Eshoo
Article of July 22, 2018, ``A Significant Anticancer Drug
Approval Lag Between Japan and the United States Still Exists
for Minor Cancers,'' Clinical Pharmacology & Therapeutics,
submitted by Ms. Eshoo
Article of January 8, 2019, ``U.S. Continues to Lead New Drug
R&D, but Asia-Pacific is Starting to Rise, According to the
Tufts Center for the Study of Drug Development,'' Intrado
Newswire, submitted by Ms. Eshoo
Article of May 29, 2019, ``Biopharma in China: Insights into a
market at a crossroads,'' McKinsey & Company, submitted by Ms.
Eshoo
Article of August 12, 2019, ``China's Biopharmaceutical Strategy:
Challenge or Complement to U.S. Industry Competitiveness?,''
Information Technology & Innovation Foundation, submitted by
Ms. Eshoo
Article of October 16, 2019, ``CBO estimate on Pelosi drug bill
misses its long-term impact on health,'' STAT, submitted by Ms.
Eshoo
Memorandum of October 21, 2019, ``Legal Analysis of Title I of
H.R. 3, the Lower Drug Costs Now Act of 2019,'' Congressional
Research Service, submitted by Ms. Eshoo
Article of October 25, 2019, ``Nonpartisan congressional report
suggests Pelosi's drug pricing bill could be found
unconstitutional,'' STAT, submitted by Ms. Eshoo
Report of the National Council on Disability, ``Quality-Adjusted
Life Years and the Devaluation of Life with Disability,''
submitted by Ms. Eshoo
Article of November 12, 2019, ``It's tiny biotechs--not big drug
makers--that fear `nuclear winter' from Pelosi's drug pricing
bill,'' STAT, submitted by Ms. Eshoo
Letter from 13 biotechnology investors, submitted by Ms. Eshoo
Article of November 18, 2019, ``In a rare political move,
prominent biotech venture capitalists speak out against
Pelosi's drug pricing bill,'' STAT+, submitted by Ms. Eshoo
Letter from 138 emerging biotechnology companies, submitted by
Ms. Eshoo
Letter from Phillip L. Swagel, Director, Congressional Budget
Office, to Chairman Frank Pallone, Jr., submitted by Ms. Eshoo
Fact sheet, Biotechnology Innovation Organization, submitted by
Ms. Eshoo
Article of July 24, 2019, ``Do Biopharma Companies Really Spend
More on Marketing Than R&D?,'' Regulatory Affairs Professionals
Society, submitted by Ms. Eshoo
Article of January 30, 2020, ``Pharma to the Rescue,'' Wall
Street Journal, submitted by Ms. Eshoo
Article of August 11, 2020, ``As venture capital slows in China,
biotech booms,'' BioWorld, submitted by Ms. Eshoo
Commentary of November 4, 2020, ``Socialized Medicine and
Rationing COVID Care Defy American Principles,'' Inside
Sources, submitted by Ms. Eshoo
Brief of January 19, 2021, ``Biohaven adds to a long list of
Alzheimer's drug failures,'' Biopharma Dive, submitted by Ms.
Eshoo
Letter from the Medicare Payment Advisory Commission, submitted
by Ms. Eshoo
Article of January 28, 2021, ``Europe's Self-Defeating Vaccine
Fight,'' Wall Street Journal, submitted by Ms. Eshoo
Article of February 3, 2021, ``EU's slow vaccine roll out risks
100 billion euros in extended lockdowns and lost growth,''
Fortune, submitted by Ms. Eshoo
Letter from the parents of two sons afflicted with cystic
fibrosis to Tyler Shandro, Minister of Health, Alberta, Canada,
submitted by Ms. Eshoo
Fact sheet, ``HR 3 Threatens Patient Access to Treatments,''
PhRMA, March 2021, submitted by Ms. Eshoo
Article of March 1, 2021, ``Xi Mobilizes China for Tech
Revolution to Cut Dependence on West,'' Bloomberg News,
submitted by Ms. Eshoo
Article of April 5, 2021, ``Thank private risk-taking, not public
funding, for COVID-19 vaccines, therapies,'' STAT, submitted by
Ms. Eshoo
Article of April 14, 2021, ``Don't Repeat Europe's Vaccine
Catastrophe,'' RealClear Health, submitted by Ms. Eshoo
Article of April 20, 2021, ``Bluebird bio lays off staffers in
Europe as Zynteglo rollout hits an early reimbursement snag,''
Fierce Pharma, submitted by Ms. Eshoo
Brief of April 20, 2021, ``Bluebird to withdraw gene therapy from
Germany after dispute over price,'' Biopharma Dive, submitted
by Ms. Eshoo
Document of statements from 20 healthcare organizations,
submitted by Ms. Eshoo
Letter from the Alliance for Aging Research, submitted by Ms.
Eshoo
Statement from the Academy of Physicians in Clinical Research,
submitted by Ms. Eshoo
Press release from Incubate, a coalition of life science venture
capital organizations, submitted by Ms. Eshoo
Blog post from PIPC, submitted by Ms. Eshoo
Letter from 10 U.S. Senators to the Honorable Xavier Becerra,
Secretary, U.S. Department of Health and Human Services, and
Liz Richter, Acting Administrator, Centers for Medicare &
Medicaid Services, submitted by Ms. Eshoo
Analysis of April 2021, ``Examples of New Medicine Availability
in the United States vs. Other High-Income OECD Countries,''
PhRMA, submitted by Ms. Eshoo
Press release from the Alliance for Aging Research, submitted by
Ms. Eshoo
Blog post April 22, 2021, ``Letter to Congress: Chronic Care
Policy Alliance Opposes H.R. 3,'' Chronic Care Policy Alliance,
submitted by Ms. Eshoo
Weekly Checkup from the American Action Forum, submitted by Ms.
Eshoo
Article of April 26, 2021, ``Europe Negotiates A Poor Vaccine
Rollout,'' Forbes, submitted by Ms. Eshoo
Fact sheet, ``The United States Has Breakthrough Treatments Not
Available Abroad,'' submitted by Ms. Eshoo
Article of April 28, 2021, ``H.R. 3's international reference
pricing misses the mark,'' STAT, submitted by Ms. Eshoo
Letter from the National Council on Disability, submitted by Ms.
Eshoo
Charles River Associates assessment, ``Government Scorekeepers
Likely Underestimate the Impact of Lower Drug Costs Now Act
(H.R.3) on Investment and Innovative Medicines,'' submitted by
Ms. Eshoo
Blog post from the Cystic Fibrosis Research Institute, submitted
by Ms. Eshoo
Letter from the Alliance for Aging Research, submitted by Ms.
Eshoo
Press release from the Part B Access for Seniors and Physicians
Coalition, submitted by Ms. Eshoo
Article of September 13, 2020, ``Our son and daughter BOTH have
terminal disease that's robbing them of their ability to talk,
walk, eat and see,'' Irish Sun, submitted by Ms. Eshoo
Article of September 17, 2020, ```Burning liquid fire': Sick
Aussies endure agonising injections while painless drug is
available overseas,'' Nine News, submitted by Ms. Eshoo
Press release from Doctors for America, submitted by Ms. Eshoo
Report, ``Modeling the Population Outcomes of Cost-Related
Nonadherence: Model Report,'' AmerisourceBergen, submitted by
Ms. Eshoo
Statement from the American Pharmacists Association, submitted by
Ms. Eshoo
Press release from Health Care Voter, submitted by Ms. Eshoo
Letter from the Center for Medicare Advocacy, submitted by Ms.
Eshoo
Statement from Public Citizen, submitted by Ms. Eshoo
Letter from Families USA, submitted by Ms. Eshoo
Statement from Patients for Affordable Drugs Now, submitted by
Ms. Eshoo
Statement from Lower Drug Prices Now, submitted by Ms. Eshoo
Statement from the Medicare Rights Center, submitted by Ms. Eshoo
Statement from the National Association of Specialty Pharmacy,
submitted by Ms. Eshoo
Letter from the National Committee to Preserve Social Security
and Medicare, submitted by Ms. Eshoo
Statement from the National Multiple Sclerosis Society, submitted
by Ms. Eshoo
Statement from Social Security Works, submitted by Ms. Eshoo
White paper from West Health Policy Center, submitted by Ms.
Eshoo
Statement from the American College of Physicians, submitted by
Ms. Eshoo
Press release from the Endocrine Society, submitted by Ms. Eshoo
Article of August 11, 2020, ```It will be too late for her':
Parents race to afford `world's most expensive drug','' CTV
News Canada, submitted by Ms. Eshoo
Report, ``Twelfth Annual Report on Delays in Approvals of
Applications Related to Citizen Petitions and Petitions for
Stay of Agency Action for Fiscal Year 2019,'' Food and Drug
Administration, submitted by Ms. Eshoo
Fact sheet, ``Survey of German Physicians Reveals Concerns with
Government Intrusion in Health Care Decisions,'' Part B Access
for Seniors and Physicians Coalition, submitted by Ms. Eshoo
Article of September 3, 2020, ``Slash red tape to help NHS save
lives,'' Daily Record, submitted by Ms. Eshoo
Statement from the National Association of Health Underwriters,
submitted by Ms. Eshoo
Letter from the National Taxpayers Union, submitted by Ms. Eshoo
Letter from the Alliance for Retired Americans, submitted by Ms.
Eshoo
Report, ``Fixing Medicare Part D: How a Patient-First Approach to
Out-of-Pocket Costs Will bring Treatments Within Reach,'' May
2021, Leukemia & Lymphoma Society, submitted by Ms. Eshoo
Article of July 27, 2020, ``Huron County, Ont. mom leading fight
for new cystic fibrosis treatment,'' CTV News London, submitted
by Ms. Eshoo
Statement from the National Association of Chain Drug Stores,
submitted by Ms. Eshoo
Letter from the Patient Access Network Foundation, submitted by
Ms. Eshoo
Fact sheet from the Part B Access for Seniors and Physicians
Coalition, ``Survey of French Physicians Reveals Concerns with
Government Intrusion in Health Care Decisions,'' submitted by
Ms. Eshoo
Fact sheet, ``Survey of U.K. Physicians Reveals Concerns with
Government Interference in Health Care,'' Part B Access for
Seniors and Physicians Coalition, submitted by Ms. Eshoo
Fact sheet, ``Access Restrictions in Germany,'' PIPC, submitted
by Ms. Eshoo
Document of recommendations from Americans for Prosperity,
submitted by Ms. Eshoo
Letter from the Consortium for Citizens with Disabilities,
submitted by Ms. Eshoo
Article of July 1, 2020, ``Pharmac refuses funding for life-
saving drug Spinraza,'' New Zealand Herald, submitted by Ms.
Eshoo
Article of July 15, 2020, ``Otago farmer's upsetting cancer
diagnosis after shrugging off headaches,'' New Zealand Herald,
submitted by Ms. Eshoo
Fact sheet, ``U.S. physicians overwhelmingly disagree with
Germany's determination of the value of diabetes medicines,''
November 2019, Eversana, submitted by Ms. Eshoo
NEGOTIATING A BETTER DEAL: LEGISLATION TO LOWER THE COST OF
PRESCRIPTION DRUGS
----------
TUESDAY, MAY 4, 2021
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 11:30 a.m., via
Cisco Webex online video conferencing, Hon. Anna G. Eshoo
(chairwoman of the subcommittee) presiding.
Members present: Representatives Eshoo, Butterfield,
Matsui, Castor, Sarbanes, Welch, Schrader, Cardenas, Ruiz,
Dingell, Kuster, Kelly, Barragan, Blunt Rochester, Craig,
Schrier, Trahan, Fletcher, Pallone (ex officio); Guthrie
(subcommittee ranking member), Upton, Burgess, Griffith,
Bilirakis, Long, Bucshon, Mullin, Hudson, Carter, Dunn, Curtis,
Crenshaw, Joyce, and Rodgers (ex officio).
Also present: Representatives Rush, DeGette, Schakowsky,
Soto, McKinley, and Pence.
Staff present: Jacquelyn Bolen, Health Counsel; Jeffrey C.
Carroll, Staff Director; Waverly Gordon, General Counsel;
Tiffany Guarascio, Deputy Staff Director; Fabrizio Herrera,
Staff Assistant; Stephen Holland, Health Counsel; Mackenzie
Kuhl, Digital Assistant; Una Lee, Chief Health Counsel; Aisling
McDonough, Policy Coordinator; Meghan Mullon, Policy Analyst;
Kaitlyn Peel, Digital Director; Tim Robinson, Chief Counsel;
Chloe Rodriguez, Clerk; Rebecca Tomilchik, Policy Analyst;
Kimberlee Trzeciak, Chief Health Advisor; C.J. Young, Deputy
Communications Director; Alec Aramanda, Minority Professional
Staff Member, Health; Sarah Burke, Minority Deputy Staff
Director; Grace Graham, Minority Chief Counsel, Health; Caleb
Graff, Minority Deputy Chief Counsel, Health; Brittany Havens,
Minority Professional Staff Member, Oversight and
Investigations; Jack Heretik, Minority Press Secretary; Nate
Hodson, Minority Staff Director; Peter Kielty, Minority General
Counsel; Emily King, Minority Member Services Director; Bijan
Koohmaraie, Minority Chief Counsel, Minority Oversight and
Investigations Chief Counsel; Clare Paoletta, Minority Policy
Analyst, Health; Kristin Seum, Minority Counsel, Health;
Kristen Shatynski, Minority Professional Staff Member, Health;
Olivia Shields, Minority Communications Director; and Michael
Taggart, Minority Policy Director.
Ms. Eshoo. The Subcommittee on Health will now come to
order. Due to COVID-19, today's hearing is being held remotely,
and all Members and witnesses will be participating via
videoconferencing. As part of our hearing, microphones will be
set on mute to eliminate background noise, and Members and
witnesses will need to unmute their microphone each time you
wish to speak.
Documents for the record should be sent to Meghan Mullon at
the email address we provided to your staff. All documents will
be entered into the record at the conclusion of the hearing.
The Chair now recognizes herself for 5 minutes for an
opening statement.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
A U.S. law prohibits Medicare from negotiating directly
with drug companies. We are the only developed country in the
world with such a law, and because of that, Americans are
paying three to four times more for prescription drugs than
other countries. We can change that, and if we do, we will not
only save lives, we will prevent bankruptcies across the
country.
In the absence of direct negotiation, American prescription
drug prices have gone up year after year while large drug
companies saw huge profit margins of about 20 percent on
average. These price hikes have caused Americans to choose
between buying their prescriptions and paying rent and buying
food.
For example, one in four diabetes patients report rationing
their insulin. Thirty percent of Americans have skipped a
medication dose due to cost. The Council on Informed Drug
Spending Analysis has estimated that by 2030, 1.1 million
Americans will die prematurely due to high out-of-pocket drug
costs.
Every member of this committee has heard from their
constituents about high prescription drug costs. Today our
subcommittee can help them by moving H.R. 3 forward, the Elijah
E. Cummings Lower Drug Costs Now Act, obviously named after our
beloved colleague.
H.R. 3 will finally give Medicare the power to negotiate
lower drug prices for drugs that have no market competition,
and extend those lower prices to all Americans. The legislation
caps out-of-pocket spending on drugs at $2,000 for Medicare
beneficiaries. Today, seniors can pay more than $15,000 a year
for a single prescription drug. During our markup of H.R. 3 in
2019, I added a provision to the bill to cap how much seniors
with high out-of-pocket costs pay per month to $250.
H.R. 3 will also stop drug price hikes like the ones we saw
from EpiPen and Martin Shkreli. If a manufacturer raises the
price of a drug, including generics, above the rate of
inflation, then the manufacturer must pay the entire price
above inflation back to the Treasury.
Nonpartisan analyses found H.R. 3 will reduce U.S. drug
prices for negotiated drugs by 40 to 55 percent on average,
save the Federal Government and taxpayers $500 billion over 10
years, save patients $158 billion in lower insurance premiums
and out-of-pocket costs, and save private businesses $46
billion.
With these savings, we can make a major investment to
kickstart drug research and development at the NIH, FDA, and
the Advanced Research Projects Agency for Health, ARPA-H, which
the President described in his address to Congress last week.
These investments will support the development of innovative
cures that will be available and affordable to all Americans.
This bill is popular, and it is bipartisan across the
country. In an April poll, 93 percent of Americans support
giving Medicare the power to negotiate with drug companies for
lower prices. AARP, the American Hospital Association, the
American Medical Association, the Purchaser Business Group, and
the AFL-CIO all support H.R. 3.
A recent poll of executives from 300 large private
employers found that 72 percent agree that a stronger
government role is needed to negotiate prices for high-cost
drugs. This bill could be bipartisan. In Congress, there has
been bipartisan support for the VA's direct negotiation
authority for 30 years. Several provisions in H.R. 3 are
similar to the Senate's bipartisan bill from the last Congress.
The last Republican President also supported negotiating drug
prices but didn't deliver on it.
I think it is time to live up to our promises to lower the
cost of prescription drugs for all our constituents.
[The prepared statement of Ms. Eshoo follows:]
Prepared Statement of Hon. Anna G. Eshoo
A U.S. law prohibits Medicare from negotiating directly
with drug companies. We're the only developed nation in the
world with such a law, and because of that Americans are paying
3 to 4 times more for prescription drugs than other countries.
We can change that. And if we do, we'll save lives and
prevent bankruptcies.
In the absence of direct negotiation, American prescription
drug prices have gone up year-after-year while large drug
companies saw huge profit margins of about 20 percent on
average.
These price hikes have caused Americans to choose between
buying their prescriptions and paying rent. For example, one in
four diabetes patients report rationing their insulin. Thirty
percent of Americans have skipped a medication dose due to
cost. By 2030, the Council for Informed Drug Spending Analysis
estimates that 1.1 million seniors will die prematurely due to
high out-of-pocket drug costs.
Every member of this committee has heard from their
constituents about high prescription drug costs. Today our
subcommittee can help them by moving forward H.R. 3 the Elijah
E. Cummings Lower Drug Costs Now Act.
H.R. 3 will finally give Medicare the power to negotiate
lower drug prices for drugs without market competition and
extend those lower prices to all Americans. It will also:
Cap out-of-pocket spending on drugs at $2,000 for
Medicare beneficiaries. Today, seniors can pay more than
$15,000 a year for a single prescription drug. During our mark-
up of H.R. 3 in 2019, I added a provision to the bill to cap
how much seniors with high out-of-pocket costs pay per month to
$250.
H.R. 3 will also stop drug price hikes like the
ones we saw from EpiPen and Martin Shkreli. If a manufacturer
raises the price of a drug (including generics) above the rate
of inflation, then the manufacturer must pay the entire price
above inflation back to the Treasury.
Nonpartisan analyses found H.R. 3 will:
Reduce U.S. prices for negotiated drugs by 40% to
55% on average.
Save the Federal Government and taxpayers $500
billion over 10 years,
Save patients $158 billion in lower insurance
premiums and out-of-pocket costs, and
Save private businesses $46 billion.
With these savings, we can make a major investment to
kickstart drug research anddevelopment at the NIH, FDA, and the
Advanced Research Projects Agency for Health (ARPAH) which the
President described in his address to Congress last week. These
investments will support the development of innovative cures
that will be available and affordable to all Americans.
This bill is popular and bipartisan. In a poll from April,
93% of Americans support giving Medicare the power to negotiate
with drug companies for lower prices.
The AARP, the American Hospital Association, the Purchaser
Business Group, and theAFL-CIO all support H.R. 3. A recent
poll of executives from 300 large private employers found that
72% agree that a stronger government role is needed to
negotiate prices for high-cost drugs.
This bill could be bipartisan. In Congress there's been
bipartisan support for the VA's direct negotiation authority
for 30 years. Several provisions in H.R. 3 are similar to the
Senate's bipartisan bill from last Congress. The last
Republican President also supported negotiating drug prices,
but failed to deliver.
It's time to live up to our promises to lower the cost of
prescription drugs for all our constituents.
Ms. Eshoo. The Chair now recognizes Mr. Guthrie, our
wonderful ranking member of the subcommittee, for 5 minutes for
his opening statement.
OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Guthrie. Thank you, Madam Chair. Thank you for holding
this important hearing.
I am very concerned about the consequences of Speaker
Pelosi's partisan drug bill, H.R. 3, that is before us today.
There is no doubt that Congress must do something to lower
prescription drug prices. We know the American people want
lower prices. But they do not want to sacrifice access to life-
changing treatment. H.R. 19, the Lower Costs, More Cures Act
that I helped introduce, would lower prescription drug costs
while protecting innovation for new cures.
We also know the American people do not want the Medicare
taxes and premiums they pay diverted to liberal pet programs,
which I am afraid is the direction H.R. 3 is headed. Speaker
Pelosi's bill brings us one step closer to single-payer
healthcare systems. Supporters of single payer often cite
health systems around the world as examples that the U.S.
should follow. However, I believe single-payer systems are a
very dangerous idea.
In the United States, we have access to cutting-edge,
innovative drugs and the brilliant scientists and companies who
develop them. The key word here is ``access.'' Under H.R. 3, we
would be forced to sacrifice this access for bureaucracy and
fewer cures. A partial estimate from the CBO said H.R. 3 will
result in 15 fewer new drugs developed, and the White House
Council of Economic Advisors under the previous administration
estimated up to 100 fewer drugs.
Two years ago, when we first examined H.R. 3, one of our
colleagues said in a hearing that he was willing to forfeit the
CBO-estimated cures that would not be developed due to
Government price setting. I challenge my colleagues: Would you
still agree with this statement, knowing that one of those
forfeitures could have been the COVID-19 vaccine?
Last week the White House announced that 100 million
Americans, almost 40 percent of U.S. adults, have now been
fully vaccinated against COVID-19, and 55 percent of U.S.
adults have received at least their first shot. America is in a
very different spot than our allies in Europe, who due to their
single-payer systems prioritized price over vaccine research
and development and innovation.
Thanks to President Trump, America took a very different
approach than our European allies. Through Operation Warp
Speed, we partnered with private industry and invested in
research and development. We have the results to our approach
to prove it: three safe, effective vaccines rolled out in
record time.
These vaccines have allowed our country to open and move
forward. H.R. 3 disincentives research and development, and had
it been in place last year, could have led to a worse outcome
for all Americans in the fight against COVID and the race to a
viable vaccine.
There are bipartisan solutions to lower drug prices,
including H.R. 19, the Lower Costs, More Cures Act that will
level the playing field for American consumers while still
allowing for vital innovation that Americans depend on. Just
last week, President Biden said in his joint address, and I
quote, ``Now, if Congress won't pass my plan, let's at least
pass something we agree on.''
I think that is exactly what the American people want us to
do. There is room for bipartisan action to lower costs. H.R. 19
is all bipartisan policies. And I am particularly interested in
value-based agreements and Medicare Part D reform. These two
areas have strong bipartisan support and would positively
impact the lives of millions of Americans.
[The prepared statement of Mr. Guthrie follows:]
Prepared Statement of Hon. Brett Guthrie
Chair Eshoo, thank you for holding this important hearing
today.
I am very concerned about the disastrous consequences of
Speaker Pelosi's partisan drug pricing bill, H.R. 3, that is
before us today. There is no doubt that Congress must do
something to lower prescription drug prices. We know the
American people want lower prices, but they do not want to
sacrifice access to life changing treatment. H.R. 19, the Lower
Costs, More Cures Act, that I helped introduce would lower
prescription drug costs while protecting innovation for new
cures. We also know the American people do not want their
Medicare taxes and premiums they pay diverted to liberal pet
programs, which I am afraid is the direction H.R. 3 is headed.
Speaker Pelosi's bill brings us one step closer to single-payer
healthcare systems. Supporters of single payer often cite other
healthcare systems around the world as examples that the U.S.
should follow. However, I believe single-payer healthcare
systems are a very dangerous idea.
In the United States, we have access to cutting-edge
innovative drugs and the brilliant scientists and companies who
develop them. The key word here is ``access.'' Under H.R. 3, we
would be forced to sacrifice this access for more bureaucracy
and fewer cures. A partial estimate from the CBO said H.R. 3
would result in 15 fewer new drugs developed, and the White
House Council of Economic Advisers under the Trump
administration estimated up to 100 fewer drugs.
Two years ago, when we first examined H.R. 3, a colleague
across the aisle said in our hearing that he was willing to
forfeit the CBO estimated cures that would not be developed due
to government price setting. I challenge my colleagues across
the aisle, would you still agree with this statement knowing
that one such forfeiture could have been the COVID-19 vaccine?
Last week, the White House announced that 100 million
Americans--almost 40% of U.S. adults--have now been fully
vaccinated against COVID-19. and 55% of U.S. adults have
received at least their first shot. America is in a very
different spot than our allies in Europe, who due to their
single-payer systems, prioritized price over vaccine R&D and
innovation.
Thanks to President Trump, America took a very different
approach than our European allies. Through Operation Warp
Speed, we partnered with private industry and invested in
research and development. We have the results to our approach
to prove it: 3 safe and effective vaccines rolled out in record
time. These vaccines have allowed our country to open and move
forward. H.R. 3 disincentivizes research and development and
had it been in place last year, would have led to a worse
outcome for all Americans in the fight against COVID-19 and the
race to a viable vaccine.
There are bipartisan solutions to lower drug prices,
including H.R. 19, the Lower Costs, More Cures Act that will
level the playing the field for American consumers while still
allowing for the vital innovation Americans depend on. Just
last week, Biden said in his joint address, and I quote, ``Now,
if Congress won't pass my plan--let's at least pass what we
agree on.'' I think this is exactly what the American people
want us to do. There is room for bipartisan action to lower
drug prices. I am particularly interested in value-based
agreements and Medicare Part D reform. These two areas have
strong bipartisan support and would positively impact the lives
of millions of Americans.
I would like to yield my remaining time to Dr. Burgess.
Mr. Guthrie. I would like to yield my remaining time to Dr.
Burgess.
Mr. Burgess. I thank the gentleman for yielding. Of course,
we did have this debate in October of 2019. But so many of us
know we serve in the people's House. In many ways, this is the
people's committee. And in this committee, we do have a history
of working both sides of the dais together for things that are
important to the American people.
So I certainly appreciate, Chairwoman Eshoo, that H.R. 19
has been included in the list of policies that we are
discussing today, because it does include bipartisan drug-
pricing policy solutions that, in fact, could be signed into
law tomorrow. In fact, 17 policies from H.R. 19 from the last
Congress have already been signed into law. And of course,
there were several Democrats who voted for H.R. 19 on the House
floor when it was proposed as an alternative to H.R. 3 in
October of 2019.
H.R. 3 did not become law. It did not become law because it
is a partisan exercise and will limit patient access to
treatments and cures. Parts of H.R. 19 did become law because
they were bipartisan and they do improve patient access.
Let's do what the President has suggested and pass what we
can. And Representative Guthrie is exactly right in making that
request. And I yield back to the gentleman.
Ms. Eshoo. The gentleman yields back.
The Chair now is pleased to recognize the chairman of the
full committee, Mr. Pallone, for his opening statement for 5
minutes.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairwoman Eshoo, and thank you for
this very important hearing. I really think that healthcare is
still the number one priority for the American people, and
within that context lowering the costs of prescription drugs is
the biggest priority.
So today we are considering H.R. 3, the Elijah Cummings
Lower Drug Costs Now Act, and other legislation that will
provide much-needed relief to Americans, who are fed up with
the outrageously high prices of their prescription drugs. And I
am pleased we are holding this hearing to highlight once again
why we must act and why H.R. 3 is the comprehensive solution
this country needs to fix our broken market for prescription
drugs.
For too long, Americans have been forced to ration their
medication, go without, or exhaust their life savings in order
to afford the drugs they need, all while large pharmaceutical
companies continue to make record profits. Americans pay three,
four, or 10 times the amount that people pay in other countries
for the exact same drug. And how is that fair? It is not. In
fact, it is outrageous, and it is long past time that we
negotiate a better deal for Americans.
Now, H.R. 3 gives the Secretary of Health and Human
Services the ability to negotiate lower drug prices directly
with drug manufacturers on high-cost prescription drugs that
don't have any competition. The Secretary negotiates lower
prices on behalf of Medicare, but those same lower prices will
be available to all Americans with private insurance.
H.R. 3 also stops unfair and unjustified price increases by
requiring drug manufacturers to pay a rebate if they increase
prices faster than inflation. The bill also caps Part D out-of-
pocket costs for Medicare beneficiaries so they pay no more
than $2,000 out of their own pockets a year for their
prescription drugs.
H.R. 3 provides the reforms we need to lower the cost of
prescription drugs and uses some of those savings to reinvest
in efforts to find the next scientific breakthroughs at the
National Institutes of Health and improve drug review at the
FDA.
And H.R. 3 will save consumers and taxpayers billions of
dollars, and it will lower healthcare costs and premiums while
also improving health outcomes. In fact, the Congressional
Budget Office estimates that because H.R. 3 will reduce drug
prices, the estimated cost of health insurance will also be
reduced, leading to more take-home pay for workers. CBO also
determined that the Medicare program will save $42 billion in
other healthcare expenditures because beneficiaries will be
healthier since they will be able to afford the medicines and
take then as prescribed.
And H.R. 3 will have a tremendous impact on the lives of
everyday Americans, people like Therese Ball, who is going to
testify before the committee today. Her experience, while
unfortunately not unique, encapsulates so clearly why H.R. 3
must become law. The medication Therese relied on to treat her
multiple sclerosis, as she will tell you, wiped out her
savings. Eventually she was forced to stop taking this
medication because of the cost, even though she knew she would
face health repercussions as a result.
I just don't believe that any American should have to
choose between paying for the prescription drugs they need to
stay healthy and other basic necessities like food and rent. As
President Biden noted last week during his Joint Address, it is
long past time that Americans are no longer saddled with higher
drug costs than people in other countries. It is long past time
to negotiate lower prescription drug prices for the American
people, and I look forward to moving H.R. 3 through the
committee once again and for it to become law this year, as the
President suggested.
In addition to negotiation and stopping the inflation of
drug prices, we also know that competition is key to bringing
down costs for Americans. In 2019 alone, patients and the
healthcare system saved more than $300 billion due to generic
and biosimilar competition. So today we are also discussing
several other bills that will increase competition.
And then we will hear from our witnesses today about
finding comprehensive solutions to high drug prices and why
that can no longer wait. So I am pleased that we are
considering all these legislative proposals today.
[The prepared statement of Mr. Pallone follows:]
Prepared Statement of Hon. Frank Pallone, Jr.
Today, the committee is considering the Elijah E. Cummings
Lower Drug Costs Now Act and other legislation that will
provide much needed relief to Americans who are fed up with the
outrageously high prices of their prescription drugs. I am
pleased we are holding this hearing to highlight once again why
we must act, and why H.R. 3 is the comprehensive solution this
country needs to fix our broken market for prescription drugs.
For too long, Americans have been forced to ration their
medications, go without, or exhaust their life savings in order
to afford the drugs they need, all while large pharmaceutical
companies continue to make record profits. Americans pay three,
four, or ten times the amount that people pay in other
countries for the exact same drug. How is that fair? It's not--
in fact, it's outrageous and it is long past time that we
negotiate a better deal for Americans.
H.R. 3 gives the Secretary of Health and Human Services
(HHS) the ability to negotiate lower drug prices directly with
drug manufacturers on high cost prescription drugs that don't
have any competition. The Secretary negotiates lower prices on
behalf of Medicare, but those same lower prices will be
available to all Americans with private insurance.
H.R. 3 also stops unfair and unjustified price increases by
requiring drug manufacturers to pay a rebate if they increase
prices faster than inflation. The bill also caps Part D out-of-
pocket costs for Medicare beneficiaries so they pay no more
than $2,000 out of their own pockets a year for their
prescription drugs.
H.R. 3 provides the reforms we need to lower the cost of
prescription drugs and uses some of the savings to reinvest in
efforts to find the next scientific breakthroughs at the
National Institutes of Health and improve drug review at the
Food and Drug Administration.
H.R. 3 will save consumers and taxpayers billions of
dollars, and it will lower healthcare costs and premiums, while
also improving health outcomes. In fact, the Congressional
Budget Office estimates that because H.R. 3 will reduce drug
prices, the estimated cost of health insurance would also be
reduced, leading to more take-home pay for workers. CBO also
determined that the Medicare program will save $42 billion in
other healthcare expenditures because beneficiaries will be
healthier since they will able to afford their medications and
take them as prescribed.
H.R. 3 will have a tremendous impact on the lives of
everyday Americans. People like Therese Ball, who is testifying
before the Committee today. Her experience--while unfortunately
not unique--encapsulates so clearly why H.R. 3 must become law.
The medication Therese relied on to treat her multiple
sclerosis--as she will tell you--wiped out her savings.
Eventually she was forced to stop taking this medication
because of the cost, even though she knew she would face health
repercussions as a result.
I just don't believe that any American should have to
choose between paying for the prescription drugs they need to
stay healthy and other basic necessities like food and rent.
As President Biden noted last week during his Joint Address
to Congress, it is long past time that Americans are no longer
saddled with higher drug costs than people in other countries.
It is long past time to negotiate lower prescription drug
prices for the American people. I look forward to moving H.R. 3
through the committee once again and for it to become law this
year as the President suggested.
In addition to negotiation and stopping the inflation of
drug prices, we also know that competition is key to bringing
down costs for Americans. In 2019 alone, patients and the
healthcare system saved more than $300 billion due to generic
and biosimilar competition. Today we will also discuss several
other bills that will increase competition.
As we will hear from our witnesses today, finding
comprehensive solutions to high drug prices cannot wait any
longer. That is why I am pleased we are considering the
legislative proposals before us today.
Thank you, I yield back.
Mr. Pallone. And I would like to yield now a minute to the
gentleman from Oregon, Kurt Schrader.
Mr. Schrader. Thank you very much, Chairman Pallone, for
the time to speak today in favor of a couple of bills I have
here before the committee. The BIOSIM Act is a commonsense
approach to increase the utilization of biosimilars in this
country. As we will hear today, biologic injectable drugs are
very expensive. Increasing the use of generic biosimilar forms
will decrease patient costs.
The BLOCKING Act is also a market-based reform to ensure
generic competition in the drug marketplace to decrease costs
to patients. In the current system, some generic manufacturers
delay bringing their drugs to market by ``parking'' their
applications once being awarded exclusivity. Doing so blocks
other generic drugs that are actually ready from coming to the
market, and delays these less-expensive drugs from reaching our
patients.
The rising cost of drug prices is deeply impacting all
Americans. It is time to move forward with policies that have
broad support.
And I yield back.
Ms. Eshoo. The gentleman yields back. I thank him for his
work.
I would just add a source of pride to me is that I was the
author of the biosimilars legislation. So thank you.
The Chair now recognizes the ranking member of the full
committee, Representative Cathy McMorris Rodgers, for your 5
minutes for an opening statement.
OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mrs. Rodgers. Thank you, Madam Chair, and to our witnesses
for joining us today.
The story of American innovation is one that should be
celebrated, bringing hope and early access to the most
lifesaving, life-changing treatments in the world. In the case
of Khrystal Davis, who will share her story today, it saved her
son's life after doctors diagnosed him with spinal muscular
atrophy with no chance of survival.
Khrystal and parents like her who have a child with a rare
disease, they are fighting for the promise, for the next life-
changing cure and treatment. I am certain that we have all
heard stories before from caregivers and patient advocates like
Khrystal. We have listened to people who want a fighting chance
at life.
That fighting chance came with the American way, freedom
and opportunity. Take Alzheimer's, for example. We need major
breakthroughs to transform how we treat this disease and slow
its progression. It would lift one of today's biggest costs and
care burdens on both families and our healthcare system. It is
more than just hope. Whether it is a rare disease like SMA,
cancer, or Alzheimer's or another dementia, new cures and
treatments are a very real possibility if we can protect and
spur the private investment for more discoveries.
That brings me to Speaker Pelosi's government price-control
scheme before us today. It is a false choice, forcing us to
jeopardize cures and breakthroughs in the name of saving money.
According to CBO experts and others of the Speaker's own
colleagues, it would result in dozens of fewer cures.
Last Congress the White House Council of Economic Advisors
said it would lead to as many as a hundred fewer drugs over the
next decade. What could one of these cures or treatments mean?
We don't know. But we know that if this becomes law, we would
lose hope to cure cancer or treat generic conditions. We would
become more reliant on China.
And then, if those discoveries are even made at all, we
would be reliant on a Federal bureaucrat, someone in
Washington, DC, to let us have it, like in Canada, the U.K., or
other countries. The power would rest with the Federal
Government to crudely measure lives in dollars and cents.
I just heard about a family in Canada. They have two boys,
both with cystic fibrosis. Their 10-year-old has his
medications. For their younger son, they are forced to
painfully beg the government for his treatment. At first the
government just said no. Now they are being told their 8-year-
old son must drop 20 percent of his lung function within a 6-
month period.
The mom said he has to become really sick to qualify. She
said, ``I compare it to waiting for a person to go on a
ventilator before you give them the COVID vaccine, or waiting
for a person to reach stage 4 cancer before you treat them with
chemo.'' There is nothing just about a system like this. It
discriminates against people with disabilities and chronic
illnesses.
The preexisting conditions--those with preexisting
conditions. The National Council on Disabilities has warned us
about the approach that is laid out by Speaker Pelosi that is
harmful. It is discriminatory. And it will be harmful on the
most vulnerable.
Unfortunately, this is the socialist healthcare system and
the future that Speaker Pelosi is imposing upon us. Instead of
price controls, we should focus on areas for bipartisan work.
We agree seniors and patients are paying too much out of
pocket. Let's address that.
We have seen the benefit of innovation in the fight against
COVID-19. Now more than ever we should be working together on
American solutions, uniquely American solutions that save
lives, lower costs, and uphold the dignity and the right of
every person to live a full life. Energy and Commerce can lead
the way. We have plowed the hard ground with the bipartisan
proposals in the Lower Costs, More Cures Act to build unity,
deliver results.
President Biden signed three of these provisions already
into law this year. President Trump signed 16 into law last
Congress. Let's not let Speaker Pelosi's government price-
control scheme jeopardize the work to lower seniors' out-of-
pocket costs. Let's do what is right for moms like Khrystal,
representing millions of moms, not just for hope but for real
lifesaving solutions, too.
And with that, I yield back.
[The prepared statement of Mrs. Rodgers follows:]
Prepared Statement of Hon. Cathy McMorris Rodgers
INNOVATION
Thank you, Madam Chair ... and to our witnesses too for
joining us.
The story of American biomedical innovation is one that
must be celebrated.
It's brought hope and early access to the most treatments
in the world.
In the case of Khrystal Davis--who will share her story
today--it saved her son's life after doctors diagnosed him with
Spinal Muscular Atrophy with no chance at survival.
Khrystal and parents like her who have a child with a rare
disease ...
... they are fighting for the promise for the next game
changing cure and treatment.
STORIES
I'm certain that we have all heard before from caregivers
and patient advocates like Khrystal.
We've listened to people who want a fighting chance at
life.
That fighting chance comes with America leading.
Take Alzheimer's, for example.
We need major breakthroughs to transform how we treat this
disease and slow its progression.
It would lift one of today's biggest cost and care burdens
on both families and our healthcare system....
It's more than just hope.
Whether it's a rare disease like SMA ... cancer ...
... or Alzheimer's or another dementia ...
... new cures and treatments are a very real possibility IF
we can protect and spur the private investment for more
discoveries.
PRICE CONTROLS
That brings me to H.R. 3, Speaker Pelosi's government price
control scheme before us today.
According to the Congressional Budget Office, experts, and
even the Speaker's own colleagues--it would result in dozens of
fewer cures.
Last Congress, the White House Council of Economic Advisers
said it could lead to as many as 100 fewer drugs over the next
decade.
What could one of these be a cure or treatment for? We
don't know.
What we do know is, if H.R. 3 becomes law ...
... we'd become more reliant on China ...
... we'd lose hope to cure cancer or treat genetic
conditions.
And then--if those discoveries are even made at all--we'd
be relying on a bureaucrat to let us have it.
Like in Canada, the U.K., and other countries ...
... the power would rest in the government to crudely
measure lives in dollars and cents before politicians decided
whether a cure is ``worth it.''
CANADA
I just heard about a family in Canada. They have two boys--
both have cystic fibrosis.
Their 10-year-old has his medications.
For their younger son, they're forced to painfully beg the
government for his treatment.
At first the government just said ``no.''
Now, they are being told their 8-year old son must drop 20
percent of his lung function within a six-month period.
The mom said he has to become really sick to qualify:
She said:
``I compare it to waiting for a person to go on a
ventilator before you give them the COVID vaccine or waiting
for a person to reach stage 4 cancer before you treat them with
chemo.''
[pause]
She's right. There's nothing just about a system like this.
It discriminates against people with disabilities and
chronic illnesses--which are pre-existing conditions.
Unfortunately, this is the socialist system and future
Speaker Pelosi is asking for.
OUR SOLUTION
Instead of price controls ...
... we should focus on the areas for bipartisan work.
We agree seniors and patients are paying too much out of
their own pocket.
Let's address that.
... like we do in H.R. 19, the Lower Costs, More Cures Act.
Let's put a cap on seniors' out-of-pocket costs and make
the Medicare drug insurance program look more like an insurance
program to protect them against catastrophic costs.
But what we cannot afford to do is empower China and
sacrifice innovation to superficially address the list price of
drugs.
CONCLUSION
We've seen the benefit of innovation in the fight against
COVID-19.
Now more than ever, we should be working together on
uniquely American solutions to save lives, lower costs, and
uphold the dignity and right of every person to live a full
life.
Energy and Commerce can lead the way.
Republicans have plowed the hard ground in H.R. 19, the
Lower Costs, More Cures Act, to build unity and deliver
results.
President Biden signed 3 provisions from this already into
law.
President Trump signed 16 into law last Congress.
Let's not let Speaker Pelosi's government price control
scheme jeopardize work to lower seniors' out of pocket costs.
Let's do this right for moms like Khrystal--not just for
hope, but real lifesaving solutions too.
Ms. Eshoo. The gentlewoman yields back.
The Chair reminds Members that, pursuant to committee
rules, all Members' written opening statements will be made
part of the record.
I now would like to introduce our witnesses.
First, Ms. Therese Ball is a registered--is a retired
registered nurse from Ogden Dunes, Indiana. She is a multiple
sclerosis patient and a Medicare beneficiary. Welcome, and
thank you for testifying today.
Mr. Michael Carrier is a distinguished professor of law
from Rutgers Law School. And we welcome you back to the
subcommittee, Mr. Carrier. Thank you.
Dr. Gaurav Gupta is the founder of Ascendant BioCapital.
Welcome to the committee, and thank you for being with us.
Ms. Khrystal Davis is a rare disease caregiver, a patient
advocate, and the founding president of the Texas Rare
Alliance. Welcome and thank you to you.
And last but not least, Ms. Rachel Sachs. She is an
associate professor of law at Washington University in St.
Louis. And that is the school of law. Welcome to you, and thank
you for being with us.
So Ms. Ball, you are recognized for 5 minutes. Please
remember to unmute. And thank you again for being willing to
testify before our subcommittee today.
STATEMENTS OF THERESE BALL, PATIENT; MICHAEL A. CARRIER,
DISTINGUISHED PROFESSOR, RUTGERS LAW SCHOOL; GAURAV GUPTA,
M.D., FOUNDER, ASCENDENT BIOCAPITAL; KHRYSTAL K. DAVIS,
FOUNDING PRESIDENT, TEXAS RARE ALLIANCE; AND RACHEL E. SACHS,
ASSOCIATE PROFESSOR, SCHOOL OF LAW, WASHINGTON UNIVERSITY IN
ST. LOUIS
STATEMENT OF THERESE BALL
Ms. Ball. Chairwoman Eshoo, Ranking Member Guthrie, and
members of the committee, thank you for the opportunity to
share my story. My name is Therese Ball, and I am a proud
grandmother and retired registered nurse from Ogden Dunes,
Indiana. I am here as a person living with multiple sclerosis,
a Medicare beneficiary, and a patient advocate.
I have dedicated my life to taking care of patients.
Because of my nursing training, I have provided medical care
and alleviated suffering for thousands of patients. But nursing
school did not prepare me for the suffering I saw when my
patients could not afford needed treatment.
I had a front row seat to the horrifying reality of our
drug pricing system. Drugs don't work if people can't afford
them. I never thought I would be one of those struggling
patients until 2003, when I was diagnosed with MS and
prescribed a medication called Copaxone. Let me tell you about
Copaxone.
The drug came to market in 1997 at a price of $769 a month.
Today that same monthly supply costs $7,114, almost 10 times
higher. The drug company that makes it, Teva, accomplished this
by hiking the price 27 times over two decades. This pattern was
not mirrored in other countries. By 2015, the price of Copaxone
was, on average, five times higher in the United States than in
other comparable nations.
I faced these prices firsthand when I began taking
Copaxone. It cost me $1,800 a month. And within a year, it
completely wiped out my savings. It was devastating.
Fortunately, I was able to find a grant from an independent
charity, but I lived in fear that I might lose access.
That day came in 2017 when the foundation did not renew my
grant. At that point, Copaxone had increased in price to $6,000
a month. I was completely overwhelmed by this price tag, and no
matter how many times I crunched the numbers, I couldn't make
it work. So I made the terrifying decision to go without the
drug.
The health consequences were immediate and severe. I lost
my memory, and my quality of life suffered tremendously. My
family began making preparations for when I no longer would be
able to walk or live independently. Eventually my doctor
switched me to an infusion that I am fortunate to be able to
afford through Medicare.
But MS is a progressive disease, and I know I will continue
to need different and likely very expensive medications. And
one day I hope there will be a cure for MS, which is why I
understand the importance of innovation. Drug companies have
taken this idea of innovation, this hope, and turned it into an
ultimatum for patients.
They say we must let them charge whatever prices they want
or we can say farewell to future cures. But that is a false
choice. Expert research has demonstrated that brand-name drug
companies could lose $1 trillion in sales over 10 years and
still be the most profitable industry in the United States.
Drug companies spend billions each year on TV ads and
lobbying. They can more than afford to cut prices while
maintaining their investment in research and development. We do
not have to settle for a false choice. We can have more
affordable drugs and meaningful innovation at the same time.
Affordable drugs are more important now than ever. The
COVID-19 pandemic has not just devastated the financial well-
being of millions of people, it also continues to increase the
number of people with chronic disease who will now rely on
expensive medications. I know this because last year I had
COVID-19. The infection was so destructive to my lung tissues
that now I have to take an expensive inhaler called Breo,
adding to my already steep monthly drug cost.
Members of the committee, today you are considering a bill
called H.R. 3. This bill would end the ban on Medicare
negotiation and help beneficiaries like me by instituting a cap
on what we pay out of pocket. In addition, the lower prices
achieved through negotiation would be extended to everyone,
regardless of what insurance they have.
Today you have an opportunity to bring relief to me and
millions of other Americans struggling to afford our needed
medications. As you consider this legislation, please remember
our stories. I can't control my disease or change that I have
MS. But telling you my story and advocating for lower drug
prices is something I can control.
Thank you, and I urge you to vote in support of H.R. 3.
Patients have waited long enough.
[The prepared statement of Ms. Ball follows:]
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Ms. Eshoo. Thank you, Ms. Ball, for being with us to tell
your story.
Mr. Carrier, thank you again for being with us. You are now
recognized for your 5 minutes of testimony.
STATEMENT OF MICHAEL A. CARRIER
Mr. Carrier. Great. Thank you so much, Chairwoman Eshoo,
Ranking Member Guthrie, members of this subcommittee.
Drug prices are too high, and one main reason why is that
brand companies play all sorts of games to delay generic entry.
Today I am going to focus my comments on two: pay-for-delay
statements and citizen petitions. This conduct makes no sense
at all other than harming the generic, and if there were
legislation that would pass, it would not affect innovation at
all, but it would make consumers' lives better.
My name is Michael Carrier. I am a distinguished professor
at Rutgers Law School, where I focus on the intersection of
antitrust and intellectual property. Coauthor of the leading
treatise in the field on antitrust and IP. I have written 130
articles on this, and I have frequently filed briefs with
courts.
So the first type of conduct that this subcommittee can
address is pay-for-delay settlements. Sometimes a brand company
pays a generic to stay off the market. Now, in 2013 the Supreme
Court, in a case called FTC v. Actavis, said that these
settlements could have anticompetitive effects and could
violate the antitrust laws.
So after that decision, we saw that the number of pay-for-
delay settlements went down. But there still are pay-for-delay
settlements, and the parties still have every interest to muddy
the waters, to raise arguments that were rejected in Actavis,
and to try to continue to engage in these settlements.
And so the legislation at issue here, H.R. 153 and H.R. 19,
would address these real problems. First, it would allow the
FTC to bring these cases in court. It is very hard, when the
brand companies pay the generic not in cash but in these
increasingly complicated deals, for the FTC to figure that all
out. So this takes years and years and costs millions of
dollars in litigation. And so first, in order to give the FTC a
chance to win this stuff in court before a decade or two goes
by, the legislation would be incredibly helpful.
And second, the legislation would fix some of these
judicial mistakes. Sometimes courts don't apply Actavis the way
that they were supposed to. Sometimes they fail to recognize
payment. And sometimes they say that entry before the end of
the patent term is automatically OK, even though the Supreme
Court explicitly rejected that argument in Actavis. And so the
second reason why settlement legislation is so important is to
fix some of these mistakes in the court.
So at the end of the day, I am a big supporter of H.R. 153
and H.R. 19, which would make patients' lives better without
touching innovation.
Second, I would like to talk about citizen petitions.
Citizen petitions are designed to raise legitimate safety
concerns with the FDA, but in reviewing every petition filed
between 2001 and 2015, I found that most of these petitions
actually are filed just to delay the generic. And the FDA
actually denies most of these, 92 percent of them, 98 percent
at the last minute. These petitions are filed just to delay
generic competition.
So what can this committee do? H.R. 2387, the STOP GAMES
Act of 2019, would provide at least four benefits in stopping
these frivolous citizen petitions.
First, it would make sure that the FDA has a summary
disposition power to get rid of these frivolous petitions
without spending so much time on them. Technically they have
the power right now, but it is so difficult to satisfy that the
FDA has never used the power at all. And so opening that up, as
this legislation does, would be an excellent start.
Second, it sheds light on what a primary purpose of delay
is. When you look at all these petitions and you see the
recurring themes of delay petitions and repetitive petitions
and ones filed at the last minute, you see a bunch of themes.
And, so if you take all of those facts and weave them into the
primary purpose of delay, then that helps all parties in
stopping this conduct.
Third, there is a time limit. You can't find out about this
petition and then wait for 5 years, as Mylan did with an EpiPen
citizen petition. You have to file it within a finite period of
time.
And fourth, there is more information that the FDA needs to
provide to Congress. So when you think about the fact that we
don't know--the petitions that are filed, how much delay
actually happens from these petitions--more information into
this flat box will be incredibly helpful.
So at the end of the day, the legislation on pay-for-delay
settlements and citizen petitions would not touch innovation in
the slightest, but it would make consumers' lives better.
Thank you very much.
[The prepared statement of Mr. Carrier follows:]
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Ms. Eshoo. Thank you, Mr. Carrier.
The Chair is now pleased to recognize Dr. Gupta. Thank you
for being with us. You are now recognized for your 5 minutes
for your testimony.
STATEMENT OF GAURAV GUPTA, M.D.
Dr. Gupta. Chairwoman Eshoo, Ranking Member Guthrie, and
members of the committee, thank you for the opportunity to
testify today on H.R. 3 and the deleterious effect it would
have on biopharma innovation and on patients.
Let there be no doubt that we are living at the dawn of a
golden age of therapeutic innovation. The first FDA approvals
of oligonucleotide, bi-specific, oncolytic virus, CAR-T and AAV
and lentiviral gene therapy all took place within the last
decade.
Novel small molecule drugs have cured thousands of
Americans of hepatitis C, added decades to the lifespan of
patients with cystic fibrosis, and positively impacted the
lives of patients with sickle cell disease, while
immunotherapies have transformed the lives of patients with
cancer. Promising technology such as targeted protein
degradation and gene editing are perhaps not far behind. Future
rewards will be greater still if we preserve our current system
of incentivizing innovation.
America is the global epicenter of accelerated drug
development. Fifty-seven percent of all new medicines are
invented by U.S. companies. The bulk of the remainder are
developed by foreign companies in and for the U.S. market.
indirect benefit of this is that most novel therapeutics
undergo clinical development and early commercial launch here
in the U.S. The rest of the world understands that the American
patient has earlier and broader access to groundbreaking third
parties via these mechanisms.
The scientific literature is unequivocal about the improved
health outcomes generated from pharmaceutical purchasing. The
1.4 percent of GDP we currently spend on branded medications
incentivizes future research and development and ensures that
the global center of gravity of the pharma industry remains
here in the U.S., where our citizens can enjoy the fruits of
early access. On top of that, the biopharma industry's economic
output in 2017 was estimated at $1.1 trillion, and the sector
employed over 800,000 workers, one-third in key STEM
occupations.
It is undeniable that our healthcare system does not
equally distribute innovations, with high out-of-pocket costs
presenting barriers to medication access for many Americans.
Insurance companies, pharmacies, and pharmacy benefit managers,
PBMs, all sit between the medication and the patient who needs
it. incredibly confusing system of discounts and rebates
obscures how much money goes to manufacturers and how much goes
to middlemen.
Actions to improve access to medications and reduce out-of-
pocket costs for patients are long overdue. We can achieve
these goals while preserving America's unique capacity for
innovation.
I would like to contextualize pharmaceutical spending to
other cost drivers in the healthcare system. The growth in
overall national health expenditure is predominately attributed
to hospital spending. Branded drugs account for only 8 percent
of the total. Our expenditure on prescription drugs encompasses
not only what is paid to pharma companies but also what is paid
out of the system to middlemen.
I would submit to the committee that a good-faith effort to
meaningfully curb healthcare spending demands addressing both
the largest drivers, hospitals, and hidden costs, the
prescription drug middlemen.
In the context of prescription drugs, the very existence of
out-of-pocket costs doesn't make sense. No patient gets a
medication without a doctor prescribing it, and often insurance
plans require that the doctor seek explicit prior
authorization. It doesn't follow that insurance companies
haven't agreed that a patient needs a particular medicine based
on FDA labeling for that product, then ask a patient to put
skin in the game by paying a portion of the cost. They have
skin in the game: their disease.
Insurance reforms that tap or even eliminate out-of-pocket
costs, not just in Medicare Part D but also for Americans who
receive coverage from their employers through healthcare
exchanges and other types of health plans, would be a high-
impact step toward ensuring broad access.
The critical flaw of H.R. 3 is that it conflates drug
prices and patient out-of-pocket costs. Importing foreign
pricing would only marginally reduce what patients with high-
deductible plans, including Medicare, are forced to pay. It
wouldn't solve their problem. What it would do is dramatically
underline the ability of American biotech companies to develop
innovative medicines that could treat and cure innumerable
diseases in the future.
I would like to conclude with a point about American
competitiveness. The ability for parts of today's hearing to
take place in person was made possible by the whirlwind
development of vaccines and monoclonal antibodies for COVID-19,
and this innovation capacity out to be a source of national
pride.
My perception as a biotechnology professional is that other
countries are eager to siphon our pharmaceutical prowess,
particularly China, which has made biotech a strategic pillar.
In 2016, the market capitalization of all Chinese biopharma
companies was $1 billion. Only 5 years later, the combined
market capital of Chinese biopharma companies is north of $20
billion. In 2019, for the first time ever, a drug developed in
China was approved by the U.S. FDA.
When I speak to Chinese biotechnology executives and
Chinese physicians, they boast that they can run clinical
trials faster than their U.S. counterparts. The danger of H.R.
3 is that it will effectively drive biotech innovation to
China. If we close up the market in the U.S. while China is
opening their market to innovative new products, we will see
companies launching impactful, novel medicines in China based
on critical trials conducted in China.
In order for patients to be able to buy American, we have
to protect America's capacity to be a home for innovation.
Let's continue to nurture this important work on our soil.
Thank you.
[The prepared statement of Dr. Gupta follows:]
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Ms. Eshoo. The gentleman yields back, and we thank you for
your testimony.
The Chair now recognizes Ms. Davis for your 5 minutes of
testimony, and we thank you again for being with us.
STATEMENT OF KHRYSTAL K. DAVIS
Ms. Davis. Chairwoman Eshoo, Ranking Member Guthrie, and
distinguished members, I am privileged to be here today as a
rare-disease parent, caregiver, and patient advocate to share
my perspective and represent the 1 in 10 Americans affected by
more than 7,000 rare diseases.
I founded Texas Rare Alliance to improve access and health
outcomes for nearly 3 million Texas rare-disease patients. That
is a large number, and it is correct. More Americans have a
rare disease than HIV, heart disease, or stroke combined, and
95 percent of rare diseases lack an approved treatment. We know
what happens to patients in other countries referenced by H.R.
3. They get worse access to treatments because the lives of
people with rare diseases and disabled people are undervalued.
In 2011, our newborn son lost nearly all movement at 2
weeks of age. At one point, my husband asked if I had shaken
Hunter. I could never hurt out baby, but he was hurting. When
doctors diagnosed our newborn with SMA, our world changed
forever.
SMA is like ALS in babies. It robs the ability to move,
swallow, and ultimately breathe, and is the number-one genetic
cause of death for infants. Doctors told us there was no
treatment and no hope, but we couldn't afford to listen. The
stakes were too high.
With the help of a researcher, we manufactured a compound
in the U.S. and took it to Mexico for a trial. Eight weeks
after his diagnosis, Hunter was the first SMA patient to
receive a lifesaving treatment. Nearly 5 years later, Hunter
and his friend Ben started the Spinraza expanded access program
together. Soon after, the FDA approved Spinraza, the first SMA
treatment.
Upon FDA approval, insurers developed policies for
Spinraza. Both Hunter and Ben were insured by United. Hunter
met the Spinraza inclusion criteria. However, Ben failed to
meet it because he depends on a machine to breathe for him.
Ben's mom, Melissa, and I cried. She asked why Ben wasn't worth
saving too. Ben was worth saving, but I couldn't change the
policy.
Biogen covered Ben in a patient assistance program until he
secured a Medicaid waiver, providing Spinraza. ICER evaluated
Spinraza, scoring SMA patients a .2, determining its cost was
not effective. We are already advocating against the use of
ICER's QALYs. Adopting reference pricing that incorporates
discriminatory qualities undermines our advocacy efforts.
We know CBO scored H.R. 3 assuming the use of QALYs to set
prices relied on by foreign countries. The NCD shared their
concerns with the committee on H.R. 3 and its implications for
discrimination. At one point during the pandemic, we moved back
to our St. Louis home after learning of QALY-based medical
rationing in Austin. We knew St. Louis Children's Hospital
valued Hunter and worked to save his life many times.
This should provide some context for why I oppose H.R. 3.
The burden studied by the EveryLife Foundation found indirect
and nonmedical costs accounted for nearly 60 percent of overall
costs to rare-disease families, with prescription medications
accounting for only 10 percent. We can't expect to address
affordability if we are focusing on such a small percentage of
the problem.
Rare-disease parents work hard to keep our children alive.
We become medical experts, providing standard of care at home
exceeding care at hospitals. That is not a smug statement. When
our children are in the hospital, we don't leave their side. We
know the standard of care for their rare disease, and we know
if the hospital follows the protocol for a child with typical
health, our children would be harmed and might not survive.
We manage machines that feed, breathe for, or monitor our
babies and children. We give them medicine and do their
treatments. We don't get time off, because the rare diseases
our children fight against never take time off. Doctors tell us
there is no hope, but we have more than hope. We have
unconditional love for our children, and we refuse to give up
on them. We value every breath they take, and we dare not take
a single breath for granted.
H.R. 3 would also greatly reduce research and development
of rare-disease treatments. We don't see approvals coming from
those countries. They are innovation deserts, a cruel place
when you need innovative treatments to survive.
Research and development are the stuff dreams are made of.
We hold bake sales, runs, parties, and pretty much anything we
can think of to fund research. The thing is, our funds only get
researchers so far. Without follow-on funding from the NIH,
biotech companies, or biopharmaceutical companies, the research
stalls.
At the current pace, it will take thousands of years to
secure treatments for all rare diseases. Meanwhile, a third of
children with rare disease will not survive to their fifth
birthday. Research for rare diseases can move with the same
relentless urgency as COVID-19 research. We must respect and
value the lives of medically fragile, disabled, and elderly
individuals.
We cannot afford to stop opposing H.R. 3. We refuse to save
our children only to have a system adopt qualities that give up
on them.
Thank you.
[The prepared statement of Ms. Davis follows:]
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Ms. Eshoo. Thank you very much, Ms. Davis.
The Chair now recognizes Ms. Sachs for your 5 minutes for
testimony. And thank you again for being with us.
STATEMENT OF RACHEL E. SACHS
Ms. Sachs. Thank you. Chairwoman Eshoo, Ranking Member
Guthrie, and other distinguished members of the Health
Subcommittee of the House Committee on Energy and Commerce. My
name is Rachel Sachs, and I am an associate professor of law at
Washington University in St. Louis, where my research focuses
on innovation and access to new pharmaceuticals.
Thank you for the opportunity to testify before you today
about the high prices of prescription drugs and how this
committee might help solve these problems. My testimony will
explain why comprehensive prescription drug pricing reform
should include three types of policy solutions.
First, reform should lower patients' out-of-pocket costs.
Second, reform should fix misaligned incentives and our
existing pharmaceutical pricing system. And third, reform
should address the underlying problem of high drug prices.
There is no single way to accomplish each of these three
goals, and different countries have chosen different answers to
each of them. But H.R. 3 pulls all three of these policy levers
to lower drug prices. Other congressional proposals do not.
Today, prescription drug prices in the United States are
high and rising. Individual drug prices are rising. Between
2018 and 2019, pharmaceutical companies raised their list
prices on half of all Part D drugs faster than inflation.
Systemwide spending is also rising. Between 2007 and 2017, Part
D spending rose from 46.2 to 79.9 billion. Part B spending rose
from 15.4 billion in 2009 to 35 billion in 2018.
These dynamics create challenges for patients. About one in
four people report difficulty affording their medication, and
they may respond by rationing their medication or by delaying
filling prescriptions. Patients have died as a result of these
impossible choices. A large bipartisan majority of Americans
believe that prescription drug costs are unreasonable.
This committee has an important role to play in responding
to the problem of high prescription drug prices in three key
areas.
First, limiting patients' out-of-pocket costs is necessary
to relieve the financial pressures facing many patients. Today
there is no cap on Medicare Part D beneficiaries' out-of-pocket
costs, and 1.1 million Part D beneficiaries have out-of-pocket
spending above the catastrophic threshold. H.R. 3 addresses
this problem by imposing a cap on Part D out-of-pocket costs.
This committee might also consider additional policy
reforms to accomplish this goal. For instance, as the National
Academy has recommended, Congress might authorize CMS to limit
patients' cost-sharing for classes of drugs or treatment
adherence to reduce total case costs.
Proposals in this category would help millions of patients
who have difficulty affording their medication. But lowering
patients' out-of-pocket costs in isolation could even increase
financial burdens on other patients and on Medicare. So these
reforms ought to be paired with others which would directly
address prescription drug prices.
Second, our existing system for paying for prescription
drugs waives incentives for actors to drive prices up rather
than down over time. H.R. 3 includes two key elements to fix
these misaligned incentives. It requires drug manufacturers who
raise the prices of their drugs more rapidly than inflation to
pay rebates back to Medicare, as Medicaid already requires. And
its Part D benefit redesign gives both manufacturers and Part D
plans greater incentives to manage price and formulary designs.
There are many other examples of incentives this committee
should consider addressing, including some of the often
criticized business practices of pharmacy benefit managers.
These attempts to address misaligned incentives are important,
but they would not fundamentally address the underlying high
prices of these drugs either. So, third and finally, this
committee should consider reforms that would strengthen
Medicare's negotiating authority and increase the likelihood
that our public payers can obtain fair prices for these
products.
H.R. 3 addresses this issue by providing the Secretary of
HHS the authority to negotiate with the manufacturers of select
high-priced drugs. To facilitate this negotiation, H.R. 3 uses
international reference pricing, creating an average
international market price across six countries as the basis
for a target fair price in negotiations.
There are many different ways of constructing an effective
drug price negotiation system, and H.R. 3 offers just one
potential example. Several of the countries included in H.R.
3's market basket provide examples of this and other
approaches.
This committee has the ability to help solve the problem of
high drug prices not only for patients but also for our public
payers. Chairwoman Eshoo, Ranking Member Guthrie, members of
the committee, I am appreciative of your focus on this
important issue, and I look forward to answering your
questions.
[The prepared statement of Ms. Sachs follows:]
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Ms. Eshoo. Thank you very much for your testimony. And now
we are going to move to Member questions, and I will recognize
myself for 5 minutes for mine.
First, to Ms. Ball, thank you for being willing to share
your story. It is a very powerful one, as well as your work as
a registered nurse. In your testimony you said that the MS
drug, Copaxone, went from costing you $1,800 a month to $6,000
a month.
Ms. Ball. Yes.
Ms. Eshoo. Was there any innovation that changed that drug
between 2003 and 2017 to account for the price change?
Ms. Ball. No. Actually, there was no innovation. What had
happened was they raised the price 27 times. But what they did
was they had a new one brought out in 2014. So usually with
Copaxone you do seven injections, right, one a day. They
brought a new one out that was the 40 milligram, and what it
did was it made it easier. You only did it three times a day.
Ms. Eshoo. I see.
Ms. Ball. So it [inaudible] the physicians and to the
evidence.
Ms. Eshoo. Right. Excuse me. Were there other countries
that saw comparable price hikes to that drug during that time?
Do you know?
Ms. Ball. Yes. But they pay less than we do, even with
that, because they negotiate on their drugs.
Ms. Eshoo. I see. Is Copaxone your only option? Does it
have any market competition?
Ms. Ball. It really doesn't. The only thing it had was, is
that when it came up to do the 40 milligrams, they were
starting to lose their abilities to patent it and everything.
So that is why they redid it. It did not change anything.
Ms. Eshoo. I see.
Ms. Ball. There is no evidence that it improved. And it
also----
Ms. Eshoo. OK. Thank you.
Dr. Gupta, thank you again for being with us today. I would
like to ask you the following question. You have heard Ms.
Ball's story. It is a powerful one. It covers a range of issues
relative to pricing, a drug that has no competition, the price
hikes over X number of years and how that has impacted her
life. It is a story of many people in our country.
Specifically, what can you say to her? I mean, you hold
your view, which I respect. But what would you say to Ms. Ball?
What do you have to offer to her?
Dr. Gupta. Thank you, Congresswoman. And Ms. Ball, I was
moved by your story, of course. I would--I am a physician as
well as a biotechnology investor, and I can assure you that
having moved over to the biotechnology industry, I am impressed
every day with the passion and tenacity of the folks in our
industry and their commitment to patients first and foremost.
And at the core or everything we do, we know patients are
waiting. And that is why it is frustrating when patients don't
have access to drugs. And Ms. Ball, from my understanding, the
out-of-pocket costs were particularly a barrier for you, and I
think that, from our perspective, we agree there.
I mean, we--the data is unequivocal. Just a $10 increase in
out-of-pocket costs by insurers has been shown to increase
mortality by 33 percent for some patients. And these are easy
fixes. And I would say that we can find common ground and make
it easier to access medications for all patients.
Ms. Eshoo. OK. We all have limited time, and I appreciate
your directing some of your comments to her.
To Ms. Sachs, as a lawyer, are there any provisions in H.R.
3 that would keep Medicare from continuing to cover all the
drugs that it does today? And are there any provisions, in your
view, in H.R. 3 that would limit patient choices?
Ms. Sachs. Thank you for the question. This is such an
important one. And as you know, access is at the heart of H.R.
3. By making it easier for patients to afford their
medications, it would increase access to them. And nothing in
H.R. 3 disrupts any of Medicare's requirements to cover drugs,
including any of its protected classes.
I also want to make a very brief clarification about what
we mean when we talk about access. What we mean is that a
pharmaceutical company would rather pull their drug from the
American market than charge us the same prices, or even a
premium, that they are already charging in other countries, and
at which we know they make a profit.
So when we talk about access, we are talking about choices
that the pharmaceutical company is making, not Medicare.
Ms. Eshoo. Thank you. I think my time has just about
expired. And a reminder to all of the witnesses that Members
will have the opportunity to submit questions to each one of
you, written questions, and we ask that you respond and answer
them in a reasonable time frame.
So the Chair will now recognize--let's see. I think that I
am going to recognize, per our agreement, Mr. Guthrie, to
recognize Mr. McKinley. And welcome to the subcommittee, Mr.
McKinley, and you have 5 minutes to ask your questions. And we
hope and pray that your wife's surgery--that is my
understanding--goes well.
Mr. McKinley. Thank you. Thank you, Anna, and thank you for
the chance--the opportunity--this chance here, for you to give
me the chance to get back to the hospital to be with her.
Ms. Eshoo. Certainly.
Mr. McKinley. And for Ranking Guthrie, I appreciate it.
Look. We all know there is a need for drug pricing reform.
I don't think there is any one of us who would be arguing
against that. But pursuing this highly partisan H.R. 3 is just
an example of overreach, unfortunate overreach, that occurs too
often in Washington, and it gets in the way.
All the observers that I have read about in Washington in
the press are saying that H.R. 3 is not going to pass the
Senate. So I have got to say, fundamentally, why are we doing
this? Why aren't we working together to try to pass something
that can be signed into law?
So there are bipartisan solutions that were included in
H.R. 19. So, unless we change the course of this projection of
this legislation, we know how the story is going to pan out. We
have seen it before in immigration. We are about to see it in
the infrastructure bill again--overreach on that--and we are
seeing it now in this drug pricing.
These are all bipartisan issues that we would all work
together on if we focus on what we need to get done, focus on
those. But that is not what is happening with this. Look. We
were here to get solutions to it, and I really want to get to
it.
H.R. 3, unfortunately, is an overreach, and unfortunately
it gives me the impression, for those in the package, that
Congress is seemingly willing to let American patients suffer.
This is a high-stakes political game we are in here right now,
and if the Senate doesn't pass it and it doesn't get to the
President's desk for signature, the American public is going to
suffer.
I think they deserve better. H.R. 19 includes caps for
insulin deductibles. It passes on rebates directly to State
Medicaid programs, ensuring that PBMs do not profit off
government programs. And it makes it unlawful for pay-for-delay
practices whereby drug companies enter agreements with generics
and biosimilar manufacturers to delay a competing drug coming
to market.
These are all obvious. These are just a sampling of the 40
bipartisan bills that we already passed out of our committee.
So we know the loser here is going to be the American public if
we don't get a bill to the President's desk for signature.
So I would add, with--my question is now: We know that
utilizing generic medications is one of the best ways to lower
drug pricing. But PBMs and Part D plans are not covering
generics. And this practice costs seniors $4 billion, insurance
costs, $4 billion annually.
So Ms. Sachs, in your testimony you discuss some of these
issues about the formulary designed in Part D. The current
system incentivizes--places an entire cost, drug brand prices,
over generics. And in the bill that I am working with Kuster
about, 2846, addresses this issue by ensuring it would lower
the price.
Can you speak more to this issue of formulary design and
how the current trend is leading to increased cost for patients
rather than lowering?
Ms. Sachs. Yes, absolutely. So without going too far into
the details of the Part D benefit design, as this committee is
well aware, the current incentives unfortunately may lead both
manufacturers and PBMs and plans to increase or drive up prices
over time rather than to reduce them.
And so the Part D redesign elements in H.R. 3 and also in
H.R. 19 are important for minimizing some of those incentivize.
However, they only work where there are generic or biosimilar
opportunities available for patients. And in many of these
cases, there are not.
So in my testimony I also give the example of a drug like
Humira, which was first approved in 2002 and has lively
biosimilar competition in Europe but where we still have no
competition today, and won't for another 2 years. Yet it is one
of the top-10-selling drugs in Part D . The idea that we would
negotiate the price of a drug like Humira and be able to obtain
better prices for partners and our payers is at the heart of
H.R. 3, but it is not part of H.R. 19.
Mr. McKinley. If I could, I want to ask a last question to
Dr. Gupta because the United States, we are still--across the
country still experiencing a wave of drug overdoses at a higher
rate than we have ever seen before. So my question, Dr. Gupta:
How would H.R. 3 affect the price and discovery or new
nonaddictive pain medication and treatment, medically assisted
treatments? How would H.R. 3 affect that? Can you share some of
your thoughts?
Dr. Gupta. Thank you, Congressman. Yes. So I think the need
for developing nonopiate, nonaddicting pain medications is one
that the entire biopharma industry is working hard to tackle.
We are aware of both the need for treating pain but also the
need of creating alternatives to opiates.
It is early stages still. There are several things in
development that we don't know if they are going to work yet.
And I would caution that price controls--which, by the way,
don't ensure that we will be passing savings directly on to
patients--would really put a lot of that work on risk.
Mr. McKinley. OK. Thank you. My time is expired. And I just
want to say Anna and Brett, thank you. I want to be with my
wife. So God bless.
Ms. Eshoo. And we want you to, Mr. McKinley. I will keep
her in my prayers. Thank you. Godspeed.
Mr. McKinley. Thank you.
Ms. Eshoo. The Chair now recognizes the chairman of the
full committee, Mr. Pallone, for your 5 minutes of questions.
Mr. Pallone. Thank you, Chairwoman Eshoo.
I am going to get right to a question to Ms. Ball, and then
I am going to try to get a few in to Professor Sachs. I am
trying to ask you if you can limit your remarks.
Ms. Ball, can you tell this committee, in your words, why
Congress must take action to give Medicare the power to
negotiate drug prices, and why this task is so urgent, and how
it will make an impact on the lives of individuals like
yourself who are struggling with the high cost of prescription
drugs?
Ms. Ball. Yes. Thank you for asking. The question you have
asked is how it would help me. It would help me because when
you lower the price of the drugs, then it is more affordable to
people and they will be able to get the drugs with the H.R. 3
that not only takes care of lowering the drug prices--it is
most important because, even though the cap is at $2,000, right
now our Part D drug is $15,000.
So if we can do both, reduce the medication prices and also
maintain the cap, it is going to help us 100 percent. There are
too many people going without because of the fact that it is so
expensive.
Mr. Pallone. Thank you. Now, I think we all recognize that
we must act, and we have to acknowledge it all. But we should
also acknowledge that not all drug pricing legislation is the
same, and not all policies are equally effective. There are a
number of proposals we are considering today that do not
include the goal of negotiating prices or the inflation rebate
that is in H.R. 3. And I strongly believe that we need to act
immediately on H.R. 3 because it offers a comprehensive
approach.
So let me go to Professor Sachs. Three questions. As you
briefly mention in your testimony, can you discuss why
reforming the Part D benefit and capping out-of-pocket costs in
Part D, while critical in conjunction with other policies, on
its own is not sufficient to actually reduce prices?
Ms. Sachs. Yes. So, although capping out-of-pocket costs is
important to help patients, it doesn't actually lower prices or
spending. It just moves money around in the system. MedPAC
projected that lowering patients' out-of-pocket costs could
even increase overall premiums a little bit and increase
Medicare spending as a subsidy for those premiums.
So, although it is important to reduce out-of-pocket costs,
that needs to be coupled with other reforms, which would
directly address those high prices.
Mr. Pallone. And can you explain how the different titles
of H.R. 3 work in tandem, and why, in order to effectively
lower prices, we have to use more than one approach to deliver
real savings?
Ms. Sachs. Yes. The restructuring of the Part D benefit is
critical. It helps seniors afford the costs of their
prescription drugs. And because it just moves money around in
the system, the other titles are also important.
So the inflationary rebate provisions as a floor of H.R. 3
extend to Medicare a strategy that has worked well in Medicaid
to control price increases in that program and should
discourage companies from raising the prices of their drugs as
we have heard about with Copaxone.
But even that won't fundamentally address the underlying
high prices of these drugs or the Government's lack of
negotiating leverage. And that is where the negotiation element
of H.R. 3 comes in. So, particularly for specialty drugs with
little or no competition, H.R. 3 strengthens Medicare's
negotiating authority and enables our public payers to obtain
more fair prices for these products.
Mr. Pallone. And then lastly, my understanding is that H.R.
19--this is the Republican alternative that we are considering
today--does not establish a negotiation framework, nor does it
contain the inflation rebate provisions that are included in
H.R. 3.
Given that, is H.R. 19 effective at reducing drug prices?
And if not, why not?
Ms. Sachs. That is a correct description of H.R. 19
precisely because H.R. 19 is centered around only the
restructuring of the Part D benefit. It is unlikely to save our
system very much money. So it would certainly help seniors with
their out-of-pocket costs, but it has no answer for the company
who raises the prices of Copaxone, I believe we heard, 27 times
in a decade, from 700 to 7,000.
That would not be addressed in something like H.R. 19, and
it might even increase premiums for seniors and Government
spending overall.
Mr. Pallone. All right. Thank you very much.
Thank you, Madam Chair.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize the ranking member of our
subcommittee, Mr. Guthrie, for your 5 minutes of questions.
Mr. Guthrie. Thank you, Madam Chair. I really appreciate
it. And this is a very valuable hearing. I think we are seeing
this a lot, and we agree on--I agree with a lot of what
Professor--almost all of what Professor Carrier said, a lot of
what Professor Sachs has said.
We want to put together real answers, and it may be an
answer to the President's call. Let's pass what we can agree
on. And I will agree with what Ms. Ball said. I think Chair
DeGette and I, we were in the--when I was in O&I, we looked at
insulin when we have long-existing therapeutics that increase
faster than inflation. And that is something I think we need to
look at, why that is moving forward.
And I think the number one is to get competitors into the
marketplace. And as a matter of fact, last week, I think,
Representative Schrader was in the Oval Office. I was in
Kentucky getting a bill signed about dealing with patents and
the way that people gain patents.
So there are ways to move forward with this. We know we are
talking about negotiation, and the way this bill is structured
is more price-setting. That is our concern, not just
negotiating. It is a way the price-setting mechanism looks
forward. And I think it was quoted that 93 percent of the
people support negotiating, or essentially lower drug prices.
But I have seen similar polling just saying, if you ask at
the expense of access to lifesaving therapeutics, that drops.
And I can't imagine what it would be if savings in Medicare
would be used as a pay-for for some other type of issues.
But the assumption in H.R. 3 to me is that you can change--
this is--I want to get to Dr. Gupta--you can change how you pay
for a product without changing what you receive and what you
get. And that is the concern in all--President Biden in the
joint session kept talking about foreign payments and the way
foreign payment drugs are moving forward.
I think COVID-19 is a good example for Dr. Gupta. The
COVID--Europe decided they want to negotiate for a COVID
vaccine up front, before--and we went the opposite. We said we
are going to invest in pharmaceutical companies working
together to bring a vaccine forward. And we know the results.
Europe is currently--unfortunately, very unfortunately for our
allies, in a lockdown, where we are--in Kentucky you do get one
today if you wanted a vaccine.
So Mr. Gupta, would you talk about what Europe did and how
that is an example of what H.R. 3--if we are going to import
European-style drug pricing, how that could change the results
we get?
Dr. Gupta. Absolutely. Thank you, Congressman. So we see on
our side is that other countries seem to be willing to deny
[audio drop] particularly acute in the setting of--as
illustrated by COVID vaccines, but also as we see routinely
with cancer medications, where there are significant delays
that sometimes border on years to deliver groundbreaking cancer
medications to patients, in an even more extreme example.
And I think those are also examples we so look at as the
kind of risk that would be entailed here if we were to have
price controls as per H.R. 3.
Mr. Guthrie. Priced the way they price, in my opinion,
without having the results that they receive. Dr. Deeks, in our
long-haul COVID hearing--and I will quote him--he talked about
how we are going to have innovative therapies for long COVID.
And he said, quote, ``Developing therapies will not happen
unless we somehow find a way to incentivize our partners in the
pharmaceutical industry,'' unquote.
And so what--we are looking for innovative therapies. And
we need to deal with situations like Ms. Ball, absolutely. But
we don't need to affect the young children with SMA. And that
is what we--we want to move forward.
Also, Dr. Gupta, I want to touch on value-based agreements.
These are arrangements that a new reimbursement method, where
manufacturers are paid if their drug works, and if it doesn't
work as intended they will return payments via refunds or
rebates. Representative Schrader and Representative Mullin and
I are working on the bill for these two arrangements.
Could you talk about value-based agreements and how that
could affect drug pricing?
Dr. Gupta. Yes. Thank you. I think that is a promising
avenue [audio drop] and medicine basis, which is to say sort of
a voluntary basis. I think it makes sense for companies to put
together those kinds of credit-price proposals. And I think we
should explore the better understanding of the potential
impact, and how this could improve access.
Mr. Guthrie. I am a big believer in the Medicare Part D,
that we do need get smoothing so people don't have to pay
everything up front in January when their new deductible moves
forward, and also cap out-of-pocket expenses. If you are just
subsidizing a rising drug price marketplace, it does change--
moves money around, as Dr. Sachs said.
So I think we need to do work to do patent reform, as
Representative Schrader and I have worked on already to make
sure that we get competition into the marketplace as soon as--
protect patents for innovation, but bring competition as soon
as possible.
And Madam Chair, my time is expired. Thank you for having
this hearing.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize the gentleman from North
Carolina, Mr. Butterfield, for your 5 minutes of questions.
Mr. Butterfield. Thank you, Madam Chair, and good morning
to you. It is still morning here on the East Coast--no, it is
not. No, it is not. It is after 12 noon. But thank you. It is
still morning on the West Coast.
Ms. Eshoo. Right.
Mr. Butterfield. But we have passed that noon mark here in
Washington. But thank you for convening this most important
hearing today.
You know, Madam Chair, we have talked about drug pricing on
this committee now for years, and it is time for action. I
could guarantee passage if my Republican friends would just
work with us, not just throw one-liners at us but just work
with us. We can get this done. We can get it done in this
session of Congress. So thank you for the hearing today, and
thank you to our witnesses.
Let me begin with Professor Sachs. Thank you for your
testimony. During my time in Congress, I have heard from
countless constituents who say they cannot afford their
prescription medications. We all hear it when we go home. It
isn't right that someone in our country should have to choose
between food and medicine. It is just not right. It is not
right that one in three U.S. adult patients forgo desperately
needed medications because of cost.
In my home State of North Carolina, including right there
in my district, we are the home to many biotech and
pharmaceutical manufacturers. And I believe that innovation by
these companies should be encouraged. But clearly, the American
people are suffering, and we all know that.
The status quo is not acceptable. Congress must act to
ensure that the American people have access to and can afford
the treatments that they need. And so all of that is to say,
Professor Sachs, H.R. 3 creates a new $2,000 out-of-pocket cap
on Part D spending. I think you would agree that this new limit
would be welcome news to millions of beneficiaries.
You explained a few minutes ago, if I heard it correctly,
to Chairman Pallone that an out-of-pocket cap cannot lower drug
costs on its own. I think you said that. How will the other
pieces of H.R. 3 lower costs for savings?
Ms. Sachs. Thank you, Congressman. This is an important
distinction. H.R. 3 recognizes that reducing patient out-of-
pocket cost is critical, but on its own that is not the same
thing as reducing drug prices. It covers those up. It actually
makes it harder to see that a company is raising its prices 27
times, as we have heard from Ms. Ball.
So it is important to lower patients' out-of-pocket costs,
and that $2,000 cap would be a huge help to many Medicare
beneficiaries. But it is important to also use the other
elements of H.R. 3 to discourage companies from increasing
their prices as fast as we have heard them do already in this
hearing, and I am sure we will hear more about it as well. And
it is important to use the negotiating elements of H.R. 3 to
really make sure that the Government has a strong hand in
bargaining for the prices of these products when we are paying
many times more than comparable countries for the very same
drugs.
Mr. Butterfield. Precisely, and thank you so much for that.
Let's talk for a minute or two about rare diseases. You may
know that I am the cochair of the Rare Disease Caucus here in
the House. Over 95 percent of rare diseases--people don't
realize this--over 95 percent of rare diseases do not have any
treatment at all.
Many, like sickle cell, which predominately affects African
Americans, are chronically overlooked and underfunded. We must
foster the creation of cures for these conditions. Ms. Sachs,
you discuss in your testimony various ways that H.R. 3 could
impact future drug development. Do you anticipate a large
impact on first-in-class products for rare diseases like sickle
cell?
Ms. Sachs. I do not, and here is the reason why: Most rare
disease drugs won't qualify for negotiations under H.R. 3
because only the top 125 drugs under Medicare Part D and the
top 125 drugs more generally are even eligible for negotiation.
And so, for the top-selling drugs in Medicare, we are often
talking about drugs that hundreds of thousands of Medicare Part
D patients are taking, to say nothing of patients outside of
Medicare, that by definition orphan drugs are treating very
small populations of patients. And it is very difficult for
them to become top-spend drugs of the type that would even
qualify for negotiation.
I also do know that there has been bipartisan interest in
Congress in the last few years of looking at when companies
might be abusing the Orphan Drug Act, such as to extend their
monopolies by stacking orphan drug exclusivity periods. So it
is possible that there might need to be some attention to those
concerns.
But it is very unlikely that rare-disease drugs would be
under the negotiating scope of H.R. 3--not never, but unlikely.
Mr. Butterfield. Thank you so very much. I will end with
the last statement that--the first statement that I made during
my remarks: 95 percent of rare diseases will not have a
treatment. Colleagues, let's redouble our efforts.
Thank you, Madam Chair. I yield back.
Ms. Eshoo. The gentleman yields back, and we thank him.
The Chair is pleased to recognize the ranking member of the
full committee, Ms. Cathy McMorris Rogers.
Mrs. Rodgers. Thank you, Madam Chair. And just let me say,
we are anxious to go to work to focus on cures for those with
rare diseases and beyond. I am committed--Republicans are
committed--to addressing how we bring down the cost of
prescription drugs. It is a priority issue.
Anxious to work with Republicans and Democrats on
solutions. We can build on right to try, we can continue to
expand the generics. Transparency, accountability for problems
is a priority. I am very concerned, though, about the current
approach and the impact that it is going to have on innovations
and curing diseases from a very big picture.
So I wanted to start with Dr. Gupta, and just thank you
again for joining us, bringing your expertise and experience.
You spoke about us living at the dawn of a golden age of
innovation, and it is one of those times that we should just be
focusing on how we continue to lead in ways that are going to
result in lifesaving, life-changing therapies and treatments.
I would like to ask you: What are you most excited about?
And put in layman's terms what it means for patients and
families across the country, and if you have any concerns about
the proposal before this committee this morning.
Dr. Gupta. Thank you, Congresswoman. What I am most excited
about is several years ago we used to have a concept in our
industry of targets that were called ``undruggable,'' which
meant that with the toolkit that we had to develop medicines,
we simply couldn't hit them. We knew where the disease was
coming from, but we couldn't do anything about it.
Increasingly, that word is leaving our vocabulary. And I
think that is the most exciting development. I hope, when I say
we are at the dawn of a golden age, I really believe that. And
as you said, Congresswoman, I think we should pour gasoline on
the fire rather than trying to snuff it out.
Mrs. Rodgers. Yes. Thank you for that.
Ms. Davis, I wanted to thank you for joining us today and
sharing your story. Now, as a mom, I am always amazed and
inspired by others, and especially all that you have done for
your son Hunter and fighting for him. You basically took a
never-say-no attitude, and that determination is one that we
all admire.
I appreciated you highlighting the miracle drug that has
now been made available to those with SMA. And as we just heard
from Dr. Gupta, the concern is that proposals like H.R. 3 are
going to disrupt the path to those breakthroughs for the next
generation of children like Hunter.
As you know, the SMA treatment became more widely available
in the U.S. in February of 2017. But sadly, it wasn't made
available in Australia until 11 months later, or 6 months later
in Canada, 4 months later in France, 5 months later in Germany,
6 months later in Japan, 6 months later in the U.K. The bill we
are discussing today would import into the U.S. the pricing
schemes from those countries who didn't have the kind of drug
that Hunter needed available until much later.
So what would you tell the members of this committee about
what the extra 4, 5, 6, or 11 months without this treatment
would have meant for you and Hunter?
Ms. Davis. So for SMA, every day matters. Sometimes every
minute matters. Once motor neurons are lost, we can't get them
back. And so what it would mean is more babies and children
would be permanently disabled, and more lives would be lost.
This is something we cannot afford. In fact, we really need to
be working for presymptomatic diagnosis and treatment, not only
for SMA but all of these childhood conditions.
Mrs. Rodgers. Thank you very much. And I also wanted to ask
if you would just speak to the way that other countries define
the value of a life, and how that impacts the availability and
also potentially the price of drugs.
Ms. Davis. Yes. It is based on the quality metrics. And it
is used by discounting the value of the patient's life based on
how chronically ill or disabled they are, and then multiplying
that, the number of years that they anticipate the survival.
And so it is a very discriminatory practice, and it is
something that we have acted vigorously to prevent from
happening in the U.S., and we have done with ICER. We prevented
CVS Caremark from importing ICER's quality metrics, and we also
opposed the ventilator medical rationing during COVID using
those measures as well.
Mrs. Rodgers. Thank you for joining us and speaking out. My
time is expired. I yield back.
Ms. Eshoo. The gentlewoman yields back.
The Chair is pleased to recognize the gentlewoman from
California, Ms. Matsui, for your 5 minutes of questions. Great
to see you, Doris.
Ms. Matsui. You, too, Anna, and everybody else. And thank
you very much, Madam Chair, for calling this hearing. It is so
important. And thank you for the witnesses for being here. It
is important to hear about your experiences and your expertise.
I know there has been a lot of conversation on the out-of-
pocket cap and Part D, and I have listened to Professor Sachs.
I understand that this is just one tool. But particularly for
beneficiaries as they have challenging prescription drug costs,
it is really very, very important.
So just a comment, Ms. Ball. Can you share what, say, a
$2,000 out-of-pocket maximum in the Part D plan would mean for
you? Would this provide you with better certainty for your
total drug costs for the year?
Ms. Ball? Are you present?
She is having trouble. Let me go on here.
Ms. Ball. I had trouble with unmuting. I am so sorry. Yes.
You know, it would benefit me in that I would be able to know
exactly what I would need if my pricing went up to $2,000. But
basically, what happens is that I would have the ability to
receive my drugs, which is the most important part because at
the time that it went to $6,000, there was no way that I could
have. And that really was devastating to my health and to my
family. So it would help a great deal.
I am sorry. We can't hear you, ma'am.
Ms. Eshoo. Doris, you need to unmute.
Ms. Matsui. Sorry about that. I got unmuted.
I want to talk about the role of rebates. Reforms like the
inflationary rebates and insurance premiums will realize
incentives that manufacturers have for raising their prices,
but may be limited in their ability to assist Medicare in
obtaining lower prices, particularly on specialty drugs.
A similar problem exists with rebates that drug
manufacturers pay to PBMs and insurers. Typically, these
postsale rebates or discounts are not available for drugs that
lack competition. Professor Sachs, for expensive drugs that
have no manufacturer rebates, what leverage do Part D plans and
PBMs currently have to negotiate lower prices?
Ms. Sachs. They have little to no leverage today.
Ms. Matsui. OK. Professor Sachs, inflationary rebates can
address the overall growth of a drug's price over time. But
what other mechanisms are needed to reduce costs, particularly
for specialty drugs with an initial high list price?
Ms. Sachs. Exactly as you just said. The inflationary
rebates will be important to discourage or prevent drug
companies from hiking the list prices of their drugs more
quickly than inflation. But the companies that set a high price
in the first place, especially where the price is many times
what other countries are paying for the same drugs, H.R. 3
gives the Secretary the authority to negotiate for the prices
of those drugs and strengthen their hand in that negotiating
process.
Ms. Matsui. OK. Thank you. I want to go back to--we were
talking about out-of-pocket caps. Professor Sachs, can you
briefly describe how H.R. 3's proposal to cap out-of-pocket
costs compares to H.R. 19 that we are also considering today?
Ms. Sachs. Yes. So the ideas are very similar, to help
patients afford their out-of-pocket costs. But the details are
different in two important ways.
So first, H.R. 3 is more protective of patients and imposes
a $2,000 annual limit on points' out-of-pocket costs rather
than a $3,100 out-of-pocket limit on patients' out-of-pocket
costs. And then second, H.R. 19 imposes less responsibility on
manufacturers in the catastrophic phase, only 20 percent
compared to 30 percent in H.R. 3, which will help manufacturers
be discouraged from driving patients into that phase of their
benefits.
Ms. Matsui. OK. Fine. Thank you, Madam Chair, and I yield
back my time.
Ms. Eshoo. The gentlewoman yields back.
A pleasure to recognize the former chairman of the full
committee and the Republican lead author of the Cures--what is
the matter with me?--the 21st Century Cures Act. I just had a
blank moment there. Mr. Upton, you are recognized for your 5
minutes of questions. Great to see you.
Mr. Upton. Well, it is. Thank you, Madam Chair, and thanks
for bearing with me a little bit for our little issue with
WebEx, getting access to what we all are doing. And we all hope
that Mr. McKinley's wife, Mary, does well with her surgery this
afternoon.
A couple things. It is no secret that all of us on this
committee have been very involved in health research. And
obviously, 21st Century Cures is a major milestone for us when
we passed it back in 2016. President Obama signed it into law.
For me, doubling the money for the NIH back in the '90s,
working with Henry Waxman and John McCain, my good buddy, which
was successful, and obviously now, as we are beginning to work
on Cures 2.0, Eshoo, myself and others very involved in that,
as well as Pallone and the leadership on both sides .
I just want to thank Ms. Davis. Just a touching story for
me and many on the committee that were on the committee back in
2015. They saw two of my constituents, two little beautiful
girls, we actually called Sleeping Beauty and Cinderella, from
my district who were impacted with SMA and just so excited
about the progress that is being made.
But that is the case with every rare disease. So cystic
fibrosis, all of them--we all want cures for these diseases. We
really want to get to the point where we can be the lifeline
for those families.
One of the things that also drove us to get 21st Century
Cures done was that we realized that venture capital was
leaving our country. It dropped by 50 percent back in the early
part of the 2010s, the early part of that decade, going
overseas because we weren't the leader in innovation. We
weren't the leader in getting these drugs approved.
And I have a fear that countries like China and India--they
haven't explicitly stated that they want to become global
leaders in medical innovation yet, although they are trying.
But it is often--those manufacturers that often seem to be
cited the most in terms of tainted drugs, quality manufacturing
issues, and the policies of H.R. 3 could in fact make those
countries potentially more attractive for R&D and manufacturing
investments than the U.S.
So Dr. Gupta, do we want to take the chance that we could
lose U.S. global leadership in this space and end up with
impure medicines, potentially longer delays in access to new
medicines in the laboratory systems which may not have the same
gold standard that we have in the U.S.?
Dr. Gupta. Thank you, Congressman. And I think you have
outlined precisely the risk that we face under some of the
provisions of H.R. 3. China is signaling to its companies it
wants them to catch up and that they can charge relatively high
prices in China. It is expensive to run a clinical drug trial
to the FDA standard, and I think you have outlined precisely
what we may see if that would happen.
Mr. Upton. One of the things, too, is that I hear
colleagues on both sides talk about where we are. We all want
lower drug prices. That is for sure. But we went through this
same argument last year by saying we have a bill, H.R. 19, that
was actually bipartisan. It was made up of bipartisan bills.
Every one of them had Democratic and Republican support that we
packaged together.
And H.R. 3, we said, isn't going to get to the finish line.
And exactly that same thing happened. And that is the fear
again in this Congress, that H.R. 3, the way that it is
designed now, same bill as last year, isn't going to get to the
President's desk whether it be a Republican or a Democrat. So
why not take what we know we can agree on and move that, at
least do it first rather than wait for H.R. 3?
But I guess in my last minute, I just want to say one of
the provisions in the Cures that was signed into law was the
precision medicine initiative at the NIH and many new,
innovative therapies, highly targeted, underscoring the
importance of patients having access to a range of treatment
options.
The future of precision medicine and the highly effective
therapies is not for sure a one-size-fits-all. That approach is
at odds with how the drug pricing proposal would set prices for
medicine. Determining a single price based on the price that we
pay for medicines in other countries, and population level
compared to the effectiveness of research--neither of these
factors, as I understand it, will account for the value of
those treatments to an individual patient.
So are there any recognitions for personalized medicines
included in the price-setting in H.R. 3, Dr. Gupta? In my last
2 seconds.
Dr. Gupta. Thank you, Congressman. I will be brief.
Personally, I am actually unfamiliar with any provisions that
might cover that. I will have to review that and get back to
the committee. Thank you.
Mr. Upton. OK. With that, Madam Chair, I yield back the
balance of my time.
Ms. Eshoo. The gentleman yields back. And it is a pleasure
to recognize the gentlewoman from Florida, a wonderful member
of our committee, Ms. Castor, for your 5 minutes of questions.
Ms. Castor. Well, thank you very much, Chairwoman Eshoo.
Thank you for leadership here. This is a very important hearing
on legislation to lower the cost of prescription drugs, so
thank you for calling us all together, and thank you for the
testimony of our witnesses as well.
I encourage everyone to go back to the memo that summarizes
the reason that we are here. Drug prices in the United States
continue to soar. The Rand study was cited in that summary
memo. Americans pay 256 percent more for their prescription
drugs than the average 32 countries. And when you are talking
about brand name drugs, it is more than that: 344 percent more.
That is outrageous, and it is exacting a toll on families,
all of our neighbors. And it sure impacts the Federal budget
and the bottom line because of more extensive outlays for
Medicare and Medicare Part D.
This just doesn't make sense any more, that there is a
prohibition on Medicare negotiating prices. And I wanted to
give a shout-out to our colleague, Peter Welch, who has spent a
good bit of his time in Congress fighting for this. And I
think, Representative Welch, I think this is our year that we
are going to get it done. And I really invite our Republican
colleagues to join us on this, to lift that prohibition on
negotiating drug prices. We do it in the VA. It works. And it
is really anti-American, isn't it, that we would prohibit
anyone from negotiating something in America?
But I would like to spend, Professor Sachs, a little time
with you to talk about generic alternative and sole source
drugs that don't have the market forces to draw the price down.
We have seen, in the current market, we don't have the tools to
restrain those costs.
Will you describe for us the way that drug makers often
determine a price for sole source products? Is it fair to say
that there isn't a lot of leverage for employers or insurance
companies to control costs for these drugs, short of excluding
coverage, that we don't want to?
Ms. Sachs. Thank you. As to your question of how companies
determine prices for these drugs, it is very common to hear
that drug companies charge what the market will bear. They are
not looking just to recoup their R&D investments. They are
looking at other drugs. They are looking at services and
benchmarking their prices accordingly.
And you are also right to suggest that there isn't a lot of
leverage for employers or insurers to control costs for those
drugs. But I don't think it is necessarily the case that
exclusion or the threat of exclusion is necessary. And so for
an example--and I think we can look to Medicaid--Medicaid is
required by law to cover essentially all FDA-approved drugs.
But in exchange, it is a entitled to preferred pricing
benefits, including inflationary rebates of the type we are
considering today. And different governmental reports have
shown that those inflationary rebates are very effective in
helping Medicaid get much better prices than Medicare Part D
for the same product.
Ms. Castor. So given this, you appear to agree that it
makes sense to give the Secretary of HHS the power to negotiate
prices of certain high-priced drugs that the lack of
competition and--where we have a lack of competition and our
neighbors are forced to choose between taking their medications
or eating or paying for a roof over their heads. is that right?
Ms. Sachs. Yes. Yes. Unfortunately, too often, as I
mentioned, one in four, almost one in four Americans, 24
percent, including 23 percent of seniors, have difficulty
affording these medications.
Ms. Castor. So some of the bills today do address the issue
of generic competition by addressing some of the major barriers
to effective, timely generic entry. These policies are crucial
to making markets for prescription drugs work more effectively.
However, why is it not enough on its own? Why must we also
have a comprehensive solution like what is contained in H.R. 3
in order to meaningfully bring down drug prices for all
Americans?
Ms. Sachs. Yes. This is such an important question. And
these bills promoting generic competition are important. I
don't want to suggest that Congress shouldn't pass them. But
they are reactive. So as we heard from Professor Carrier's
testimony, pharmaceutical firms have been engaging in pay-for-
delay deals, citizen petitions--product hopping is another
example of this--for years.
And if Congress is now able to crack down on those,
industry will develop innovative new ways to extend their
monopolies. A comprehensive negotiating strategy would limit,
although probably not completely avoid, the need to play this
kind of Whac-a-mole with pharmaceutical company gaming tactics
in the first place.
Ms. Castor. I agree. I think H.R. 3 is a very important
comprehensive approach to controlling drug prices for all of
our neighbors.
So thank you, Chairwoman Eshoo, for having this hearing,
and I yield back my time.
Ms. Eshoo. The gentlewoman yields back.
It is a pleasure to recognize Dr. Burgess for your 5
minutes of questions.
Mr. Burgess. I thank the chair. And just like in the last
Congress, this hearing has been very instructional. And
certainly I have enjoyed the testimony of our witnesses.
Dr. Gupta, if I could ask you, I think we would all
acknowledge that the National Institutes of Health is a
national treasure, and it has contributed mightily to the basic
research and understanding of many diseases. But it doesn't
seem to me like the agency was designed with the development of
bringing new drugs to market in mind.
So could you elaborate on that a little bit, the process of
bringing a new drug to market and the process, for example, in
scaling up to coronavirus vaccine?
Dr. Gupta. Yes. Thank you. Thank you, Congressman, I think
that is a very important point. And the NIH is a fabulous
organization, world class. But it is not a drug development
organization, and the core skill set of biotech and pharma
companies is developing medicines, getting them--manufacturing
them, running them through clinical trials, interfacing with
the regulators, and then of course actually selling them.
There is no glide path to market a drug once it is
approved. There is no national formulary. And it is actually--
and I think big companies are better than small companies. It
is actually important to have the ability to make sure that
physicians and patients can get them and are aware of them. And
the NIH is not equipped to take the prototypes that they
sometimes build, or the scientific ideas they sometimes
generate, all the way through that lengthy process.
Mr. Burgess. All right. When Zika was a concern several
years ago, and I had multiple meetings with Dr. Fauci of the
NIH on this topic, he did point out that they have a small
manufacturing capability--capacity--at NIH. But I would
underscore small, and nothing of the sort that would have
permitted the rapid introduction of the coronavirus vaccine,
for example. That did require the involvement of the private
sector. I think we are all grateful that that involvement
occurred.
So Dr. Gupta, staying with you for a minute, you actually
have some experience in the business world. You have probably
been a part of negotiations yourself from time to time. The
excise tax that is enumerated in H.R. 3, does that look like a
negotiation process to you?
Dr. Gupta. Thank you. I think that that mechanism would
provide a lot of leverage to a party that would disadvantage
greatly the counterparty to that.
Mr. Burgess. Well, and again, you also understand the
capital, investment of capital, is on a lot of things, and a
lot of them are good things. But capital is generally not known
for being courageous. And so if capital is challenged in one
location, what is likely to happen?
Dr. Gupta. Well, thank you. I appreciate the chance to
comment on this as well. Just from the laws of economics, I
can't think of an example where investors would put their
capital at risk in a field that faces price controls. But I
think it is also worth sharing a little bit about the odds of a
drug making it all the way through the FDA.
Only 1 in 25 drug candidates will make it from preclinical
studies through FDA approval, and on average the cost required
to support a development program is between 1 and 2 billion
dollars. And keeping the incentive structure we have in place
is clearly necessary to continue the output that we have.
Mr. Burgess. I appreciate your input on that. I am going to
leave to our colleague, Morgan Griffith, to discuss about the
takings clause and the constitutionality of the legislation. I
think he tried to rescue it last Congress. I don't know if he
is of a mind to try to rescue it this Congress. But again, I
will let him speak to that.
Ms. Davis, if I could just ask you, are there any
medications or therapy that your son is currently taking that
would not be available in the countries the H.R. 3
international reference pricing is--that concept is based upon?
Ms. Davis. So it varies on the type of patients, especially
for the patients that are on ventilators. They are not able to
access treatments in many of the countries because the QALY
metrics used to develop the inclusion criteria excludes those
patients. Their lives are not deemed valuable enough to access
the treatment.
Mr. Burgess. So the calculation of the QALY-adjusted life-
year makes them ineligible. And by making them ineligible, what
does that do to their--the outlook for their lifespan?
Ms. Davis. It significantly diminishes their lifespan--and
not only their lifespan, but the quality of life during that
lifespan.
Mr. Burgess. We need to be mindful of things like that as
we contemplate a bill like H.R. 3. H.R. 19 has a number of
great provisions, all bipartisan. A number of them got passed
last Congress. A couple of them have passed this Congress and
been signed into law. So for my money, we ought to be working
on what works, get it done, and let the American people help us
sort it out.
I thank the chair for the recognition, and I yield back.
Ms. Eshoo. The gentleman yields back. Please note I gave
you 35 extra seconds there.
The Chair is pleased to recognize the gentleman from
Maryland, Mr. Sarbanes. You have those shades on. Where are
you?
Mr. Sarbanes. I am over here. Thank you very----
Ms. Eshoo. There you are. Oh, we can see your whole face.
Mr. Sarbanes. Yes. Thank you very much, Madam Chair.
Appreciate the opportunity.
Before his passing in 2019, Chairman Cummings, who
represented Baltimore, as I do, and for whom this critical
legislation is named, as you know, he worked tirelessly to
uncover why the prices of lifesaving drugs were so high that
people simply could not afford them, why people would need to
ration their drugs or go without.
He felt this very, very deeply. I saw that every single day
as he moved around his district, his neighborhood. He just
couldn't understand why this was the case in a nation as great
as America. We both heard, he and I--and I continue to hear--
these stories today from Maryland constituents as to how the
high price of prescription drugs forces them to make impossible
choices, endangering their health and their lives.
And all of this is happening while drug companies continue
to rake in these incredible profits. Between 2011 and 2016, we
know that list prices went up 129 percent for 14 of the top-
selling drugs--top-selling because they are so critical for
people out there. At the same time, out-of-pocket spending by
patients increased by 85 percent for specialty medicines and by
42 percent for nonspecialty drugs, even after taking inflation
into account. This is just plain wrong.
As former chairman of the Oversight Committee, a committee
on which I also served, Chairman Cummings worked tirelessly, as
I have said, to fix this problem. The Oversight Committee's
work centered on both lowering prices for individuals and
families across the country as well as removing waste, fraud,
and abuse from government spending, and our hearing today
continues that effort.
Professor Sachs, it seems like we are asking you the same
basic questions over and over again. We are doing that because
it is really important, because this bill can solve a lot of
the challenges that Americans face. So tell me again, why is
giving Medicare the power to negotiate such a central tool in
effectively lowering drug prices? And maybe focus on the
centrality piece of that.
Like there are a lot of other things that we can and we
should do to address the high prices. But this specific tool of
giving Medicare the opportunity to negotiate is really at the
heart of--it is in the center of our toolkit. So can you speak
to that a little bit more?
Ms. Sachs. Yes, absolutely. And just to clarify, because
the prescription drug pricing issue is so complicated, there is
not one reason why the price of a drug can be high or why
patients might have difficulty affording their medication. It
is important to ask and answer these questions in slightly
different formats repeatedly, so that we know what is at stake
here for patients and innovation and access.
So to answer your question more specifically, the
centrality of negotiation to H.R. 3 is that is gives the
Government more authority to have an equal position at the
bargaining table with these drug companies who are the
manufacturers of high-priced sole-source drugs.
What do you do for Copaxone? What do you do for Humira?
There is a question there about whether companies that have
been on the market for a long time, who now recouped their
monopolies, but have managed to delay generic competition. And
it is really hard to crack down on a hundred patents in a
single drug portfolio or on some of these other tactics.
Allowing the Government to negotiate, just as many other
countries do, would allow us to lower the prices of some of
these drugs and to get more fair prices for patients and
payers.
Mr. Sarbanes. Thank you. And it is so American to allow
negotiation in the market. Yes, the Government will be
negotiating. OK. But that is the way it is supposed to work in
our system, with two parties bargaining to get to a good result
here. And obviously, the Government's hands have been tied
arbitrarily for years now.
My understanding is that the CBO estimates a negotiation
framework will lower Federal spending by $456 billion--that is
incredible--while also saving Medicare $42 billion on other
health expenses simply because beneficiaries will be able to
fill the prescriptions that will keep them healthy. Let me just
emphasize that: Because patients will be able to get
prescription drugs that they cannot get right now, they will be
healthier and Medicare will save $42 billion on healthcare
costs.
Madam Chair, thank you for this hearing. Very, very
important. I yield back my time.
Ms. Eshoo. The gentleman yields back. Thank you for having
us look back at, really, the central work of our--as I said in
my opening statement--our promoted colleague, Elijah Cummings.
In so many ways he set the table for what we are doing today
and going forward.
It is a pleasure to recognize the gentleman from Virginia,
Mr. Griffith, for your 5 minutes of probing questions.
Mr. Griffith. Thank you very much. I appreciate it very
much, Madam Chair.
Let me just say that--and I have got to get this off my
chest--we have been talking about negotiations. But we don't
have negotiations in this bill. And that is the problem,
because what we have is a system that says, if you don't agree
to the price dictated by the Government, you can pay a tax of
65 to 95 percent of the gross revenues for that drug in order
to be able to sell it in the United States.
Now, I get very concerned about that, as I did 2 years ago,
because when it comes to the constitutionality of a bill, it is
not just the courts that have jurisdiction to determine that
constitutionality. This committee and Congress also have a role
and have a duty to determine whether or not we are passing
bills that are constitutional.
The Court may be the final arbiter of that question, but we
have a duty to look at it, too. And when you look at the
concerns that were raised--not just by me two years ago, but by
owners, including the Congressional Research Service--we have
Eighth Amendment concerns.
While Congress has the power to levy taxes, that levy is--
that ability is not without limitations, especially with regard
to taxes that are actually moral penalty fees or fines. And I
think a court could reasonably find these taxes are, at least
in part, punitive and therefore in violation of the Eighth
Amendment of the Constitution.
The one that I very first raised was the Fifth Amendment
concern, and that is the Takings Clause, because when you say
to somebody, ``You can't sell your intellectual property or
your product in the United States unless you give us 65 to 95
percent of your gross sales,'' you are taking that property
away from them. You are taking away fair market earned
intellectual property. And I have concerns about that.
Now, I am one of the people on the Republican side of the
aisle that actually would consider negotiation, that I think we
should have some negotiation ability, and I even have a bill in
to do that in certain stressed areas. That being said, we have
to do it in a constitutional manner. And Madam Chair, I just
don't think this bill is constitutional.
When you limit prices manufacturers can charge and you
say--you are being forced to accept the price for a drug, and
that could mean significant economic loss to the developer
because you are going to take not of the profit but up to 95
percent of the gross sales, that is a taking, Madam Chair.
And I know that everybody is trying to do the right thing,
and you have heard that H.R. 19 has some positives from the
witnesses, and we have heard that there are other positives.
But if we are going to do the right thing, even when we
disagree, let's at least do the constitutional.
Now let me shift--before I finish my time today, let me
shift to H.R. 2843 because I think this one also has concerns.
And I think we can all agree that the FDA citizen petition
process can be very useful and must be implemented in a way
that prevents abuse. And that bill, H.R. 2843, known as the
STOP GAMES Act, seeks to address potential abuses. While I
admire that goal, I remain concerned that the bill currently
does nothing to resolve potential First Amendment issues, which
also were raised back in 2019.
Now, that deals with the First Amendment. It guarantees the
right to petition the U.S. Government for redress of
grievances. Yet H.R. 2843 would allow the FDA to summarily
deny, that is, to not even consider, citizen petitions at its
own discretion--even if they raise valid science--they think
are regulatory concerns.
If there is a scientific basis for petitioning the FDA that
has not been considered previously and has been timely
submitted, I believe the agency should have a timely process to
review the petition and make a decision based on the merits.
Now, Madam Chair, I think we can both agree--and I think
all of us can agree--that we need to have a process that is a
little quicker. And right now it is being used in games by
certain parties in the system to make this process long and
drawn out.
But again, let's figure out a way we can fix that without
completely eliminating the right to seek redress from the
Government by citizens who may have a legitimate concern. And
there are bad actors, and we have to figure out how we set that
system up. But I will submit to you that H.R. 2843 is not the
vehicle, as it is currently written, that we ought to do that
with.
So Madam Chair, I hope as we work forward in this, as we go
through subcommittees, we go to full committee with actual
bills and the bills that we are discussing today, that we are
open to doing some amendments to try to make sure that we can--
even if I don't agree with it 100 percent, let's at least pass
a product out of this committee that meets the constitutional
test and that we can all feel comfort is actually
constitutional.
And Madam Chair, my time is up and I yield back. Thank you
so much.
Ms. Eshoo. Thank you. The gentleman yields back. Always
thoughtful.
The Chair now, with pleasure, recognizes the gentleman from
Vermont, Mr. Welch. And I think I am going to announce who
follows so just in case you want to step away, you know that
your time is almost at hand--followed by Mr. Bilirakis from
Florida. So Mr. Welch, thank you for all of the work you have
done in the whole area of drugs and their costliness. You are
recognized.
Mr. Welch. Thank you very much. First of all, we have got
two lawyers following one another, and I disagree with Mr.
Griffith on the constitutionality of this. But I do agree with
many of the proposals that our Republican colleagues have in
their bill.
What the issue is here is government negotiations. And
there is a number--I am going to step back for a minute and put
this in a context. The pharmaceutical industry is dead set
against governmental action through negotiation. And why
wouldn't they be? They have record profits. Representative
Castor mentioned that we pay two and three times the prices
paid for the same drug in other countries.
Pharma is not opposed to governmental action, and it is
governmental action that provides them with patent protection
and the exclusive right to use the product. Pharma is not
opposed to governmental action when it comes to taxpayer
financing of the National Institutes of Health and all of the
research that taxpayers pay for that then are oftentimes
utilized and monetized by the pharmaceutical industry.
Pharma is not opposed to governmental action when it comes
to creating a guaranteed market in Medicare and Medicaid. So
pharma has a pretty good arrangement. They have got a
guaranteed market. They have got pricing power that is
legislative and authorized by the Government. And what we have
seen is that it is a model that works, and they make billions
and billions of dollars, and the CEOs make millions and
millions of dollars in salary.
Pharma oftentimes spends far more on advertising than it
does on research and development. And all of these things add
up to an incredible, punitive, price-gouging impact on
taxpayers, on individuals, and very significantly on many of
our employers, who are doing every single thing they can to
maintain employer-sponsored healthcare for their valued
employees.
And when those employers get the notice from the insurance
company that premiums are going up 15 and 20 percent, and then
talk to their workers about, ``This year I am afraid we can't
have a raise because we have got to keep your insurance,'' all
of that is continuing to occur and will never stop unless we
address the cost.
The biggest threat, the biggest threat to access to
healthcare is the cost of healthcare. It is the cost. So unless
we face this--and the cost of healthcare is most exploding in
the area of pharmaceuticals--we are going to allow the erosion
of access to healthcare for American workers, American seniors,
and American kids.
The argument is being made that if we proceed with price
negotiation of any sort, it is going to adversely affect
innovation. And I would like to ask--I would like to ask
Professor Sachs to address that directly.
Ms. Sachs. Thank you, Congressman. I want to say that as a
property law professor, I share your skepticism of the takings
argument. I would be happy to discuss that in more detail at a
later date.
But to respond directly to your question about innovation,
you are right. Industry argues that innovation will be harmed
no matter what the reform is. They make this claim without
regard to the size of the placing reform, without regard to
when in a product's life cycle it would take effect, without
regard to what products it would impact.
Today they make this argument about H.R. 3, but they also
made it on bills that would crack down on pay-for-delay
arrangements or product hopping. HHS Secretary Alex Azar called
this a ``tired talking point,'' and he was right. If industry
won't distinguish between the CREATES Act and H.R. 3, then this
committee should consider how seriously their arguments
should----
Mr. Welch. I have to interrupt you. Thank you. I just want
to make two points. One, we have got to get rid of DIR fees
that's hammering our local pharmacies, and they provide good
service. And then second, I want to address this question of
COVID and us having it and Europe being behind us. We
negotiated with pharma to buy, at a reasonable price, the
vaccine and refunded them. In Europe their problem wasn't
negotiation. They had 27 countries that couldn't come to an
agreement on what bid they would make.
I yield back, and I thank the chair and my colleagues for
this hearing.
Ms. Eshoo. The gentleman yields back.
A pleasure to recognize the gentleman from Oregon--no, the
gentleman from Florida, I am sorry, Mr. Bilirakis, followed by
the gentleman from Oregon, Mr. Schrader. So you are recognized
for your 5 minutes. Great to see you, Gus.
Mr. Bilirakis. Thank you. Good seeing you too. With all due
respect to Mr. Schrader, my good friend, I want to remain in
Florida.
I do want to say this: I want to respond to my good friend,
Representative Castor, with regard--she brought up the VA. And
I understand there is an access issue. I know that the VA does
negotiate drug prices. However, 24 of the top 50 drugs on the
national formulary are not covered by the VA. And I don't think
that is a good thing for our veterans.
And I understand only 63 percent of our veterans actually--
that qualify that are enrolled in the VA use the--get their
drugs from the VA. So that is a big problem, folks, and we need
to address that. There is no question.
I want to get into now the rare diseases, if that is OK.
And I want to thank the chairman for this hearing. A very
informative hearing. And I remain committed to working with my
DNC colleagues on both sides of the aisle to put patients over
politics by advancing bipartisan solutions.
So that said, I am very concerned about the impact of H.R.
3 on patients with incredibly complex rare diseases. As you
know, I am the cochair of the Rare Disease Caucus along with
Representative Butterfield. We have done some really good
things for our rare-disease patients the last few years.
So the bulk of R&D for medicines for rare diseases comes
from the biopharma industry. In 2018, the biopharma industry
invested $102 billion in R&D, 100 percent of which was focused
on drug development. Contrast that with the entire NIH budget
of fiscal year 2018, which was $35.4 billion, with only 8
percent focused directly on research related to drug
development.
We need a robust biopharma industry, and I think everyone
agrees to that, investing in rare diseases. If referenced
pricing or similar policies are put into place, I worry that
direct investment in rare diseases, where the failure rates are
high, would diminish and companies will only again do the safe
things, make the safe bets. And our children are suffering. Our
people with rare diseases are suffering.
And Representative Butterfield was right about that, 95
percent of these rare diseases have no cures or treatments.
Very unfortunate. Policies like referencing pricing and
government price-settings will effectively turn our biopharma
industry to a risk-averse, think-inside-the-box-rather-than-
outside-the-box commodity industry. And I am concerned. That is
not what American citizens want.
OK. Dr. Gupta, I have a question for you. Can you speak to
how H.R. 3 would impact complex rare diseases and investments
there due to the economic incentives in H.R. 3, where the
signal to manufacturers to invest in rare diseases are lower
cost following up? What kind of an effect would H.R. 3 have on
investment, R&D, with regard to rare diseases, please?
Dr. Gupta. Thank you, Congressman. Well, first I think it
is important to recognize that small biopharma companies are
the ones driving innovation. They comprise about 70 percent of
drugs in phase 3. And they are the ones that primarily serve
rare-disease patient populations.
So they are the ones that have to seek raising capital from
investors. And I think because of that phenomenon and because
rare-disease populations are of course smaller, meaning that
price controls would actually impact them disproportionately in
terms of the revenue potential of most things that are being
developed, my belief is that price controls, as contemplated by
H.R. 3, would significantly negatively impact rare disease
patients.
Mr. Bilirakis. OK. One last question, and then I want to go
to Ms. Davis, if I am permitted. Ultimately, would H.R. 3
increase or decrease China's and foreign influence over U.S.
biomedical research? Yes or no? This is for Mr. Gupta.
Dr. Gupta. I don't think it would increase influence over
existng U.S. companies. I think it would give China a chance to
equilibrate and develop an ecosystem where they could structure
and innovate drugs to market.
Mr. Bilirakis. I know I don't have--well, you know what,
Madam Chair? I am sorry. I am not going to go over the time.
All right? So I will yield back. Thank you. I just had the
vaccine shot, so I am a little bit fatigued. But I apologize
for that. But I appreciate your giving me the time.
Ms. Eshoo. Well, thank you, Gus. And bravo to you for
getting the--for being vaccinated. That was a great thing----
Mr. Bilirakis. Thank you. My second dose, second dose, so I
am very happy.
Ms. Eshoo. It is a great example to everyone else and the
people in our country. And you give my love to Mom and Dad, all
right?
Mr. Bilirakis. That I will. Thank you.
Ms. Eshoo. It is a pleasure to recognize the gentleman from
Oregon, Mr. Schrader. We are all grateful to you for your
thoughtfulness, for your work. And he will be followed by the
gentleman from Missouri, Mr. Long. So you are recognized, Kurt,
for 5 minutes.
Mr. Schrader. Thank you very much, Madam Chair. Appreciate
it. Appreciate the hearing. This is good stuff.
Dr. Gupta, I am just trying to follow up a little bit on
what my good friend and colleague Gus Bilirakis was talking
about. But on the flip side, given your role in venture
capital, if we were to do H.R. 3, how or would that impact
investments in the biotechnology startup sector?
Dr. Gupta. Thank you, Congressman. I think that the impacts
would be far reaching, they would be wide, and they would be
generally negative. I think that, if there are sectors that
could seek that investment that provide safer returns or better
returns, the prospect of that, you may see a diminishment of
the types of risk that investors are willing to take in
biotech.
Mr. Schrader. Would there be any difference if, instead of
the benchmarking to set price, we just allowed negotiations on
the part of Medicare like with the VA and, in certain States,
Medicaid? Would that be different?
Dr. Gupta. I think that it unfortunately doesn't help
address the core issue, which I think remains the various
access primarily at the end of the funnel, which is out-of-
pocket costs. And price controls of any sort do not ensure that
the payers will pass those savings on to patients. So I
hesitate to suggest that there may be some amount in
negotiation without focusing first on what we see as the larger
problems.
Mr. Schrader. OK. OK. I just saw negotiation as distinctly
different than benchmarking, personally. We do that in so many
other areas, and I assume that a lot of folks take that into
account when they make their investments going forward.
Ms. Sachs, you mentioned a couple of other topics you would
like to see the committee address, maybe at a later data,
looking at other parts of the supply chain. I think this
committee totally agrees with you. We have had numerous
hearings over the last several years on this.
Are there particular policies that address entities beyond
pharmaceutical manufacturers that you think we should be really
prioritizing?
Ms. Sachs. Yes, absolutely. So in particular, in thinking
about the ways in which different actors have incentives to
drive prices up rather than down. I do think it is important to
look not just at the pharmaceutical industry but also at the
role insurers, pharmacy benefit managers, and even physicians
or provider groups in general can play in driving prices up
rather than down.
So this committee has already considered some of these
proposals. But others would include taking a closer look at
pharmacy benefit manager practices and some of these issues in
terms of spread pricing. I know this is also a topic of robust
interest at the State level, with several State attorneys
general interested in either having already brought lawsuits
against the topic certainly we have been discussing so
publicly.
Mr. Schrader. You also discussed a little bit about
considering the linking of medical value to price of drugs paid
for particularly by a government on any--do you think that
allowing governments to craft arrangements for a drug, paying
for it over a period of time, or based on outcomes would be
beneficial also?
Ms. Sachs. Congressman, I actually think that is two
different questions, so I am going to answer them very briefly
because I know we are short on time.
So first, this idea of value investment, if we have two
drugs that are treating the same condition, value assessment
means we want to pay more for the drug that works better. And
if we do that, companies will know that the better the drug
they make, the more money they are going to make. They will
invest more in products treating unmet needs.
But this idea of value-based pricing, which has come up
already in a discussion today, that is what the pharmaceutical
industry wants to call it, this idea of outcomes-based
contracts. But there is nothing about either the initial or the
rebated price of the product, which are necessarily tied to a
clinical value. So I like to call them innovate contracting
models.
The point I want to make about them is that they are
voluntary for industry to engage in. Industry won't engage in
these deals unless they think it makes them more money, not
less. Right now they are not required to enter into those
deals, and that is certainly of concern for payers.
Mr. Schrader. That may be something we want to work on in
the future, get at those concerns that you have. I am a big
supporter of negotiating prices in the arrangement. We already
do it in VA. We do it for many States and Medicaid.
But I also want to make sure we get something done. I do
have some reservations about the indexing, personally, and so
do my constituents. I have heard from a bunch of them of late.
But I think there is overwhelming bipartisan, bicameral
agreement to work on some sort of solution here and accomplish
some of H.R. 19, which is great but doesn't go far enough and
may be something not quite as robust as our H.R. 3.
But I am feeling good about the opportunity here, and
really having you here.
Madam Chair, thank you very much. I yield back.
Ms. Eshoo. The gentleman yields back. And you have our
gratitude for your thoughtful work.
The Chair is pleased to recognize the gentleman from
Missouri, who is always--well, there is no one like Billy Long.
So you are recognized for 5 minutes.
Mr. Long. Thank you.
Ms. Eshoo. Followed by--excuse me--followed by Mr. Cardenas
from California.
Mr. Long. Thank you, Madam Chair, and I appreciate it very
much. I am saddened by--we can't tackle this situation, the
drug pricing situation, the same way with the same
bipartisanship and the same enthusiasm that we did 21st Century
Cures, when you and Chairman Upton worked so hard with the
entire committee. And I remember a vote coming out of the
subcommittee that was 52 to nothing. I don't know if that had
ever been done before.
And I don't know what it takes to get back to that place in
America. I don't know what it takes to get back to that place
in Washington, DC. But we all need to work overtime trying to
get back because that was stellar. Ten thousand diseases and
500 cures, and we tackled the problem with your help and
Chairman Upton's help. The whole committee pulled together. And
then we find ourselves in a cantankerous effort like we are
here today.
Dr. Gupta, it is clear that everyone on this panel wants to
make sure that prescription drugs are affordable to all who
need them. While we may strongly disagree on how to achieve the
goal, there is bipartisan agreement that the Part D program can
be improved. A redesigned benefit that could protect benefits
from high drug spending is included in both H.R. 3 and H.R. 19.
I thought that we could seize on this rare bipartisan
opportunity to get these important benefit improvements signed
into law this year and to not get bogged down in a partisan
fight over other drug pricing reform. Can you please elaborate
on why it is important to cap beneficiaries' out-of-pocket
costs in Part D?
Dr. Gupta. Thank you, Congressman. Capping out-of-pocket
costs is the key to ensuring access, ultimately, as well as the
question of emphasizing that new drugs are created. But patient
costs in 2019 were about $82 billion, and we know that 25
percent of patients will walk away when out-of-pocket costs are
above $50. So it is important to eliminate those barriers to
access.
Mr. Long. I have heard from my colleagues on the other side
of the aisle about the enormous profits that the biomedical
industry purportedly receives at the expense of patients. But
many of the same companies, especially smaller startups in
places like California and New York, are enormous job creators
and constantly reinvesting their revenue into research and
development and cutting-edge jobs.
Dr. Gupta, could you please speak a little more to how H.R.
3's policies might impact the vibrant biotech job growth
factor, not only in Silicon Valley but in the rest of the
country? And would you say that many of these jobs could move
overseas if H.R. 3 were enacted?
Dr. Gupta. Yes. Well, thank you. That question is reminding
[audio drop] 1.4 percent GDP that we spend on branded drugs. We
get a lot of bang for the buck, not only in the improved [audio
drop] was over a trillion dollars, and we employ over 800,000
workers in biopharma. One-third of those are in key STEM
occupations, and most of the workers are highly mobile Federal
workers for any industry.
If H.R. 3 and price controls are set in a way that it has
the deleterious effects the industry and we all think it would,
I could see an impact on the economic--a significant impact on
the economic output of the sector, affecting jobs of course in
California, Massachusetts, New York, New Jersey, and across the
country where the sector is, you know, employs people.
Mr. Long. I don't know if somebody is not muted or what,
but I am also on the Telecom Subcommittee and I think I need to
get to work on that as much as you were breaking up there on my
end. So if anyone is not on mute, you might want to hit mute
there.
Dr. Gupta, sticking with you here, your testimony
emphasizes much of the biotech advances being made in China in
recent years. It seems they are already nipping at our heels
and see biotech as an industry of enormous strategic
importance. How do you expect China's strategy to change if
H.R. 3 becomes law?
Dr. Gupta. Well, I think we have two advantages today in
the United States because of the NIH, our tremendous public
science funding or tremendous university system. The only way
China will ever catch up--the only way we will ever fall behind
is if we do it to ourselves.
So my sense--and I am not an expert on China's policies or
how they might react--my sense is that they would really lean
in, trying to catch up and trying to siphon as much of the
talent, as much of the IP, and as much of the know-how in a
very defined way.
Mr. Long. And if H.R. 3 were to become law, would it be as
simple as flipping a switch to turn our biotechnology system
back on to follow if investment does move to China and other
countries?
Dr. Gupta. Probably not as simple as flipping a switch. I
think that we have tremendous advantages here, such as the NIH
and the public university system, that we can always rely on
and we can always go back to that well to reclaim our
leadership advantage.
Mr. Long. I hope that everyone got to see ``60 Minutes'' on
Sunday, with China's chip development and our lack of chip
development. I don't want to see that going to the drug rep
phase.
I am over time here, Madam Chair. And thank you for having
a great hearing today. And with that, I yield back.
Ms. Eshoo. The gentleman yields back. And thank you, Mr.
Long, for highlighting what the biotechnology industry
represents in our country, certainly in my congressional
district. It is a great source of pride to anyone that
represents them because of the innovation that they produce. In
fact, for big pharma, the big companies look for innovation to
the biotechnology industry and acquire them for--because of
their innovation. So thank you.
The Chair now has the pleasure to recognize the gentleman
from California, Mr. Cardenas, followed by Mr. Markwayne Mullin
of Oklahoma. So you are recognized, Tony, for 5 minutes. Great
to see you.
Mr. Cardenas. Thank you, Madam Chairwoman. And I appreciate
you and Ranking Member Guthrie for holding this important
hearing. And thank you to all the witnesses for your expertise
and opinions today.
We know that lowering prescription drug costs is a priority
for all Americans, and I think that lowering healthcare costs
overall is a priority as well. Even before the pandemic, one in
four Americans reported difficulty affording their medications.
Our current economic reality has only made it worse.
As the wealthiest country in the world, the high cost of
prescription drugs is unjust, and for too long it literally has
become a matter of life and death for many families and many
children. No one should be forced to ration or avoid taking
medications as to whether or not they can afford it. This is
not what Americans or any person deserves, and I am glad that
our committee is working on the solution to address it today.
And I hope that we can continue this fight to address the other
90 percent of costs that Americans are concerned about when it
comes to healthcare overall.
And as we have prioritized affordability for patients with
families. It is also important that we ensure research,
development, and production of existing and new medicines can
continue to make it to market so that we can have more cures
and more lives saved, and also the quality of life of Americans
is improved.
Ms. Ball, again thank you so much for your testimony today
and for sharing such a personal story, not only about yourself
but about the people you care for. Can you please expand on
what it felt like for you to know this about patients who are
rationing their care or who can't afford to get the care that
they need because of prices? And what does it mean to you?
Ms. Ball. What it meant to me is that not only did I have
difficulty with my memory and my physical being, I also had to
stop nursing. And that was the love of my life, so that was
huge. It also is what I see is all my fellow advocates, people
that I have run into in special groups--they are past the point
of what they can do. Their disease is progressing at a rapid
pace, and they are not able to get their drugs.
I think that we need to look at this, as you said, that we
need to get this bill passed in order for us to save the people
in the United States with MS alone. I am sure it is affecting
almost every disease, those that are disabled and also for the
rare diseases. So it is something that needs to be dealt with.
You can't imagine that 1.1 billion people will die from the
fact in the next decade for not receiving their medications.
People in the United States should not, one, depend on charity
to get their drugs, and people in the United States should be
able to take care of themselves without having to depend on
either charities or ``Do I get my groceries?'' You see the
imperative that we take this and we take it for--it is for all
of us.
Mr. Cardenas. Thank you, Ms. Ball. Some bills we are
discussing today involve biosimilars, biologics that are
similar to other already Food and Drug Administration-approved
biologic medicines. I believe biosimilars play a role in
helping lower prescription drug costs for patients across the
board.
That is why I reintroduced the Increasing Access to
Biosimilars Act. By authorizing a Medicare pilot program, this
bill would help encourage physicians to prescribe less
expensive biosimilars, promoting healthy competition and
increasing patient access to lifesaving prescription drugs by
making it more affordable for them.
Professor Sachs, could you please discuss your thoughts on
biosimilars and how they could help increase affordability for
patients and families?
Ms. Sachs. Absolutely. And biosimilars and generic small
molecule drugs are a key part of the social bargain that we
have made with drug companies, where we give them exclusive
rights, patents and an FDA exclusivity period, but we expect
that at some point, competition through biosimilars and
generics will enter and increase affordability for patients,
increase our system affordability, and drive down prices.
And the U.S. has yet to realize the full promise of
biosimilar competition, and it is very important to consider
bills that would increase biosimilar competition in the U.S.,
as biosimilar competition in Europe is quite ahead of us by
points of margin.
Mr. Cardenas. Well, one of the things that I have a problem
comparing us to Europe is that the United States invests more
money in R&D in this field than they do in Europe. In addition
to that, in the United States we have more talent, thank God,
and the reason why we have more talent is because somehow, some
way, we have been able to create that environment. Hopefully we
don't have a negative effect on that when we are trying to
correct this issue of drug pricing in America.
My time is expired. I am sorry, Madam Chair. I yield back.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize the gentleman from Oklahoma,
Markwayne Mullin. And we all hope that your son continues to
make the progress that he has been making, which is really
miraculous. And he will be followed by Dr. Ruiz from
California. So you have your 5 minutes for questioning.
Mr. Mullin. Well, thank you, Chairwoman Eshoo, and thank
you for always being concerned about my son. It is ironic
because we are talking about drug pricing, and one that I have
to point out, that my son, he has to take a shot every week--or
every day, I am sorry--and it costs about $4,900 a month now
because of the----
Ms. Eshoo. Wow.
Mr. Mullin. And sometimes the insurance pays. Sometimes the
insurance doesn't. And it is a bit tough for my wife and I,
much less think about what my son, who is 17 now, what he is
going to do. I mean, when my wife and I got married, I was 19
and she was 18 and we were making $500 a week combined. We were
just barely going to get by. And to just think you are going to
handcuff--literally handcuff--someone like that.
So when we are talking about drug prices, I understand it.
I get it. It is something real to us, and we're up to deal with
it. But I still have a little bit of a hard time with H.R. 3.
When you start thinking about H.R. 3, it is government takeover
of healthcare because, when the Government gets into setting
prices, then they are telling the manufacturers--which is
independent from the Federal Government, they are
entrepreneurs. it is what the United States thrives on, not
government takeover but of entrepreneurship--when you start
telling them how much they can charge, it is--it does affect
what they do and what they are willing to invest in, because
they are going to be capped on what they are able to get
reimbursed for, whereas my opinion is we should be looking at
what is prohibiting competition from coming into the market.
What is prohibiting individuals from entering the market?
Why are we seeing the consolidation of pharmaceutical
companies, because with more competition, we would see prices
come down because they are going to be competing for our
pricing, they are going to be competing for our business. If
you are talking about insulin or you are talking about the shot
that my son has to take every night because there is only one
manufacturer that makes my son's shot too. And so there is no
market. It is either take it or leave it.
Dr. Gupta--I hope I am saying that right, I know we have
all been using different names to get to you--but Dr.
``Goopta,'' is that how you pronounce it?
Dr. Gupta. Yes, Congressman. Thank you.
Mr. Mullin. Would you agree that innovation is the best way
in the market to control pricing?
Dr. Gupta. Well, I think that that is exactly right. And I
think there are a couple of different aspects to it. As I have
mentioned, the value we get from good prescription drugs via
pharmaceutical purchasing in terms of improved health outcomes
is second to none.
We have to remember that these drugs that we are talking
about keep people out of the hospital, thereby saving overall
healthcare costs. And I think that is an important point to
remember. And I think, tying in to your comments just a moment
ago, when these drugs go generic, when there is competition, we
as a society save over $200 billion a year, $2 trillion a
decade. And I think that is exactly the phenomenon that you
were referring to.
Mr. Mullin. So is it fair to say, then, that modernizing
and recalibrating the natural price control like the generic
drug pricing would help protect innovation and control pricing
a little bit better then?
Dr. Gupta. It would not just protect it, sir. It would
actually stimulate it. The generic--genericization of medicines
is not only a natural price control, it actually stimulates
innovate biopharma companies to develop new medicines. As an
investor, that is a process that we support.
Mr. Mullin. Right. I appreciate that. So with government
control in the market, do you feel like that really creates
more partisan regulations that would prohibit new companies
from entering into the market, then?
Dr. Gupta. I think we can all agree that we should be
limiting barriers to generic competitors. I think there have
been good ideas posited on that. And I wanted to make a quick
comment in this regard on biosimilars.
I see evidence of successful biosimilar entry in the U.S.
as well. Biosimilars for drugs such as Avastin and Herceptin
now have a 50 percent market share. There is a new company in
those cases that has started to offer discounts. And that is
natural price control in action.
Mr. Mullin. All right. Well, listen. I appreciate your
time. Chairwoman Eshoo, thank you for always being concerned.
Thanks for bringing us together, too, because I do agree with a
lot of my colleagues that there is room here for us to work on,
and I think this affects all of our lives. And there is a lot
of opportunity. I just really wish we had a more bipartisan
approach.
H.R. 3, I don't think we really had a whole lot of say in.
It has almost been like the committee is going to take it or
leave it. And this committee has had a history of working
together, and ever since we have been on it, we have had a
history of working together. And I know you want to work with
us. I know there are other people across the aisle that want to
work with us.
So I hope this is the beginning of us actually looking for
a solution to have H.R. 3 work for all of us, Republicans and
Democrats alike. So with that, I yield back.
Ms. Eshoo. Thank you, Mr. Mullin. And thank you for always
sharing your story with us. The American people are tuned in to
these hearings. I think they sometimes have a picture that is
not quite accurate about individual Members of Congress, the
vulnerabilities in our families, what takes place in our lives.
It is like holding a mirror up to the country. So I salute you
for that. It really is very important.
The Chair is pleased to recognize one of the doctors on our
committee, Dr. Ruiz of California, followed by one of our
pharmacists in the Congress, Mr. Carter from Georgia. So you
are recognized, Dr. Ruiz, for 5 minutes.
Mr. Ruiz. Thank you. Thank you very much for holding a
hearing on this very important issue. And thank you to our
witnesses for being here today.
During debate over the drug pricing policies, how Congress
should address access and portability, it is important to
remember why we are having this debate in the first place,
which is the patient. Unfortunately, the patient and the
importance of access to health and life-giving medications
sometimes gets lost in the shuffle.
But that is exactly what the core of this debate needs to
be about. It is about the dad who can't afford the medication
for his child and has to decide every month whether to cut
corners on food for the family or medicine for his child.
It is about the mom who is working two jobs to help pay for
her aging mother's medicine while also paying for healthcare
for her kids.
It is about my patient who told me once that she collected
cans to help pay for her insulin and told me that she figured
out a way to afford her medicine by only taking half of the
dosage to make it last longer, which makes her medicine, of
course, ineffective.
The average American often cannot afford their medication
even if they have insurance, even if they have Medicare. So
seniors and families all across America are rationing their
medications. They are going without them completely because
they simply cost too much. And I know I am hearing about it
from my constituents, and I am sure that even up here on the
dais is hearing similar stories.
For example, David, a senior from Beaumont, California, in
my district contacted my office recently to tell me about the
heart medication his doctors want to prescribe but for which
there are no generic alternatives. The medication is so
expensive that after the first 3 months of the year, David goes
into the doughnut hole, where he will remain for the rest of
the year, paying $3,294 in 9 months just for his heart
medications.
For seniors living on a fixed income, this is not
affordable and is not acceptable. Individuals and their doctors
should choose the treatment based on what is best for the
health of the patient, not primarily on whether the patient can
afford to pay for the drug out of pocket. This system is
unacceptable. America can and must do better. And it is time we
do something about it.
Healthcare is a right for everyone, and access to
prescription medication should not be reserved as a privilege
only for the wealthy few. Professor Sachs, thank you again for
your testimony. This is a lot of discussion about the most
effective way to bring down drug prices, including allowing the
Secretary of HHS to negotiate prices directly with
manufacturers, much like the VA does.
So H.R. 3 requires the Secretary to negotiate at least 25
of the most expensive sole-source drugs in the first year and
at least 50 each year after that, as well as insulin. Would you
agree that negotiating eligible drugs is the most effective way
to deliver the greatest amount of savings and best use of
resources? And do you think that H.R. 3's mechanism for
selecting drugs for negotiation provides the most, quote,
``bang for our buck''?
Ms. Sachs. H.R. 3 certainly seems to be designed to provide
the most bang for our negotiating buck. So the Secretary is
explicitly told to select for negotiation the drugs the
Secretary thinks will result in the greatest savings to either
the Federal Government or beneficiaries throughout the relevant
period.
And it makes sense to phase in the program and start with
the subset offering drugs most likely to deliver the most
savings before expanding.
Mr. Ruiz. Thank you. And let's translate that to what it
means for the patient. So CBO estimates that prices could be
reduced by up to 55 percent for the first set of drugs
negotiated by the Secretary. So what impact would those price
reductions have on healthcare out-of-pocket costs for the
patients?
Ms. Sachs. Well, as a physician, you are an expert,
certainly. But the CBO has said that, if patients are more
easily able to afford their prescription drugs, then they will
take those prescription drugs. And in at least some conditions,
they will have lower overall healthcare costs. If you can avoid
hospitalizing a patient because they are taking their
medication on a regular basis, that is very important and it
can lower healthcare costs overall.
Mr. Ruiz. Thank you very much. This is so important for our
Nation. It is not fair that America has to pay three times as
much as other countries on the exact same medication. So
America can and must do better. And I thank everybody for being
here today, and I yield back my time.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize the gentleman from
Georgia, Mr. Carter, followed by our colleague Congresswoman
Debbie Dingell of Michigan. So you are recognized, Buddy, for 5
minutes.
Mr. Carter. Thank you, Madam Chair. And thank all of you
for being here, to the witnesses. And you know, as a pharmacist
for over 30 years, this is the one issue that has frustrated me
more than any other issue that I have tried to work on while I
have been a Member of Congress because the answer is so simple
and is so clear.
The problem to me, from my perspective, is the vertical
integration that exists within our healthcare system. When you
have the insurance company that owns the PBM that owns the
pharmacy, you have a vertical integration there by which, any
time you squeeze that balloon, the only thing that is going to
happen is it is going to go somewhere else. And that is what is
happening here.
Dr. Gupta, you referenced PBMs and the problems that they
had in your opening testimony. And that is the problem. I know.
I am a pharmacist. I was a retail pharmacist, an independent
retail pharmacist. I am the one who signed the front of the
paychecks. I had to make the numbers work. And I know where the
problem is.
And the problem right now is that you have three PBMs that
are all owned by insurance companies. Someone made the point--I
believe it was you, Dr. Gupta--that prescription drug prices
are only a small percentage of the total healthcare cost. And
they are.
But the problem is, the reason that prescription drug
prices are so high is because, when you have Aetna that owns
Caremark that owns CVS, when you have Cigna that owns Express
Scripts PBM that owns Express Scripts mail order pharmacy,
which by the way is the second busiest in terms of volume in
the Nation, when you have United, which has the insurance, the
PBM, and the pharmacy as well, then you have three PBMs that
own--that cover over 70 percent of the market. There is no
competition there.
And that is what has got to be broken up. And yet we tend,
in Congress, to try to attack it from a different perspective.
And then we have a bill like H.R. 3. I appreciate and I applaud
you, Madam Chair, and I applaud the majority party as well as
the minority party for trying to address this problem. But this
is going to hurt more than it is going to help.
I tell this story all the time. When I first started
practicing pharmacy in 1980, if you were diagnosed with
hepatitis C, it meant you were going to die because we didn't
have a cure for it. Now, through research and development by
the pharmaceutical manufacturers, you can take a single pill
and be cured of it. That is nothing short of phenomenal.
However, if that simple pill costs $85,000 and you can't
afford it, it does you no good whatsoever. The problem is, we
have got to break up that monopoly, that vertical integration.
Dr. Gupta, I want to ask you: How important do you think
this issue is and saving patients would have if PBMs were held
accountable, if the middlemen, who bring no value whatsoever to
the healthcare system, if they were made to be transparent and
accountable?
Dr. Gupta. Well, Congressman, I couldn't agree wity you
more. There is a [audio drop] in the PBM industry and in
general among prescription drug middlemen, in fact, of what we
spend on prescription branded drugs. Only 53 percent is
estimated to actually make it back to manufacturers, and the
middlemen are not just taking a small cut. They are taking, in
many cases, a substantial cut. And transparency----
Mr. Carter. I am sorry, Dr. Gupta. What are they doing with
that 47 percent? Are they putting it back into research and
development? At least the pharmaceutical manufacturers are
putting it back into research and development.
Dr. Gupta. You are right, Congressman. I think that the
middlemen have consolidated, and three entities have really
outsized market power right now because they represent such a
vast proportion of lives.
Mr. Carter. And my concern with H.R. 3 is it is going to
stifle innovation. I mentioned hepatitis, and I mentioned all
the other things that I have seen nothing short of miracles
come out of research and development over my many years of
practice in pharmacy.
I think about my friends that suffer and that have family
members that suffer from Alzheimer's. Right now there are
currently estimated to be almost 6 million Americans with
Alzheimer's. But by 2050, the Americans age 65 and older with
Alzheimer's is projected to be as high as 14 million.
We have had 146 unsuccessful attempts to develop medicines
to treat Alzheimer's. Dr. Gupta, what is H.R. 3 going to do to
research and development for potential cures for Alzheimer's?
Dr. Gupta. I think it could be done, not just Alzheimer's
but these--ALS and similar diseases, where we haven't,
unfortunately, made very much progress. We continue to try. We
continue to take the best and purpose resources into them. But
eliminating the potential for incentivizing that innovation, I
think, could be devastating.
Mr. Carter. Madam Chair, I appreciate your indulgence. I am
just telling you, the solution is simple. It is right before
us, and we are not getting it. We are not understanding that it
is right--all we have got to do is break up this vertical
integration that exists within the healthcare system. If we
break it up, we can do something about prescription drug
prices. We can do something about healthcare costs.
Thank you, Madam Chair, and I'll yield back.
Ms. Eshoo. Thank you, Mr. Carter. And I agree with you on
the issue of PBMs. I really think that we miss an opportunity
for very important reform, and I have held that view for some
time. So thank you for your consistent passion about that.
The Chair now has the pleasure to recognize the gentlewoman
from Michigan, a name that is honored over decades in the
Congress, Congresswoman Dingell, followed by one of our
distinguished doctors on the committee. Dr. Neal Dunn of
Florida will follow her.
Debbie, you are recognized, 5 minutes.
Mrs. Dingell. Thank you, Madam Chair. And my heart is with
my pharmacist colleague, too. We do need to talk about that.
But I don't want to draw attention from some of the issues that
we are talking about today. And Ranking Member Guthrie, thank
you, too, because this hearing is just so important because so
many of us have constituents who simply can't afford their
medicine.
We have heard some arguments here today that, if H.R. 3
were to become law, then there is a likelihood that innovation
would be driven to China. I think that this is a red herring,
let's be clear, because absolutely nothing in H.R. 3 is closing
the U.S. market for drug manufacturers or drug development.
The fact is that the United States is the largest
pharmaceutical market in the world and the pharmaceutical
industry relies heavily on the premium academic institutions
for their R&D work. There is no reason to believe H.R. 3 will
fundamentally alter this dynamic. Innovation occurs where the
best science is done, and the best science happens here in the
United States of America.
And there is no doubt that the U.S. will continue to be the
world's leader in funding for basic medical science. And H.R. 3
provides additional resources to NIH to maintain our Nation's
role as a global leader in innovation.
So Professor Sachs and Professor Carrier, we have heard
claims today that China can run clinical trials faster than
U.S. counterparts. But does that mean they are better?
Americans expect that the drugs that they and their families
are going to take should meet rigorous review standards in
order to ensure they are safe and effective.
Do you agree that the Food and Drug Administration is the
gold standard for drug approvals in the world? And whichever
one of you wants to go first.
Mr. Carrier. Yes. I do think that the U.S. FDA is the gold
standard for the world.
Mrs. Dingell. Professor Sachs?
Ms. Sachs. I agree completely.
Mrs. Dingell. Additionally, Professor Sachs and Professor
Carrier, isn't it fair to say that China pays relatively low
prices for drugs? Why would we expect the Chinese market to
have greater innovation potential than the United States?
Ms. Sachs. That is absolutely correct. China pays lower
prices for drugs than we do. And I think you put it well when
you said that innovation occurs where the best science is done,
not where the drug prices are the highest.
Mrs. Dingell. Professor Carrier, any comments?
Mr. Carrier. Sure. I think that one issue that we haven't
talked enough about is the type of innovation that would be
affected by H.R. 3. So we are not talking about that many
drugs. It is only 8 to 15 fewer drugs out of a total of 300,
according to the studies.
And if you look at the type of drugs here, they are not the
most revolutionary drugs. So for example, there is one study
that has come out that looked at 122 ultraexpensive drugs in
Medicare annual spending of $63,000 a year, and found that 73
to 85 percent of them have no or low additional added value.
And so when we are talking about this, we are not talking about
the blockbuster drugs. We are talking about a lot of ``me too''
drugs.
Mrs. Dingell. Well, let me ask you about that because I
hear from my constituents about the high cost of older drugs
like albuterol. I mean, everybody on the committee knows that I
cannot get the story of the mother out of my head who has to
pay $800 for an inhaler. And so, for example, inhalers to treat
asthma can cost hundreds of dollars, but they are decades-old
drugs.
Professor Sachs and Professor Carrier, how will the H.R. 3
framework incentivize new innovative frontline research rather
than the ultra ``me too'' drugs that you just discussed?
Mr. Carrier. Well, it will force pharma to create new
innovations. Pharma has played all sorts of anticompetitive
games, and they have relied on those games, and they have
relied on charging whatever price they want in the U.S. so they
don't have to do quite as much innovation.
Sure, innovation of the revolutionary kind is hard, but to
the extent you can rely on these tricks that have gotten you to
this point, then there is no need to go beyond that.
Mrs. Dingell. Professor Sachs?
Ms. Sachs. I agree--yes. My apologies. I agree. If you look
at the top-selling drugs in Medicare right now, Part B and Part
D, most of them are over a decade old. These are drugs that
have recouped their investment and have had plenty of protected
time on the market.
Negotiating for the prices of these drugs won't harm
innovation in the future. It will make space for future
innovation in just the way Professor Carrier said.
Mrs. Dingell. Thank you both. Madam Chair, with 12 seconds
left, I guess I will yield those back.
Ms. Eshoo. The gentlewoman yields back.
It is a pleasure to recognize Dr. Dunn of Florida. And he
will be followed by our colleague Congresswoman Kuster. Dr.
Dunn, you are recognized.
Mr. Dunn. Thanks very much, Madam Chair.
Ms. Eshoo. Thanks for your patience.
Mr. Dunn. Appreciate it. No, no, I appreciate your having
this hearing.
We all know that the policies we make in Washington can
have tradeoffs, both good and bad. But any policy that will
choke off investment in an entire industry--and an industry
that is in the industry of making cures--is bad policy.
I want to associate myself with Dr. Gupta's testimony. I
think we are living in a truly fascinating age with medicine
and cancer treatments, gene therapies, CAR T therapies,
monoclonal antibody treatments, and many more are in
development or recently hit the market.
And we all want Americans to have access to these new,
innovative cures. Americans already have access to more cures
than do the citizens of the nations that H.R. 3 seeks to tie
our drug prices to. Why take a step backwards and restrict
access to cures for sick Americans?
The quality-of-life metric, so-called QALYs or quality-
adjusted life years, are built into the prices some of our
European friends pay for their prescription drugs. By these
calculations, a treatment that extends the life of a disabled
patient is worth less than a treatment for a young, healthy
patient. This is not an attitude we should be importing, and it
flies in the face of the Americans with Disabilities Act.
In Florida, the estimated impact of H.R. 3 is a loss of
nearly $7 billion in economic output, 300,000 jobs, many of
them at small and medium-sized biotech companies, and doing
clinical research. H.R. 3 is an industry-killing proposal at a
time when so many cures are on the horizon, and it is
strikingly short-sighted in the wake of a global pandemic.
To be clear, I think Americans should have access to the
kinds of cures I am talking about at an affordable price. We
all want the prices to come down. I associate myself with Buddy
Carter's remarks on that. But let's not destroy the American
pharmaceutical industry and strangle innovation in the process.
H.R. 19, the Lower Costs, More Cures Act, is full of
bipartisan provisions to achieve just that. Fully 17 of these
provisions were signed into law last year after careful
bipartisan reaction. We passed transparency. We classified
insulin as a biologic, improved generic medicines. Forty more
bipartisan provisions are included in the H.R. 19 bill this
Congress.
And it includes provisions to reduce out-of-pocket costs,
learn more about the costs of middlemen in the pharmaceutical
industry, combat shady practices, extending patents, et cetera.
I am disappointed by this shortsighted effort to control prices
at the cost of tradeoffs that are just too harmful to patients
suffering from many diseases.
Dr. Gupta, I would like to direct my questions to you. We
just witnessed the incredible speed at which vaccines were
developed in COVID. Can you think of any control on H.R. 3's
international reference price list that produced and delivered
multiple COVID vaccines to market over the last year? And do
you relate that to the relative capabilities of the
pharmaceutical industries in those countries before the
pandemic arrived?
Dr. Gupta. Absolutely. Thank you, Congressman. I think it
is important to recognize that, for instance, there were
certain therapies such as dexamethasone, which was a generic
drug which ended up being effective. Perhaps we would have been
able to develop the monoclonal antibodies--I think we would
have--that serve for acute patients. And certain types of the
vaccine, including the antivirus vaccine, may have been
developed as well.
But the mRNA vaccines, I think it is important to recognize
that it was biotech investment over the preceding several years
that laid the foundation that allowed them to be positioned and
rapidly developed an effective vaccine in under a year.
Mr. Dunn. Thank you. So let me charge ahead with our
limited time. Dr. Gupta again, it takes 10, 15 years for new
treatment to make it through the pipeline. There are currently
over 250 cell and gene therapies in early clinical stage
trials, 17 for ALS, 16 for MS, and 300 for rare pediatric
diseases. What happens to these potential cures if H.R. 3 is
signed into law? And do you think the manufacturers will pursue
approval for these drugs if H.R. 3 is enacted?
Dr. Gupta. I think some of them may. I think some of them
try to do the math and realize that there is no longer an
argument to be made to pursue it. I think that the longer
extreme danger is that it will close up the funnel at the top
end and we might never get to 1,000, 2,000, or 10,000 cell and
gene therapies in the pipeline, which is where we should be
headed.
Mr. Dunn. Good. So I want to relate a quote from an
Australian physician in the last few seconds here. He said, ``I
disagree with government decisions often because I want to use
a medication which is shown to be of benefit and is the
standard of care in the United States that I just can't use.''
That was by an Australian hematologist.
This is what we risk if we go down the path of H.R. 3. Why
on Earth would we want to import these frustrating, tragic
stories to our practices?
With that, Madam Chair, I yield back. Thank you again for
having this important hearing.
Ms. Eshoo. I thank the gentleman, and he yields back.
The Chair is pleased to recognize a good friend to all of
us, the gentlewoman from New Hampshire, Ms. Kuster, being
followed by Mr. Curtis of Utah.
Annie, you are recognized for your 5 minutes of questions.
Ms. Kuster. Thank you so much, Chairwoman Eshoo, for
holding this important hearing today to discuss legislation to
lower the cost of prescription drugs for the American people.
For too long Americans have been grappling with the
skyrocketing costs of prescription drugs, and the current
trajectory for what Americans, and particularly seniors on
Medicare Part D, pay is simply unsustainable, and the status
quo is simply unacceptable.
For years since I began running for Congress, I have been
calling on Medicare to be able to negotiate the price of
prescription drugs, a policy that has broad support amongst the
American people and would generate literally billions of
dollars in savings. So I am so pleased to see this provision
included in the Elijah Cummings Lower Drug Costs Now Act.
Legislative reforms to how we price drugs and medication in
America should be a nonpartisan issue. It doesn't matter what
your party affiliation is or where you live. Americans in every
corner of our country are seeing more and more of their hard-
earned dollars going to prescription drugs and lifesaving
treatments.
And that is why I am so pleased to partner with my friend
and colleague, Republican Congressman David McKinley, on
bipartisan legislation to create billions in savings for
Medicare Part D beneficiaries. Last week we introduced the
Ensuring Access to Lower Cost Medicines for Seniors Act, which
aims to ensure Medicare beneficiaries receive the full benefit
of affordable generic drugs.
The placement of generic and biosimilar medicines in the
same pricing tier as more expensive brand drugs has led to
seniors paying more out-of-pocket costs for their medicine. Our
bipartisan bill seeks to reverse this trend by ensuring
automatic coverage of lower-cost generic medications
immediately after launch, and the creation of a dedicated
specialty tier for specialty generics that offer lower-cost
sharing for seniors.
The Ensuring Access to Lower Cost Medicines for Seniors Act
could save seniors $4 billion per year through reforms to how
generics and biosimilars are covered. And I want to thank
Chairwoman Eshoo for including this bipartisan bill in today's
hearing.
Ms. Sachs, thank you for your testimony and for describing
how some of the misaligned incentives, it is how Medicare Part
D operates. In your opinion, does Medicare Part D's design
currently incentivize the coverage of brand-name drugs even
when lower-cost generic medicines might be available?
Ms. Sachs. I would agree that there are elements of the
Part D design which contribute to this. But it is also really
about the relationships between the Part D plans and the PBMs
as well.
Ms. Kuster. So thank you. Several Part D plans offer more
favorable formulary placements to branded drugs than they do to
lower-priced generics. Would the creation of a separate
specialty tier for generic drugs in Part D have the possibility
of lowering out-of-pocket costs for seniors?
Ms. Sachs. It would absolutely have the possibility of
doing that. And the reason is that today, a lot of seniors'
out-of-pocket costs are based on the list price of the drugs
even if the negotiated net price is much lower than that. And
so giving them those generic prices would be very helpful.
Ms. Kuster. And do you have any sense of what the savings
could be for seniors across this country?
Ms. Sachs. I don't. That would be a question for CBO. But
more generally, you are right to say that this is the type of
bill which responds to some of the misaligned incentives,
particularly involving the PBM-insurance plan relationship.
Ms. Kuster. Great. Well, thank you very much. I appreciate
it.
And Madam Chair, let the record reflect I yield back with a
minute to go.
Ms. Eshoo. You go. Thank you. The gentlewoman yields back.
A pleasure to recognize the gentleman from Utah, Mr.
Curtis, followed by our colleague Ms. Barragan from California.
So you are recognized for 5 minutes, Mr. Curtis. Nice to see
you.
Mr. Curtis. Thank you. Yes. Very good to see you. Thank
you, Madam Chair. It has been a very great hearing. Appreciate
the comments of all my colleagues. And I would particularly
like to associate myself with the representative who referred
to this as ``good stuff.'' That is a great way to describe it.
Mr. Gupta, I love to brag about the startup economy here in
Utah, which is largely responsible for us being on the
forefront of economic development and recovery. I'm aware of 20
startup biotech companies that are working on cures for deadly
diseases like COVID-19 and rare forms of cancer.
To bring this home, in Utah alone it is estimated that H.R.
3 would result in the loss of nearly 20,000 jobs and a loss of
over $4 billion in economic output. My experience tells me that
regulations like what we're looking at in H.R. 3 are
disproportionately hard and hurt small businesses.
Could you share how you feel smaller biotech companies
would access funding that they need in order to do the drug
discovery and eventually drug development if H.R. 3 becomes
law?
Dr. Gupta. I'd be delighted to, Congressman. And that's
particularly the intersection of biotechnology and finance in
which I find myself, which is to say that reminding ourselves
that it's smaller biotech companies that are primarily charged
with bringing innovative products forward and represent about
70 percent of innovative drugs in phase 3 today.
With price controls, I think that the smaller biotech
companies will be disproportionately impacted, which is why the
overall impact on innovation will be high. There might be large
organizations that will have other access to capital or be able
to reprioritize from large budgets. But small biotech companies
will be very vulnerable to this legislation.
Mr. Curtis. Thank you. Ms. Davis, while we were all touched
by your story of Hunter, I am told that many companies have
patient assistance programs that help patients pay for costs of
medications at little or actually no cost. They also have cost-
sharing programs to assist the insured patients pay for out-of-
pocket costs.
I am curious: Have you or any of your families you know
benefited from these programs?
Ms. Davis. Yes. In my testimony I discussed Ben, who
participated in a free drug patient assistance program. I also
know a number of patients that participate in patient
assistance programs that provide assistance towards their
copays, deductibles, and coinsurance, which have risen so high
in recent years.
Sadly, insurers have enacted copay accumulator programs,
which make the benefits of patient assistance programs really
inapplicable to patients.
Mr. Curtis. Thank you. And quickly, Dr. Gupta, as a
followup, is it fair to say that if H.R. 3 is enacted, this
charity care would be among the first things that we would see
going?
Dr. Gupta. You know, Congressman, I haven't contemplated
that in the past, and I think I would have to get back to you,
actually.
Mr. Curtis. OK. I would love to know that. Let me also
point out, Dr. Gupta, we know these rare diseases strike in an
unpredictable and very cruel way. As an example, I have lost
three neighbors--and by neighbors, I am talking within two
blocks of my home--to ALS over the last several years, and
currently another neighbor and a very close friend of mine is
an ALS patient. Fortunately, he has the resources to enroll in
clinical trials for experimental therapies to treat his ALS.
And quite frankly, he credits these trials for the very, very
small progression of the disease, which is unusual.
If H.R. 3 were to pass, there are studies that indicate
that there would be a 90 percent reduction in drugs developed
by small biotech companies over the next decade, some of which
could help ALS patients. Do you share the same belief, that
H.R. 3 would lead to reductions in competition and overall
reductions in drug development?
Dr. Gupta. Absolutely. And I think it is something that we
heard earlier, was that types of drugs that would be eliminated
would be primarily noninnovative drugs. I don't agree with
that. I think that the types of drugs we would lose out on
would be the most innovative, the most risky, and for the
diseases where we have made the least progress, and that
includes ALS, Parkinson's, and Alzheimer's disease.
Mr. Curtis. Yes. Just in the few seconds I have left, can
you explain the impact of H.R. 3 on clinical trials that have
helped my friend?
Dr. Gupta. Very briefly I would say that I think it will
reduce the incentive to fund the clinical trials, which are
expensive, and therefore reduce the number of innovative
medicines available via clinical trials.
Mr. Curtis. Very good. And Madam Chair, thank you very
much. I yield my time.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize our colleague from
California, Ms. Barragan, followed by one of our distinguished
doctors on the committee, Dr. Joyce of Pennsylvania. So you are
recognized, Annette. Great to see you.
Ms. Barragan. Thank you, Chairwoman Eshoo, for holding this
important hearing on legislation to lower prescription drug
prices, including H.R. 3.
The last Congress, we took some of the savings from this
bill and reinvested them to expand Medicare. I hope that we
decide to do that again, and this time to expand things like
access to dental coverage for Medicare beneficiaries.
Two-thirds of seniors and individuals with disabilities in
the Medicare program do not have oral health coverage.
Oftentimes these individuals are living on a fixed income, and
beneficiaries struggle to be able to afford and receive dental
care.
I currently have a bill, the Medicare Dental Benefit Act,
which is H.R. 502, which would expand Medicare Part B benefits
to cover dental and oral health services, including things like
routine cleanings, exams, fillings, crowns, major services such
as root canals and extractions, emergency dental care, and
other necessary services. I am hopeful that my bill as well as
other proposals by my colleagues to expand Medicare services
can be considered as we move forward.
Now I want to talk a little bit about labeling exclusivity.
In addition to H.R. 3, today we consider my legislation to
bring more competition to the drug market. The bill is called
the Prompt Approval of Safe Generic Drugs Act. We know that, as
more generic drugs come into the market, prices drop
dramatically. However, throughout our system, small hurdles
remain for generic competition, and my bill addresses one
example of how we can address that.
Under current law, generics can be blocked from entering
the market if safety information on a brand drug label is
protected under exclusivity but no other hurdles remain. My
bill would create a path forward for generic competition in
these instances by allowing the Food and Drug Administration to
allow a statement of appropriate safety information to the
generic drug's label to assure safe use.
My bill stands for something quite simple: Safety
information should be a feature of drug labels, not a bar to
competition. The FDA supports this legislation, and the CBO
recognizes this is a problem, estimating that fixing it would
save $164 million.
Professor Carrier, I recognize this is just one issue we
are discussing here today. But can you discuss how regulatory
issues like this can promote competition and lower drug prices
for consumers?
Mr. Carrier. Yes, I can. Thank you for the question. And
you are absolutely right that this is an important issue. There
are many ways in which generics are not able to enter the
market, and you put those all together and American consumers
suffer because they are not able to afford their drugs.
And so I appreciate your leadership on this piece of
legislation. You are right that generics should be able to
enter the market if the only thing that is blocking them is the
label from the brand company. And so this would be one piece of
legislation that could bring generics to the market faster.
Ms. Barragan. Great. Thank you. Another issue that we've
been hearing a lot about today is, just let the market do its
thing and that will take care of itself. And that hasn't
worked. That's why Congress has to step in and do something.
Just taking a look at things like insulin, where it started and
where it has gone is a good example of why we need H.R. 3 and
why we need action.
Communities of color, including my community, that has a
very high rate of diabetes--my district is almost 90 percent
Latino, African American, low-income--have really high rates.
Professor Sachs, what will be the impact for diabetics,
especially communities of color, if insulin prices are
negotiated?
Ms. Sachs. It could be very significant for health and for
closing health disparities because we have these decades-old
drugs whose prices continue to rise year after year, seemingly
without justification. So by lowering those prices, we can
improve adherence and help mitigate some of those racial
disparities.
Ms. Barragan. Thank you. And thank you to our panelists and
to the chairwoman. With that, I yield back.
Ms. Eshoo. The gentlewoman yields back.
The Chair now is very pleased to recognize the doctor, a
gentleman from Pennsylvania, Dr. Joyce, followed by our
colleague from Delaware, Ms. Blunt Rochester. So you are
recognized, Doctor. Good to see you.
Ms. Joyce. Thank you for yielding, Madam Chair and Ranking
Member Guthrie. Thank you for all the witnesses for being here
with us today to discuss this incredibly important issue.
I want to first talk about a case that I personally was
involved with. Ten years ago I diagnosed Charlie, a 62-year-old
man, with melanoma on his right thigh. And at diagnosis, the
disease was only found locally, and further evaluation showed
that there at that time was no spread of the disease.
Two years later, he developed evidence of metastatic
melanoma involving internal organs. And then he received what
was at that time standard-of-care therapy with interferon, and
unfortunately his melanoma progressed. Subsequently, he was
started on one of the new immunotherapies approved for
metastatic melanoma, similar to what we know President Carter
has subsequently received as well.
Initially his disease did respond to the therapy. But
within weeks, the melanoma continued to spread. My then-64-
year-old patient was started on a different immunotherapy to
treat his melanoma. His response was remarkable, and it was
significant. He continued on that therapy until complete
remission of the disease was attained.
Today, 10 years later, he is symptom-free. He is disease-
free. His imaging studies, which include CAT scans, MRIs, PET
scans, show no evidence of disease. Last Friday, April 30th, I
talked to Charlie on the phone, and he has such great insight
on how the opportunity to have tried two different
immunotherapies as the treatment for metastatic melanoma have
allowed him to be completely cured.
During that phone call I asked Charlie if he had been given
the opportunity to have tried a second immunotherapy but not
have had that cure in the United States, he said, ``I would
have pursued it wherever I could.'' But given the opportunity
to have tried a second immunotherapy after the first one
failed, I asked Charlie, ``What does that mean to you?''
Charlie is very blunt and straightforward with me. He said,
``Without the opportunity to have tried two immunotherapies to
treat my metastatic melanoma, I would be dead.''
The drugs that he was allowed to use were Opdivo and
Keytruda, and they presented huge advancements in the treatment
of metastatic melanoma. The chance to have two therapies for
metastatic melanoma has allowed today for patients to be cured.
My questions first are for Dr. Gupta. Knowing that there
are countless tragic stories of physicians in other countries
who cannot allow their patients to have these innovations
because they don't have access to them because of their
government authority.
Opdivo is only approved for 5 of the 14 indications in
Australia, and in France only 4 of the 14 indications are
approved. This frustration should serve as a warning to all of
us--to American patients, to American physicians--that if we go
down the path of H.R. 3, we are going to lose access,
innovation, and cure.
Dr. Gupta, as a physician, can you tell us more about what
H.R. 3's foreign price controls would mean for U.S. physicians
and for the patients that you serve and the patients that need
these innovations?
Dr. Gupta. Well, thank you, Congressman, for the
opportunity. And I think it is actually right that other
countries have shown a willingness to block groundbreaking
medicines from reaching their citizens. And I think that is
morally indefensible. I think that is the last thing that we
should be trying to import from another country.
As a physician, having had the privilege of practicing
medicine like yourself, what I most wanted for my patients was
for them to get the medications that were prescribed for them.
And there should be nobody coming between a patient and their
doctor. And I think that we should not be emulating the systems
that other countries have to blockade innovations from getting
to patients.
Ms. Joyce. So is it fair, Dr. Gupta, to say that American
doctors could be put in that position where they wouldn't be
able to prescribe what they know their patients need and what
they know could cure their patients?
Dr. Gupta. I think that is possible, yes.
Ms. Joyce. And does that mean that these patients,
particularly our most vulnerable, may be at risk for worse
health complications, worse outcomes, if restricted access to
drugs and therapies were implemented?
Dr. Gupta. Absolutely. As we have heard, not just days but
hours and minutes can matter, and it is a matter of getting
innovative drugs to patients as fast as possible to help the
most number of people. And I think that is what we all are
attempting to do.
Ms. Joyce. I thank you for your answers.
Madam Chair, I thank you for allowing us to present and
talk about access, innovation, and cure. And I yield my
remaining time.
Ms. Eshoo. The gentleman yields back.
And it is a pleasure to recognize the gentlewoman from
Delaware, Congresswoman Blunt Rochester. And she will be
followed by the gentleman from North Carolina, Mr. Hudson. So
you are recognized, Lisa. Great to see you.
Ms. Blunt Rochester. Good to see you, Madam Chairwoman. And
thank you so much, Madam Chairwoman, for your leadership on
this issue. I know we have talked many times about it on the
floor as well as in committee, and I know this is a priority.
And thank you especially to our ranking member and the
witnesses for joining us here today. As evidenced by the
interest and ideas of my fellow Members, you can see that we
all know that the current system is not sustainable and that
the focus really needs to be on making sure that Americans are
well and safe.
And Ms. Ball, I essentially want to thank you for sharing
your story with us. As someone who has both spent much of your
life caring for others as a registered nurse and as a multiple
sclerosis patient yourself, today you represent millions of
Americans who are struggling to afford medications that improve
their health and save their lives. The pandemic has been hard
on many families like yours, and it is unacceptable that you
and so many others should have to really choose between taking
medications and paying your bills while the prices continue to
rise.
And so, Ms. Ball, you mentioned that the cost for your
medication has gone up substantially over time. What did that
means for your out-of-pocket spending when your drug cost
increased? How did it impact your monthly budget for other
things, like groceries and gas?
Ms. Ball. When I received the information that I had the
grant, it was $6,000. I called so many pharmacies to see if it
could be less. So basically, we tried to rearrange everything
that we could as far as groceries, and going to live at my
daughter's house, also having the fact that I wasn't able to
practice anymore, so there was no income coming in.
As far as groceries and such, when I made the final
decision that I couldn't take the drug, that kind of put it
back a little bit into perspective. But in essence, it is very
difficult. Very difficult. When I did my $1,800 at the very
beginning of my diagnosis, it was--I had to move to a smaller
place. I had--there was many, many, many things. And I had the
advantage of having a family that could help me. And there are
many of us out here that don't.
Ms. Blunt Rochester. I know you talked about the increase
in the price year after year. What sticks out to you the most
about that experience?
Ms. Ball. I guess what sticks out to me is that if they
would have been doing something innovative, if they were doing
something that was reaching to a cure, I could have understood,
even for a small amount of time, because they have to pay for
what they are doing.
But the fact that all it was anymore a way of them to take
the price up for something that is absolutely the same--it
wasn't really approved in the sense that they didn't think it
made the FDA and people from NIH didn't feel that it had given
any kind of improvement. And it didn't. So that is a lot of
money that people are putting out for something that is not
coming close to a cure.
Ms. Blunt Rochester. And what do you think that this means
for retired Americans who live on fixed incomes? And lastly,
from your perspective, could you also talk about the inflation
rebate proposal included in H.R. 3, and if you think that that
would help you afford the prescriptions that you need?
Ms. Ball. Well, for people that have a--that are retired,
such as myself, it is very difficult because you only get so
much in Medicare. So if you have a $2,000 cap, which would be
great, and you don't have the amount of money as far as
negotiating the money for us to get the right amount of money
to pay for it, the $2,000 cap would help. So we need to be able
to do that.
And I must apologize. I am not very well-versed on that
part of that because I have never had to work with it. But
thank you for asking me.
Ms. Blunt Rochester. No problem. Thank you.
Ms. Sachs, I just had a question for you. What do you say
to people who say that H.R. 3 won't actually lower the cost of
drugs?
Ms. Sachs. I think it absolutely will lower the cost of
drugs, not only for patients but also for payers. And here, I
think the CBO's estimate of how much it will save, $456 billion
over a decade--if that's off even by a little bit, it would be
a tremendous savings for American patients, savings which could
be used to expand access to insurance more generally.
Ms. Blunt Rochester. Thank you so much. I think what we
have heard today is that this is a complex issue, that we need
to be comprehensive in our approach, and that we need to make
sure that we are watching out for our constituents as well as
not stifling innovation. I believe that we can do it, and we
need to do it.
Thank you so much, Madam Chair, and I yield back.
Ms. Eshoo. The gentlewoman yields back.
It is really a pleasure to welcome back to the committee
our wonderful colleague Mr. Crenshaw. A lot of us prayed for
you. It is great to see you. Hope you are feeling 100 percent
better and that what you endured has brought you back to full
eye strength. And I am so happy to see you. I hope you got my
message, too. So you are recognized for 5 minutes, Mr.
Crenshaw. And you'll be followed by our colleague from
Minnesota, Ms. Craig. Mr. Hudson had to leave, so that's why
you're next. Really nice to see you.
Mr. Crenshaw. Well, thank you for the kind words, Madam
Chairwoman. It is a pleasure to be with you all. I still can't
see you, but I do feel better.
I should see normally in a few weeks, I hope. I have got to
wait for this procedure to sort of follow its actual path. But
we are optimistic that I will have some sense of normal in a
few weeks to a month.
Ms. Eshoo. Great. Great.
Mr. Crenshaw. Thanks for all the good wishes. Really
appreciate it. But like I said in the last hearing, even a
blind knuckle-dragger can do hearings. So here we are.
Look, this bill is really important. I've been talking
about this bill for a long time, and I appreciate us doing a
hearing on this really important topic. I think we all want
lower drug prices. I think the question is: How do we get there
without killing the goose that lays the golden egg?
There has been a lot of concern about innovation. There has
been a lot of concern about the fact that when we reverse
incentives to invest, one study shows that this will directly
hit the smaller biotech firms. Over 90 percent of them will
reduce their investment. We will see a massive decrease in new
cures, cures that could save lives, that could reduce
healthcare costs in the long term.
And we talked a lot about negotiation. Ms. Sachs, this
question is for you. Is it really fair to call the process laid
out here a negotiation?
Ms. Sachs. Yes. I believe it is. Nothing in H.R. 3 tells a
pharmaceutical company what they can and can't charge. They
limit how much those companies are able to demand those prices
of the Federal Government.
Mr. Crenshaw. Right. But if they don't come to the table
with the Federal Government, they are levied a 95 percent tax
on their revenues. Correct? That doesn't seem like a
negotiation. It seems like extortion.
Ms. Sachs. And right now Medicare is a price taker. They
have to accept the prices being demanded by pharmaceutical
companies and have relatively little ability to push back on
those prices. That is not how the free market negotiation
works.
Mr. Crenshaw. Right. But if I am the Government and you are
a private citizen and I want your services, and you say,
``Well, for that price that you are offering me, sir, I won't
give you my services,'' and I say, ``If you don't give me your
services, I am going to levy a tax on you, 95 percent of your
revenues from now on''--that is not a negotiation. Nothing
close to it.
The other problem I see with the process laid out here is
that, again, it is called a negotiation, but that is not how
bureaucrats work. It can't work that way because of the
Administrative Procedures Act, because of Section 1871 within
Medicare. It can't possibly work that way. It can only work as
a formula. So it's just simply false to say it is a
negotiation. Isn't it just price-setting?
Ms. Sachs. I would welcome more details on how the
Administrative Procedures Act is a barrier here. It is not
entirely clear to me how it would be. What I will say is that
CMS and----
Mr. Crenshaw. I will tell you. Let me--I will explain it
really briefly. What it basically says is that you have to have
an objective way of setting a price. It can't be subjective.
And of course this makes sense because we can't give one
company a subjective negotiation and say, ``Hey, you know what,
we will give you 90 percent of your costs'' and then we, say,
give another company only 80 percent of the cost. You are a
lawyer. What would happen? You would have lawsuits. You would
have endless lawsuits. That is why we have these procedures in
place.
Ms. Sachs. So what we have here is a clear delegation to
the Secretary of the criteria they should use in engaging in
negotiation.
Mr. Crenshaw. Exactly. And every lawyer we have talked to,
every single one, says there is only one outcome that will
happen here. The Secretary will set up a formula. It is not
going to be the Secretary talking to the CEO of Pfizer, is it?
No. It is going to be a midlevel bureaucrat. That midlevel
bureaucrat isn't allowed to think subjectively about how they
negotiate, right? They have to follow a formula. It is going to
be a failure----
Ms. Sachs. No. That is a mischaracterization of H.R. 3.
Mr. Crenshaw. But that is exactly now it will be
interpreted into the rulemaking, wouldn't it?
Ms. Sachs. No. I think there is no reason to believe that
that would be----
Mr. Crenshaw. Well, every other lawyer we talked to--the
counsels from CMS, counsels from CRS--say that that is exactly
how this would be interpreted. In fact, it has to be, according
to Section 1871 from Medicare.
Ms. Sachs. I think what is important here is to remember
that we are talking about paying prices that are closer to the
much lower prices that are being paid abroad. And that is
setting up the framework for this broader negotiation. And the
Secretary is given the discretion to use different criteria to
negotiate within that framework.
Mr. Crenshaw. That may be the case for older drugs, but
newer drugs will simply not be invested in. Again, I don't
dispute your earlier comments that it would immediately lower
drug prices. Of course. I mean, by law it is making their drug
prices lower. The concerns we have are, of course, with
innovation.
And look, let's get philosophical for a second. I think
that if we had all the cures, all the drugs that we would ever
want for the human race right now--they existed--you could make
a good moral argument that the Government could just confiscate
them and deliver them to people. Right? You could make a moral
argument that way.
But of course, that is not the situation that we are in.
The situation we are in is that we want more drugs available to
us. In America, we have access to a lot more innovative drugs
than any other country. There is a study, of the over 300 new
drugs approved since 2011 America has access to 87 percent, and
something like----
Ms. Eshoo. All Democrats left?
Mr. Crenshaw. Australia has 39 percent access. The U.K. has
50 percent. Canada has less than 50 percent.
So innovation is a big deal. I don't know who was just
talking, but I reclaim my time. Ms. Davis----
Ms. Eshoo. Mr. Crenshaw, your time--I am sorry, your time
is expired. You are over by----
Mr. Crenshaw. Oh, thank you, Madam Chairwoman. Sorry. Can't
see the timer. I apologize.
Ms. Eshoo. No. That is all right. Thank you. I gave you a
little more time so you could finish a couple of your sentences
there. And again, we are really thrilled that you are back.
Keep making progress.
Mr. Crenshaw. I appreciate it, Madam Chairwoman. Thank you
for indulging me. I am sorry. I can't see the time.
Ms. Eshoo. That's all right. That is OK.
Now it is a pleasure to recognize the gentlewoman from
Minnesota, Congresswoman Craig, to be followed by--we don't
have any Republicans left. So there is going to be a string of
Democrats following. The gentlewoman from Massachusetts, Mrs.
Trahan, will follow Congresswoman Craig.
So great to see you, Angie. You are on.
Ms. Craig. Thank you so much, Madam Chair. And thank you to
our panelists for your patience and resilience here today in
this hearing.
Look, the burden of high out-of-pocket costs of drugs on
Medicare beneficiaries is significant. Over the next decade,
approximately 1.1 million older adults are predicted to die
prematurely due to this cost burden. One study found that if
Medicare is able to negotiate, lower drug prices and cost-
sharing responsibilities for beneficiaries are reduced. It may
decrease premature deaths by about 94,000 per year and generate
nearly $500 billion in savings by the year 2030. This is
particularly important for those today who must choose between
filling their prescriptions and treating their illnesses or
paying their bills.
Bob Miller is a constituent of mine living with MS. Over
the course of 12 years, the list price of his medication rose
from $13,000 a year to over $103,000. While on his employer's
coverage, Bob was able to get copay assistance to make the drug
affordable for him. but under Medicare he is now ineligible for
that same type of assistance.
Faced with the reality that the cost of his drugs would
jeopardize his retirement security, Bob opted to stop taking
the drug. He understood he was rolling the dice on his health,
and he wants Congress to act so that no one else must make this
life-threatening decision.
So let me start with Professor Sachs. Can you generally
describe how H.R. 3 will benefit low-income people in
particular, recognizing that some people have access to cost-
sharing assistance through the low-income subsidy--they already
have some help--but what about others who don't qualify for
this extra help? How would their out-of-pocket expenses and
premiums potentially be low?
Ms. Sachs. Thank you. And this is an important question, to
think about where the low-income subsidy phases out and how it
isn't helping enough seniors who may be on a fixed income,
especially. So this out-of-pocket cap would be particularly
helpful for seniors who are just out of low-income subsidy
qualification but who have these expensive out-of-pocket costs.
Ms. Craig. Professor Sachs, you heard my statistic that I
have cited there. Do you agree that lowering drug costs and
reducing out-of-pocket expenses could prevent premature death,
as recent studies have shown?
Ms. Sachs. Yes, relying on those studies. And it is really
easy to see how something like that is true for something like
insulin.
Ms. Craig. Absolutely. Additionally, the Congressional
Budget Office has estimated that the Medicare program will save
billions because people can finally afford to take their
medications. Do you expect H.R. 3 will also lead to better
health outcomes?
Ms. Sachs. Yes. Especially--or potentially for low-income
beneficiaries, given those high out-of-pocket costs that they
face today.
Ms. Craig. Thank you so much. I recently introduced H.R.
2464, the More Help for Seniors Act, that would expand the
ability for seniors to receive extra help under the Part D low-
income subsidy program. Not only do we need to provide more
help to low-income seniors so more could take advantage of the
program, we need to effectively reduce drug costs for everyone.
That is why I personally believe H.R. 3 is so important. It
is clear that lowering costs for seniors will not only improve
their lives, but research has shown that for thousands of
people each year, it will also save lives.
And I have got just a little more than a minute left, and I
just want to say that much of the question and discussion here
today, as someone who spent more than 20 years working in
medical technology for a company that had to compete to be on
the VA contract every couple of years--some years we were, some
years we weren't, for the technology company that I worked
for--I just have to say that the sky-is-falling dynamic here is
just, frankly, unbelievable.
And if you look at net operating profit for any large Brand
A pharmaceutical drug company in this country, it is really
hard for me to believe that this sector that has continued to
just increase price, increase price, has never really been held
to account here--look. We know, we all agree, that we have to
balance innovation. But at the end of the day, I think this
sector in healthcare has been able to escape any, or much, of
the accountability in this country for what has happened with
drug costs.
And let's talk about--we don't have time today, but
specialty drugs, and compound drugs. Look, this sector needs
more competition, not less. And at the end of the day,
Medicare, just like the VA, should be able to negotiate its
drug pricing in the United States of America.
And with that, Madam Chair, I yield back.
Ms. Eshoo. The gentlewoman yields back. We all benefit from
your membership on our subcommittee.
And now the Chair with pleasure recognizes the gentlewoman
from Massachusetts, another new member to our subcommittee--all
of our new members are just such value added; I keep saying
this every time I introduce them, but I think that it is
important to reiterate--the congresswoman from Massachusetts,
Mrs. Trahan. And she will be followed by our colleague from
Texas, Mrs. Fletcher.
So Lori, thank you for your patience.
Mrs. Trahan. Thank you so much, Chairwoman Eshoo.
Ms. Eshoo. I love seeing the backgrounds of everyone.
They're so varied. Yours looks especially lovely.
Mrs. Trahan. Thank you. I appreciate that.
Ms. Eshoo. Well, good.
Mrs. Trahan. And I appreciate this hearing, our ranking
member, certainly our witnesses who are with us today.
I did want to respond to my colleagues' argument that if
H.R. 3 was in effect, we would not have COVID-19 vaccines and
treatment, which I find to be misguided and would like to just
spend a bit of time clearing, or setting the record straight.
As my colleagues will remember, last Congress we passed
billions of dollars of funding for NIH and BARDA to aid in the
research, development, manufacturing, and purchase of COVID-19
vaccines and therapeutics. We just followed that up with even
more in the American Rescue Plan a few months ago. That
funding, along with the hard work and expertise at NIH and
BARDA and, yes, our private pharmaceutical manufacturers led to
the development of several safe and effective vaccines.
This has been a collaborative effort. Take the Moderna
vaccine, for example, the first product the company has ever
commercialized. The United States invested $2.5 billion in
clinical research, development, manufacturing, and purchase of
just that vaccine, removing almost all of the risk for the
pharmaceutical manufacturer. And before last year, Moderna was
already relying on the work of the NIH to help develop its mRNA
technology. Almost all of the company's investment in its
vaccine came from these Federal dollars.
I will also note for the Pfizer vaccine and all of the
authorized vaccines, the Federal Government negotiated the
price it would pay. These resources went to manufacturers due
to the bipartisan work of Congress, which paid off massively
for the American people.
So negotiation never would have hurt the ability for
vaccines to come to market. And using that as a scare tactic
just doesn't stand up to the facts.
Professor Sachs, I would love for you to just comment on
this. It might be helpful just to hear unequivocally, if H.R. 3
had been enacted prior to the emergence of COVID-19, would it
have impacted the ability to bring COVID-19 vaccines to market?
Ms. Sachs. Absolutely. And I want to be clear: Nothing
about H.R. 3 would have impacted the creation of Operation Warp
Speed or development of vaccines and treatments for COVID-19.
And in fact, Operation Warp Speed, as you said, it helped
encourage the development of new vaccines. That is exactly the
type of government initiative which disproves the idea that
there is a tradeoff between innovation and access.
And then just one more brief comment. This is what is
important. Congress made the decision that patients could not
be charged out-of-pocket for these products. They were to be
provided free at the point of sale or treatment to those
patients. So we have both innovation and investment from the
Federal Government and no-cost access for patients.
Mrs. Trahan. Thank you for that. Well, H.R. 3 takes a bold
step to flip the status quo in a system that has made billions
in profit while working families, like the one I grew up in,
are struggling to pay for their lifesaving medicines.
Ms. Ball, I just want to thank you once again for coming
here today. Your story is one that resonates personally. My
father has had MS for the past 27 years, and in the early days,
when he was healthier and could walk, he would come to Capitol
Hill for Patient Advocacy Days. And I have seen the sacrifices
that he and my mom have had to make for his treatment and care.
MS is unpredictable, and it is a costly disease, and your
testimony today was so helpful.
In my remaining time, one critical area that I think must
remain at the center of our policy discussions is health
equity. We have had so many hearings that have highlighted the
disparities that exist across our healthcare delivery system,
and prescription drugs are no exception.
Given the disproportionate impact that the pandemic has had
on communities of color, Congress does have an urgent
responsibility to address those disparities that have long
predated COVID-19. And so, Ms. Sachs, with the remaining time,
it is common sense that if people can afford to take their
medications, that they will remain healthier. How will the
policy in H.R. 3 lead to better health outcomes for low-income
communities and people of color?
Ms. Sachs. Yes. It is certainly my hope that the lower drug
prices created by H.R. 3, both through the Medicare out-of-
pocket cap and the negotiation provision, will allow for
increased adherence, increased affordability, especially in
low-income communities and in communities of color, and can
help really mitigate some of these racial disparities.
Mrs. Trahan. Thank you. I appreciate that. I will yield
back the no time I have left.
Ms. Eshoo [laughing]. I want to thank the gentlewoman.
Excellent line of questioning and observations. I am proud of
all of the members of our subcommittee. I think that it is the
best subcommittee at Energy and Commerce--how about in the
whole House, everybody? That is how proud I am of you.
OK. Now, the Chair is going to recognize the gentlewoman
from Texas, Mrs. Fletcher. And then following her, there are
four Members that are waiving on, and then our colleague, Dr.
Kim Schrier, has asked to be last because she has a conflicting
event. So I don't want anyone to think that I am leapfrogging
over her.
So a pleasure to recognize you, Lizzie, and you have 5
minutes. And then we will take the Members that are waiving
onto our subcommittee today.
Mrs. Fletcher. Wonderful. Thank you so much, Chairwoman
Eshoo, for holding this hearing today. Bringing down the cost
of pharmaceutical drugs has been one of my top legislative
priorities, and it obviously is one of this Congress. As we
have heard today, there has been a bipartisan priority for
many, and many of the bills being considered today have
bipartisan support.
But a lot of the questions and comments in today's hearing
seem to have presented us with a false choice between lowering
drug prices for Americans and developing innovative treatments.
So I am really grateful to our panel for insights, all of your
insights today, and I would like to focus a little bit on this
issue, the idea that high drug prices provide a funnel for
innovation, and if profits decline, it will impact efforts to
find new cures.
At the same time we hear that, industry experts have noted
that the pharmaceutical industry is one of the most profitable
sectors and sees greater profits than other industries on the
S&P 500, for example.
So Professor Sachs, can you briefly discuss whether there
is evidence for the claim that high drug prices are truly the
conduit for innovation? Would the pharmaceutical industry
continue to invest in R&D if H.R. 3 became the law, or would it
no longer invest in R&D if we were to pass H.R. 3?
Ms. Sachs. They absolutely would continue to invest in R&D.
Now, to be sure, there are projections that there would be a
small decrease in the number of drugs coming to market over the
next decade or more as a result of H.R. 3.
But I want to emphasize that it is not just the amount of
drugs we get, it is the kind. We have heard a lot of discussion
about the importance and the need for cures. And I absolutely
agree with that. We don't just want new drugs. We want good new
drugs that fulfill unmet needs for our patients.
And economists looking at the creation of Medicare Part D
found that it gave a large new subsidy to pharmaceutical
companies to do innovation, but that most of that innovation
was concentrated into these classes with lots of existing
treatments. So if we are lowering prices a little bit in
Medicare Part D, we might be taking away some of those ``me
too'' drugs, but there is no reason to think that we would be
limiting incentives for companies to develop these truly new
cures because these are actually the products that command very
high prices in other countries against which we would be
referencing.
Mrs. Fletcher. Well, thank you for that. And your answer
touches on another issue that we have sort of covered a little
bit today. But I think when it comes to research and
innovation, we have talked a little bit about the funding that
we have done recently, and there is funding in H.R. 3 for
research and development and innovation. There is $10 billion
of direct funding to the NIH to bolster research in cancer,
rare diseases, regenerative medicine, antibiotic resistance,
and treatments for substance use disorder, among others. There
is also, in H.R. 3, $2 billion to the FDA to enhance drug
development, review, and safety, including investing further in
activities authorized under the 21st Century CARES Act.
So I think that is important when we talk about research.
And Ms. Sachs, would you agree that investments in the NIH and
FDA, like the efforts I just described, would help enhance
research and development on new drug therapies?
Ms. Sachs. Absolutely. And one example of that is we have
heard somewhat today about the fact that we really want new
drugs for conditions like Alzheimer's. But we have also heard
about the fact that even today we have hundreds of candidates
which have failed clinical trials. So even today, without H.R.
3, we don't have these effective new therapies.
What we really need is some public investment and figuring
out more about how some of these diseases work, about what
approaches might be important for private pharmaceutical
companies to pursue. So H.R. 3, developed in 2019, isn't the
reason that companies have failed over the last decades to find
new drugs for Alzheimer's, and it is not going to prevent us
from finding a solution either.
Mrs. Fletcher. And thank you. With the little bit of time I
have left, there is also some recent research that shows that
many of the patented prescription drugs, like some of the
innovative things we are talking about today, were actually
first discovered through taxpayer-funded NIH research and
grants. Is that your understanding?
Ms. Sachs. Yes. And I think we also just heard a little bit
about the Moderna vaccine, where there was a huge amount of
public investment not just in the development but the
partnership with the NIH in completing those clinical trials.
So that is a very recent example where that is absolutely the
case.
Mrs. Fletcher. Well, thank you so much, Ms. Sachs. And in
the time I have left, I just want to thank all of our
witnesses. This is clearly a really important topic for our
constituents and for people across the country. So in addition
to supporting innovation, H.R. 3, as well as some of the other
legislation we are discussing, is really the critical
legislation we need to lower prescription drug prices so
Americans can live longer, healthier lives.
And Madam Chairwoman, I yield back.
Ms. Eshoo. The gentlewoman yields back, and we thank her.
How we will go to four Members that are members of the full
committee of Energy and Commerce, and they are waiving on
today, and we welcome them. The first will be the gentleman
from Illinois, Mr. Rush, followed by the gentlewoman from
Colorado, Ms. DeGette, followed by the gentlewoman from
Illinois, Ms. Schakowsky, followed by the gentleman from
Florida, Mr. Soto.
So do we have the gentleman from Illinois, Mr. Rush?
Mr. Rush. Madame Chair, so delighted to see you once again.
I want to thank you for allowing me to participate in today's
important hearing on H.R. 153. I am also very pleased several
speakers, if you will, like myself in many--and once again
considering H.R. 3, the Elijah E. Cummings Lower Drug Costs Now
Act, which I am proud to cosponsor. Madam Chair, these bills
would take [audio drop] to ensure fundamental drug pricing for
Medicare recipients and patients of all ages throughout the
country.
Professor Carrier, it is nice to see you once again. And I
appreciate your coming back to once again testify on my bill,
the Protecting Consumer Access to Generic Drugs Act. You and I
want to stop these insidious practice of what is called pay-
for-delay for far too long. It is inarguably a complete and
complex issue. Can you walk us through an example of a time
when this practice has hurt consumers and led to higher drug
prices for American patients?
Mr. Carrier. Sure. Thank you so much, Representative Rush,
for your leadership on this issue now and your leadership going
back for years. You have discovered the problem of pay-for-
delay settlements as early as anyone has. The problem with pay-
for-delay is a brand company pays a generic to stay off the
market, and that generic could be delayed for years.
And so there are multiple examples involving drugs like
Impax and Loestrin and the antibiotic Cipro, many drugs that
are worth a lot in terms of revenue where the consumer is
delayed getting an affordable drug for years.
Mr. Rush. Thank you very much. Also, Professor Carrier, I
appreciate the helpful suggestion [inaudible] 153. Can you
please, or would you please, walk us through it, each
amendment, and explain why they are needed to stop the practice
of pay-for-delay once and for all?
Mr. Carrier. Sure. So for starters, I think that your bill
is an excellent approach to the problem. The Supreme Court in
2013 said that pay-for-delay settlements could violate
antitrust law. But the settling parties--and here we include
the generics, because the settling generics are just as bad as
the brands here--they do everything in their power to muddy the
waters, to say that it is not really a payment, or it is a
payment for generic services, not really for delay, or that
there is no delay because the patent is good.
And so your bill would really solve this problem by dealing
with the FTC and giving the FTC the power to go after this in
court in a way that's really hard now to fix some of these
mistakes that courts have done, like not recognizing payment,
like adopting the scope of the patent test. And so if you were
to consider other changes to the legislation, I suggested
things like applying it to the patent trial and appeals court.
So this is one place where the settling parties are trying
to hide payments. Detail of settlements, patent trial and
appeal board settlements, are not reported to the FTC. So that
would be one place to start. Don't let them hide it there.
Include that in the bill.
Mr. Rush. Thank you so very much. Let me move on to
Professor Sachs.
Professor Sachs, in your testimony, you discuss various
mechanisms other countries have implemented to strengthen the
hands of their payers, too, and their classes than they are now
presently--present, rather. Are these [inaudible] lifesaving
prescription drugs battling COVID in other countries? And real
importantly, are there other to ensure Medicare can effectively
negotiate without losing access to the medications and [audio
drop]?
Ms. Sachs. Thank you, Congressman. And to your question
about how H.R. 3 would protect Medicare beneficiaries' access
to these medications, it is important that nothing in H.R. 3
changes that Medicare is obligated to cover at least two drugs
per class, all drugs in the six protected classes. Nothing
about H.R. 3 changes that.
Mr. Rush. Thank you very much.
Madam Chair, again, thank you for your kindness, and I
yield back no time because I don't have any time.
Ms. Eshoo [laughing]. Well, thank you, Mr. Rush. You are
always welcome at the subcommittee. And thank you for your
important legislation.
The Chair now has the pleasure to recognize the gentlewoman
from Colorado. She is the chair of the Energy and Commerce
Subcommittee on Investigations and Oversight. Great to have you
with us, Diana. And she will be followed by Congressman Soto of
Florida because our colleague Jan Schakowsky had to drop off.
And then we will have, I believe, the last Member, last but not
least, Dr. Schrier.
So there is some light at the end of our hearing tunnel
here. And so great to have you, Diana. Your 5 minutes of
questions--and thank you for your patience in joining us.
Ms. DeGette. Well, thank you so much, Madam Chair, for
allowing me to waive on. I feel like I should be an adjunct
member of the committee anyway, and I really want to thank all
the witnesses for your tenacity in holding on. And I really
want to thank you, Anna, for considering this H.R. 3 because
the Oversight Subcommittee, as you know, has had a number of
investigations over the last number of years on the broad issue
of drug pricing, and this really is a national crisis, as we
keep hearing, and it is not going to be getting any better.
[Audio drop] on this committee know that I am the cochair
of the Congressional Diabetes Caucus, and this is the largest
issue-based caucus in Congress. We heard about the MS drugs.
But diabetes drugs are probably the biggest textbook example of
what has happened to patients in America because if you are
Type 1 diabetic and you take insulin, if you don't get your
insulin, you die.
And in the past two decades, prices for the most commonly
prescribed insulins went up from $20 to over $200--$250--a
vial, which is more than a 700 percent increase. And the drugs
were the same drugs. And the reason is the way that these drugs
are marketed and because of the inherent markup in the system.
And I found this out. The problem is, Members of Congress
are actually healthcare consumers themselves. Everyone, all the
Members on this committee, know my daughter Francesca and have
known her since she was like 4 years old, some of them.
Well, she was on my insurance, and her insulin cost about
$30 a bottle. Then when she turned 26, she went off of my
insurance, of course. She had insurance provided for her by her
employer. And she went over to get her insulin after she went
on the new insurance. Well, her insulin was not listed on the
formulary. So guess what? When she went to get her insulin, it
was $312 a bottle for a 26-year-old young woman.
And I have had so many people tell me they were working
four jobs to get their insulin. They didn't know what to do.
And by the way--[telephone rings]--excuse me--and by the way,
when my other daughter, who is a doctor, tried to get her a
coupon to get that insulin, the coupon only took $20 off. So
anybody who says the coupons fix this situation, it is untrue.
So I have a couple of questions for our witnesses. The
first one is for Dr. Sachs. Dr. Sachs, how would the
negotiation process in H.R. 3 bring down the price of drugs
like insulin, which is listed in H.R. 3, for patients who need
them to survive?
Ms. Sachs. Congresswoman, I want to thank you for your
leadership on this important issue of insulin because, as you
know, H.R. 3 specifically instructs the Secretary to negotiate
for the price of insulin. And we have these decades-old drugs
whose prices continue to rise. They cost many times more here
than they do abroad. Bringing down those prices would be
particularly important for patients.
Ms. DeGette. That's right. And Ms. Ball, I just want to
tell you I thought your testimony was very, very moving because
you had the same kind of experience that my daughter and many
other--millions of Americans have in trying to just live, just
to be alive. So what would the impact have been for you if an
out-of-pocket cap existed for your medications?
Ms. Ball. Thank you, Representative DeGette. I am saying
that if I would have had that, my life in the 5 years after I
was diagnosed, before I had to quit working, it would have been
much easier for me to pay for them. It also is the fact that,
when you're not getting your drug because of this cost, you
have to pick: eat, pay your rent, or get the drug that is going
to keep you walking and thinking.
So that is what the impact was for me. If we had the H.R.
3, I would have been able to probably afford my drugs. And that
is what is most important.
Ms. DeGette. Well, that's right. I met a young woman who
was working four jobs to get her insulin.
Ms. Ball. Yes.
Ms. DeGette. And she was living in her car. That is exactly
to what you are saying.
Madam Chair, once again, thank you so much. This is such a
critical issue. And I would hope that our Republican colleagues
across the aisle, if they don't like H.R. 3, then work with us
to find something that is for real because just having a Band-
Aid that we say is going to solve something isn't going to
actually solve issues like Ms. Ball's. And I yield back.
Ms. Eshoo. We all thank you, Diana, especially for your
leadership in so many areas, but most particularly in always
highlighting the issue of diabetes. And we see you or hear your
name, right next to it is ``diabetes.'' So thank you.
Now I have the pleasure of recognizing the gentleman from
Florida, Mr. Soto, again another Member that has really brought
high value to our committee, and we are thrilled to have you
waive on. You are recognized for 5 minutes.
Mr. Soto. Thank you, Chair Eshoo. Let's start with the
facts.
Americans pay more for prescription drugs than any other
nation in the world. Many can't afford those drugs, and so they
go without. What good is having amazing drugs if many of my
constituents can never afford them?
Here is another fact: The VA hospital, Medicaid, both
negotiate their drug prices. They have done so for decades. Yet
Medicare cannot. That is why we are here today, because you
have this big gap between VA and Medicaid negotiations. But why
doesn't Medicare? And that leads to higher prices for our
seniors.
This makes no sense. And a lot of our colleagues across the
aisle talk about competition, for years, except for right now.
Why? Why are we not talking about how--competition is not good
for Medicare, but it is good for all these other programs? That
makes no sense.
And then I hear all the scare tactics today, and it reminds
me of what we heard back in the 1960s at the founding of the
Medicare program. Ronald Reagan said, ``If you don't stop
Medicare, one of these days you and I are going to spend our
sunset years telling our children and our children's children
what it was once like in America when men were free.'' Wow.
Well, that didn't happen.
George Herbert Walker Bush described Medicare in 1964 as
``socialized medicine.'' Yet you all are rigorously defending
the program today.
Barry Goldwater, ``Having given our pensioners their
medical care in kind, why not food baskets? Why not public
housing accommodations? Why not a vacation resort? Why not a
ration of cigarettes for those who smoke and beer for those who
drink?'' Ridiculous things were said during this Medicare
debate, and Bob Dole--I was there--fighting the fight, voting
against Medicare. Scare tactics didn't work back then, and they
are not going to work now.
We have to go forward to make sure that we can increase the
access to lifesaving drugs for all Americans. And that is what
this is all about. I know I have had countless town halls in my
district with Democrats and Republicans in liberal and moderate
and conservative areas in my district. And seniors of all
stripes, of all political persuasions, tell me they are paying
way too much, and many of them have to ration their drugs. They
have to make sure at the end of the month--they take a half a
pill or half of what their doctor said because they are waiting
for their Social Security check to come in at the end of the
month, at the end of the month for the beginning of the second
month. So they are rationing that.
Some of them are even forgoing groceries in the most
prosperous nation in the world. That is what the issue is
today.
I have a question for my fellow Scarlet Knight, Professor
Carrier. One of the areas we have heard some abuses about is in
the petitions at the FDA. Professor Carrier, I would like to
follow up on the portion of your testimony in which you discuss
a number of reasons why we should move forward with stopping
abuses to the citizen petition process.
Can you explain why it is difficult for the FDA to dismiss
a citizen petition currently? Why is it difficult for them to
prove that a petition's purpose is primarily for delay and that
there are no valid scientific or regulatory issues raised in
the petition? And could FDA's resources be better used if we
change that?
Mr. Carrier. Absolutely. Thank you for the question,
Representative Soto. And you are right that a lot of these
citizen petitions are filed just to delay generic entry.
Everybody knows it. The FDA knows it. But the FDA cannot
summarily dispose of these petitions.
Why? Because the standards are too high. The standards are,
as the FDA says, ``Extremely difficult to meet.'' That is the
FDA talking. Why? Because the FDA has to show two trainings,
both of them:
First, if there is a primary purpose of delaying the
generic. How is the FDA going to know what the brand company's
primary purpose is? It is not going to say in the petition,
``Oh, by the way, we are doing this to delay the generic.'' So
it doesn't really know that.
And then the second one is, the petition doesn't, on its
face, raise a valid scientific or regulatory issue. There is so
much scientific legalese in all of these documents, but it is
really hard for the FDA to conclude, right off the bat, that
there is no issue at all.
And so when you put these two things together, the FDA has
never used this power. In its annual reports to Congress, it
says that the provision, quote, ``has neither curbed the filing
of provisions'' submitted with a price purpose of delay nor,
quote, ``permitted FDA to dispose of petitions without
expending substantial amounts of resources.''
It is important for FDA to summarily deny frivolous
petitions. FDA has never done so. That is why switching and/or
could make a really big different.
Mr. Soto. Thanks so much. And there is the appearance of
creating a manufacturer's delay to petition the FDA. In your
opinion, if this is enacted, would a manufacturer stakeholder
still be able to use the petition process for legitimate
scientific or regulatory issues? Yes or no?
Mr. Carrier. Yes. Absolutely. And there is always a sham
exception to petitioning. That is what is going on.
Mr. Soto. Thank you. My time is expired.
Ms. Eshoo. The gentleman's time is expired, and we thank
you again for waiving on.
Now, last but certainly not least, one of the fine doctors
that is a member of our subcommittee--and we are thrilled that
she is--the gentlewoman from Washington State, Dr. Kim Schrier.
Thank you, Kim, for your patience.
Ms. Schrier. Thank you, Madam Chair. Thank you for your
patience. And thank you to our witnesses.
This is such an important discussion, and while much of our
work this past her was really focused on the immediate needs to
come at the pandemic, the urgent need to bring down the cost of
prescription drugs has not gone away for my constituents or any
others.
And like so many of my colleagues have already highlighted,
many of our prescription medications cost far too much, and
their prices have continued to increase, for no reason, far
faster than the rate of inflation, even when nothing about them
has changed. We heard about Copaxone, and Humira, and insulin
is another classic example. I have Type 1 diabetes, and so I
just want to show you how tiny this little bottle is.
Twenty years ago, this bottle of insulin cost $40, and now
it costs over $300. And nothing has changed about it. That
holds 10 milliliters, 2 teaspoons of medicine that I can't live
without, and most insulin users use 2 or 3 bottles a month. So
this is just one example of why this issue of drug pricing is
so important.
And that example is particularly egregious, kind of the
poster child for price gouging. But the issue is nuanced. And
Professor Sachs, you were quoted a couple years ago as saying,
``We probably are underrewarding drug innovation for some types
of diseases, such as early stage cancers requiring long
clinical trials, and then overrewarding it for others.''
And I was hoping we could talk a little bit about
innovation and that point because there is a big difference
between new, lifesaving, curative, truly transformational
treatments and a second, third, or fourth drug in a class that
doesn't really represent a big therapeutic advantage over
existing therapies.
And I am from Washington State. Here are a couple things
that have happened in my home State, which is a hub for cancer
treatments, cell therapies like CAR T, gene therapies. One
local company spent more than 8 years pioneering personalized
cancer immunotherapy for patients with lymphoma that hadn't
responded to anything else by going to a special manufacturing
facility, changing cells, re-engineering them to fight cancer.
There is also a one-time gene therapy that has shown
promise for patients with thalassemia, potentially freeing them
from a lifetime of transfusions. And there are countless
oncology treatments that meaningfully extend survival and
improve quality of life.
But research and development is not easy, and there is no
guarantee of success, and it could take many, many years. And
so I want to talk about the nuance and the use of a scalpel
instead of a hatchet in these conversations.
Can you tell me, Professor Sachs, how can we better
incentivize innovation that represents these therapeutic
advances instead of the ``me too'' drugs that just follow on
what we already have?
Ms. Sachs. Thank you for this very important question. I
think you are absolutely right to quote my own words back at me
because I don't think that all drug prices are too high and
should just be decreased. I think some drugs are priced too
high, but others are not. I think we need more investment in
certain areas, but we probably have too much investment in some
of the ``me too'' areas like you mentioned.
So in my opinion, this isn't just about the number of drugs
that we get, it is about the kind. We want innovation that
works for patients. We want cures. And the better the drug is,
the more we will pay for it and the more we should pay for it.
And so all of that really matters in thinking about
competitive clinical effectiveness, which is something not just
many countries but also U.S. payers do. We say, ``Is this drug
better than the current drugs we have for treating the same
condition?'' If it is not better, maybe we don't want to pay
more for it. But if it is better, we should pay more for it.
And so thinking----
Ms. Schrier. Right. The notion of what would it cost us
over the long run for this patient to have all of these
horrible consequences, how much time would they spend in the
hospital who didn't have it? And that is a way to think about
whether the cost of a drug is justified.
I was just going to ask about H.R. 3. Can you tell me what
guardrails are already in H.R. 3 or could be added in order to
ensure that those innovative treatments are treated
differently, that we take into consideration the big benefit?
How can we make sure that happens?
Ms. Sachs. Absolutely. So H.R. 3 already instructs the
Secretary to think about comparative clinical effectiveness,
right? Is this drug better than other drugs for the same
condition? If so, that matters as to how we think about
negotiating and setting a fair price for that product.
H.R. 3 is also limited to the top-spending drugs in
Medicare and more generally. So a lot of rare disease drugs
won't even be eligible for negotiation, and rare-disease
patients should have--be concerned about the impact of
negotiating on the price of those drugs.
Ms. Schrier. And they will take it into consideration when
we have a treatment for Alzheimer's, for example, that will be
worthy and valuable and will be treated as such.
Thank you, and I yield back.
Ms. Eshoo. We all pray for that day. Thank you, Dr.
Schrier.
Well, I think that that--we have heard from 41 Members,
witnesses. So you have really held our attention. I want to
thank each one of you on behalf of all my colleagues today.
Each one of you brought great value in your testimony. So a
great shout-out and enormous thanks to each one of you, Therese
Ball, Michael Carrier, Dr. Gupta, Khrystal Davis, and Rachel
Sachs. You really got a workout there, Rachel, from both sides.
But very sincerely, thank you to each one of you. And on behalf
of the American people, because they are listening in, and I
think that this was a 101 on the subject matter.
Now, I need your help, Mr. Guthrie. We have coming--we have
90 documents that I would like to move to place in the record.
I don't think that you want to stick around to help me read 90
of them.
Mr. Guthrie. Yes. I won't do that. So I'll give you
unanimous consent not to read.
Ms. Eshoo. All right. OK. So as ordered, and all the
documents that have been submitted to the subcommittee will be
made part of the record.\1\
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\1\ The documents have been retained in committee files and are
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=112551.
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Now, pursuant to committee rules, Members have--as you know
or may not recall, you have 10 business days to submit
additional questions for the record. As I said to the
witnesses, you will be hearing from Members. Many of them will
submit a written question. And we ask the witnesses to please
respond as promptly as you can to any questions you receive. So
with my thanks to each one of you both to the tone, the value
of your observations, your questions, the answers of the
witnesses, I think you have just been terrific. This has been a
great experience.
Mr. Guthrie. Might we share?
Ms. Eshoo. Yes. Certainly.
Mr. Guthrie. I think I said I will give unanimous consent.
I actually can't do that. So I will move unanimous consent----
Ms. Eshoo. I asked for unanimous consent----
Mr. Guthrie. OK. I will not object. [Laughs.]
Ms. Eshoo. Thank you. Thank you, Mr. Guthrie. Appreciate
it. You are wonderful. Can you imagine if we had to sit here
for--listen to me read out 90.
Where was I? I think at this time I can say that the Health
Subcommittee meeting of today is adjourned with my thanks to
all of the Members and our superb witnesses.
Thank you. Everyone stay healthy, please.
[Whereupon, at 3:41 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
[Dr. Gupta did not answer submitted questions for the
record by the time of publication.]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
[Ms. Davis did not answer submitted questions for the
record by the time of publication.]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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