Nomination of Dr. Robert Califf to Be Commissioner of Food and Drugs — Senate Hearing 117-203 (2021)
Summary
Senate Hearing 117-203 is the record of the December 14, 2021, hearing of the Committee on Health, Education, Labor, and Pensions on the nomination of Robert McKinnon Califf, of North Carolina, to be Commissioner of Food and Drugs, with Chair Patty Murray presiding. Chair Murray's opening statement gives the dates the committee received the nomination and paperwork in November and says the pandemic has killed over 800,000 Americans. Ranking Member Richard Burr gave an opening statement and introduced the nominee. Additional material listed includes letters of support, a letter of opposition, a New England Journal of Medicine item on the safety of Mifepristone and testimony listed under Hon. Mike Braun.
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“Nomination of Dr. Robert Califf to Be Commissioner of Food and Drugs — Senate Hearing 117-203 (2021).”
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[Senate Hearing 117-203]
[From the U.S. Government Publishing Office]
S. Hrg. 117-203
NOMINATION OF DR. ROBERT CALIFF
TO BE COMMISSIONER OF FOOD AND DRUGS,
FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF
HEALTH AND HUMAN SERVICES
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING THE NOMINATION OF ROBERT MCKINNON CALIFF, OF NORTH CAROLINA,
TO BE COMMISSIONER OF FOOD AND DRUGS, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
__________
DECEMBER 14, 2021
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
46-783 PDF WASHINGTON : 2023
-----------------------------------------------------------------------------------
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont RICHARD BURR, North Carolina,
ROBERT P. CASEY, JR., Pennsylvania Ranking Member
TAMMY BALDWIN, Wisconsin RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut SUSAN M. COLLINS, Maine
TIM KAINE, Virginia BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota MIKE BRAUN, Indiana
JACKY ROSEN, Nevada ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado MITT ROMNEY, Utah
TOMMY TUBERVILLE, Alabama
JERRY MORAN, Kansas
Evan T. Schatz, Staff Director
David P. Cleary, Republican Staff Director
John Righter, Deputy Staff Director
C O N T E N T S
----------
STATEMENTS
TUESDAY, DECEMBER 14, 2021
Page
Committee Members
Murray, Hon. Patty, Chair, Committee on Health, Education, Labor,
and Pensions, Opening statement................................ 1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State
of North Carolina, Opening statement........................... 4
Witnesses
Califf, Hon. Robert, M.D., Durham, NC............................ 7
Prepared statement........................................... 9
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Murray, Hon. Patty:
Letters of Support for the Nomination of Robert Califf....... 42
New England Journal of Medicine on the safety of Mifepristone 82
Braun, Hon. Mike:
SFLAction Chemical Abortion Testimony-Toni McFadden.......... 93
Letter of Opposition for the Nomination of Robert Califf..... 80
NOMINATION OF DR. ROBERT CALIFF
TO BE COMMISSIONER OF FOOD AND DRUGS,
FOOD AND DRUG ADMINISTRATION,.
DEPARTMENT OF
HEALTH AND HUMAN SERVICES
----------
Tuesday, December 14, 2021
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:01 a.m., in
room G50, Dirksen Senate Office Building, Hon. Patty Murray,
Chair of the Committee, presiding.
Present: Senators Murray [presiding], Sanders, Casey,
Baldwin, Murphy, Kaine, Hassan, Smith, Rosen, Lujan,
Hickenlooper, Burr, Collins, Cassidy, Braun, Marshall, Scott,
Romney, and Tuberville.
OPENING STATEMENT OF SENATOR MURRAY
The Chair. Good morning. This Committee will come to order.
The Senate Health, Education, Labor, and Pensions Committee
will please come to order. Today we are holding a hearing on
the nomination of Dr. Robert Califf to serve as Commissioner of
the Food and Drug Administration. Ranking Member Burr and I
will each have an opening statement, then Senator Burr will
introduce the nominee.
After Dr. Califf's testimony, Senators will have 5 minutes
for a round of questions. And while we were again unable to
have this hearing fully opened to the public or media for in-
person attendance, live video is available on our Committee
website at help.senate.gov. And if you are in need of
accommodations, including closed captioning, you can reach out
to the Committee or to the Office of Congressional
Accessibility Services.
We received Dr. Califf's formal nomination on November
15th, his Office of Government Ethics paperwork on November
17th, and his Committee paperwork on November 22nd. Dr. Califf,
thank you for joining us. You are a long ways away there, but
we can see you.
Dr. Califf. I think I can see you there, thank you.
[Laughter.]
The Chair. I want to welcome your family who is with you
today, your wife, Lydia, your son Sam, your daughter Sharon,
your son in law, Chris, and your grandchildren, Brooke and Noah
as well. Welcome to all of you. Families across the country
count on the Food and Drug Administration every day to follow
the science and the data and keep them safe, and COVID-19 has
put that rule in the spotlight like never before. This pandemic
has been incredibly hard on our Nation. It has killed over
800,000 Americans and upended our lives in countless ways.
As we continue our work to end this crisis and rebuild our
Nation stronger and fairer, we are all grateful for the
tireless work of FDA scientists to review and authorize safe
and effective tests, treatments, and of course, vaccines for
COVID-19.
While the COVID-19 pandemic remains one of the most urgent
challenges in our Nation, there are countless other ways FDA
works--that work matters to families. Every day people put the
well-being of themselves, their families, and even their pets
in FDA's hands. When we sit down for a meal, we count on FDA's
efforts to ensure the safety of our food supply and provide us
with the information we need to make healthy choices.
When we get our prescriptions filled or rely on medical
devices to stay healthy, we count on FDA's work to uphold the
gold standard of safety and effectiveness. The FDA needs strong
leadership to continue that work and to address other pressing
challenges--challenges like the opioid crisis. We lost over
100,000 people to drug overdoses between April 2020 and April
2021. That is an all-time high and nearly double the number of
deaths we saw only 5 years ago. Challenges like youth tobacco
use. E-cigarettes and other flavored tobacco products have led
to skyrocketing tobacco use among kids.
According to the CDC, 2 million youth use e-cigarettes and
a quarter of that group uses them daily. Challenges like
antimicrobial resistance, a threat which could make current
treatments for infections fundamentally ineffective, and common
procedures like joint replacements or organ transplants and C-
sections life threatening. Challenges like improving health
equity. We know too many communities are left behind in our
public health response, including in clinical trials, which
historically have left out certain populations like people who
are pregnant, people of color, and others.
This undermines people's health by delaying information
they and their health care providers need to understand how a
treatment will affect them specifically or whether it is safe
during pregnancy, and by making it hard to identify differences
in the safety and efficacy of treatments for these patient
populations. So over the last few years, I have repeatedly
raised the need for FDA to improve diversity in clinical
trials. Then there is the constant challenge of keeping pace
with discovery. Senator Burr and I both are focused on making
sure FDA stays ahead of the massive discoveries and
technological advances being made in medical science and
biotechnology.
While we need a strong leader at FDA to tackle all of these
challenges, we also need to make sure we are giving the agency
the tools it needs to do this work and keep our families safe.
That is why in the year ahead, this Committee is continuing its
long tradition of working in a bipartisan way to reauthorize
all the user fee programs set to expire in 2022. The user fee
programs are critical to supporting the agency's work to review
and approve products and uphold the gold standard of safety and
effectiveness in a timely and efficient manner.
Without these programs, it would take longer for FDA to
help bring safe and effective medical devices to the U.S.
market and to review generic and biosimilar drugs, which can
lower drug costs by offering patients cheaper alternatives for
drugs they need. And as we work to support FDA's drug review
process, we also need to stop drug companies from misusing the
process to keep cheaper drugs off the market.
Patients desperately need us to fight skyrocketing drug
costs with every tool in our arsenal, and that includes making
sure affordable drugs are not kept off the shelf by
pharmaceutical companies who are gaming the FDA approval
system. We also need to make sure the Food and Drug
Administration has the authority it needs to keep families safe
from products that have gone for too long with too little
scrutiny. When it comes to cosmetics, we have discovered known
carcinogens like asbestos and formaldehyde in products like
baby powder, children's makeup kits, and hair products.
When it comes to dietary supplements, people across the
country who are looking to make healthy choices are faced with
a shelf full of products that make claims about their health
benefits but lack rigorous oversight because FDA does not have
the authority to collect basic information about those products
or even to know what products are on the market. Families
across the country buy and use these items every day. They
deserve to know all the products they entrust their health to
are subject to type of careful FDA oversight they already trust
to keep their food and drugs and medical devices safe.
Families also deserve to know they have an experienced
leader at the FDA who understands the many challenges our
Nation is facing and the importance of ensuring science comes
first. Dr. Califf has worked on these issues before, when he
was previously confirmed to lead FDA in an overwhelmingly
bipartisan vote. I look forward to working with him again to
ensure FDA continues to protect families across the country,
uphold the gold standard of safety and effectiveness, and put
science and data first.
Throughout this crisis, FDA has empowered its experts and
ensured its decisions are based in science and data. And as we
have seen him in the growth of misinformation around issues
like vaccines and reproductive health care, maintaining that
commitment to always put science first will be more important
than ever to maintaining the trust of the American people.
Now, before I turn it over to Ranking Member Burr for his
opening remarks, I seek unanimous consent to put in the record
13 letters in support of Dr. Califf's nomination signed by more
than 90 organizations representing health care providers,
academic research, and patient advocates, including a letter
from six former FDA Commissioners appointed by Presidents of
both parties. So ordered.
[The following information can be found on page 42 in
Additional Material:]
The Chair. I will turn it over to Ranking Member for your
opening remarks and for introducing Dr. Califf.
OPENING STATEMENT OF SENATOR BURR
Senator Burr. Thank you, Madam Chair. Thank you for holding
this important hearing today. With the indulgence of the Chair,
I am going to include Dr. Califf's introduction in my opening
statement before the Committee. Dr. Califf, last time you were
here interviewing for this job, I introduced you to my
colleagues as a wonderful father, grandfather, great doctor,
great man. Let me say to my colleagues, all that remains the
same today. Welcome back. Dr. Califf is a distinguished North
Carolinian who previously served as Commissioner of the Food
and Drug Administration under President Obama from February
2016 until January 2017.
Prior to becoming Commissioner, Dr. Califf served as the
Deputy Commissioner of the FDA's Office of Medical Products and
Tobacco beginning in February 2015. Before joining the FDA, Dr.
Califf was a Professor of Medicine and Vice Chancellor for
Clinical and Translational Research at Duke University in
Durham, North Carolina. Dr. Califf spent more than 35 years in
leadership roles at his alma mater, including the positions of
Director of Translational Medicine Institute and the Director
of Clinical Research Institute. He has also worked to move the
promising field of translational science forward as the
director of the Clinical Trials Transformation Initiative.
Dr. Califf currently is the head of Clinical Policy and
Strategy for Verified Life Science and Google Health at
Alphabet, Google's parent company. His experience also includes
serving as vice Chancellor for Health Data Science and Director
of Duke Forge and the Donald F. Fortin, M.D. Professor of
Cardiology at the Duke University School of Medicine. Dr.
Califf's unique perspective as an FDA Commissioner, coupled
with his understanding of partnerships with the private sector
and academia that assist in fueling innovation will be vital if
confirmed as the next FDA Commissioner.
Dr. Califf, thank you for being here to answer questions
today. I say to my colleagues, I am not sure you could write a
resume of somebody more qualified to be considered for
Commissioner of the FDA than Rob Calif. To your family, you
should be proud today. All of the criticism he will endure
during this process is the result of his own success. Thank you
for the sacrifice that you are making to allow him to return to
the FDA. I am thankful to finally have an opportunity to hold a
hearing on one of the most significant positions in the
Administration during the worst pandemic in over a century.
This Administration has left the FDA Commissioner position
open since January 20th, almost a full year in the middle of a
pandemic. I am disappointed that it took so long, but I am glad
to see you here again sitting before this Committee. Since your
last--since you were last here, the FDA has made some major
strides in updating and modernizing their behavior.
Now, in the midst of a global response to the pandemic, so
much more is at stake. The FDA is responsible for ensuring the
safety and effectiveness of medical devices, medical products
in the United States and protecting our Nation's food supply.
Safety and efficacy is your mission. Is the product safe
for use and does it work as intended? FDA regulates
approximately $0.20 of every dollar in the U.S. economy. The
products and practices it regulates are diverse, and there will
be more demands on your time than there are hours in a day.
You are familiar with the FDA as an agency and with its
responsibilities, its challenges, and its ability to reach the
lives of every American. Because of FDA's reach, there are
infinite things that you could do if you are confirmed, but
your priorities should align with where FDA can have the
greatest impact, supporting the next generation of biomedical
science and innovation, and protecting our Country from public
health threats. It has been almost 5 years since you last
served at the FDA.
You will be a newcomer to the agency's pandemic response
and to the ways the FDA has improved over the past 2 years. You
are filling the shoes of a legend. The Nation has been
fortunate to have Janet Woodcock at the helm. The FDA success
is her success, and we need to build on that. I have
significant concerns that FDA could revert to its old ways of
doing things, going back to the ways before COVID.
Your last--you last led the agency during peacetime. We
need a wartime Commissioner who will lead us through the next
phase of the response to coronavirus, and build a stronger,
more nimble FDA for patients and America's consumers. The past
2 years have tested the FDA. Its authorities and regulatory
practices have come under scrutiny as the gatekeeper for
medical countermeasures needed to protect us against
coronavirus. The pandemic has exacerbated existing systemic
challenges at the agency and created entirely new ones that you
will face if confirmed.
The FDA has made historic progress. The agency finally
leaned into its authorities to move as quickly and safely as
possible. It worked with manufacturers to develop and rapidly
scale up manufacturing of 3 vaccines, 12 treatments, and more
than 420 tests to protect us against, detect, and diagnose a
virus. Many of these countermeasures were developed and
authorized for use in a matter of months or even weeks, without
compromising safety and efficacy, a testament to the agency and
its partnership with innovators. FDA provided flexibility and
certainty. It made all the difference. The next Commissioner
cannot take their foot off the gas. The agency has come too
far.
The FDA's regulatory readiness is important for the next
threat that we will face, but also for the unmet needs for
devastating diagnosis like cancer, Alzheimer's, and ALS. The
pandemic demonstrated that medical products can be developed
more quickly without compromising the FDA's gold standard. The
time it takes to develop a new drug increased from an average
of 7 years in 1997 to 9 years in 2017.
According to NIH, it can take up to 7 years to develop a
diagnostic. We need to go the other way. We developed
treatments and vaccines for COVID in under a year and
diagnostic test in a matter of a few months. Many vaccines and
treatments used during COVID leveraged platform technology that
we can adapt to address new targets. I think they are one of
the best ways to accelerate development at the FDA is to work
with innovators to streamline the development and review of new
products built on these cutting-edge platforms, whether for new
pathogen or for a lifesaving, life changing disease.
Next year, this Committee will be charged with evaluating
the FDA's user fee program and consider their reauthorization.
I have strong, deeply held feelings about this important
program. I have served in Congress for all but the first user
fee process. Since their creation, user fee programs have grown
to enormous sizes. Over the decades, the PDUFA program fees
collected have roughly doubled, and MDUFA program fees have
more than quadrupled. This growth in user fees from industry
weakens FDA's accountability to Congress and to patients that
we serve.
The purpose of the user fee program is to supplement the
money FDA received from Congress for the review of medical
products to bring treatments and therapies to the American
people as quickly as possible. Today, after all, the agencies
have been through, with what they have been through with the
pandemic response, our approach to the user fees will
undoubtedly, undoubtedly look different.
Today, after all the--as FDA and industry work to finalize
the commitment letters for Congress to review next year, I
expect that each agreement will take stock of lessons learned
over the last 2 years. Dr. Califf, should you be confirmed, I
look forward to working with you during the most important user
fee cycle that this Committee has faced. I spent almost 30
years working to hold the FDA accountable so that the
American--Americans benefit from innovative medicines.
The best way for the agency to achieve this goal is to
provide clear, predictable pathways for markets--for products
to come to market. FDA has made progress on this for some of
the products it regulates, approving lifesaving drugs and
medical devices every year.
FDA has issued specific guidance for rare disease, cell and
gene therapy, and complex generic drugs, but more work remains
to speed the slow gears of regulation. FDA also still has much
to do to provide a clear and predictable pathway to market for
tobacco products and diagnostic tests. Leadership, vision, and
understanding of the innovation of products are critical to
fair, predictable regulatory pathways for any product regulated
by the FDA.
The Centers for Tobacco Products receives the second
highest user fee dollars of any center at the agency, except
for the drug center. More than a decade after receiving
authority from Congress, FDA just recently issued the
foundational rules to provide a regulatory roadmap for a new
and potentially less harmful tobacco product.
Can you imagine if FDA did not have foundational
regulations for the review of new drugs while still requiring
products to submit applications? Despite 13 years and more than
$7.5 billion, it has authorized under the premarket pathway
only one, one, Vapor product, a class of product that can
provide a new, potentially less harmful alternative for
lifelong smokers.
CTP is charged with the regulation of tobacco products,
which includes a mission to regulate these products for the
protection of public health. It is not meeting that mission,
either. According to data FDA gave me in 2019, CTP spent
millions more on advertisements than it did on enforcement
against bad actors. Dr. Califf, should you be confirmed, I
would ask you to take a hard look at the Tobacco Center and get
the house in order. Enormous innovation is occurring in areas
of diagnostic tests. We have experienced this innovation
throughout the pandemic response.
The laboratory community rapidly developed tests to detect,
diagnose, and surveil the coronavirus. There was confusion
early on in the response as to whether these tests were under
FDA's regulatory purview, and if so, what was required of them
to be available to the American people.
Public health officials, test developers, providers, and
patients need the law to provide regulatory certainty and
predictability that allows for innovation to continue on the
same trajectory we are experiencing during the pandemic.
Dr. Califf, I hope you can agree that Congress needs to
speak to resolve this decades old issue once and for all. If
you are confirmed as Commissioner, which I expect you will be,
you will be responsible for maintaining FDA's mission as we
enter a new era of biomedical innovation. This new era rule
will require FDA to recruit, higher, and retain the right
talent. FDA has long faced systemic hiring challenges. It will
be on--it will be one of the top challenges that you face as a
Commissioner.
If you are confirmed, I look forward to working with you to
help to address this issue. You will be responsible for policy
decisions to help Americans as they safely return to normal
life, to prepare to respond to future pandemics, and to build
upon successful policies that have enabled medical innovation
to reach patients more quickly. Effective and accountable
leadership at FDA is paramount.
My questions today are intended to make sure that you are
up to the task of leading the FDA while we are still battling a
once in a lifetime pandemic. I urge you to focus on what
matters most, to not lose sight of all the ground gained, and
to use the tools we have given you to your fullest extent. I
look forward to our conversation today and hearing your plans
for returning to the agency to address many challenges that we
face. With that, Madam Chair, I yield the floor.
The Chair. Thank you, Senator Burr. We will turn it over to
Dr. Califf for his opening remarks. Again, welcome to our
Committee, and welcome to your family as well.
STATEMENT OF HON. ROBERT CALIFF, M.D., DURHAM, NORTH CAROLINA
Dr. Califf. Thank you so much, Chair Murray and Ranking
Member Burr. I want to thank you and Members of the Committee
for inviting me here today to discuss my nomination to be
Commissioner of the Food and Drug Administration.
Five years ago, I was before you in the same position. Much
has happened over those 5 years, including the devastating
COVID-19 pandemic, but many fundamental issues I addressed at
that time remain important areas for the FDA, our Country, and
the world to advance toward an era of unprecedented health.
I am excited to be accompanied by my family today and thank
you for your kind introductions of them. Also want to take a
moment to honor my parents who were with me at the last meeting
and who passed away peacefully in their 90's.
The support of my family has been essential to my career.
This unique opportunity to help create a better world for my
grandchildren is personally motivating. I previously served
with pride as FDA Commissioner, and I am honored that President
Biden has nominated me to lead the FDA for a second time.
I want to thank Dr. Janet Woodcock, the rest of the FDA
leadership team, and the entirety of the FDA workforce for
their exemplary service over the years, and especially during
the COVID-19 pandemic. To the many Committee Members I have met
with over the last several weeks, about 23 total, including
Committee Members, I thank you all for your willingness to
share with me your perspective on ways the FDA can better serve
the American people.
If confirmed, I will be a Commissioner who understands the
importance of working closely with Congress, as well as other
parts of the executive branch. I will also be a Commissioner
who can hit the ground running because of my past experience as
a civil servant and in leading the agency.
My career has been dedicated to advancing the health of
individuals and the public as a physician, researcher, and
leader in both the public and private sectors, as well as
academia. My family, like many American families, has
experienced firsthand how important it is to find a critical
balance between appropriate safeguards for patients and
innovative treatments.
My daughter was born with a serious congenital heart defect
requiring open heart surgery as an infant. My mom benefited
directly from the accelerated approval of new drugs from
multiple myeloma that without a doubt and in meaningful years
to her life. My professional experiences too have shaped my
understanding of our health system over the years.
As a physician, I care for people with serious
cardiovascular disease, and I worked with colleagues on the
development and evaluation of life saving medicines and
technologies for the treatment of heart disease that have
helped millions of Americans.
This experience also taught me about the painstaking work
of developing a safe and effective medical product, then
conducting the critical clinical trials and seeking FDA
approval for that product. In this process, the majority of
proposed new drugs and devices failed because the risks
outweigh the benefits. I learned firsthand that it is essential
that we produce high quality evidence to sort the effective and
effective treatments.
My first priority, if confirmed, will be emergency
preparedness and response. The FDA must continue to be a strong
partner in battling COVID-19, taking into account lessons
learned from the pandemic so we can apply them to the ongoing
current pandemic and so we are ready for the next one.
Second, all FDA's actions regarding the products of the
agency, that the agency regulates, must focus on protecting
consumers and patients. Safety matters. Now is the time to
develop a systematic approach to evidence generation that will
improve patient safety and provide a much more efficient way to
understand the benefits and risks of medical products when used
in practice, and to ensure that our food is safe. And we must
protect kids from tobacco products.
As surveys indicate, youth use remains at an alarming rate.
Our Nation is also experiencing an epidemic of addiction and
overdose, with over 100,000 overdose deaths recorded over a 12
month period for the first time ever. FDA must work with the
public health, clinical, and policy committees to turn the
tide.
Third, FDA must stay current on the latest advances in
science and technology in order to provide guidance to industry
and stakeholders on everything from clinical trial conduct to
regenerative medicine to best practices for protecting the
safety of the U.S. food supply.
With each of these priorities, a common thread is my
commitment to ensuring that the agency is more inclusive,
diverse, equitable, and accessible in the work it does for the
American public.
As I work to implement these priorities, attracting and
retaining FDA scientific workforce maybe even more important
than any particular policy because it is the agency's day to
day decision-making that protects the public.
This is a once in a generation time for public health, and
the FDA must continue to play a vital role in protecting and
promoting the health of all Americans by leveraging the
acceleration of technology and biomedical knowledge.
If confirmed, I would be honored to lead the agency again.
Thank you for allowing me to testify before you today, and I am
happy to take your questions.
[The prepared statement of Dr. Califf follows:]
prepared statement of robert m. califf
INTRODUCTION
Chair Murray and Ranking Member Burr, I want to thank you and
Members of the Committee for inviting me here today to discuss my
nomination to be Commissioner of the Food and Drug Administration
(FDA). Five years ago, I was before you in the same position. Much has
happened over those 5 years, including the devastating COVID-19
pandemic, but many fundamental issues I addressed at that time remain
important areas for the FDA, our country and the world to advance
toward an era of unprecedented health.
I am excited to be accompanied by family today. Sitting behind me
are my wife of 48 years and high school sweetheart, Lydia; two of our
three children, Sharon and Sam; and two of our six grandchildren,
Brooke and Noah. I also want to take a moment to honor my parents, who
were with me at the last hearing, and who passed away peacefully in
their 90's. The support of my family has been essential to my career.
The unique opportunity to help create a better world for my
grandchildren is personally motivating.
I previously served with pride as FDA Commissioner, and I am
honored that President Biden has nominated me to lead the FDA for a
second time. I also want to thank Dr. Janet Woodcock, the rest of the
FDA leadership team, and the entirety of the FDA workforce for their
exemplary service over the years and especially during the COVID-19
pandemic.
To the many Committee Members I have met with over the last several
weeks: I thank you all for your willingness to share with me your
perspectives on ways the FDA can better serve the American people. If
confirmed, I will be a Commissioner who understands the importance of
working closely with Congress, as well as other parts of the executive
branch. I will also be a Commissioner who can hit the ground running
because of my past experience as a civil servant and in leading the
Agency.
BACKGROUND
My four-decade career has been dedicated to advancing the health of
individuals and the public as a physician, researcher, and leader in
both the public and private sector--as well as academia. But, like each
of you, my understanding of our health system was shaped by both my
personal and professional life experiences, which will guide my work at
the FDA, if confirmed.
Personal
My family, like many American families, has experienced firsthand
how important it is to find a critical balance between appropriate
safeguards for patients and innovative treatments.
My daughter was born with a serious congenital heart defect
requiring open heart surgery as an infant. My mom benefited directly
from the accelerated approval of new drugs for multiple myeloma that,
without a doubt, added meaningful years to her life.
Professional
My professional experiences, too, have shaped my understanding of
our health system over the years. When I began my career as a
cardiologist, heart attack was the leading cause of death in the United
States and our understanding of the cause of heart attack was limited.
I, along with a global network of health professionals, worked to
figure out why. Together we developed ``clot busting'' drugs to restore
blood flow to the heart, improve the recovery of the heart muscle and
help prevent future heart attacks. We also developed life-saving
technologies, including balloon angioplasty, cardiovascular stents, and
implantable defibrillators, that have helped millions of Americans; and
we stopped the development of numerous drugs and devices for which the
risks outweighed the benefits. Thanks to these technologies death rates
from acute heart problems have been cut in half.
This experience also taught me about the painstaking work of
developing a safe and effective medical product, then conducting the
critical clinical trials and seeking FDA approval for that product.
Like clinical decisions, FDA decisions are best made when the evidence
is robust. My career has been focused on developing better systems for
generating reliable evidence to support the everyday decisions that
consumers, patients, clinicians and policy makers must make to achieve
better health.
PRIORITIES
My priorities, if confirmed, would be: emergency preparedness and
response; consumer and patient protection; and modernization and
innovation.
When it comes to emergency preparedness and response, the FDA must
continue to be a strong partner in battling COVID-19. And, it must have
infrastructure in place that reflects lessons learned from this
pandemic so it is ready for the next one.
Second, all FDA's actions regarding the products the agency
regulates must focus on protecting consumers and patients. Safety
matters. Now is the time to develop a systematic approach to evidence
generation that will improve patient safety and provide a much more
efficient way to understand the benefits and risks of medical products
when used in practice. The FDA must continue to build the science base
needed to give people confidence that their food is safe and their
medical products are safe and effective. And we must protect kids from
tobacco products, as surveys indicate youth use remains at an alarming
rate.
Our Nation is also experiencing an epidemic of addiction and
overdose, with over 100,000 overdose deaths recorded over a 12-month
period for the first time ever. FDA must work with the public health,
clinical and policy communities to turn the tide.
Third, FDA must stay current on the latest advances in science and
technology in order to provide guidance to industry and stakeholders on
everything from clinical trial development to best practices for
protecting the safety of the U.S. food supply.
With each of these priorities, a common thread is my committment to
ensuring that the agency is more inclusive, diverse, equitable and
accessible in the work it does for the American public.
As I work to implement these priorities, I would also continue my
previous focus on investing in our workforce. Attracting and retaining
the FDA's scientific workforce may be more important than any
particular policy because it is the agency's day-to-day decision-making
that protects the public. The scientific and technical world is moving
quickly--the FDA needs the talent to keep up and protect the public
while supporting scientific innovation.
CONCLUSION
This is a once-in-a-generation time for public health, and the FDA
must continue to play a vital role in protecting and promoting the
health of all Americans by leveraging the acceleration in technology
and biomedical knowledge. If confirmed, I would be honored to lead the
agency again. Thank you for allowing me to testify before you today,
and I am happy to take your questions.
______
The Chair. Thank you very much, Dr. Califf. We will now
begin a round of 5 minute questions, and I ask my colleagues,
please keep track of your clock and stay within your 5 minutes.
Dr. Califf, let me begin. The opioid use epidemic continues to
cause tremendous harm to far too many families and communities.
As I mentioned in my opening statement, the new CDC data
shows that more than 100,000 people died of drug overdose in
the 12 months ending in April 2021. That is a new and very grim
record high. During your time as FDA Commissioner, you started
the process of reevaluating how the agency approached the
approvals of opioid. What are the actions the FDA can take to
address this worsening crisis?
Dr. Califf. Senator Murray, I really appreciate your
bringing this up right at the start because the opioid crisis
and the addiction crisis overall, now with synthetic opioids
and stimulants on the streets of America, it is gut wrenching
for American families.
I think all of us know someone who has been affected by it.
I have had relatives in the last year who have been prescribed
30 days of opioids for minor surgery, for example, so I know we
have work to do. I am happy to go over my history and working
on this problem since 1999.
But you asked about what we need to do now, and I think we
need to learn from all that has happened over the last several
decades with this and reassess where we are today, because
whatever we have done up until now is not enough. It is going
to take all hands on deck, and specifically, the FDA needs to
redouble its efforts on prescriber education. This is an area
that has been worked on since my tenure, but it still needs a
lot of work, as evidenced by my own family's prescriptions.
Second, we need to continue to keep track of the use of
opioids and crack down on those who are using them
inappropriately or prescribing inappropriately. We need to
redouble our efforts to develop medications for pain and also
behavioral therapies.
Here I would point to the PCORI Network and the NIH co-
laboratory that just published a paper showing that cognitive
behavioral therapy is effective for chronic pain. We still have
a lot of work to do because we are not seeing a lot of these
medications that are not addictive being developed at this
point.
Then I would say, finally, we are all going to need to work
together because the problems now with the explosion of this
epidemic on the streets of America with these synthetic opioids
is going to require that all of HHS work together. There is a
concerted plan, and I would call your attention to it. I am all
on board for the FDA to play its role in this plan.
The Chair. Okay, thank you. On another topic, right now we
are seeing the Omicron variant of COVID-19 spread and quickly
learning about its impact. As we have seen throughout this
pandemic, access to diagnostic testing is a critical component
of our public health response, allowing the Government to
understand new variants, respond quickly.
If confirmed, what would you do to make sure that the
country is well equipped to handle future testing needs for
COVID-19?
Dr. Califf. Well, I am a big data person and I think
essential in the development of tests for a population as large
as the United States, and as a matter of fact for the world, is
that we understand the operating characteristics of the tests
and the underlying technology.
I was just thinking about this yesterday because my son Sam
was feeling kind of punky after his third--his booster dose of
the vaccine yesterday and he stopped in at the local drugstore,
got a rapid test. It was negative, and then we all felt Okay
about Sam getting on the plane.
I think we have really got to redouble our efforts now with
Omicron on the scene because we know it has a much higher rate
of reinfection of people who have already been infected or in
breakthrough infections and people that are vaccinated. So
this--I am well aware of the issues with testing in general. It
is complicated.
I can answer questions in more detail, but fundamentally we
have got to work together to make the tests available so that
they are not expensive. Every family should have a quantity of
tests that they can use for purposes like Sam yesterday.
The Chair. Okay, thank you. I will reserve the balance of
my time. We do have votes at 11 a.m.
Senator Burr.
Senator Burr. Thank you. Thank you, Madam Chair. Let me
just note for Members that 55 percent of FDA's budget is
approved through the appropriations process in Congress. 45
percent of the FDA budget comes from user fees. I would tell
you this is an alarming trend that we have seen over two
decades of the reliance on the industry to fund an agency that,
quite frankly, Congress could fund.
Dr. Califf, you have been--you have had the benefit of a
previous tour of the FDA. Should you get the opportunity to
return, you will have more years of academic and industry
experience under your belt and likely with more time to achieve
your goals than the 10 months of your last term of service.
What is going to be your biggest priority at the agency?
Dr. Califf. Well, Senator Burr, as we discussed in terms of
priorities, obviously the pandemic is No. 1, and it is not just
this pandemic. I was around for the wide guidance at the end of
my tenure last time around, and I am fully aware of the need
for the FDA to help develop platforms that will be essentially
ready to go when emergencies come up.
We need also a workforce which is capable of working with
those technologies. But in addition to that, as I said, we have
got to find the right balance of protecting Americans in a safe
way and being innovative in the development of products that
can move along quickly. And essential in that priority is the
development of a better evidence generation system. You
yourself have advocated for more rapid approval.
If we do that, we have got to have a system that can keep
track of the benefits and risk of the use of these treatments
over time so that when we find something that is not so good,
we stop using it. When we find it really is good, we got to use
it much more often. And I can go into much more detail about
how to go about that.
Senator Burr. I look forward to working with you on that.
You have a history with the risk evaluation and mitigation
strategy or REMS for the drug, Mifepristone. Many around the
country have asked that you address this issue. Do you believe
that the FDA needs to take any action to further weaken the
REMS for this or similar drugs? Or can you reassure us that no
changes are needed at this time?
Dr. Califf. Senator Burr, I appreciate the importance of
this question. As you are well aware, a fundamental principle
at FDA is that Americans should have access to drugs that are
safe and effective for their FDA indicated use, and guiding
those decisions is the best available evidence with core
scientific principle, just like any other area regulated by the
FDA.
I am aware, as are you, that FDA has filed a court document
indicating that its review of the REMS stay on the Mifepristone
is soon going to be available. As you know, in this position I
am in now, I am not involved in those discussions and I can't
predict the outcome, but I have great confidence in the FDA
staff that they will use the latest available evidence and core
scientific principles to make the best possible decision.
Senator Burr. More than 265 treatments and therapies have
been approved under the accelerated approval pathway and have
made a marked difference in cancer treatment. The accelerated
approval pathway dates back to 1992, when patients diagnosed
with HIV or AIDS had no effective treatment to help them. The
accelerated approval pathway is a successful and important
pathway at FDA. It brings us game changers faster.
It has recently been the subject of scrutiny, but I think
it is one of the best ways to show that we are serious about
breakthroughs and bringing new hope to Americans battling
things like ALS, cancer, or Alzheimer's. Can you commit to me
and to patients who may rely on cutting edge treatments that
you will not support efforts to narrow this pathway or raise
the bar for drugs to be approved under those pathways?
Dr. Califf. Senator Burr, first, let me just say that one
great thing about the FDA is it is always under scrutiny from
every angle. In fact, it is often said the best position for
the FDA is when all sides are, I won't use the word, but are
angry, I will just put it that way, about the decision. I
think--I am a fan of accelerated approval for the right
conditions. As you well know, I have spent countless hours with
patient groups, people with rare genetic diseases, cancer,
serious diseases for which there is no treatment.
American people prefer to get earlier access. But I would
also stress, as we discussed in your office, it doesn't stop
there. The very fact of accelerated pathway means that we are
accepting that there is more uncertainty, and the FDA has
tremendous latitude about the decision it makes with those
pathways. And that means we have got to have a better system to
evaluate these products as they are used on the market. And I
think there are ways that we can do that.
Now, technology is making this possible in a way that just
wasn't possible before, so I would really look forward to
working with you on that part of it also.
Senator Burr. I look forward to working with you on those
post approval reviews as well. Thank you, Madam Chair.
The Chair. Thank you.
Senator Sanders.
Senator Sanders. Thank you, Madam Chair. And Dr. Califf,
thanks so much for being with us and thank you for your years
of work as a physician. Dr. Califf, I am sure you were aware,
the pharmaceutical industry is probably the most powerful
special interest here in Washington, DC. It has spent over $4.5
billion on lobbying and hundreds of millions of dollars in
campaign contributions over the past 20 years, not to mention
the huge amount of money it spends on advertising.
As Senator Burr mentioned, on top of all of that, 45
percent of its budget comes from user fees. And one of the
major reasons why the pharmaceutical industry, among many
others, is so powerful is its close relationship with the FDA
and other regulators in Washington. As you may know, over the
past 40 years, 9 out of the last 10 FDA Commissioners went on
to work for the pharmaceutical industry or to serve on a
prescription drug company's Board of Directors.
A gentleman named Curtis Wright, who was not a Commissioner
but a high ranking official, in 1996, left the FDA to receive a
$400,000 compensation package at Purdue Pharma, less than a
year after he approved OxyContin with a label that said it was
``very rare'' for patients to become addicted to that opioid.
Tragically, obviously, that was not the case. Unfortunately.
Dr. Califf, you are not the exception to that rule.
Since you left the FDA in 2017, you have made several
hundred thousand dollars from pharmaceutical companies and have
received consulting fees for Merck, Biogen and Eli Lilly.
According to your financial disclosure form, you own up to--you
currently own up to $8 million in stock of major pharmaceutical
companies.
At a time when the American people are outraged by the high
cost of prescription drugs, deeply disturbed about what
happened with Purdue and OxyContin, what kind of comfort can
you give to the American people when you have been so closely
tied to the pharmaceutical industry yourself? How are they
going to believe that you are going to be an independent and
strong voice against these enormously powerful special
interests?
Dr. Califf. Senator Sanders, I do appreciate your concerns
and I am totally with you on the concept that the price of
pharmaceuticals is way too high in this country. I have a
public record on this. It is in print in a number of articles
that have been written. With regard to my own status, I am a
physician first and foremost. In the early part of my career, I
spent working in intensive care units taking care of----
Senator Sanders. I don't have a lot of time. I apologize.
Could you answer the question? You own millions of dollars in
stock. You are going to consultant to the industry. How can the
American people feel comfortable you are going to stand up to
this powerful special interest?
Dr. Califf. Senator Sanders, I have a history of doing
that. But I would also point out this Administration has the
most stringent ethics pledge in the history of administrations.
They have reviewed my status. I have agreed to the ethics
pledge, and FDA and HHS have excellent staff whose job it is to
make sure that those ethics pledge----
Senator Sanders. Thank you. Let me ask you another--I
apologize. There is not a lot of time. According to the FDA's
website, its mission is to ``make medical products more
effective, safer, and more affordable, more affordable.'' If
confirmed, what would you do to make the outrageously high cost
of prescription drugs in this country more affordable?
Do you believe, for example, that when the Federal
Government pours millions and millions of dollars into the
development of a drug, we should have a reasonable pricing
clause which prevents the drug companies for charging, for
charging consumers what they have already paid to develop? Do
you believe in reasonable pricing?
Dr. Califf. I certainly believe in reasonable pricing. And
four specific things, I will just quickly mention, just rail
them off. No. 1, we need to develop even more robust generics.
90 percent of prescriptions are generic. The biosimilars
program needs to continue to develop that scenario where----
Senator Sanders. But do you believe--again, I apologize,
just not a lot of time. When the Federal Government puts money
into the development of a drug, should consumers be protected
from high prices, yes or no?
Dr. Califf. In any situation, consumers should be protected
from high prices.
Senator Sanders. Should Medicare be able to negotiate
prescription drug prices?
Dr. Califf. Yes, and I am on record. There was a policy of
the previous Administration----
Senator Sanders. You think Medicare should do what the
Veterans Administration does?
Dr. Califf. Well, I can't say exactly what the Veterans
Administration----
Senator Sanders. VA pays half the price that Medicare pays
for its drugs. Should Medicare do what the VA----
Dr. Califf. I am on record of being in favor of Medicare
negotiating with the industry on prices.
Senator Sanders. Thank you very much.
The Chair. Thank you.
Senator Romney.
Senator Romney. Thank you, Madam Chair. Appreciate the
chance to hear from you, Dr Califf. And we had the chance to
discuss some of these things when we were together in my office
and I would like to raise them again, in part so they are on
the record, but in part also to elaborate on them. One is with
regards to two clinical trials.
There is a perspective that drugs that are approved are,
the clinical trials are paid for by the industry, by the drug
companies themselves, and that the Government itself doesn't
have the occasion to develop its own clinical trials and to
promote the evaluation of a product which the Government may
think is of interest, but there is no company that is
interested in pursuing it.
Does the Federal Government fund clinical trials at all?
And No. 2, should we do more of that? And if so, how?
Dr. Califf. Well, first of all, thank you and I enjoyed our
discussion. I hope the Government will continue to do what it
has done, is to fund clinical trials. I, over time have been
one of the highest funded NIH investigators doing independent
clinical trials when I was in academia.
As we discussed, the industry does fund its own clinical
trials for its own purposes. But there are many issues of
public health, essential public health importance where only
the Government can fairly ask the question. And your
institutions on Utah have been key contributors to those
clinical trials that have been done. I would like to see more
Government funded trials so that we ask the unbiased questions
about which therapies are the best for which people.
Last, I will mentioned PCORI, the Patient-Centered Outcomes
Research Institute, which Congress graciously just refunded for
10 years, is created just to do that particular part on behalf
of patients. As a doctor, the most common question I got is
which treatment is best for me, and that takes comparative
clinical trials that the Government is very well suited to do.
Senator Romney. Thank you. I don't happen to be a believer
in this horse deworming product known as ivermectin. But it is
my recollection that is something which is actually going
through clinical trials funded by the Government, not by the
industry. Is that correct?
Dr. Califf. That is correct. The NIH is funding two large
trials right now, one of which using a network which I helped
create with the NIH and this Patient-Centered Outcomes Research
Institute. So I think we also see treatments, and I made the
point in my opening statement. Most of what we develop, no
matter how good the science looks, turns out to have risks that
supersede the benefit.
Only 10 percent of drugs that make it into human clinical
trials actually make it to market because of this problem. So
we have got to have an open mind. We have got to do the trials
and then we have to follow the science, follow the data.
Senator Romney. Thank you. I was made aware of a practice
that perhaps you could elaborate on, which is that a product
may be approved for usage by a physician but limited in when it
can be used or how it can be used.
I am thinking with regards to monoclonal antibodies, it was
related that individuals in a hospital with advanced COVID had
been in the hospital for several days, wanted to get a
monoclonal antibody treatment, but was told you can't get that,
we won't allow you to have that in the hospital, the FDA
doesn't allow us to treat you with monoclonal antibodies, even
though at the beginning of the disease they would have been
potentially effective. Later on, we don't think they are, so we
won't treat you.
That seems to be an awfully unfair way to deal with someone
who is in a life threatening circumstance. Is that the correct
practice? Is that a correct understanding rather of that
practice? And does it make sense? And if so, why?
Dr. Califf. Well, I will try to be brief and the answer
here. First of all, let me just say I followed this closely
because we knew monoclonal antibodies were highly likely to be
effective against SARS-CoV-2 because they worked for the first
SARS epidemic, which fortunately was stopped early and never
became a global pandemic.
As these drugs were developed, it is an amazing effect of
90 percent reduction in death and hospitalization, but most
effective if used early. And that really should be the focus.
And I think that is the basis for which the practice that you
described may have evolved. Very effective, if at all, in
people who go--as you know, you get sick with the virus and
then a week or 10 days later, you may get sick enough to enter
the hospital. By that point, there is much less effect.
Now, the specific practice of preventing prescription of
antibodies, I am not aware that is happening, but it may be,
and I think that would need to be looked at in context. There
are some people who don't develop an antibody response where
the treatment may be effective.
Senator Romney. Thank you. I have got more questions, but
my time is up. Madam Chair, thank you.
The Chair. Thank you.
Senator Casey.
Senator Casey. Thank you, Chair Murray. Doctor, thanks for
your willingness to commit more time to public service at the
FDA. We are grateful for your willingness to do that. I wanted
to raise at least two subjects with you. One is over the
counter monograph reform and then also antimicrobial
resistance.
But first, on the over-the-counter monograph reform, I
appreciate the commitment you expressed during our meeting with
regard to implementation of the reform law that was passed last
year as part of the CARES Act, and I also appreciate the work
and the challenges that FDA confronts with implementation.
We are grateful for the steps that have been taken so far
to implement the law. This--the law, as you know, included new
tools for both the FDA and the over-the-counter industry to
facilitate innovation accompanied by appropriate regulatory
oversight. This includes the user fees that accompany the
regulatory authority to enable FDA to build out a modern over-
the-counter regulatory system with the necessary human
resources.
I appreciate the early implementation milestones, such as
the deemed administrative orders being issued. So here is my
question, as this implementation continues, will you commit to
the following, No. 1, ongoing communication and transparency
with Congress? No. 2, transparency with regard to--with the
public health and industry stakeholders?
Dr. Califf. Yes. Thank you, Senator, and thank you for
getting this through. It is--in the world of regulation, this
is pretty exciting. And I personally visited the drug store
early this morning to get an over-the-counter medicine, and it
was noticeable to me as Commissioner last time around that we
needed to do something so that these monographs could be
updated as innovation is made, but we also were empowered to
look at the safety of these over-the-counter products. So it is
really appreciated, and I do commit to transparency and
discussion with you and others in Congress.
Senator Casey. Thanks, doctor. Next on antimicrobial
resistance, this is an issue that presents right now urgent
public health challenges. According to the Centers for Disease
Control and Prevention, there are more than 2.8 million
antimicrobial--antibiotic resistant, I should say, antibiotic
resistant infections in this country every year, causing more
than 35,000 deaths.
This Committee has tackled this issue in a number of ways
over the years, including the passage of the so-called GAIN
Act, the Generating Antibiotic Incentives Now Act, and that was
back in 2012. The GAIN Act gave FDA new tools and provided new
incentives to drug developers to encourage them to meet this
urgent public health threat. Yet since that time, we have made
very little progress in getting new antibiotics approved to
combat these drug resistant infections.
Numerous experts have expressed concerns that the COVID-19
pandemic could exacerbate the spread of antimicrobial resistant
infections. And I want to note the work with Senator Cassidy on
this. We have been able to work with him on this and other
Members of the Committee. What do you see as the barriers to
more antimicrobial drug development? And how would you work to
support that drug development within the FDA, if confirmed?
Dr. Califf. Thank you for raising this issue. And while we
are so consumed with the pandemic right now, we cannot lose
sight of this other threat. In my lecture after leaving the
FDA, I gave, safety and effectiveness of medical products,
food, tobacco and always put in preparation for emergencies.
At the time, 5 years ago, people sort of scratch their
heads like, what is that? I think we all know what that means
now. But we can't lose sight of the fact that we could get a
super resistant bug, and if we don't have antibiotics on the
shelf that are ready to go, we are going to have a big problem.
It will be difficult, if not impossible, to treat. This
involves a whole variety of things, one of the most important
of which is one health, the combination of animals and human
evaluation, because many of these resistant bacteria are
developed in animals that are treated with antibiotics.
But in addition, there is what you mentioned. We have to
have a system of developing antibiotics, essentially not
intending to use them because you want to hold them in reserve.
And there are several mechanisms to do that I would look
forward to working with you on.
One pathway you have already passed in Congress and that is
in motion now, but we are going to have to do a lot better or
we may be taken by another surprise, and we don't want another
one like the current pandemic.
Senator Casey. Thanks, doctor.
The Chair. Thank you.
Senator Braun.
Senator Braun. Thank you, Madam Chair. Dr. Califf, enjoyed
our conversation in my office not too long ago, and we covered
a broad array of topics. I have been one interested in
reforming health care in general to add transparency,
competition to it, FDA specifically, and I think we did cover
some discussion on making it more agile, especially on maladies
that don't have really good treatments out there.
You said you would be amenable to that. I like to hear
that. This is a question I have asked since the origin of the
COVID kind of navigation, and now we got a lot of data. We are
lucky that we did have Warp Speed. We got the vaccine done.
Looks like with variants, they are going to be renditions of it
that we still need to tackle.
Whether vaccines will be the only leg that we use--I have
been a believer that it needs to be broader. In the subject of
therapeutics, are you willing to put the same interest in
developing therapeutics, especially in light of the fact that
some either choose not to get it for the wrong or right reason?
Where does that fit in your opinion in terms of the
relative importance, especially given the fact that it looks
very difficult logistically, we will get the world vaccinated
in a way to suppress variants? How important are therapeutics,
and where will you be, your posture in terms of promoting that
second leg, if not a third one down the road in terms of
protecting against it in the first place? Focus on the
therapeutics.
Dr. Califf. I am a cardiologist, so we are fairly well
known in the medical community as being aggressive people over
the garden therapeutics, and I think it has made a huge
difference in heart disease. We have drugs and devices, many of
which I have worked on in my career, and I think the same holds
here. Vaccines are far and away the first line of defense, in
addition to the behavioral measures that we all know about. But
for people who were unlucky enough to get infected,
particularly those that are high risk, the therapeutics are
absolutely essential.
Already made the point with Senator Romney, the
therapeutic, antibiotics have a 90 percent effect, and now it
looks like we have oral antivirals that may also be in that
category.
We have got to stay on top of this because the virus
doesn't really care about us, it is mutating constantly, and we
have got to have platforms that will produce therapeutics just
in time for the variants as they come up. But so, therapeutics
is a big part of the FDA. It is a big part of my history, and I
will definitely work hard on this.
Senator Casey. I think from what you said there that you
are willing to acknowledge that it is going to have to be a
significant part of how we tamp this down over time and I am
glad to hear that. Another question I have. Under your
leadership, in 2016, the FDA weakened the risk evaluation and
mitigation strategy on protocols on Mifepristone--hard to
pronounce, but a drug that is used, early in the stages of when
you are entertaining an abortion.
A recent study analyzed 423,000 taxpayer funded abortions
between 2002 and 2015, and I have got a question. Do you think
that we need to be in that relaxed kind of interpretation of
that particular approach? Or is this something you are going to
listen to current information and technology on so that you
give a full kind of consideration of that particular
methodology on abortions?
Dr. Califf. Well, as I have already discussed with Senator
Burr, I do appreciate the question. There is a document filed
by FDA in court about the evaluation of the data on
Mifepristone. And, the reevaluation is imminent. I am not
involved in that particular reevaluation, but I can assure you
the staff will be looking at the latest data and applying the
best science and make the best possible decision. I have
confidence in that staff, and I know them well.
Senator Braun. I think that is in the context of what we
are seeing, even with what the courts are taking up in terms of
trying to get the proper balance on Roe v. Wade and that issue
is going to be out there. And I think to many Americans, it is
an important, including the question I just asked.
Madam Chair, I ask unanimous consent to submit for the
record the testimony of an individual that experienced
complications resulting from a chemical abortion drug.
The Chair. Without objection.
[The following information can be found on page 93 in
Additional Material:]
Senator Braun. Thank you.
The Chair. Senator Murphy.
Senator Murphy. Thank you very much, Madam Chair. Dr.
Califf, thank you for your continued willingness to serve the
country. I am going to submit two questions for the record that
I hope you will take a hard look at. One, on the continued
delay in regulating medical gases. This is something that there
is bipartisan interest in. The current regulatory system just
doesn't work for medical gases, and we would love for you to
take a look at how we can expedite that process. And second, a
question for the record on the issue of counterfeit medical
products.
We are thinking about bipartisan legislation here that
would provide some new authorities to crack down on counterfeit
products. We have obviously seen a disturbing growth in the
distribution of counterfeit devices during the pandemic, PPE
and testing kits at the top of the list.
But the two questions I would love to have you answer in
person are on mental health drug development and drug
shortages. On this question of mental health drug development,
it is pretty stunning the slow pace that we have seen of new
and transformative drugs in the mental health space.
Right now, there are some products in the pipeline like for
schizophrenia. But overall, relative to the need, we aren't
seeing enough new innovative products come forward. And that
has to do in part because of the complex patient populations
that we are talking about here that can make research and
clinical trials and data collection more complicated.
You have written about the need to streamline the clinical
trial process and the opportunity for digital technology to
expand people that can participate in trials. Do you think that
reform can help unlock more research and more clinical trials
for individuals with behavioral health needs?
Dr. Califf. I mean, the short answer would be yes, but I
would like to give a slightly longer answer. I won't take too
much time because this is an area of great passion for me and
experience. I don't think people in America realize enough that
before the pandemic, we were experiencing an unprecedented
reduction in our life expectancy in the U.S., largely driven by
the opioid crisis, that is addiction, and also by suicide.
In addition to common chronic diseases, it is often driven
by people who are in despair and not taking the best care of
themselves. And we also haven't talked enough about the fact
that in addition to the disparities that we all know of, with
up to 10 year difference in life expectancy according to race
and ethnicity, we have an enormous urban, rural issue in this
country where the rapid decline in life expectancy are people
in rural America.
I don't see any way to connect to everybody in America
except through digital technology, but it should be
supplemented by people on the ground who help people deal with
digital technology in the local community.
I see this as the way forward. We started a drug addiction
program in Dayton, Ohio, where the highest mortality rate per
population was occurring. And in that take all comers program,
the ability to use telehealth to reach people in rural Ohio has
made an enormous difference. So that is a longer answer to say,
yes, let's get on it. We need to do something about this.
Senator Murphy. Well, and I appreciate that answer. I want
to make sure that we are, focusing on more widespread and
traditional behavioral health disorders, not simply on
addiction, where we need--drug development is covering both.
But it is still pretty stunning that in the area of treating
depression today, we are living in a trial and error world.
We still lack the data necessary to be able to know with
the kind of certainty with like what drugs are going to work
right off the bat. And a lot of patients have to try and fail
on multiple therapies before they find the one that works. And
so I look forward----
Dr. Califf. I have led my own number of failed clinical
trials trying to develop new treatments for depression
specifically and also for anxiety. So we have got--I completely
agree, we have got to address these very prevalent mental
health conditions directly.
Senator Murphy. Quickly on the issue of drug shortages. In
2012, the FDA Safety and Innovation Act gave FDA new tools to
address drug shortages. And I just want to make sure that we
are looking into the future where we might have increased
tensions with countries that are critical to our drug supply
chain. Do you think that FDA has the authority it needs to
really think 5, 10, 15 years down the line to look at shortages
that may result based on changes in our relationships with
economic allies?
Dr. Califf. Senator Murphy, I really appreciate that
question. And let me just say I was serving on the National
Academy of Medicine Supply Chain Committee, which is due to
produce a report any minute now. I can't reveal what is in the
report but let me just say I don't think people are aware of
the tenuousness of our current supply chain.
We have to have transparency and build in resilience, or we
are going to be at risk. And in fact, if you talk to hospitals
and medical practices, it has already happened that we have
fallen short of critical supplies periodically. So we really
need to work on this.
The Chair. Senator Cassidy.
Senator Cassidy. Hey, Mr. Califf, nice to see you.
Dr. Califf. Great to see you.
Senator Cassidy [continuing]. From afar. I am told that--I
was out at another Committee hearing, but I am told that
Senator Sanders asked if you support negotiation and you
agreed. Now, do you think that the FDA has a role in this
negotiation? Let me first ask you this.
Dr. Califf. No, and we were a bit short on time, so I was
trying to compress my answers. I mean, I have a published
record saying, I think negotiation is a good idea, but that is
not the role of the FDA. So that is the answer.
Senator Cassidy. That is fine. I also want to associate
myself with Senator Casey's remarks about the work we are doing
on antimicrobial resistance. And I think you--I know you will
be very aware of that, and how do we come up with ways for
these necessary antibiotics to somehow have a business plan
which works, so just to mention that as well.
Dr. Califf. I really appreciate your help with that. And I
remember in 2016 sitting there with all of the relevant
agencies and you are trying to keep track of the microbial
underpinnings on a global basis because we are all connected,
and we, it is a great place for big data if you love the
science, but we have got to figure out how to get a handle on
this.
Senator Cassidy. You had mentioned in a conversation we had
prior to this that I had raised the issue, and I want to
follow-up on it just to set the stage, we know that complex
generics, if I remember my term are correct, that for example
the EpiPen, that you could change whether or not you turn the
device to the left or to the right, and that would give a lease
of life of exclusivity upon the product.
Dr. Gottlieb suggested, your predecessor, to allow
equivalency between, Okay, you can--you don't have to turn left
or right, it can still be considered the same product, but with
alternative instructions. You had mentioned great idea, but
that FDA needed tools to allow that to be implemented. We
didn't follow-up in the conversation. Is there more you want to
say to that?
Dr. Califf. I would just say, it is going to take a lot of
work for me to get completely up to date on all the current
tools that are at our disposal. But your point is so well
taken. I think you and I agree that what we want to reward is
innovation and creating new things that make a difference in
people's health. People should do well if they do that. But
having legal tricks that extend patents and reduce
competitiveness, I just don't think that's a good idea under
any circumstances.
Senator Cassidy. Let me ask, how long would it be until you
think you could come back to this Committee with
recommendations as to how we can address those legal tricks to
give FDA the ability to offset them, if you will?
Dr. Califf. Well, I would say to give a specific time, but
it should be short. I mean, I am not ignorant on the issue, and
we had a good list in 2016, but I think a number of those
things on the list have already been taken care of, like the
buying a generic company to prevent the competition from
occurring. I think these things you all have already helped
with, so I want to make sure I have got the updated list. It
should be fairly, very quick, I would think.
Senator Cassidy. Next--thank you, I look forward to that.
Next, we had spoken again offline about the accelerated
pathway, and how the Biogen drug for Alzheimer's obviously
addressing the need, which is devastating, but there is a lot
of concerns about efficacy, safety, and cost. And you had
mentioned using big data in order to have a quicker answer on
drugs such as this. I would like you to elaborate on that,
please.
Dr. Califf. Sure. Well, we have essentially 300 million
plus Americans with electronic health records, and our health
data is being used all the time in clinical practice. A lot of
my career has been on the issue of how do we use that data,
organize, curate it, make it useful for research.
It sometimes startles people when I say the data is good
enough to use in clinical practice, as you well know, but not
good enough for research, and people say, wait a minute, how
can that be, that it is good enough for me, but not good enough
to draw a conclusion. I think we are well down the road now and
having a functional system, but also want to assure people I am
not talking about willy nilly analysis of data.
I am talking about, well, planned studies, frequently the
use of randomization. And if we look at the UK during the
pandemic, that is what they did. They organized as a country,
they took on the big questions, and they have answered a lot of
questions very succinctly, with the advantage they don't have
to spend a ton of money collecting what is already in the
electronic health record.
Senator Cassidy. Let me ask you, do you need more--do you
need different rules that we have to give you? Or can you do
that with existing authority?
Dr. Califf. I think the FDA has adequate authority, but I
think the system, because this takes many players. CMS has to
be involved. The private health sector has to be involved. And
I think the most important thing is to develop a system that
gives Americans trust that their data can be used not for
someone else necessarily, but for their own benefit.
I mean, if I had a heart attack today, I would feel a lot
better if I knew how all the other people like me had faired
with the different treatments. And so it is in my interest to
share data, but we got to develop--I think we do have work to
do to develop a system that Americans will trust to allow this
to happen.
Senator Cassidy. I look forward to your further thoughts on
how to develop that system, and I thank you for your vision. I
yield.
The Chair. Thank you.
Senator Hassan.
Senator Hassan. Well, thank you, Madam Chair and Ranking
Member Burr. And I want to thank our witness and your family
for your willingness to serve. Dr. Califf, I want to return to
the topic of opioids. In 1995, the FDA first approved
OxyContin, as you have acknowledged, a very powerful opioid
drug. Since then, more than 500,000 people have died from
opioid related overdoses.
In 2020 alone, over 357 granite staters in my home state
lost their lives due to opioid overdoses, and tragically, many
people first became addicted to opioids through a legal
prescription for OxyContin or other FDA approved drugs. First
question, did the FDA make a mistake when it approved OxyContin
in 1995?
Dr. Califf. I think if we look back, approving OxyContin
with no long term studies and no assessment of the addictive
capabilities is something that could have been done
differently.
Senator Hassan. In 2001, the FDA revised the OxyContin
label to indicate that the drug should be used not just for
short term pain, but when a ``continuous around the clock
opioid analgesic is needed for an extended period of time.''
In other words, the FDA specifically indicated OxyContin
for long term use to treat chronic pain. Former FDA
Commissioner David Kessler, who led the agency in 2001, has
since said that there are no studies on the safety or efficacy
of opioids for long term use, and has called the FDA's 2001
decision a mistake and a, ``blank check'' for the industry. Do
you agree with that assessment?
Dr. Califf. Well, the only little part of I disagree with
is there are now long term studies underway, but at the time,
he said, I think that it was accurate, and it could have been
done differently. I mean, I am an evidence based person, and if
we are going to instruct people to take drugs for long periods
of time, we need long term studies.
Senator Hassan. Well, look, it is an old adage, but it is
worth repeating, the first step toward fixing a problem is
admitting that you have one. Repeatedly, I have asked FDA
officials about this, and I get this kind of vague answer about
whether the 2001 relabeling was a mistake. And its failure to
admit to having created problems for more than 20 years is part
of why we have an opioid crisis in the first place.
It is still troubling to me that we don't have direct
acknowledgment by FDA and FDA officials that they made mistakes
and that in 2001 the decision to re-label created an even worse
problem. Let me just move forward to one other thing, you
became FDA Commissioner in 2016.
By that time, we did know an awful lot about the addictive
nature of OxyContin and the problems with the label from 2001.
Why didn't you take action to change the OxyContin label when
you led the FDA in 2016?
Dr. Califf. Well, what I did was to, several things, one is
to take--support these long term studies that needed to be done
to get the evidence and also contract with the National Academy
of Medicine to reset the format for the evaluation of opioids.
The tradition of FDA is to evaluate risk and benefit for the
person for whom the drug is prescribed. This affects many other
people in society and that was successfully done, so I do
believe it has set the framework for that.
Senator Hassan. But doctor, when you listed in response to
Senator Murray's question, when you listed what we need to do
going forward on opioids, you said we need to reassess some
things, we need more prescriber education. You cited your own
family's experience with getting a 30 day prescription for
opioids for minor surgery. If the label were different, the
doctor wouldn't have prescribed that family member the 30 day
prescription. So explain to me why we shouldn't aggressively be
pursuing relabeling.
Dr. Califf. I think as the evidence comes in, we are going
to need to aggressively look at relabeling. And that was the
purpose of setting a different framework so that we would have
a legal framework for doing that.
Senator Hassan. The evidence has been here for a long time.
It is the evidence of thousands of people, hundreds of
thousands of people dying in this country. It is the evidence
that I see when I go to the funeral of a constituent who has
been in recovery multiple times and has relapsed.
It is the evidence that I see when I go to the funeral for
that constituent's sister and listen to a mother who has lost
two adult daughters to this illness despite their repeated
attempts to enter recovery. There is plenty of evidence about
what we need to do about this epidemic and the FDA needs to
take the lead. Thank you, Madam Chair.
The Chair. Thank you. I am--we have three votes, and I am
going to go vote, and turn the gavel over to Senator Burr. The
next two Senators will be Senator Tuberville and Senator Smith.
Senator Tuberville. Thank you, Madam Chair. Thank you, Dr.
Califf, for being here today and bringing your family, and
being part of this and continue to want to service such a tough
time in our Country. Very quickly, the State of Alabama. We
have lost people in our state because of testing. We don't get
to them quick enough in the rural areas. What is your
suggestion on that?
Dr. Califf. Well, I mean, we have got to make tests
available and either free or low cost, and they need to be
readily available in the person's home. There is also just a
tremendous amount of education that we need to do to make sure
that people are aware that when they have symptoms or when they
think they have been exposed, they should get tested because of
the extreme risk, particularly if their high risk.
In the rural population, as I have already stated, there is
a huge amount of common chronic disease that really means that
we have a lot of high risk people in the rural areas. And I
wouldn't understate the critical importance of education
programs for the primary care practices in rural areas. These
folks are overwhelmed and incredibly busy, and we got to catch
people early on because these treatments that we talked about
are highly effective if used early.
Senator Tuberville. Yes. While we are on this subject, what
is your thought about this new pill that they have come out
with, I forget which company, this new therapeutic that they
are saying is very effective?
Dr. Califf. Well, there is the saying in God we trust, all
others must bring data when it comes to the FDA. So the press
releases out, I think, this morning on something that looks
really exciting. And there is every reason to believe that a
direct antiviral should work because it works in other viral
diseases.
I really look forward to the FDA's evaluation of the actual
data, which I think is going to be done very quickly, just like
the other therapeutics. And the idea that if you are unlucky
enough to get infected, let's say even if you are vaccinated,
the idea that there is a 90 percent effective treatment is
truly exciting.
Senator Tuberville. In my former job, the last 10 years of
my 40 years of coaching, I would bring players in, and more and
more each year, a higher percentage of kids would come in
taking drugs. You would bring 25 in, 20 years ago, there might
be one, maybe two that take an insulin or something like that.
Now you bring 25 and half of them are taken attention
deficit drugs like Ritalin. I think we are overprescribing
these drugs. I think we get them involved in drugs at too early
of an age. What are your thoughts about these mental health
drugs that Senator Murphy was talking about?
Dr. Califf. Well I think there is sort of a Goldilocks
thing here, not too big, not too small. And we have got to find
the right place for each treatment, for each type of problem
that people have. And the only way we really know that is to do
the clinical studies, get the evidence, and then we know what
the risks and benefits are. Too often with children, we have
not had the right evidence early on and the docs are guessing,
the prescribers, maybe a nurse practitioner are guessing about
what the best treatment is.
I mean, my answer this week is, got to double down on
getting the evidence. We have talked about some of the ways of
doing it already this morning using electronic health records
and such. Once we have the evidence, if someone is
prescribing--I think in the example, the Senator Hassan said of
the opioids, if someone's prescribing a bunch of unnecessary
stuff, we need to have a system that deals with that
effectively.
I think almost all the drugs on the market, they--the drugs
have been shown to be effective for an FDA approved indication,
but when they get out beyond those indications, we have got a
lot of work to do to get the right evidence.
Senator Tuberville. Thank you, Dr. Califf.
Senator Burr. Senator Smith.
Senator Smith. Thank you very much. Dr. Califf, welcome to
the Committee, and welcome to your family, and thank you for
your willingness to serve again as FDA Commissioner. And I
appreciated our conversation of a couple of weeks ago, I think
it was now, and I just want to say I particularly appreciated
your commitment to advancing equity. I think that is a matter
of such great importance. I want to follow-up first, though--I
am going to try to touch on two or three things.
I want to follow-up first on a question that Senator Murray
brought up, touching on how we can get more rapid COVID-19
testing to the market. As COVID-19 becomes more endemic,
affordable, available, and in-home rapid testing is going to be
so much--so essential. And the FDA has taken steps to
streamline the review process for authorizing COVID-19 tests,
including rapid tests.
Some policy folks are arguing that we should be
reclassifying rapid COVID-19 tests as a public health tool
rather than as a medical device, and that this would help to
increase supply and reduce prices. So I am wondering if you
could, Dr. Califf, could you based on your experience, what do
you think about this idea? What do you see as the downsides?
And what more do you think that we could do to speed up the
supply and lower the price of rapid tests at home?
Dr. Califf. Well, that exact solution--well, first of all,
thanks for the question. I think you may not have been here
when I mentioned my son, Sam, back here, got two rapid test
yesterday because he wasn't feeling too good after his booster
shot and it was negative. So I fully personally appreciate the
impact of having readily available rapid tests. But that
specific solution, I don't think it solves a problem. It may be
one pathway, I would have to study it. What I do know, I mean,
I started my career evaluating cardiovascular tests. This was
in 1978. It was a long time ago.
But the principles are the same, and the purpose of the
test is really important. A test to screen for a disease, a
test to diagnose the disease, a test to determine the
prognosis, what is the likely outcome, the operating
characteristics that you measure are different. And we do need
to have a system, and I know Senator Burr and others are
working on this, now we need to have a system that takes these
different purposes into account.
Just like with a drug, a drug may have a use and several
different indications, and the dose may even be different in
different indications. So we got to have a flexible system that
takes these things into account and an evidence generation
system that makes sure that when we are using it for one
purpose or another, we actually understand what the test result
means.
Senator Smith. If you are confirmed as FDA Commissioner,
will you commit to reviewing the current process for
authorizing tests and take steps to streamline this process,
and make sure you let us know if there are things that we need
to be doing here at the Committee to support that effort?
Dr. Califf. Yes. Yes, I would very much look forward to
working with you on that, and I would actually get back to
where I started my career, so I would find it in an already
sort of way pretty, pretty exciting.
Senator Smith. Thank you. That is good. Dr. Califf, while
the FDA doesn't set the price of prescription drugs, the FDA
has significant power to bring more low cost generics and
biosimilars to market. This has been a big priority of mine. In
fact, the first bill that I introduced when I came to the
Senate is a bill to prevent parking of--the parking situation
that we have.
In fact, this is a bipartisan bill that I have with Senator
Braun, and it would prevent generic manufacturers from getting,
and name brand manufacturers, from gaming the system and help
to streamline getting those generic drug approvals done. Could
you talk a little bit about how you would use the tools at your
disposal at the FDA to prevent anti-competitive behavior like
parking in the prescription drug market?
Dr. Califf. I think I have already mentioned, in 2016 we
had a long list of ways pharmaceutical companies could extend
the patents or otherwise get around the intended move to
generic status after an appropriate period of patent
exclusivity. And I think there is no other way than making a
list, and it is a little bit like Whack-A-Mole. You have to--
there are really smart people on the other side looking for
ways to circumvent the rules.
You got to be on your toes, and then in some cases, FDA has
the same power to make a difference. And in other cases, it
would involve something that we would need from Congress to
help take care of it, as in the case that you mentioned.
I would also mention, I am very aware in the supply chain
issues that we have got to shore up the generic supply chain
while we are also reducing the costs. And that is a big issue
we need to pay attention to.
Senator Smith. I absolutely agree with that. In the
interest of time, I am going to submit for the record my final
question, which is around how to address the need to include
more pregnant women in clinical trials. And I will submit that
question to you. Thank you.
Dr. Califf. Thank you. I want to take a quick second and
say that, as you know, I work very hard on including children
and clinical trials, and that work is getting better and
better. Pregnant women is a big frontier. It is a very high
risk situation.
Everybody is concerned. But if we don't do the studies, we
end up with, like my daughter, who I mentioned had congenital
heart disease. I have a granddaughter sitting back here, too.
But when you have a chronic disease, you need to take medicine
for it, even if you are pregnant. We have almost no studies
that addresses those issues. So, I would really look forward to
working with you on that issue.
Senator Smith. Thank you very much. Thank you, Mr.
Chairman.
Senator Burr. Senator Collins.
Senator Collins. Doctor, I was very pleased to hear you say
twice this morning that your first priority is improving
emergency preparedness so that we are better able to counter
the inevitable next pandemic that comes our way. As you know,
from our discussion, for a number of years, I have been very
concerned that the United States drug market is increasingly
reliant on the manufacture of active pharmaceutical ingredients
at facilities overseas.
In fact, the FDA in 2019 testified that 72 percent of the
facilities that manufacture APIs are located overseas, a lot of
them in China and in India. In addition, we know that China has
virtually cornered the market on manufacture of the
antibiotics. I am very concerned that we see, as we saw with
India, when there is a pandemic like COVID that countries began
to hoard medicines that were destined for our markets.
I strongly believe that part of reforming the medical
supply chain has to include incentivizing manufacturers using
both carrots and sticks to locate their facilities in the
United States, starting with the 100 essential medicines list.
And perhaps we could link it to participation in the VA health
program, for example. Perhaps tax incentives are needed. What
are your thoughts on our vulnerabilities in the supply chain?
Dr. Califf. Thank you, Senator Collins, for the question.
And as I have mentioned already, I served on the National
Academy of Medicine Supply Chain Committee, which is about to
come out with its report, so I don't want to say too much about
the specific recommendations there.
But your facts are correct, and in the discussion I just
had with Senator Smith, the active pharmaceutical ingredients
are not just for innovator drugs that we think about, but also
for generics, where often we don't have enough competitive
entities in what has become sort of a commodity business.
We need a number of steps to make the system more
resilient. Purely on-shoring is probably not the complete
solution, but it is a part of it that is significant. But we
need the supply chain to be secure and resilient in multiple
directions, and a transparent system for knowing where things
are in the supply chain, which we currently don't have.
I would mention one other thing, manufacturing in places
and exciting technology that people have been working on and
the idea that you can make a pill now with a small machine in a
local area is something that I believe is coming, and we need
to accelerate that as quickly as we can.
Senator Collins. In 1997, as a new Senator, I founded the
Senate Diabetes Caucus, which my colleague Jeanne Shaheen co-
chairs with me now. And it was after meeting with children with
Type I Diabetes and their parents. And in the years subsequent
to that meeting, there have been many advances in technologies
such as continuous glucose monitors and far better pumps and a
closed system. But there is still not a cure or disease
modifying therapy yet approved for Type I Diabetes.
This year, the FDA has reviewed and held two advisory
committee meetings for therapies for Type I Diabetes. One is a
biologic that may delay the clinical onset of Type I by as long
as 3 years in those at high risk. The other is cellular therapy
made from donor pancreas for those who suffer from severe
hypoglycemia.
In addition, there have been press reports that claim an
individual has been cured from Type I Diabetes as result of new
therapy. How would be FDA under your leadership continue to
foster cutting edge science at the various centers we have
created for Type I Diabetes therapies and devices?
Dr. Califf. Well, thank you for that, and let me just say
that it is exciting. These two types of diabetes, which are
different in terms of their origins and the idea that you could
cure a person with Type I Diabetes, which has been a lifetime
consignment to insulin therapy up until now, is very exciting.
I think we would like to continue this very healthy
relationship between the patient community, the industry that
makes products, and the regulators who have to determine if the
products are safe and effective. And let me just point out, I
think this is actually a paradigm. Multiple myeloma, which my
mom had, or cystic fibrosis would be other examples where when
you have an activated patient community with a group of
families that are dedicated, it creates a very different
situation where investment comes into the area.
People think of new therapies because they know that people
are going to participate in the clinical trials and the
turnaround and getting the evidence is quick. And then when
practitioners go to treat the disease, they can have confidence
they are doing the right thing because they have strong
evidence.
I would frankly love it if more people copied that model,
and it bothered me a lot at FDA when I would work with diseases
that had no effective advocacy because they couldn't benefit
from the kind of things that you created.
Senator Collins. Thank you.
The Chair. Senator Rosen.
Senator Rosen. Thank you, Madam Chair. And thank you, Dr.
Califf, for being here and for your willingness to serve. We
really appreciate that. I want to go over telehealth and remote
monitoring for a minute, because of course, as we have seen
throughout the pandemic, telehealth has become more important
than ever for improving access to care, especially among our
rural and our underserved areas. It is critical that agencies
work together, like you said, to ensure coverage, payment
policies, regulation of technology to keep up with the pace of
innovation.
Like with telehealth, home monitoring equipment has rapidly
changed and become an important tool for addressing a range of
conditions away from the doctor's office. From diabetes, like
Senator Collins was talking about, to heart disease, which you
are an expert in. It has also become a popular tool for people
to monitor their own health and the health of their children
through smart devices like their smartwatches.
If confirmed, what would you do to clarify the regulatory
pathways for manufacturers of such devices and products
specifically to ensure that they are both consistent,
efficient, safe, just make sure they are really doing what they
are supposed to and maybe not--maybe helping to promote care,
but not in place of care?
Dr. Califf. Really appreciate that question, and it is a
passion of mine. I mean, cardiology basically goes back to
measuring all kinds of things about people and then designing
interventions that work, and you made a couple of really,
really important points. First, we are seeing this decline in
life expectancy that I have already talked about, dominantly in
rural America now, and it needs to be dealt with. There aren't
going to be enough nurses and doctors to go to every community
and provide the care that is needed, so we have got to employ
digital technology.
But it also can't be digital technology alone. And I would
just put forward this is not the FDA's purview, but I would put
forward that the workforce of people needed in the communities
to help people interact with digital technology. Now that you
all have graciously passed the law that will fund broadband for
all of America. That is a great place by which people in rural
areas can get employment.
Then, with regard to the regulation, this is a complicated
area, and I can assure you that people have not dealt with
patients and the issues and health can make really bad mistakes
and the use of technology because I haven't seen what happens
when the technology is misused, and someone is hurt and badly
damaged. And so safety is an issue here, just like everywhere
else.
On the other hand, if you are too heavy handed in the
regulation, you are impeding a field where essentially, with
traditional devices, you make a change and you go all the way
back to the manufacturing plant. With software, you just update
the code much like we are all used to doing with our iPhones.
So there is a spectrum here. There is a Center for Digital
Health in the FDA, and Bakul Patel who runs it I have
tremendous confidence.
I think, we will have to work across that spectrum. But I
would echo more than anything else what you said about, it is a
human interface issue, not just a person using the technology,
but they are going to need a workforce that can help them use
it.
Senator Rosen. Well, I am glad you brought that up because
broadband, of course, I worked on that and the infrastructure
bill, and that is really important, and workforce, how do we
potentiate the telehealth, all the opportunities we have.
But as you talk about coordination, I know it is not the
FDA's purview, but what could you do maybe differently than you
might have done in the past, now with, of course, technological
changes we have, to improve the coordination between FDA and
CMS, and of course Congress to be sure that all of us are
moving forward in the same path to provide outcomes that are
great for people? It is their health, right. We want positive
outcomes.
Dr. Califf. I think one of the greatest lessons from my
previous time as Commissioner is that it is something I already
knew, but you have to experience it to realize we are all just
people. And I was reflecting back on Senator Hassan, and I
certainly made a number of mistakes, and we have all made
mistakes. One of the elements that comes into play here is that
the coordination across Federal agencies is a lot more human
and complicated than you would think on the outside.
I was surprised to see the defense mechanisms that exist
across the Federal Government that we need to break down. And
so I very much learned a lot and I really look forward to
working with the HHS family and also with Congress to solve
these kinds of problems, where we think about the FDA has an
essential critical, well-defined role, but if we ran it like a
relay race where we just threw the baton down and then the next
person had to pick it up and figure out where to go, that
doesn't work. And so we do have distinct roles, but those
interfaces are absolutely critical.
Senator Rosen. Yes, I think you are right. We have to work
concurrently on all of this instead of maybe consecutively,
like you were saying. I see that my time is up. Thank you so
much. I will submit the rest of my questions for the record.
Dr. Califf. Thank you.
The Chair. Thank you.
Senator Marshall.
Senator Marshall. Thank you, Madam Chair. Dr. Califf,
welcome. And again, thanks for visiting with me one on one, and
we appreciate your willingness to put your life out here in
front of all of us. Ranking Member, my good friend Senator Burr
spoke a little bit earlier about real world evidence.
June of this year, I thought there was enough evidence for
boosters that as a prescribing physician myself, I would have
recommended it and I did recommend it for my parents and for
senior citizens and probably people with health care risk. So
in June, I thought there was enough real world evidence, but it
was fall by the time the FDA moved on it and really November
before my parents were able to get it.
I saw the Delta wave coming. And if we could have got those
boosters in senior citizens arms this summer, we would have
saved tens and thousands of lives. How can we move more quickly
with real world evidence with a drug or vaccine that has
already had FDA clearance, but just a new use?
Dr. Califf. Well, let's dream a little bit, but I don't
think dream is far away if we get the human aspects of this
right. There is no technological limitation now to having
immediate access to all of the transactions that are occurring
in our health system, the treatments that people get, the
conditions that they are diagnosed with, and their outcomes.
But we have a labyrinth of information that needs to be knitted
together to make that happen so that we have information and as
close to real time as possible.
You have seen an approximation of this with the COVID
tracker that we all look at every day that shows us almost in
real time the number of cases, the hospitalization rates, and
the death rates. And so it is very much, if I am confirmed,
part of my agenda to get the rules in place, the systems in
place, as I have discussed, to give people confidence that it
actually is in their interest to share data.
But for that to work, we got to have those rules right and
those who misuse people's information need to be severely
punished.
Senator Marshall. Thank you. If I think about the last 20,
30, 40 greatest miracle drugs that came, have come to fruition
in this world, that maybe all of them have a relationship to
the United States. What would the international price index, if
that was instituted in this country, or Medicare price
negotiation, any type of price fixing by the Government, what
would that do to innovation in our world of medical--of drugs?
Dr. Califf. Well, Senator Marshall, I am not sure we will
completely agree on this one but let me just say that I do
think that there needs to be, wealthy countries need to share
in the cost and in paying their fair share for drugs. I am sure
you agree with that. And so, in any kind of negotiation that
occurs, if we go too far, it will squelch innovation.
But we are going to find a sweet spot, which I would argue
is a little bit off right now because I am acutely aware that,
for example, almost a quarter of cancer patients are not
following through on the chemotherapy because they don't have
the financial means to pay for these effective drugs.
People think of cardiology, my specialty is sort of nuts
and bolts, bread and butter. But it turns out financial
toxicity is now a significant issue for patients with
cardiovascular disease. So I do think we need an adjustment to
find the sweet spot, but I also think other countries need to
pay their fair share.
Senator Marshall. Thank you. RU486 is a drug I have never
prescribed as an obstetrician gynecologist, but unfortunately I
have had to take care of patients with complications from it,
typically in the emergency room. These patients not only have
physical complications, hemorrhaging and bleeding, but certain
psychological challenges after they have had that abortion.
This kind of remorse afterwards, and I am very troubled by
HHS's casual attitude about the prescription--about prescribing
RU486. Are you committed that should be in the hands of
physicians and prescribers and not handed out like candy?
Dr. Califf. Well, as we have already discussed, I think the
FDA has to make this decision based on the latest data and the
scientific principles. And as we have already discussed also, I
know more information is soon to become available. I am not
involved in those discussions, but I do trust the FDA staff to
make good decisions.
Senator Marshall. Okay. I guess I have got time for one
more. I was frustrated last year that the FDA moved really
quickly on some testing for coronavirus, but not on T cell
testing. As a clinician, I just want to have the choice, the
ability. I don't want the FDA to decide for me whether I should
use the T cell--I just want to know if it is safe, it is
available.
What can you do to make sure that the FDA going forward is
not choosing winners and losers, and why wouldn't you
prioritize the T cell every bit as much as some of the other
testing? It just felt like that became a political turmoil
rather than trying to do what is best and letting clinicians
decide.
Dr. Califf. When I came along in the 1970's, cardiology was
really exciting, and immunology was this evolving field. It was
just amazingly complicated. It was really hard to understand.
We have come a long way, and there is no question that T
cells--I mean, when you think about it, the B cells now protect
us from the acute infection, particularly in the nasal pharynx
with the pandemic. The T cells are--that is what is called into
effect in the long term to prevent death and hospitalization.
I am totally with you that we need to have T cell testing,
but it is also without going into laborious detail, and it is
not my area of expertise, I would just say that it is
complicated because just measuring something in the blood of
someone doesn't give us the information we need because the T
cells have a memory.
When they get the right stimulus, they swung into action
and created an army of T cells come in and do the job. So I
would just say, I know the FDA is interested in this.
I personally think it is a critical issue that we need to
continue to work on, but we have to have reliable tests that
give us the information we need. And maybe the combination of
evolving tests and the real world evidence that we have talked
about will give us the information that we need.
Senator Marshall. Thank you so much. I yield back.
The Chair. Thank you.
Senator Lujan.
Senator Lujan. Thank you, Chair Murray. Doctor, we have
seen a new record high of opioid deaths, with more than 100,000
Americans dying over a 12 month period. In New Mexico, these
numbers mean a loss of a loved one from overdose every 14
hours. The FDA has a long track record of proving dangerous
opioids without considering public health. A Federal judge
presiding over county and state cases against opioid
manufacturers and distributors recently wrote, ``it is accurate
to describe the opioid epidemic as a manmade plague 20 years in
the making.
While courts are holding opioid manufacturers and
distributors accountable for their actions that caused this
epidemic, it is clear that the FDA missed clear signs regarding
the risks and benefits of opioids, which created the crisis to
take hold.''
In response to a question around the role of the FDA about
curbing the use of dangerous and addictive prescription drugs,
you responded, one of those answers is better prescriber
education, which I agree with. The question that I have is,
doctor, will you commit to reevaluate the labels?
Dr. Califf. Well, Senator, I am committed to do a
comprehensive review of the status of opioids early in my
tenure, like in the first few months, should I be confirmed.
That would include everything, including the labels. Now I
would look forward to talking with you about the details of the
issues that are involved in doing that, but I am committed to
do a comprehensive review of the opioid situation, including
the labels.
Senator Lujan. I think that in your testimony, you also
shared that a family member that received a 30 day supply for
an acute issue. Had there been more accurate labeling
requirements, I don't think that would have happened, in
addition to the education. And I think that is one of the
important changes that must take place. Another area that I
raised when we met personally as well is the FDA convened an
advisory committee of scientific experts with a matter of
significant public interest, especially as involved, highly
controversial or in need of a specific type of expertise.
In 2014 the FDA approved Zohydro, which is a pure
hydrocodone drug, despite the FDA Advisory Committee strongly
voting against approval in a vote of 11-2 due to the known
dangers of overdose and death. It goes back to what that judge
said, a crisis 20 years in the making that is manmade.
My question is, as a person that would be in charge of the
FDA, if your advisory committee or one of the FDA advisory
committees voted overwhelmingly like this, 11-2, on Zohydro,
what would you do?
Dr. Califf. Well, as I have already said, had the long term
studies been done and we had the evidence, I think that
decision would have been different. It was not the right
decision in the context that it was in. With regard to advisory
committees, I think we had a good discussion about this, and I
actually went back and looked.
It turns out the FDA makes a decision that is not identical
to the advisory committee about 25 percent of the time, but
three-quarters of those 25 is for a more stringent reduction in
the use of a product instead of more use. So I think when there
is an 11-2 vote, the leaders of FDA really need to take a close
look and make sure they----
Senator Lujan. If I can interrupt, I appreciate the
evaluation looking at the FDA. I am talking about opioids, and
I am talking about constituents that are dying and mistakes
that the FDA has made 1 year after another. I am sick and tired
of the United States approving one opioid to fix another. It is
the dumbest thing that I have--I just, I don't understand it.
This is stupid. People are dying because of it.
Heroin, if I may. Heroin didn't get developed out on the
streets. It was developed in a lab by a pharmaceutical company.
And then here in the United States, we keep approving one after
another. Specific to an 11-2 vote on an opioid, doctor, what
would you do if you got that vote on something specific to this
with Zohydro, and subsequent to that, the FDA approved more
without even going to the advisory committee, they just said,
oh, we are going to ignore them, and I am going to continue to
approve these opioids and kill more people across America. What
would you----
Dr. Califf. Senator, I wasn't there at that time, but in my
leadership role, we instituted a mandatory advisory committee
and also the framework of societal consideration. There are
almost no opioids coming through the FDA now for approval. That
has really been shut down. And I think the roles that I played
were critical in doing that. But I think, I can't argue with
your points.
Senator Lujan. Chair Murray, I have several other questions
for the record, especially around non-addictive pain therapies,
which I think we need to be doing more about. And I do look
forward to following-up on that line of questioning.
There must be more done here in the United States about
taking this issue seriously, rather than companies and families
making billions of dollars and building empires off the deaths
of our constituents and our families. It is just not right, and
something has got to change, and I am hoping, doctor, that you
can be that person. Thank you, Chair Murray.
Dr. Califf. Let me assure you, I am going to--if I am
confirmed, I am going to take a very aggressive approach on
this and I appreciate your concerns.
The Chair. Thank you.
Senator Scott.
Senator Scott. Thank you, Madam Chair. And thank you, Dr.
Califf, for spending some time with us today talking about some
really important issues that we could all spend a day talking
about. I only have 5 minutes. Good news for you. So my first
question is that you are coming into a very important position
in the midst of really headwinds in the public health space.
And I appreciate the enormity of your responsibilities, if you
are confirmed, to lead the FDA.
How do you view the FDA's role in granting emergency use
authorization for the new, as well as repurposed products to
address the COVID-19 pandemic? Should the FDA use a wider
latitude to ensure multiple avenues, for instance, drugs like
by budesonide as well as COVID-19 testing kits, making sure
that they are available to combat the pandemic?
Dr. Califf. Well, as you know--and thanks, Senator, it is
good to be here with a fellow South Carolinian. I am wearing my
South Carolina bow tie today that my dad had.
Senator Scott. I am just glad it is not Clemson, but
continue----
[Laughter.]
Dr. Califf. Hey, I am a Clemson man----
Senator Scott. I know. I am just joking.
Dr. Califf. You are all aware, and it was during my tenure
that the EUA guidance was written, that potential benefits need
to be weighed against the potential risk. That is authority the
FDA is given. And so there is a lot of latitude on the types of
things that you mentioned.
Yet I would still point out we need--we do need to have
enough evidence that we can make a fair assessment of what the
potential is, and we need a system in this country, as I have
emphasized over and over, that produces the evidence more
quickly.
Because under that framework, it is possible you could get
it wrong. There is a, it is different if you have actually
measured the benefits and risk and then you are confident about
it. And so it is finding that right balance that is really in
play for the FDA.
Senator Scott. No doubt. I would suggest that based on the
severity of the challenge in the public space, that taking the
appropriate calculated risks, it seems to be necessary nowadays
more than it has been in the past. And I think we can do that
in a way that involves coming to good decisions consistently.
On the front, long view of public health, I am excited
about the role that the mRNA played in bringing the vaccine to
the forefront and saving millions of lives. What is the future
of that technology for future needs in the vaccine arena, No.
1?
No. 2, I think about the 7,000 rare blood diseases that
have very few therapies, treatments of any sort, and I focus a
little bit more on CRISPR technologies for things like sickle
cell anemia and that path going forward.
Do you see (A), more application for CRISPR in the rare
blood space or blood disease space, and (B), on the future
forefront of the mRNAs and vaccines, is that future as bright
as it appears it could be with the use of these technologies?
Dr. Califf. Well, this is one of the things, Senator, where
the excitement of being part of this is what keeps me going and
coming back. I mean, I am old enough to remember when the Human
Genome Project was just being developed, and now we have the
code for the genome, and what you are describing are the
downstream consequences of that with reading the code and
producing proteins and other substances that determine whether
we are sick or healthy. And there are a whole array of
technologies specifically with mRNA.
I think it as a platform for vaccines, this is something
that we have only dreamed about, but it is a reality now. And
this took a collaboration of FDA scientists, and of course,
academia and the private sector all working toward a common
goal over decades. But you also mentioned CRISPR, and the
ability to change the fundamental genome is an amazing
possibility, but also has significant risks.
Like everything else, we have got to come up with the
ideas, try out, and measure things and see what really works.
But almost nothing could be more exciting than curing a rare
genetic disease with a gene substitution, perhaps for life.
I think for people with sickle cell disease, I have done a
lot of work in NHLBI with Gary Gibbons, who is a great leader
there. I think this is something that is really needed, and it
ties in, chronic treatment for sickle cell disease, not going
so well in this country because many of the patients live off
the beaten path of the big high tech centers. And we have got
to get treatments that are more effective.
Senator Scott. Yes. And, Madam Chair, if you allow 30
seconds.
The Chair. Yes, we have several more Senators and votes
going so.
Senator Scott. Thank you very much. So I would just say
that I think we should at least take a second to thank Dr.
Francis Collins for his work on the product project that really
has produced amazing results for our Nation and frankly for the
world, his work--I know he is retiring or just retired. His
work has been amazing for all of mankind, No. 1.
No. 2, I would suggest that as we look into that future,
the ethical issues around the new technologies like CRISPR will
continue to pop up around the world. I know that China has had
some challenges already with the use of CRISPR, and so what
becomes the solution also becomes a problem. That is called
reality. And hopefully will wrestle with those ethical issues
in the public forum sometime in the very near future.
The Chair. Thank you.
Senator Baldwin.
Senator Baldwin. Thank you, Chair Murray. I appreciated the
chance to visit with you in advance of this hearing, and I
wanted to raise an issue that we discussed when we met, the
misuse of dairy terms on non-dairy products. It is an ongoing
problem, and it is unfair to dairy farmers and processors in
Wisconsin and across the country.
The American Academy of Pediatrics has called attention to
the misuse of dairy terms because of the potential of these
improperly labeled impostors to suggest false nutritional
equivalency to milk. I have been working on this issue for
years, and I am very glad that the FDA has been moving forward
toward providing the industry an updated regulatory guidance.
Dr. Califf, if confirmed, you will have the ability to
right this wrong, which is a product, frankly, of FDA's lack of
action enforcing its very own rules. Will you commit to
finalizing guidance without delay and providing a fair outcome
that preserves the use of dairy terms for dairy products and
that resolves this matter once and for all?
Dr. Califf. Yes, thank you. I mean, there is almost nothing
more fundamental about safety than people understanding exactly
what they are ingesting, so I am committed to making this a
priority, if I am confirmed.
Senator Baldwin. Thank you. At the beginning of the COVID-
19 pandemic, our Nation experienced a critical shortage of
donated blood. As one effort to alleviate the shortage, I led
many of my colleagues in urging the FDA to update its outdated
and discriminatory policies that unnecessarily restrict blood
donation by gay and bisexual men. I was pleased to see the
agency answer our call and shorten the deferral policy for men
who have sex with men from 12 months down to 3 months.
This is certainly a step in the right direction, but any
policy that singles out an entire group of people rather than
focusing on an individual's personal risk is unscientific and,
in my opinion, wrong. We have come a long way in our ability to
screen blood and tissue, and the science no longer supports the
use of these restrictions. Will you commit to working with me
to ensure that the FDA's donor policies are based on
individualized risk and not rooted in stigma?
Dr. Califf. Short answer is, yes. And I will just point out
that I was an intern at University of California, San Francisco
when the epidemic started. We didn't know what it was until 3
years into it. And so I understand the origin of this and there
were problems with the blood supply at the time.
But we have come a long way with the blood supply, and I am
fully aware that there is a study underway to look specifically
at individual risk assessment, and I pledge to bring this home
as quickly as we possibly can as this study results come in.
Senator Baldwin. Thank you. I know the FDA has been working
overtime to evaluate a large number of e-cigarette premarket
tobacco applications. And I am encouraged that the agency has
set a high bar for flavored e-cigarettes to be authorized for
sale in the U.S.
But I am concerned by reports that companies are taking
advantage of loopholes in the law and switching from making e-
cigarettes to making flavored synthetic nicotine products.
These products are increasingly popular, and they continue to
be targeted to our Nation's children.
As FDA Commissioner, how would you work to address the rise
in youth use of synthetic nicotine? And will you commit to
working with Congress to ensure that the FDA has the
authorities and resources it needs to crack down on these
addictive products?
Dr. Califf. Yes. And first, let me just say, as Senator
Burr pointed out, Mitch Zeller is retiring as head of the
Center for Tobacco Products, so appointing the right person in
that job is absolutely one of the most important roles at the
agency. And second, this is not limited to children. I may have
some family members using synthetic nicotine.
I learned as I was going through the paces here, and what
people don't realize is that there are two enantiomers of
nicotine, one of which is not occurring in nature, that are in
this product and its properties are not known. So we have got
to close this loophole so that we make sure that we understand
the risks and benefits and particularly deal with the issues in
children.
Senator Baldwin. Thank you.
The Chair. Thank you.
Senator Hickenlooper.
Senator Hickenlooper. Thank you, Madam Chair. And Dr.
Califf, thank you for your public service and enjoyed our
conversation last week. I hope I wasn't too hard on you. Let me
start with a fact that the United States and New Zealand are
the only two countries that permit television advertising for
pharmaceutical companies. Last year, the industry spent about
$4.5 billion on these ads.
I think there are a number of studies that show that the
soft music, the glossy scenery does soften and can distort a
consumer's ability to carefully evaluate the impact of the
drugs. Do you think that the FDA needs to take more active role
in ensuring that there is oversight, sufficient oversight in
this type of advertising?
Dr. Califf. Yes, Senator. First of all, let me just point
out I got one Colorado taxpayer sitting behind me here and
another payer back home in Colorado couldn't make it to the
hearing, so we much appreciate that you are here and----
Senator Hickenlooper. Let's forget the questions. We will
just go to----
[Laughter.]
Dr. Califf. But yes, and I would go beyond that. I mean, I
am a doc. And if you, I think if you have docs as this has been
done, none of us like the fact that there is advertising of
drugs, but we don't make those laws. So the FDA has to regulate
it.
I think we need an across the board update and a much more
active FDA in terms of getting the right information. It is
right there in the mission statement of the FDA to make an
understanding of the science behind medical products and their
use for the public. And but it is not just advertising done on
TV, like you are used to seeing, there is a huge amount of
information going on social media that we are going to have to
deal with.
As I have talked with 23 of you folks, part of the message
is if I am confirmed, I am going to be very aggressive in this
area of medical misinformation because one could argue that it
is killing more people than any particular disease right now.
Senator Hickenlooper. That is very sobering. We talked a
little bit about global clinical trials, and we have a number
of international partners that are doing critical work around
the efficacy of drugs and risk versus benefit. Clearly, we
could save money and accelerate getting to the final conclusion
on a number of new innovations and new inventions. What can the
FDA do to collect data from interconnected clinical trials from
our global partners? In other words, what more could the FDA be
doing?
Dr. Califf. Yes, I am really excited about this. It was in
1988 that I did my first global clinical trial. It was the
amazing invention of the fax machine. Actually, this is before
the internet was available. Students these days have a hard
time actually understanding what that means that there was no
internet. And we could enroll 40,000 people in cardiovascular
trials in dozens of countries overnight, almost.
We need to get back to that because fundamentally most
people want to volunteer for research, if they can do it. And
what we have got to do is to use digital technologies to
interconnect people better, curate information more
effectively.
Much like, as I have mentioned the UK did in COVID with
their recovery project, we should build a real of clinical
trials very quickly that are representative of the population
and get the answers that we need with larger populations.
I think the FDA can lead the way, it needs to work, as we
mentioned with Senator Romney in conjunction with CMS, and of
course, the NIH.
Senator Hickenlooper. Right, absolutely. We are seeing also
a crisis now, I think and COVID is only exaggerated what
already existed, but as you say, the misinformation that is out
there in social media and in the regular media as well around
not just prescription drugs per se, but around the FDA's role.
I think there is--we discussed a number of the movie
treatments and television episodes around obviously the opioids
and the issues there with the Sackler family have been well
covered, but it is a larger question of mistrust between FDA
employees going in and working for the large pharmaceutical
companies and back and forth. How do you go about rebuilding
people's trust in the system?
Dr. Califf. Well trust once lost is hard to regain. That is
an all-time statement, and I think it is true. We are going to
have to be much more aggressively outgoing and work on every
single aspect of transparency that we can.
Again, if confirmed I do think as a 70 year old person with
nothing to gain, I think through most of my career, I have done
a pretty good job of calling out other people when they need to
contribute.
I mean, a key element to me is that the medical profession
and the nursing profession, health systems, we all need to work
together to build trust where the evidence is solid and show
that we should be trustworthy. It is one thing to say we will
have a PR campaign about trust. It is different to show that
you are trustworthy.
If confirmed, I would really look forward to working on
this because as I said, this may be, we have a lot of great
medical therapies now, but if people get the wrong information
and don't take advantage of them or take things that don't work
or are dangerous, we have really lost the game at that point.
Communication is absolutely critical.
Senator Hickenlooper. I appreciate your candor. I yield
back.
The Chair. Thank you.
Senator Burr, any final comments?
Senator Burr. Thank you, Madam Chair. I think we have
exhausted all the questions of Committee Members on my side.
Let me take this opportunity to publicly congratulate and thank
Francis Collins for his leadership at the National Institute of
Health. He will be missed and can enjoy retirement. He is a
little bit older than you, Rob--can enjoy your retirement----
Dr. Califf. If I could, Senator, let me just say, I mean
one of the regrets I have if I am confirmed is, I had so much
fun working with Francis Collins. He is smart on a lot of areas
where I know nothing and I would like to think I contributed
something more in the clinical areas to his knowledge, so. But
I hear he is going to be in the area still working in his lab,
so he will still be available for consults.
Senator Burr. Well, I am sure Francis will make himself
available. As it relates to you, I believe you bring a unique
skill set at a pivotal time in global innovation. You faced
questions on many subjects today, and I think all would agree
that you have a daunting job in front of you, if confirmed.
Let me summarize that what we need right now is leadership,
leadership that is transparent, leadership that is--displays of
trustworthiness by not just people in the industry and in
Government, but by consumers, by the American people. I think
you are well-prepared to provide that type of leadership.
Madam Chair, I encourage my colleagues to support the
nomination of Rob Califf and to do that as expeditiously as we
can.
The Chair. Thank you very much. And as we end this hearing
today, I do want to make clear Mifepristone has a strong track
record of safety and effectiveness, and when it comes to
women's health, I do expect FDA decision to be made based on
science, just as I do all of FDA's decisions.
Dr. Califf, I will be watching closely to make sure
decisions are governed by the data, not by politics. And I do
ask unanimous consent to submit for the record a study
published in the New England Journal of Medicine on the safety
of Mifepristone.
[The following information can be found on page 82 in
Additional Material:]
The Chair. With that, I will end our hearing today. I would
like to thank Dr. Califf for joining us and all of our
colleagues as well. I look forward to be working with you to
make sure FDA continues to uphold the gold standard and put
science and data first and keep families across our Country
healthy and safe.
For any Senators who wish to ask additional questions,
questions for the record will be due Wednesday, December 15th
at 5 p.m., and the hearing record will remain open for 10
business days until December 29th for Members who wish to
submit additional materials for the record.
With that, the Committee stands adjourned.
ADDITIONAL MATERIAL
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[Whereupon, at 12:08 p.m., the hearing was adjourned.]
[all]
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