Congressional Hearing — COVID–19, Volume 1, S. Hrg. 116–557 (Senate Homeland Security, 2022)
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This Senate hearing record, S. Hrg. 116–557, is titled COVID–19, Volume 1, and was printed for the use of the Committee on Homeland Security and Governmental Affairs, with Ron Johnson as Chairman. The cover lists roundtables and hearings dated from February 12, 2020 through December 8, 2020. These include the Federal Interagency Response to the Coronavirus on March 5, 2020, Oversight of COVID–19 Financial Relief Packages on July 28, 2020, and Early Outpatient Treatment on November 19, 2020. The February 12, 2020 witnesses include Scott Gottlieb, MD, Former Commissioner of the Food and Drug Administration.
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- Chrg 116Shrg40549
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S. Hrg. 116–557
COVID–19
HEARING
BEFORE THE
COMMITTEE ON
HOMELAND SECURITY AND
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
ROUNDTABLE: ARE WE PREPARED? PROTECTING THE U.S. FROM
GLOBAL PANDEMICS, FEBRUARY 12, 2020
THE FEDERAL INTERAGENCY RESPONSE TO THE CORONAVIRUS
AND PREPARING FOR FUTURE GLOBAL PANDEMICS, MARCH 5, 2020
REMOTE ROUNDTABLE COVID–19: HOW NEW INFORMATION SHOULD
DRIVE POLICY, MAY 6, 2020
EVALUATING THE FEDERAL GOVERNMENT’S PROCUREMENT AND
DISTRIBUTION STRATEGIES IN RESPONSE TO THE COVID–19
PANDEMIC, JUNE 9, 2020
THE ROLE OF THE STRATEGIC NATIONAL STOCKPILE IN PANDEMIC
RESPONSE, JUNE 24, 2020
CBP OVERSIGHT: EXAMINING THE EVOLVING CHALLENGES FACING
THE AGENCY, JUNE 25, 2020
OVERSIGHT OF COVID–19 FINANCIAL RELIEF PACKAGES,
JULY 28, 2020
EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A
COVID–19 SOLUTION, NOVEMBER 19, 2020
EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A
COVID–19 SOLUTION, PART II, DECEMBER 8, 2020
Available via the World Wide Web: http://govinfo.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
(
COVID–19—VOLUME 1
S. Hrg. 116–557
COVID–19
HEARING
BEFORE THE
COMMITTEE ON
HOMELAND SECURITY AND
GOVERNMENTAL AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
ROUNDTABLE: ARE WE PREPARED? PROTECTING THE U.S. FROM GLOBAL
PANDEMICS, FEBRUARY 12, 2020
THE FEDERAL INTERAGENCY RESPONSE TO THE CORONAVIRUS AND
PREPARING FOR FUTURE GLOBAL PANDEMICS, MARCH 5, 2020
REMOTE ROUNDTABLE COVID–19: HOW NEW INFORMATION SHOULD DRIVE
POLICY, MAY 6, 2020
EVALUATING THE FEDERAL GOVERNMENT’S PROCUREMENT AND
DISTRIBUTION STRATEGIES IN RESPONSE TO THE COVID–19
PANDEMIC, JUNE 9, 2020
THE ROLE OF THE STRATEGIC NATIONAL STOCKPILE IN PANDEMIC
RESPONSE, JUNE 24, 2020
CBP OVERSIGHT: EXAMINING THE EVOLVING CHALLENGES FACING THE
AGENCY, JUNE 25, 2020
OVERSIGHT OF COVID–19 FINANCIAL RELIEF PACKAGES,
JULY 28, 2020
EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID–19
SOLUTION, NOVEMBER 19, 2020
EARLY OUTPATIENT TREATMENT: AN ESSENTIAL PART OF A COVID–19
SOLUTION, PART II, DECEMBER 8, 2020
Available via the World Wide Web: http://govinfo.gov
Printed for the use of the
Committee on Homeland Security and Governmental Affairs
(
U.S. GOVERNMENT PUBLISHING OFFICE
40–549 PDF WASHINGTON : 2022
COMMITTEE ON HOMELAND SECURITY AND GOVERNMENTAL AFFAIRS
RON JOHNSON, Wisconsin, Chairman
ROB PORTMAN, Ohio GARY C. PETERS, Michigan
RAND PAUL, Kentucky THOMAS R. CARPER, Delaware
JAMES LANKFORD, Oklahoma MAGGIE HASSAN, New Hampshire
MITT ROMNEY, Utah KAMALA D. HARRIS, California
RICK SCOTT, Florida KYRSTEN SINEMA, Arizona
MICHAEL B. ENZI, Wyoming JACKY ROSEN, Nevada
JOSH HAWLEY, Missouri
GABRIELLE D’ADAMO SINGER, Staff Director
JOSHUA MCLEOD, Senior Professional Staff Member
CHARLES CARROLL, Professional Staff Member
BARRETT F. PERCIVAL, Professional Staff Member
CHARLES CARROLL, Professional Staff Member
CAROLINE K. BENDER, Research Assistant
JESSICA J. MCTIGUE, State Department Detailee
DAVID M. WEINBERG, Minority Staff Director
ZACHARY I. SCHRAM, Minority Chief Counsel
ALEXA E. NORUK, Minority Director of Homeland Security
MEGAN L. PETRY, Minority Investigative Counsel
CHRISTOPHER J. MULKINS, Minority Senior Professional Staff Member
SAMUEL RODARTE, JR., Minority Professional Staff Member
LAURA W. KILBRIDE, Chief Clerk
THOMAS J. SPINO, Hearing Clerk
(II)
CONTENTS
Opening statements: Page
Senator Johnson ................................ 1, 319, 397, 591, 783, 893, 1031, 1147, 1957
Senator Peters.................................... 2, 322, 400, 593, 784, 894, 1033, 1150, 1959
Senator Hassan .......................................... 18, 335, 431, 607, 807, 914, 1052, 1171
Senator Carper........................................... 21, 333, 425, 620, 801, 903, 1049, 1168
Senator Scott......................................................................... 24, 343, 803, 908, 1057
Senator Harris ........................................................................ 27, 345, 427, 617, 920
Senator Rosen ............................................ 29, 338, 441, 610, 806, 910, 1055, 1177
Senator Hawley .......................................................... 31, 340, 623, 811, 1060, 1983
Senator Sinema .................................................................. 348, 436, 627, 814, 1062
Senator Romney.................................................................................... 423, 615, 912
Senator Lankford................................................................ 428, 604, 808, 902, 1166
Senator Portman................................................................................... 612, 798, 917
Senator Enzi ..................................................................................................... 1174
Senator Paul ..................................................................................................... 1976
Prepared statements:
Senator Johnson....................................... 41, 361, 631, 817, 925, 1069, 1191, 2003
Senator Peters........................................ 363, 451, 632, 818, 926, 1071, 1193, 2005
Senator Hassan ................................................................................................. 2008
WEDNESDAY, FEBRUARY 12, 2020
WITNESSES
Hon. Scott Gottlieb, MD, Former Commissioner (2017–2019), of the Food
and Drug Administration, U.S. Department of Health and Human Services 3
Julie L. Gerberding, MD, Former Director (2002–2009) of the Centers for
Disease Control and Prevention, U.S. Department of Health and Human
Services ................................................................................................................. 5
Luciana Borio, MD, Former Director for Medical and Biodefense Preparedness
(2017–2019) at the National Security Council ................................................... 7
Nikki Clowers, Managing Director, Health Care Team, U.S. Government Ac-
countability Office ................................................................................................ 9
Asha M. George, DrPH, Executive Director, Bipartisan Commission on Bio-
defense .................................................................................................................. 10
ALPHABETICAL LIST OF WITNESSES
Borio, Luciana MD:
Testimony .......................................................................................................... 7
Prepared statement .......................................................................................... 48
Clowers, Nikki:
Testimony .......................................................................................................... 9
George, Asha M. DrPH:
Testimony .......................................................................................................... 10
Prepared statement .......................................................................................... 52
Gerberding, Julie L. MD:
Testimony .......................................................................................................... 5
Gottlieb, Hon. Scott MD:
Testimony .......................................................................................................... 3
Prepared statement .......................................................................................... 42
APPENDIX
Chart submitted by Julie Gerberding .................................................................... 57
CSIS Report ............................................................................................................. 58
(III)
IV
Page
Bipartisan Commission on Biodefense Reports ..................................................... 129
THURSDAY, MARCH 5, 2020
WITNESSES
Hon. Ken Cuccinelli II, Senior Official Performing the Duties of the Deputy
Secretary, U.S. Department of Homeland Security .......................................... 323
Hon. Robert Kadlec, M.D., Assistant Secretary for Preparedness and Re-
sponse, U.S. Department of Health and Human Services ................................ 325
ALPHABETICAL LIST OF WITNESSES
Cuccinelli, Hon. Ken II:
Testimony .......................................................................................................... 323
Prepared statement .......................................................................................... 364
Kadlec, Hon. Robert M.D.:
Testimony .......................................................................................................... 325
Prepared statement .......................................................................................... 370
APPENDIX
HLC statement for the record ................................................................................ 395
WEDNESDAY, MAY 6, 2020
WITNESSES
Pierre Kory, MD, MPA, Critical Care Service Chief, Associate Professor of
Medicine, University of Wisconsin School of Medicine and Public Health ..... 402
David L. Katz, MD, MPH, President, True Health Initiative .............................. 407
Tom Inglesby, MD, Director, Center for Health Security, Johns Hopkins
Bloomberg School of Public Health ..................................................................... 411
Avik Roy, President, Foundation for Research on Equal Opportunity ............... 412
John P.A. Ioannidis, MD, C.F. Rehnborg Professor in Disease Prevention
School of Medicine, Stanford University ............................................................ 414
Scott W. Atlas, MD, David and Joan Traitel Senior Fellow, Hoover Institu-
tion, Stanford University ..................................................................................... 417
ALPHABETICAL LIST OF WITNESSES
Atlas, Scott W.:
Testimony .......................................................................................................... 417
Prepared statement .......................................................................................... 479
Inglesby, Tom MD:
Testimony .......................................................................................................... 411
Prepared statement .......................................................................................... 466
Ioannidis, John P.A.:
Testimony .......................................................................................................... 414
Prepared statement .......................................................................................... 476
Katz, David L.:
Testimony .......................................................................................................... 407
Prepared statement .......................................................................................... 458
Kory, Pierre:
Testimony .......................................................................................................... 402
Prepared statement .......................................................................................... 453
Roy, Avik:
Testimony .......................................................................................................... 412
Prepared statement .......................................................................................... 471
APPENDIX
Causes of Death chart ............................................................................................. 483
Influenza in U.S. chart ............................................................................................ 484
States Compared Chart ........................................................................................... 485
Countries compared chart ....................................................................................... 486
COVID Age Risk Calculator ................................................................................... 487
LinkedIn Article ....................................................................................................... 488
MedRxiv Article ....................................................................................................... 492
V
Page
Roger Stein statement ............................................................................................. 494
Medium Article ........................................................................................................ 558
WSJ Article .............................................................................................................. 587
TUESDAY, JUNE 9, 2020
WITNESSES
Admiral Brett P. Giroir, M.D., Assistant Secretary for Health, U.S. Depart-
ment of Health and Human Services ................................................................. 595
Hon. Peter T. Gaynor, Administrator, Federal Emergency Management Agen-
cy, U.S. Department of Homeland Security ....................................................... 597
Rear Admiral John Polowczyk, Vice Director for Logistics, Joint Chiefs of
Staff, U.S. Department of Defense ..................................................................... 599
ALPHABETICAL LIST OF WITNESSES
Gaynor, Hon. Peter T.:
Testimony .......................................................................................................... 597
Joint prepared statement ................................................................................. 645
Giroir, Admiral Brett P.:
Testimony .......................................................................................................... 595
Prepared statement .......................................................................................... 634
Polowczyk, Rear Admiral John:
Testimony .......................................................................................................... 599
Joint prepared statement ................................................................................. 645
APPENDIX
Harris Letters .......................................................................................................... 661
FEMA Hurricane Plan ............................................................................................ 678
Responses to post-hearing questions for the Record:
Admiral Giroir .................................................................................................. 737
Mr. Gaynor and Rear Admiral Polowczyk ...................................................... 751
WEDNESDAY, JUNE 24, 2020
WITNESSES
Julie Gerberding, M.D., Former Director, Centers for Disease Control and
Prevention, U.S. Department of Health and Human Services ......................... 786
Daniel M. Gerstein, Ph.D., Senior Policy Researcher, RAND Corporation ........ 788
Andrew Phelps, Director, Oregon Office of Emergency Management, on behalf
of the National Emergency Management Association ...................................... 790
Gregory Burel, Former Director, Strategic National Stockpile, U.S. Depart-
ment of Health and Human Services ................................................................. 792
ALPHABETICAL LIST OF WITNESSES
Burel, Gregory:
Testimony .......................................................................................................... 792
Prepared statement .......................................................................................... 849
Gerberding, Julie, M.D.:
Testimony .......................................................................................................... 786
Prepared statement .......................................................................................... 820
Gerstein, Daniel M., Ph.D.:
Testimony .......................................................................................................... 788
Prepared statement .......................................................................................... 824
Phelps, Andrew:
Testimony .......................................................................................................... 790
Prepared statement .......................................................................................... 842
APPENDIX
Portman Letter to DOD .......................................................................................... 856
CSIS Report ............................................................................................................. 58
Responses to post-hearing questions for the Record:
Ms. Gerberding ................................................................................................. 859
Mr. Gerstein ...................................................................................................... 870
VI
Page
Responses to post-hearing questions for the Record—Continued
Mr. Phelps ......................................................................................................... 877
Mr. Burel ........................................................................................................... 884
THURSDAY, JUNE 25, 2020
WITNESSES
Mark A. Morgan, Chief Operating Officer and Senior Official Performing
the Duties of the Commissioner, U.S. Customs and Border Protection, U.S.
Department of Homeland Security
Testimony .......................................................................................................... 896
Prepared statement .......................................................................................... 928
APPENDIX
SW Border Apprehensions Chart ........................................................................... 940
Southwest Border Apprehensions/Asylum Claims Chart ..................................... 941
SW Border Apprehensions Chart ........................................................................... 942
Statements submitted by Senator Harris .............................................................. 943
Statements submitted for the Record:
Church World Service ...................................................................................... 953
Human Rights First ......................................................................................... 954
Kids In Need of Defense .................................................................................. 960
United States Conference of Catholic Bishops ............................................... 963
Responses to post-hearing questions for the Record:
Mr. Morgan ....................................................................................................... 971
TUESDAY, JULY 28, 2020
WITNESSES
Maya MacGuineas, President, Committee for a Responsible Federal Budget ... 1035
Veronique de Rugy, Ph.D., Senior Research Fellow, Mercatus Center, George
Mason University ................................................................................................. 1037
Danielle Brian, Executive Director, Project on Government Oversight .............. 1038
Hon. Neil Barofsky, Partner, Jenner & Block, LLP, and Former Special
Inspector General (2008–11) Troubled Asset Relief Program .......................... 1040
Hon. Phil Gramm, Former U.S. Senator from the State of Texas, and Visiting
Scholar, American Enterprise Institute ............................................................. 1042
ALPHABETICAL LIST OF WITNESSES
Barofsky, Hon. Neil:
Testimony .......................................................................................................... 1040
Prepared statement .......................................................................................... 1105
Brian, Danielle:
Testimony .......................................................................................................... 1038
Prepared statement .......................................................................................... 1088
de Rugy, Veronique, Ph.D.:
Testimony .......................................................................................................... 1037
Prepared statement .......................................................................................... 1083
Gramm, Hon. Phil:
Testimony .......................................................................................................... 1042
Prepared statement .......................................................................................... 1127
MacGuineas, Maya:
Testimony .......................................................................................................... 1035
Prepared statement .......................................................................................... 1073
APPENDIX
Danielle Brian attachment to testimony ............................................................... 1130
Responses to post-hearing questions for the Record:
Mr. Barofsky ..................................................................................................... 1137
VII
Page
THURSDAY, NOVEMBER 19, 2020
WITNESSES
Peter A. McCullough, M.D., M.P.H., Vice Chief of Internal Medicine, Baylor
University Medical Center .................................................................................. 1152
Harvey A. Risch, M.D., Ph.D., Professor of Epidemiology, Yale School of
Public Health ........................................................................................................ 1154
George Fareed, M.D., Medical Director and Family Medicine Specialist, Pio-
neers Medical Center ........................................................................................... 1157
Ashish K. Jha, M.D., M.P.H., Dean, School of Public Health, Brown Univer-
sity ......................................................................................................................... 1159
ALPHABETICAL LIST OF WITNESSES
Fareed, George M.D.:
Testimony .......................................................................................................... 1157
Prepared statement .......................................................................................... 1201
Jha, Ashish K., M.D., M.P.H.:
Testimony .......................................................................................................... 1159
Prepared statement .......................................................................................... 1203
McCullough, Peter A., M.D., M.P.H.:
Testimony .......................................................................................................... 1152
Prepared statement .......................................................................................... 1195
Risch, Harvey A., M.D., Ph.D.:
Testimony .......................................................................................................... 1154
Prepared statement .......................................................................................... 1197
APPENDIX
Hatfill statement ..................................................................................................... 1226
Zelenko statement ................................................................................................... 1259
COVID studies ......................................................................................................... 1269
McCullough attachments ........................................................................................ 1580
Risch attachment ..................................................................................................... 1599
Fareed’s attachments .............................................................................................. 1900
Responses to post-hearing questions for the Record:
Dr. McCullough ................................................................................................. 1901
Dr. Risch ............................................................................................................ 1944
Dr. Fareed ......................................................................................................... 1946
Dr. Jha ............................................................................................................... 1948
TUESDAY, DECEMBER 8, 2020
WITNESSES
Ramin Oskoui, M.D., Vice President of Medical Staff, Sibley Memorial Hos-
pital, and Chief Executive Officer, Foxhall Cardiology ..................................... 1962
Jean-Jacques Rajter, M.D., Pulmonologist, Broward Health Medical Center .... 1964
Pierre Kory, M.D., Associate Professor of Medicine, St. Lukes Aurora Medical
Center .................................................................................................................... 1966
Armand Balboni, M.D., Ph.D., Chief Executive Officer, Appili Therapeutics,
Inc. ......................................................................................................................... 1969
Jane M. Orient, M.D., Executive Director, Association of American Physicians
and Surgeons ........................................................................................................ 1971
Jayanta Bhattacharya, M.D., Ph.D., Professor of Medicine, Stanford Institute
for Economic Policy Research .............................................................................. 1974
ALPHABETICAL LIST OF WITNESSES
Balboni, Armand, M.D., Ph.D.:
Testimony .......................................................................................................... 1969
Prepared statement .......................................................................................... 2039
Bhattacharya, Jayanta, M.D., Ph.D.:
Testimony .......................................................................................................... 1974
Prepared statement .......................................................................................... 2043
Kory, Pierre, M.D.:
Testimony .......................................................................................................... 1966
VIII
Page
Kory, Pierre, M.D.—Continued
Prepared statement .......................................................................................... 2023
Orient, Jane M., M.D.:
Testimony .......................................................................................................... 1971
Prepared statement .......................................................................................... 2041
Oskoui, Ramin, M.D.:
Testimony .......................................................................................................... 1962
Prepared statement .......................................................................................... 2009
Rajter, Jean-Jacques M.D.:
Testimony .......................................................................................................... 1964
Prepared statement .......................................................................................... 2017
APPENDIX
Four Pillars of Pandemic chart ............................................................................... 2047
Three stages of COVID chart ................................................................................. 2048
Statements submitted by Senator Peters .............................................................. 2049
Kory attachments .................................................................................................... 2089
Oskoui attachments ................................................................................................. 2136
Rajter attachment .................................................................................................... 2160
ROUNDTABLE: ARE WE PREPARED?
PROTECTING THE U.S. FROM GLOBAL
PANDEMICS
WEDNESDAY, FEBRUARY 12, 2020
U.S. SENATE,
COMMITTEE ON HOMELAND SECURITY
AND GOVERNMENTAL AFFAIRS,
Washington, DC.
The Committee met, pursuant to notice, at 9:34 a.m., in room
SD–G50, Dirksen Senate Office Building, Hon. Ron Johnson,
Chairman of the Committee, presiding.
Present: Senators Johnson, Lankford, Scott, Hawley, Peters, Car-
per, Hassan, Harris, Sinema, and Rosen.
OPENING STATEMENT OF CHAIRMAN JOHNSON
Chairman JOHNSON. Good morning. I want to welcome all of our
witnesses, thank you for your time and your testimony and the an-
swers you will be providing to our questions. I want to thank ev-
erybody else for coming as well.
This obviously is an important topic. I will say up front, I am dis-
appointed that we do not have a representative from the Depart-
ment of Homeland Security (DHS) or the Department of Health
and Human Services Centers for Disease Control (HHS CDC) here.
I spoke with those folks. I thought I had them convinced to come,
but apparently, they are doing an all-Senate briefing at 11:30. I un-
derstand the demand on their time in terms of briefing Senators,
but I think it is extremely important the public understands these
things as well.
I have all kinds of questions, and what I told the witnesses here
is we are not going to confine your opening statements to 2 min-
utes or 5 minutes. I want you to provide the public information.
The main reason I called this roundtable is just to put things in
perspective. The Federal Government plays a role here. We do not
want the Federal Government to underreact, but we also do not
want the Federal Government to overreact. I think the probability
that they are going to get it just right is zero, but I think it is im-
portant that we discuss what are the considerations in the actions
that we do take, what actions would be effective, what actions will
largely be ineffective.
I know a number of you have already published articles, and you
have had that kind of discussion. That is kind of what I want to
get on the table. I want this roundtable to layout the information
that the public needs to begin considering, realizing there are no
(1)
2
set answers yet. We just do not know all kinds of things, but there
is plenty that we do know. So let us acknowledge the fact that
there is a lot of unknowns in this process yet, but information in
the public realm is better than not having the information out
there.
I think we are seeing the difference right now between our demo-
cratic open-press system versus China where I think because of
that closed system, it is probably getting closer to out of control
there, where we have the real possibility by providing the public
the information they need to have, providing health professionals.
People are aware. They can take, hopefully, precautionary meas-
ures inside hospitals where you have severe cases. We can limit the
spread of this as best as possible.
I have a prepared statement. I will just enter it into the record.1
Chairman JOHNSON. I will turn it over to Senator Peters.
OPENING STATEMENT OF SENATOR PETERS
Senator PETERS. Thank you, Mr. Chairman. I will be brief too.
Thank you to all of our witnesses for being here, and I will just
share my disappointment as well with you, Mr. Chairman, that we
do not have CDC and Homeland Security, but hopefully, we will be
able to have a hearing coming up that will bring them in because
I agree getting this information out in the public is really impor-
tant. When folks do not know something, you can have a lot of mis-
information getting around there and kind of gin up fears. We do
not want to do that. We want to treat this with the seriousness
that it deserves but make sure there is full transparency as to
what is happening and how we are dealing with it.
I think this an important issue for us to address because this is
not going to be the last time. Wherever you have a disease spread-
ing fairly quickly—pandemics are part of human history. They
have been throughout human history. They are going to continue.
There are some that may argue that they become more complicated
as time goes on and as we become more of an interconnected world
as well. So I think we have to be thinking about this in the long
term, making sure our resources are there.
I certainly was disappointed in the President’s budget that shows
a pretty substantial cut to programs related to pandemics at a time
when we may be on the verge of a pandemic. It shows that that
is shortsighted, and we have to be thinking about this from a
homeland security issue as well.
We are the Homeland Security Committee. This is about pro-
tecting the homeland. I am going to be asking questions related to
our capacity to produce vaccines, for example, if and when a vac-
cine is developed, what sort of capacity is here in the United
States, and if we are relying on China to produce vaccines for us
here in the United States, I suspect they will use those vaccines
for their own people first before they come to the United States.
That would be a very rational and reasonable expectation.
We have to make sure that we have the resources in our country
to protect ourselves, not only from naturally occurring pandemics,
but actually, Dr. Gerberding, we have talked about it from the
1 The prepared statement of Senator Johnson appear in the Appendix on page 41.
3
weaponization as well in a different committee that I am on,
Emerging Threats and Capabilities. There is also the potential for
bioweapons to be used, and we need to be prepared on all fronts.
I look forward to the conversation and look forward to moving
forward on this important issue.
Chairman JOHNSON. Thank you, Senator Peters.
Why do not we start with Dr. Gottlieb, and then we will kind of
alternate back and forth.
TESTIMONY OF HON. SCOTT GOTTLIEB, MD, FORMER COMMIS-
SIONER (2017–2019) OF THE FOOD AND DRUG ADMINISTRA-
TION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. GOTTLIEB. I do not think these are working right now, but
thanks, Mr. Chairman, Mr. Ranking Member. I think they are
working now. I appreciate the opportunity to be here today before
you, and thank you for submitting my full statement to the record.1
This is a deeply concerning event, this novel coronavirus disease
2019 (COVID–19). We do not understand its true severity at this
point. We do not understand the transmissibility. I think we are
going to learn a lot more information in the coming weeks as we
start to see outbreaks emerge in other regions of the world that are
going to provide better information than we have been able to get
out of China.
But the fear right now is that this could occupy that middle
ground between contagion and virulence, where it is contagious
enough to spread very efficiently around the world but still virulent
enough to cause a lot of death and suffering when it is distributed
across a very large population.
I think one of the very instructive things right now that we
should keep a very close eye on is the situation in Singapore, which
is growing more and more concerning by the day.
I would remind folks it is quite warm in Singapore right now,
about 90 degrees at a high during the day, lows in the 70s. While
we would hope that this summer would be a backstop against prop-
agation of coronaviruses—and it typically is—it might not be in
this case where you have a very novel virus that is going to trans-
fer more easily because people do not have any cross-immunity.
Of the 50 cases that have been identified in Singapore—and they
have an excellent system for doing tracking and tracing in these
kinds of situations—eight are currently in the intensive care unit
(ICU), and so that is at least some indication of the potential sever-
ity of this.
I want to focus my brief remarks up front today on some of the
supply chain issues that this situation exposes and draw from some
of the work that I did previously at the Food and Drug Administra-
tion (FDA) as well as what we seem to be learning in the setting
of this current out break.
Wuhan, in particular, in the Hubei Province was a center for pro-
duction of pharmaceutical ingredients but not pharmaceutical in-
gredients that we typically think of when we think of the active
pharmaceutical ingredients (APIs) that go into manufacturing
drugs and into what we call the ‘‘fill-finishing process,’’ actually
1 The prepared statement of Dr. Gottlieb appears in the Appendix on page 42.
4
taking the raw ingredient of the drug product itself and putting it
in the tablet or capsule.
Typically, a lot of the APIs manufactured, some of it in
China—a lot of it is manufactured in India, some of it in Europe
and the United States. The fill-finishing work, actually taking that
active pharmaceutical ingredient and turning it into a capsule or
a tablet, that is often done in the United States or in countries like
Ireland.
What goes on in China, the kind of production that they have,
is actually making the starting materials for the active pharma-
ceutical ingredient. So the first chemicals that go into the API is
oftentimes what is made in China, and in many cases, China is the
sole source for that material.
A lot of the materials that were manufactured in Wuhan actually
got shipped to India where the Indian generic companies did the
manufacturing of the active pharmaceutical ingredient, and what
we are finding now is that in many cases, China was the only sup-
plier of these raw ingredients. So what we have identified through
this episode is a critical choke point in the supply chain for phar-
maceuticals and some critical pharmaceuticals, a lot of anti-
infectives that are manufactured, generic anti-infectives that are
manufactured in India. The starting ingredients that go into those,
those intermediate products of the anti-infectives, are actually
manufactured in China.
So it calls into question whether or not we have the right poli-
cies, I believe, in terms of how we look at potential disruptions in
the supply chain, because our orientation historically has been fo-
cused on the finished product.
We have required manufacturers historically to report to the
FDA when there are shortages or near shortages of finished prod-
uct.
We have some insight into the manufacturer of API, but on the
whole, we are not typically looking all the way down through the
supply chain or requiring manufacturers to do that and report on
what these critical choke points can be.
So it begs the question whether or not we should reconsider
those policies, and it is not just in the setting of pandemics where
this can become a risk. It could be political upheaval. It could be
political strife. It could be situation, to your point, Mr. Chairman,
where countries try to nationalize supplies, where there is a critical
supply and they hold on to enough supply to satisfy their local
needs in the setting of a public health crisis before they ship out-
side their borders.
Just in closing, some things I think we can consider going for-
ward to try to address these kinds of contingencies and these kinds
of risk to the supply chain that I believe this episode is exposing
in real time, we could, first of all, work closely in the near term
with manufacturers to try to get an alternative supply for these
chemicals into the market.
There is idle manufacturing capacity in India. These facilities
can be converted fairly quickly. The starting ingredients for phar-
maceutical production does not need to be done under what we call
good manufacturing practices. You do not have to apply all the
stringent oversight that you would to a finished drug product be-
5
cause the regulation on the finished drug product is what covers
the drug ingredients. So the drug ingredients do not need to meet
those standards as long as the finished drug product does, and that
is a long way of saying we probably could do this quickly if we
wanted to convert facilities and we had a real focus on where those
choke points and trying to mitigate them.
I think longer term, we should think about when we ask manu-
facturers to focus on shortages of final products also require them
to report on the intermediate steps and intermediate ingredients
that could also come into shortage that could create an adverse
public health outcome.
We can require companies to identify alternative supply for some
of these products. We did that after September 11, 2001 (9/11),
which Dr. Gerberding probably remembers well, where we required
manufacturers of critical products like insulin to identify how they
would come up with alternative supply of that product should their
core facility go down because of either an intentional or an unin-
tentional act.
We could do the same thing with some of these critical facilities
that supply raw ingredients for these drug products, where it is, in
many cases, sole source.
We also, finally in closing, just need to focus on getting more
manufacturing back into the United States, and this is where this
Committee has been very helpful. When I was at the agency mak-
ing investments in continuous manufacturing and other kinds of
high-tech, low-labor footprints for manufacturing pharmaceutical
ingredients and pharmaceutical products, that are the kinds of fa-
cilities that if you are a manufacturer, you would want to locate
as close as possible to your site of sale. So a continuous manufac-
turing platform really lends itself to being domesticated here in the
United States as opposed to doing it in another part of the world.
So these are just some ideas, some of which I worked on when
I was at the agency, some of which I thought about since leaving,
but I would be delighted for the opportunity to work with the Com-
mittee on these and other ideas on how we can mitigate some of
the risks that have been identified in this current episode. Thanks.
Chairman JOHNSON. Thank you, Dr. Gottlieb, and I should have
pointed out that you are the former Commissioner of the Food and
Drug Administration.
Why do not we move next to Dr. Julie Gerberding. Dr.
Gerberding was former Director of the Centers for Disease Control
during the Bush Administration from 2002 to 2009. Doctor.
TESTIMONY OF JULIE L. GERBERDING, MD, FORMER DIREC-
TOR (2002–2009) OF THE CENTERS FOR DISEASE CONTROL
AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dr. GERBERDING. Thank you. It is an honor and an important op-
portunity to provide context and information. I really appreciate
the ability to have this conversation.
I am really here wearing three hats. One is as the Chief Patient
Officer at Merck. Like many multinational companies, we have lots
of people working in China right now, and of course, we are con-
cerned about our own employees. But as Dr. Gottlieb has said, we
6
are also worried about maintaining the supply of medicines and
vaccines to the people in China who need them but also sustaining
the supply chain across the board.
I am also wearing my hat as the co-chair of the Center for Stra-
tegic and International Studies (CSIS) Commission on Global
Health Security, which recently published this report, which in-
cludes recommendations to Congress about what we could do to
end this cycle of complacency in crisis that we continuously cir-
culate through as these infectious diseases emerge. This is a com-
mission that includes bipartisan members of both the House of
Represenatatives and Senate. So we have a very involved Congress
in this issue.
Finally, I am wearing my hat as the former CDC Director who
had the privilege of serving our country during the severe acute
respiratory syndrome (SARS) outbreak. I have had some firsthand
experience with the first coronavirus that emerged but also lived
through West Nile, monkeypox, avian influenza, and a number of
other infectious disease outbreaks, and worked very hard across
the entire government to try to improve our preparedness for an
influenza pandemic with lots of exercises and advanced capability
development. I am sober to be watching this situation unfold today,
and it is a little bit of a deja vu all over again.
I thought I would just comment on kind of the big picture of how
we generally approach global outbreaks like this. The first step is
the detection, and in this case, I think we are fortunate that the
outbreak was observed and reported and information was shared
very early in the process, compared to the situation with SARS
where several months went before we were aware of what was
going on. So that is a positive improvement.
The second step is to contain the virus at its source, and I do not
think there has been, probably in human history, a more dramatic
effort to try to contain a virus than what is going on right now in
China. The number of people who are on lockdown, the scope and
magnitude of the population involvement in the quarantine and so-
cial distancing procedures is, in my view, completely unprece-
dented, and the question to us is, Will it work? Can you really keep
this virus under control?
We obviously know there is spillover into several of the provinces
in China and several countries around the world. We have also doc-
umented hotspots of sustained transmission. We still have a lot to
learn, and certainly, the experience on the cruise ship in Japan is
telling us how transmissible this can be among people who are in
a confined area. So we are very concerned about the prospects for
long-term containment.
If we cannot contain it, I think we need to be prepared for what
are we going to do to try to slow down the spread. Slowing down
spread is important because, if we have a lot of cases all at once,
we simply do not have the surge capacity to manage that in our
health care environment or in any of the related services that
would be necessary.
Slowing down means working hard to identify the people who are
infected and isolating them in a place where they cannot infect
other people and having available gloves and masks and the isola-
7
tion materials, which is also part of this supply chain that we have
some significant vulnerabilities in.
But slowing down also can involve social distancing, and by that,
I mean instructing people to avoid large crowds, early school clo-
sures, so that child are not transmitting in the opportunities of per-
son-to-person and droplet transmission that occur among young
kids in school and a variety of other measures that were employed
in the 1918 pandemic, for example.
These measures along are not likely to prevent community
spread, but when taken as a cluster of interventions, we like to use
the Swiss cheese analogy. If you hold up a piece of Swiss cheese,
there are a lot of holes in it, but if you stack them on stop of one
another, you can end up with a pretty effective barrier. I think that
is the process of slowing down until such time as we have a vaccine
or countermeasures that can be helpful in that.
I think where we are in the United States today is we are ob-
serving a clustered outbreak of a significant scale in Asia, we do
not have that situation in the United States today. So we are very
alert. I do not think we are alarmed at this point, but we need to
be leaning in to what will the next step be if we cannot contain it.
I think that is why this conversation that we are having today is
so prescient because we will need congressional support and invest-
ment to make that a feasible opportunity.
So I think I will just stop there, and we can come back to some
specifics about transmission, which we have provided to you in
kind of this summary comparison of various viruses.
Chairman JOHNSON. Thank you, Doctor.
I think we will go next to Dr. Luciana Borio. Dr. Borio is former
National Security Council Director for Medical and Biodefense Pre-
paredness and Acting Chief Scientist for the U.S. Food and Drug
Administration. Dr. Borio.
TESTIMONY OF LUCIANA BORIO, MD,1 FORMER DIRECTOR
FOR MEDICAL AND BIODEFENSE PREPAREDNESS (2017–2019)
AT THE NATIONAL SECURITY COUNCIL
Dr. BORIO. Good morning, Chairman Johnson and Ranking Mem-
ber Peters and Members of the Committee.
Dr. BORIO. OK. This one is working better. Thank you.
I am Dr. Borio, as you mentioned. I work for In-Q-Tel, which is
a non-for-profit strategic investment firm that tailors innovative
technology solutions to support the mission of the U.S. national se-
curity community, but previously, I served in U.S. Government po-
sitions and have been involved in response to many public health
emergencies. So thank you for the opportunity to be here with you
today.
You have heard about the numbers of the trajectory of this epi-
demic, but we all know that the numbers both inside and outside
of China are likely much larger. There are some places where we
now have significant transportation hubs to China that have not
reported any cases yet, either because they do not have adequate
surveillance systems or do not have access to diagnostic tests or are
not looking.
1 The prepared statement of Dr. Borio appears in the Appendix on page 48.
8
Even though there is a lot we do not know about this virus yet,
as Drs. Gottlieb and Gerberding mentioned, the futures are very
concerning for a pandemic and global spread. Even though we have
seen most of this impact today in China, in Wuhan, and the citi-
zens are suffering a tremendous amount, its impact will be felt
globally.
I want to stress that even though we do not know how lethal this
virus is, it is pretty clear that it is sufficiently lethal to stress se-
verely the health care systems because of the lack of surge capacity
that we have today to take care of large influx of patients with
acute and serious respiratory diseases.
I would like to speak a little bit about some progress we have
made since 2001 because it has been very significant progress. We
are much better prepared today than we were back in 2001, and
I want to acknowledge the work of Congress to help us prepare be-
cause a lot of that progress would not have been possible without
the laws that were passed over the years to provide the Executive
Branch with very many vital authorities to perform its duties,
whether it has been establishment of the BioShield fund or the es-
tablishment of a bar that would support the private sector in tech-
nological countermeasures, Emergency Use Authorization authori-
ties for the FDA. There are many others that proved vital for our
current State of preparedness.
Over the years, it is very clear too that the Federal response en-
terprise that comprises many agencies, but including the CDC, the
National Institute of Health (NIH), and the FDA, are stronger than
ever. The coordination and communication and collaboration and
resource sharing, the ability to get things done is stronger than
ever.
On an optimistic note, I think it is fair to say that the science
is advanced to appoint where we now can actually aim for develop-
ment, evaluation, and deployment of countermeasures in time to
maybe impact the course trajectory of a novel outbreak.
In the past, the efforts were designed to protect from subsequent
outbreaks, but now the goal really is to impact the current one.
You have heard how the NIH is moving very quickly to develop a
vaccine. The CDC moved very quickly to develop diagnostic tests.
So there has been progress.
Now, I would like to say that we have fallen short in some very
key areas, and they cannot be overlooked going forward. One has
been the lack of prioritization for diagnosis tests, and they are one
of the most critical components of outbreak management and con-
trol. They are necessary for even clinical trials for vaccines. So we
cannot afford to de-prioritize these vital tools for outbreak pre-
paredness response surveillance.
As Dr. Gerberding said, the health care system is not ready for
care of sick patients. So we have neglected our health care system
preparedness. Much needs to be done in the public health arena,
but more progress has been done at the State and local level of
public health than we have achieved in the health care sector.
I love medical countermeasures. I love therapeutics and specific
therapeutics, but we have to remember that they are an incre-
mental benefit to delivery of supportive medical care. Without that
9
foundation, those countermeasures are not going to be useful. We
need to be able to, first and foremost, take care of patients.
Last, as Dr. Gottlieb spoke about, we have not sufficiently pro-
tected our supply chain of essential medicines and medical equip-
ment, and that needs to change going forward.
I do think that we have made some progress, but we need to
brace ourselves from some difficult weeks to months to come. I be-
lieve that we are going to see a lot more cases in the United States
in the near future.
I would like to acknowledge the work of the Committee to calling
for the establishment of the National Biodefense Strategy in 2017
and the National Defense Authorization Act (NDAA), at your sug-
gestion. It has been proven very important to help coordinate the
Federal Government’s response.
I do not want to leave this opportunity without recognizing the
staff at the CDC, my former colleagues at the FDA, at DHS, at
U.S. Customs and Border Protection (CBP), and other Federal
agencies who I know are working around the clock to protect Amer-
icans from harm and from this epidemic.
Thank you.
Chairman JOHNSON. Thank you, Doctor.
Let us switch over to the Government Accountability Office
(GAO) now. We have Nikki Clowers, who is the Managing Director
for GAO’s Health Care Team. Ms. Clowers.
TESTIMONY OF NIKKI CLOWERS, MANAGING DIRECTOR,
HEALTH CARE TEAM, U.S. GOVERNMENT ACCOUNTABILITY
OFFICE
Ms. CLOWERS. Thank you, Chairman Johnson, Ranking Member
Peters, and Members of the Committee. I thank you for having me
here today to talk about GAO’s infectious disease preparedness
work.
Today I want to share four key lessons from our past work on
outbreaks as we consider the Nation’s current preparedness for and
response to the 2019 coronavirus.
First, planning and coordination is critical. Although HHS is the
lead Federal agency for public health and medical preparedness,
multiple other Federal agencies, such as the Department of De-
fense (DOD) and DHS, play an important role, with State and local
agencies on the front line; and of course, in today’s global environ-
ment with mobile populations, coordination between countries is a
must. Effective preparedness and response requires advanced plan-
ning, such as joint exercises among these entities.
Second and related to planning and coordination, entities must
understand theirs and other’s roles and responsibilities. Who is re-
sponsible for communicating with the public? What is the contin-
gency plan if a key entity’s ability to respond is limited? How can
an entity fulfill its obligation despite these limitations? Answers to
these and many other questions must be known and understood by
all to ensure effective preparedness and response, and I would note
that these are related to the issues that have been brought up by
other witnesses about the supply chain, our reliance on drug and
supplies from other countries. We have talked a lot about drugs so
far, but it is also the supplies, personal protective equipment. What
10
happens if those are limited, and where do we get those supplies
from?
Third, clear and consistent communication is essential. With the
number of entities involved in preparedness and response, it is im-
portant that the government speak with one voice to avoid confu-
sion and frustration. The lack of clear and consistent communica-
tion can also create expectation gaps, like we saw when the amount
of vaccine available for the hemagglutinin one neuraminidases one
(H1N1) influenza in 2009 did not meet the public’s expectation.
Finally, responding to the coronavirus cannot distract us from
continuing to prepare for tomorrow’s threat. We need to prepare for
and response to the coronavirus, but we also must continue to pre-
pare for other public health threats, including efforts to develop
needed medical countermeasures. Developing these counter-
measures requires sustained attention to overcome inherent chal-
lenges, such as the high failure rate for the development of most
drugs, vaccines, and diagnostic devices.
Mr. Chairman and Ranking Member, this concludes my prepared
statement. I look forward to today’s discussion.
Chairman JOHNSON. Thank you, Ms. Clowers.
Last but not least, we have Dr. Asha George. Dr. George is Exec-
utive Director of the Bipartisan Commission on Biodefense, for-
merly known as the Blue Ribbon Panel. Dr. George.
TESTIMONY OF ASHA M. GEORGE, DrPH,1 EXECUTIVE
DIRECTOR, BIPARTISAN COMMISSION ON BIODEFENSE
Dr. GEORGE. Mr. Chairman, thank you very much for the oppor-
tunity to come here today, Ranking Member Peters, and the rest
of the Committee.
The Bipartisan Commission on Biodefense has appeared before
this Committee before, and I think it is an important point to make
because it is obvious that biodefense is a Homeland Security issue.
It is not just something that is relegated to the health care and
public health arenas.
As we approach this novel coronavirus virus situation now, I
think I will leave the health care and medical commentary to my
colleagues and just focus a little bit right now on what is hap-
pening with Homeland Security.
I think it is important to note that the Coronavirus Task Force
does, in fact, have Homeland Security on it, somebody from the De-
partment of Homeland Security, but you will note that the Home-
land Security advisor is not a member of that task force.
Now, the White House can do and arrange however the White
House wants to, but what that means is that that person from the
Department of Homeland Security is the representative for Home-
land Security interests and needs to address that at a level that
would not be the same as what would happen if the Homeland Se-
curity advisor was involved.
Additionally, Homeland, as you have seen thus far, has had some
important roles to play. U.S. Customs and Border Protection and
the Transportation Security Administration (TSA) have been crit-
ical in working with CDC in terms of trying to screen people and
1 The prepared statement of Dr. George appear in the Appendix on page 52.
11
shuttle airplanes in particular directions, but other parts of the De-
partment have been involved as well. U.S. Citizenship and Immi-
gration Services (USCIS), for example, has been very clear about
the offices that they have in China and the need to close those
down, but they understand that illness can have an impact not just
there where people are trying to immigrate perhaps here to the
United States, but also vice versa with people being sick there and
trying to move around the world.
In addition, the U.S. Coast Guard (USCG) has issued a Maritime
Safety Information Bulletin, and I think these issues or these ac-
tivities on the part of the Coast Guard, CBP, U.S. Immigration and
Customs Enforcement (ICE), and so forth, these are activities that
are not necessarily new activities. Many of them have long, hun-
dreds of years of responsibilities for public health that have to do
with customs, that have to do with protecting our ports of entry
(POE), and they are simply executing those right now, as they
should.
Other parts of the Department, such as the Federal Emergency
Management Agency (FEMA) and the Cybersecurity and Infra-
structure Security Agency (CISA), they too have some responsibil-
ities. I would hope that right now they are doing what Nikki sug-
gested. They should be leaning forward right now.
We do not necessarily need to have all of the States declaring
emergencies and applying for emergency assistance under the Staf-
ford Act, but FEMA does have guidance that would enable that if
that was necessary. They should be making sure everybody under-
stands that at the State and local level, and they should be trying
to figure out how that might work when HHS is already providing
some assistance to begin with.
As far as infrastructure protection is concerned, we have to be
worried about the worst-case scenario. It is important for Home-
land to study what is happening in China, use that as a scenario
for the worst-case scenario here in the United States, and then un-
derstand what impact that has on infrastructure in particular. It
has got to be more than just a workforce management issue.
The Office of Infrastructure Protection has studied this and ad-
dressed it in the past with pandemic influenza, and I surely hope
that they are dusting off some of those plans and thoughts and
looking to apply them here again.
Other than that, I think that I would just end with a suggestion
to the Committee. There are expectations in legislation that still,
abound, back from the Homeland Security Act of 2002 and coming
forward, in which this Committee and others directed the Depart-
ment of Homeland Security to take upon themselves some respon-
sibilities for health-related public health issues.
With the reorganization to create the Office of Countering Weap-
ons of Mass Destruction (CWMD), there is a little confusion there
now with the Chief Medical Officer and the Officer in the Manage-
ment Directorate, but things like the National Biosurveillance Inte-
gration System still in the CWMD office, it is a little confusing. It
is a little unclear, even within the Department, who should be
doing what and how.
I believe that the Committee should take a look at that, but in
particular, in the context of what is going on with novel
12
coronavirus, it is something that probably needs to be fixed sooner
than later, especially if we are going to assume now that the Na-
tion is going to have to deal with biological events sooner than
later, something for you to think about.
Chairman JOHNSON. Thank you, Doctor.
I definitely remember the Blue Ribbon Study Panel testifying be-
fore our Committee. Actually, Senator Carper and I met with the
Vice President because your number one recommendation is we
need to put somebody in charge of these things. That is a prevalent
problem across a host of issues and problem areas of who is going
to be in charge. We have not worked that out. I think that remains,
from my standpoint, a top priority.
Dr. Gerberding, I think you supplied this sheet to us. We have
an acronym now. It is COVID–19.
Dr. GERBERDING. Exactly.
Chairman JOHNSON. But as I am looking at period of infectivity
versus seasonal flu 1918, SARS, Middle East Respiratory Syn-
drome (MERS), I think what is, from my standpoint not being a
doctor, most disconcerting about COVID–19 is now we are hearing
it is about a 24-day contagious period, incubation period, when peo-
ple are just asymptomatic. Does that tell us something about this
virus?
Also, let us get it on the table. There are all kinds of news stories
going about in Wuhan they had certain facilities there. Something
escaped from a lab. Can you just kind of discuss what we know?
If there are issues you can lay to rest, let us lay those things to
rest today.
Dr. GERBERDING. Thank you.
One point I would like to make is that although this seems like
it has been in the news for quite a while, these are actually early
days in terms of studying the outbreak.
One of the things that disease detectives are doing right now is
literally going door to door, finding a case, understanding where
that person was exposed, how many people were they in contact,
and what are the actual transmission frequencies. So it takes time
to do that kind of shoe-leather epidemiology that has to be done.
It does not surprise me that we have some uncertainty around
these numbers, and we will continue to do that. Different people
are observing different populations. What we see on the cruise ship
is going to be different than what we might see in a crowded hos-
pital situation with someone who is profoundly ill and not properly
isolated. So a lot of information is emerging. It makes it really hard
to make predictions or to make any firm statements about what we
can expect here.
But I am concerned about this virus for three reasons. First of
all, we do not know if the tip of the iceberg is really the most se-
verely ill patients who get admitted to the hospital, but that the
majority of the iceberg is transmission that is going around people
with mild illness or even asymptomatic illness. That is profoundly
important, obviously, but at this moment in time, we do not really
know what proportion of the total universe of coronavirus infection
is among those most sick people. So we could be having much more
transmission, but those people are not being tested.
13
On the other hand, this does appear to be a very virulent virus
with a fatality rate that is significantly higher than what we see
with seasonal influenza, as I pointed out on this chart.1 So given
that situation, I think we have to be concerned that even if most
people are not very ill, there is going to be a significant impact on
the overall population, and it does appear that vulnerable older
people and perhaps young children are certainly not immune to
this and most of the severe diseases among populations of people
who have underlying disease.
Chairman JOHNSON. That is true, just seasonable flu as well. So
that is on the spectrum of how virulent this really is and how dead-
ly, correct?
Dr. GERBERDING. That is exactly right.
Chairman JOHNSON. I am reading all kinds of things. One of the
reports I read was that they attempted to develop a vaccine for
SARS, and they were not successful; is that true? Did we ever de-
velop a successful vaccine for SARs?
Dr. GERBERDING. This is an important perspective for the Com-
mittee, I believe, and that is that when we have an outbreak like
SARS, there is a great deal of investment in doing something
quickly like developing a vaccine or a medicine.
But SARS was contained pretty quickly. 8,000 cases is a pretty
small outbreak on the global scale, and the money went away. So
the investment in bringing those vaccines all the way to the finish
line was not made. So the work was promising but incomplete, and
certainly, we do not have a SARS vaccine in the freezer today. But
I think we all recognize that——
Chairman JOHNSON. Is it because we stopped working on it, or
is it because there is just something inherent in that virus that
makes it very difficult to produce a vaccine?
Dr. GERBERDING. I think it is because the work was not com-
pleted.
Chairman JOHNSON. OK. Good. That makes me feel better as op-
posed to something inherent.
Dr. Gottlieb, do you have an explanation of why these precursors
are only made in China? From my standpoint, again, a former
manufacturer, where there is a very labor-intensive product, I can
understand that. I would not think producing precursors for drugs
would be very labor-intensive as a result of a fit for a low cost-labor
country like China. Why do not we maintain that here?
Dr. GOTTLIEB. A lot of the API and the chemical precursors are
manufactured outside the United States because the two biggest
components in terms of the cost of production are the labor inputs,
No. 1, and the second biggest component is the energy inputs to
producing API.
But it does beg the question with low-cost energy available in the
United States. You might be better off putting one of these facili-
ties next to a shale plant in Texas.
I think that there is an opportunity to try to re-domesticate more
of this manufacturing here in the United States as the labor inputs
start to diminish with different kinds of manufacturing approaches,
and that is why Congress appropriated significant resources to the
1 The chart referenced by Dr. Gerberding appears in the Appendix on page 57.
14
Food and Drug Administration the last couple of years to try to in-
vest in converting more of the industry to continuous manufac-
turing platforms on a premise that those are high-tech, low-labor,
high-energy input platforms are the kind of thing you might want
to locate in downtown Boston as opposed to Mumbai, India. So,
with that kind of a platform, I think we could see more manufac-
turing come back to the United States.
Chairman JOHNSON. As a manufacturer myself supplying to the
medical field, our International Organization Standardization (ISO)
certification is always what is your backup. What happens if some-
thing happens to your plant? Where can we get the supplies? It is
actually quite shocking to me that we have allowed this to occur
just within our manufacturing base and ISO certification, much
less would a potential solution to this be with an FDA approval on
a drug so that people prove that there are multiple suppliers for
the precursors?
Dr. GOTTLIEB. We do that right now for certain products. So if
you have a critical product where we could not sustain, from a pub-
lic health standpoint, a supply disruption, the agency requires risk
mitigation plans so that manufacturers have to identify what the
alternative supply would be and try to maintain some supply.
There are companies that literally have redundant facilities
mothballed, able to be stood up to supply certain critical products.
Nitric oxide gas is an example.
So you could expand those risk management plans to encompass
more components of the supply chain and identification of these
critical chokepoints. The manufacturers might not have full insight
into it as well. They might not know that there is a sole-source
supplier, but they could ferret out that information. The agency
working with them can identify more of these chokepoints.
Chairman JOHNSON. I know part of the whole anti-vaccine move-
ment, I think they had an effect in terms of how many vaccine
manufacturers are in the United States, just the whole litigious so-
ciety we have. Is that also a factor here, or is that not a factor?
Dr. GOTTLIEB. We made a concerted effort from a public health
and national security standpoint to try to create domestic manufac-
turing capacity for vaccines and create some redundant capacity in
the United States, including our National Strategic Chicken Stock-
pile for the production of influenza vaccine. So we have tried to
convert more of that industry to sell base manufacturing platforms
and actually invested in building up some of those platforms here
in the United States, and Dr. Gerberding was instrumental in some
of those efforts.
It has fallen off the radar in recent years. I think there has not
been as much emphasis in trying to get those kinds of facilities into
the United States.
I will just close by saying this is really critical because in the set-
ting of a pandemic flu where a lot of these vaccines are manufac-
tured ex-United States, the rational behavior of another country is
going to be to make sure that they can supply their local popu-
lation before they fulfill contracts to the United States.
Chairman JOHNSON. This ought to be a huge wake-up call for our
country in terms of having those manufacturing capabilities here
in America. So I hope we heed it. Senator Peters.
15
Senator PETERS. Thank you, Mr. Chairman.
We, the minority side, did a report on drug shortages that came
out just at the end of last year, and in hospitals that we have
talked to, it was interesting. One hospital, when we were talking
about the report in Michigan, would say every week, they have to
get together and determine which drugs will be in shortage this
week that they will not be able to get in an American hospital, top-
flight American hospital.
If they have those shortages and folks need the medicines, then
they will go to a more expensive medicine that is not available in
a low-cost generic, for example, and yet a questionable increase of
clinical benefit but costs a whole lot more money. There is a signifi-
cant problem, particularly with some of the drugs, as you men-
tioned, Dr. Gottlieb, dealing with anti-infection, things that are
mass-produced and generic.
Looked at it from a supply chain, your point too, Mr. Chairman,
is that what we have in this country is that we have manufac-
turing capability for the very high-priced drugs on patents that are
obviously making a lot of money for the drug company, so that is
manufactured here, but then as they go off into the generic world,
then it gets really competitive. It gets more and more competitive,
and then that all gets offshored. We have very low-cost drugs that
do not make a whole lot of money for anybody, and those are the
ones that tend to be in a shortage situation.
It is almost like a barbell. We have very high-priced drugs and
we have extremely low-priced drugs and nothing in the middle, and
a lot of those low-priced drugs are related to the 80 percent of the
precursors that underlie so much of the necessary medicines but
may not be very expensive because they are not the ones on patent
right now.
So how do we deal with that? To Dr. Gottlieb, some of this deals
with the government actually getting information. I think you men-
tioned this in your opening as to the supply of these drugs, the
sources. We just do not have a good handle on that. I think there
is a dearth of information that we are getting as to where these
shortages could occur and where those chokepoints are. Is that ac-
curate, and do you have some ideas on how we could fix that?
Dr. GOTTLIEB. I think that is right, Senator. I think getting bet-
ter information about where some of these critical junctures are is
important, but it is only going to be sufficient if we can try to cou-
ple with some incentives to get manufacturing back into these
spaces and get redundant manufacturing because we are not going
to be able to mandate a solution here.
The problem, I always said that there is a lot of drugs that cost
too much, and I think we would agree on that. There are some
drugs that cost too little, and with a lot of these sterile, parenteral,
meaning injectable generic drugs—and that is really the category
that goes in and out of shortages, these sterile injectable drugs.
We have driven down reimbursement to levels where they sit.
The reimbursement levels sit at slightly above cost of goods. That
is OK if you are developing a small molecule-pill drug, where the
manufacturing complexity is relatively straightforward, but when
you are dealing with a complex drug like a sterile injectable drug,
where you want there to be constant investments in upgrading
16
manufacturing, making sure the products are subject to stringent
Good Manufacturing Practices (GMP) requirements, and you are
allowing a margin that is slightly above cost of goods, it is hard to
get the kinds of investments in manufacturing that you need.
So what you have seen in these industries is you have seen con-
solidation because the reimbursement is small. So the way you
make up for the margin is you produce at very big scale. So you
have a handful of consolidated manufacturers that have been
underinvesting in their manufacturing over time. So when some-
thing goes wrong and a facility shuts down, you can create a short-
age from a single facility shutdown.
I think we need to think about how to identify these chokepoints,
how to identify where things can go awry, and then thinking about
how to change reimbursement schemes to drive incentives back
into these markets to make it profitable to develop these drugs.
We are getting a lot of these drugs at very low prices. That is
very good for consumers until there is a shortage.
Senator PETERS. Right.
It is not just the drugs. It is also medical supplies. I think, Ms.
Clowers, you mentioned that as well, the broad suite of products
that you need like masks and gloves that are necessary.
In fact, I understand the third largest import from China to the
United States are medical supplies and drug-related issues.
Given what is happening in China, there is going to be a pretty
big disruption, potentially, in that supply chain, as that is where
we get most of these supplies. So we could see shortages in things
like masks and gloves.
Do any of the panelists want to comment on concerns that we
may have related to what is happening in China for the supply
chain?
Dr. GOTTLIEB. I will just broaden that out quickly, and Dr.
Gerberding could speak to this too, because we have stockpiled a
lot of personal protective equipment in the Strategic Stockpile for
precisely these kinds of challenges.
I think where we are likely to see some potential challenges
going forward, if the supply does not get online in China, is that
a lot of components of complex medical devices are also manufac-
tured in China. So the implantable defibrillator might not be made
in China, but key components are sole-sourced in China.
When you look at a lot of the manufacturers, they have any-
where from a 1- to-month inventory on hand, including the drug
manufacturers. I think if this extends—we are now a month into
this a little bit longer where manufacturing has been shut down.
If this extends in China another month or two, I think we are
going to start to see some shortages of critical components, not just
the personal protective equipment, but also sophisticated elec-
tronics that go into medical devices.
Ms. CLOWERS. I was also going to mention the stockpile, and that
is one of the issues where Congress can play a role was as con-
tinuing oversight in terms of the agency’s management of the
stockpile before outbreaks occur during the sort of normal times, if
you will, in terms of are we stockpiling the right type of equipment.
I would also want to add on to the complexity job that FDA has
in overseeing the manufacturing throughout the world. The inspec-
17
tion regime was really set up as a domestic inspection process.
Over the last 20 years, as manufacturing of drugs and devices have
moved offshore, it stretched their capabilities. Right now, I think
it is estimated there is about 400 drug manufacturers in China. So
you can see where this could have the tentacles of this type of out-
break, not only the equipment that you need to handle the current
outbreak, the medicines for other types of chronic diseases or just
your generic drugs that you take, what type of impacts when work-
ers stop going to the factories to work. How will that impact the
delivery of those drugs?
Dr. GERBERDING. I was just going to add that the shortage that
concerns me the most is the antibiotic issue, both just in terms of
supplying the drugs that we might need, but also because when
people have a coronavirus infection, are in the hospital, they are
very prone to develop additional drug-resistant bacterial infections
on top of it. We do not have the right antibiotics to treat those in-
fections because we have a different kind of market failure there,
an inability to pay for those drugs and incentivize manufacturers
to create them.
Merck is one of the few companies that has an antibiotic pipe-
line, and we really struggle to maintain a prudent resistance
model. We have watched lots of small companies go out of business
just in the last year because they cannot get the reimbursement for
the innovation.
In this context, that is a really important part of the coronavirus
response because often with influenza that is what people die of,
the bacterial infections that complicate the underlying disease.
Senator PETERS. I appreciate that. Thank you.
I just want a quick follow-up. I am out of time, so be quick, Ms.
Clowers. You mentioned the foreign inspections and the foreign
manufacturing. The FDA has approximately 188 inspectors. Only
12 are dedicated to foreign inspections is my understanding, and
with our dependence on drugs, that seems to be a pretty low level.
Ms. CLOWERS. I think that is in reference to the foreign cadre.
There is also domestic inspectors that can play a role in the inspec-
tion process, but in general, the number of inspectors have de-
clined. As a result, we have seen the ability of FDA to maintain
a number of inspections globally decrease in recent years, and we
have ongoing work looking at those issues in terms of FDA’s capac-
ity as well as the other challenges that they face conducting inspec-
tions overseas, whether it is the need of translators when they go
onsite, to being able to find the firms.
We have seen instances where they go out to inspect, and they
show up to a facility. The facility does not exist.
We also have situations in most foreign inspections—it is
preannounced. So the firm gets about 3 months’ notice or more that
FDA is coming to visit, and so you can imagine what type of,
maybe, cleanup goes on during those 3 months. That is different
from domestic inspections where FDA could show up unannounced
that day for an inspection.
Senator PETERS. Thank you. Appreciate it.
Dr. GOTTLIEB. May I comment briefly?
Chairman JOHNSON. Yes, go ahead.
18
Dr. GOTTLIEB. The challenge, the witness is right that a lot of
foreign inspections are conducted by domestic inspectors who will
rotate into foreign inspection roles or inspect foreign facilities.
It was a challenge to recruit and retain people specifically into
this foreign inspection post, and so that is something that we need
to address. Filling those jobs was difficult.
We are also facing a situation now where the inspectors largely
have been pulled out of China, and so we need to think about from
a risk management standpoint how do we now ensure the safety
of American consumers from products that are coming in from
China if inspectors are not on the ground.
So it might require us to rethink import sampling and rely on
that more, even though it is imperfect relative to inspections, or
changing the risk management plan that the agency adopts in
terms of how it targets its oversight and focus more resources on
products coming from China, given the fact that inspections are
now being pulled out of that market.
Senator PETERS. Thank you.
Chairman JOHNSON. I think this would be a good time for me to
repeat my plea to my colleagues. We ought to take the Hippocratic
Oath. First, do no harm. Again, I pointed out the statistic, but as
best as I can determine, out of a $3.7 trillion spend on health care,
it is about $500 billion on drugs. Even at a 20 percent after-tax
rate of return, which is massive, that is only $100 billion out of 3.7.
So on a bipartisan basis, we beat up on the drug companies, and
no doubt, there are some abuses and they need to be addressed.
Let us put it in perspective and understand the situation like
this. We need pharmaceutical companies to be successful. We need
to encourage manufacturing here in the United States. I mean,
things like heparin are in shortage. It is ridiculous. Because we
have driven any profit motivation, we have made it very risky to
manufacture because the risks are high of litigation. So we need
to really recognize the root cause of this.
But I will get off my soapbox and go to Senator Hassan. She can
get on hers.
OPENING STATEMENT OF SENATOR HASSAN
Senator HASSAN. I am trying to think of which soapbox to get on,
but thank you, Mr. Chair and ranking Member, for convening us
all. Thank you to all the witnesses for sharing your expertise and
your time with us today.
Dr. Gerberding, I wanted to start with a question to you and,
first of all, just thank you for many years of service to our country.
Reflecting on your experience leading a number of public health
agencies, I would like to hear how you think we are doing this time
with respect to the coronavirus. Do you believe that the Centers for
Disease Control and Prevention have sufficient staff and adequate,
flexible staffing policies to manage a public health emergency of
this scale or larger?
Dr. GERBERDING. Thank you for that question. I am watching
from afar. I am not in the CDC Operations Center——
Senator HASSAN. Right.
19
Dr. GERBERDING [continuing]. I do not have insight into what is
going on, on a day-to-day basis, but I have to say it makes me real-
ly proud of the CDC to see what they have been able to do so far.
I think their communication is regularized. They are getting in-
formation out. They are working very closely with the State and
local health departments by building out that whole front line.
So in terms of performance in this context, I think they have a
lot to be proud of.
In the broader view, I do feel like the CDC has suffered from
what I refer to as the ‘‘herky-jerky funding.’’
Senator HASSAN. Yes.
Dr. GERBERDING. A problem occurs. A budget emerges on an
emergency supplemental basis. When that emergency is gone, then
that money is repurposed. That is not the way to maintain a con-
tinuous process of improvement in our overall preparedness, and it
is not just about the CDC. That spills over into every State and
city.
Senator HASSAN. Yes.
Dr. GERBERDING. I urge very close examination of the sustain-
ability of the effort, moving away from reactionary funding to
something that creates a more solid and allows this kind of pre-
paredness to continuously evolve over time.
Senator HASSAN. Yes. It is a good reminder that you need to in-
vest in the things that you hope you never need.
Dr. GERBERDING. Exactly.
Senator HASSAN. But you need to be ready for them, and that is
something that I think we struggle with.
I wanted to follow up on that. As I understand it, the United
States was somewhat slow to confirm potential cases of the
coronavirus largely due to logistical challenges dealing with sample
testing. What we were told in a couple of briefings we have had
now is, specifically, the delay results from hospitals and doctors’ of-
fices having to ship—and State health departments having to ship
patient samples to the CDC to be tested instead of being able to
send them to local public health labs.
So now that the CDC has developed a portable diagnostic test,
are there public-private partnerships that we could leverage in
order to scale up the production and distribution of those tests, if
necessary, so CDC can direct its focus to ongoing response efforts
as the situation evolves?
Dr. Gerberding and then, Dr. Gottlieb, if you would like to follow
on.
Dr. GERBERDING. So when there is a new infection of any sort,
it does take a little bit of time to develop a test and perfect it, and
then you have to prove its sensitivity and specificity in its actual
performance before it can be released.
FDA has created provisions so that unlicensed tests can be made
available to public health labs, but there are a number of quality
steps that have to go on. So it does not happen as fast as I think
people would have liked.
I too saw some of the reports of 36 hours to rule in or rule out
infection. So it is a problem.
I think the private-public partnerships ultimately do occur.
Senator HASSAN. Yes.
20
Dr. GERBERDING. That is the natural history of how these tests
evolve, but in the early days, I think the most important thing is
to just get the reagents made and get them out to the public health
lab network where people are familiar with using the Polymerase
Chain Reaction (PCR) tests, et cetera, and just deal with the crisis
and then move into a more stable manufacturing platform.
Senator HASSAN. OK. Dr. Gottlieb.
Dr. GOTTLIEB. So CDC made in very efficient time—and it is a
real testament to the efforts of the CDC and FDA—200 test kits
available to the Laboratory Response Network. Each test kit can
test between 700 and 800 samples. If you assume that on a typical
patient, you are going to be sending off multiple samples, you can
still test for upwards of maybe 50,000 patients with the tests that
have been made available.
Those are just now being put in place. There was a press release
yesterday from the Public Health Department in Illinois that they
just stood up that test, and so we are just beginning to get testing
capacity in place.
I think two things need to happen. One, we need to broaden the
criteria of who gets tested. Right now, the criteria requires that
you are either a recent traveler from China or have been in touch
with someone who has traveled to China or been in touch with
someone who has been diagnosed with a disease. We really should
be trying to test anyone who presents with an atypical severe
pneumonia that tests negative for the flu, negative for the multi-
plex test that currently tests for different viral forms of pneumonia.
We should be looking for coronavirus. We should be trying to find
it in the community. That is how we are going to spot small out-
breaks and prevent them from becoming larger outbreaks.
The other thing that we need to try to develop in efficient fashion
is a point-in-care diagnostic, like we have for the flu, something
that does not require a reference lab but can either be done in
Quest Lab or some other kind of reference lab or perhaps can be
done as a screening tool more at the point of care.
So you think of a company called Cefheid. It has a platform
called GeneXpert that they use to test for all kinds of things, in-
cluding it was, I think, adapted for Ebola as well.
One of these sort of point-of-care platforms to get these tests into
the hands of physicians is to broaden screen. That is how we are
going to identify an outbreak in this country quickly.
Senator HASSAN. OK. Thank you.
Dr. Gottlieb, I wanted to follow up with you too on asking you
to elaborate a bit on the role that the FDA plays during a public
health emergency. Can you describe the FDA’s process for allowing
the use of unapproved medical devices and treatments during
emergencies, known as the Emergency Use Authorization (EUA),
and why is it important in a public health emergency?
Dr. GOTTLIEB. I am going to ask my former FDA colleague, Dr.
Borio, to comment on this as well.
Senator HASSAN. Sure.
Dr. GOTTLIEB. She headed up this program at FDA for the agen-
cy.
The agency has now issued an EUA, for the diagnostic tests.
That is how they were able to get it out. So it allows the agency
21
to bypass some of the traditional steps that would have to be done
that would extend the development timeline.
The flip side of that, though, is that at least with the diagnostics,
there might have been companies capable of promulgating these
tests as laboratory-developed tests inside their own reference lab-
oratories because the technology for doing this is not that complex.
But now that the EUA has been issued, companies are unable to
promulgate laboratory-developed tests. Now they affirmatively
need to come into the agency to ask for permission to put those
tests into the market.
Dr. BORIO. Thank you, Dr. Gottlieb.
I will say that the agency, when I was there—and my under-
standing, it is still the case—they are very proactive in a public
health emergency with reviewing things in real time as data are
received, and they are very proactive in communicating to devel-
opers what is it that is expected. It really is a very streamlined val-
idation process because there is an urgency of getting tests out
there.
It is, however, important to have a certain comfort with the vali-
dation before these tests are being used because we do not want
to be in a situation like we are seeing in China, for example, where
there is a little bit of a concern about whether the results are actu-
ally accurate.
So even though these tests are very routine and routinely used
everywhere, they still require some training and some validation.
Last, I will just say that I cannot stress enough the importance
of moving forward having a point-of-care diagnostic test. We should
not be relying on a send-out test in a public health emergency. It
is not the way—anything that changes the way physicians or clini-
cians are practicing with their patients makes the response less ef-
ficient, and the technology exists today. But these tests have had
a very hard time in coming into the market because of the more
systemic issues that we discussed earlier.
Senator HASSAN. All right. Thank you very much.
Thank you, Mr. Chair.
Chairman JOHNSON. So just for my colleagues here, there will be
some votes being called. They are stacked. By the way, we are
under discussion about sitting at our desks on these stacked votes
to make it more efficient. Hopefully, we can get that accomplished.
I am going to stay here. Apparently, my vote is not going to be
necessary. So I am going to keep the hearing going. All I am going
to ask of my colleagues, if you are going to go and if you are going
to come back, let me know, and we will try and keep it going for
you. But if you are going to leave for good, let us know that as well.
Senator Carper.
OPENING STATEMENT OF SENATOR CARPER
Senator CARPER. Thanks, Mr. Chairman.
I want to thank all of you, not just for coming here, not just for
your testimony, not just for responding to us, but some of you, we
know pretty well, and it is good to see you. For those who are here
for their first time, welcome. Thank you for what you do with our
lives, and thank you for what you do when you try to preserve a
life here in this country and maybe around the world.
22
My colleagues heard me tell this story before, but when I was a
brand-new Governor-elect, I remember meeting with a bunch of
people who were giving me advice before I raised my right hand
and took that oath of office. One very wise, old Methodist minister
from southern Delaware once said to me these words. He said,
‘‘Tom, just remember the main thing is to keep the main thing, the
main thing.’’ I said, ‘‘Would you say that again?’’ He said, ‘‘The
main thing is to keep the main thing, the main thing.’’
We are covering a lot here. We are an oversight committee. We
have oversight of the whole Federal Government. There is a lot in
our bailiwick, but try to help us narrow down our responsibilities
here on the oversight committee, the Homeland Security Com-
mittee, what we should be focusing on as we go into this.
Nikki, would you just lead us off? Because we work a lot with
GAO, as you know, and we are grateful for what your agency does.
Ms. CLOWERS. Thank you, Senator.
Senator CARPER. Just be succinct.
Ms. CLOWERS. Yes, sir.
To pick up the focus on the main thing, one of the things I would
stress is that we do not lose sight of tomorrow. Responding to the
coronavirus today is very important, but there is other public
health threats. We cannot get in a cycle which we sometimes find
ourselves in as chasing Disease X, what is going on this month,
and we lose sight of the routine preparedness that needs to occur,
the funding of the routine preparedness, what you would consider
routine. When we lose sight of that, then we get in this sort of
never-ending cycle of chasing.
Senator CARPER. OK.
Ms. CLOWERS. The other thing I would mention, as we have al-
ready discussed, is the reliance on manufacturing overseas, and so
I will not go into depth on that.
The other thing I would stress is just the important role that you
play as a committee in providing oversight to the agencies, both be-
fore, during, and after an outbreak. The before, making sure that
they are preparing, that they have the plans in place, that they
know the roles and responsibilities. After, are they conducting
after-action reports? We found that often after an outbreak occurs,
it does down, people want to walk away. After-action reports are
not completed. If they are, they are delayed or they do not include
all of the participants, and we are missing an opportunity to learn.
Then the last thing I would say is just what we have been talk-
ing about as well. There is a Federal role to play in terms of cre-
ating a market for countermeasure development. What kind of in-
centives can we put in place to draw manufacturers to develop
needed countermeasures?
Senator CARPER. Thank you. Thanks so much.
Dr. Gerberding. Very succinct, please, the main thing.
Dr. GERBERDING. Right now in the United States, I think the
main thing is to exercise how we will sustain essential services if
we begin to see sustained transmission in our communities, essen-
tial services meaning health care, of course, but also all of the
other Homeland Security services necessary to keep our society
operational, our supply chains running, and civility among our citi-
zens.
23
We have seen in previous outbreaks, for example with SARs,
what happens in a community when those services are disrupted,
and now is the time to exercise and make sure that we have a plan
in place to do that, if this does become worse.
Senator CARPER. Thank you.
Dr. Gottlieb, good to see you. Thank you. The main thing, please,
just succinctly.
Dr. GERBERDING. Modeling has shown that the time from first in-
troduction in China, which was probably in November, to epidemic
spread was about 10 weeks, if you think that cases were introduced
into the United States undetected late December or early January,
which is probably the case. Statistically, it is quite probable. We
are going to start to see those outbreaks emerge sometime in the
next 2 to 4 weeks.
I think that we should be leaning in very aggressively to try to
broaden diagnostic screening right now, particularly in commu-
nities where there was a lot of immigration, where these outbreaks
could emerge, to identify them early enough that they will be small
enough that we can intervene to prevent more epidemic spread in
this country.
Senator CARPER. Thanks so much.
Dr. Borio, same question. What is the main thing?
Dr. BORIO. I think we need to assume that we are going to see
a lot more cases here, and I really worry about the health care sys-
tem preparedness and ability to take care of patients, and I think
we cannot afford to lose a minute in getting this health care system
as ready as we can before the influx of patients arrive.
Senator CARPER. All right. Thanks. Dr. George.
Dr. GEORGE. Senator, I think that the Committee should be look-
ing at what all of the Departments are doing right now to address
coronavirus, not just for employee safety, but in terms of all of
their responsibilities.
All of the Cabinet Departments and many independent agencies
have responsibilities for biodefense, and those should carry forward
now. We should not be waiting around. They should not be waiting
around until things get much worse to lean forward, dust off their
plans, and do what they need to, even if it means that they have
to stand back down because things did not get as bad as they
could.
Senator CARPER. OK. Thanks.
Who is the lead agency responsible for coordinating the develop-
ment of a vaccine in a pandemic? I do not care who takes that one.
Who is the lead agency responsible for coordinating the develop-
ment of a vaccine in a pandemic? Who would like to take that? Just
very briefly.
Dr. GERBERDING. NIH.
Senator CARPER. OK. That was pretty brief. Can you be more
brief? [Laughter.]
What lessons did U.S. agencies and our foreign counterparts
learn from formulating vaccines and treatments for SARS, for
Ebola, and other global health threats?
Dr. GERBERDING. I can take the question from the perspective of
Ebola because I work for the company that has the licensed Ebola
24
vaccine that is currently being used in the Democratic Republic of
the Congo (DRC).
I think the biggest lesson overall was the incredible number of
partnerships that have to emerge rapidly and effectively to bring
a product rapidly through clinical testing for safety. All of the
kinds of permits that have to happen to move it cross-borders, et
cetera, amazing requirement for all kinds of agencies of govern-
ment and civil society, and that is just getting it into the clinical
development.
Once we want to get it into the country to actually use it, it
brings up a whole other round, including the importance of the
front-line health workers.
Senator CARPER. Last, one quick one. Can the reported 12- to
month timeline for developing vaccines and treatments be short-
ened safely and effectively? That could be either a yes or no, and
if it is a yes, then how? Just very briefly.
Dr. GOTTLIEB. You are the expert.
Dr. GERBERDING. I think the Ebola virus vaccine development
proved that work that started in Canada right after the turn of the
century, 13 years before Ebola emerged, really was required to get
us to the point where from that point forward, we could sprint.
Now we have a new entity called the Coalition for Epidemic Pre-
paredness (CEP) Innovation, which is a private-public partnership
funded by countries, by Gates, by Wellcome, by others, civil soci-
eties, that is investing building products and vaccines through
phase IIB so that they are in the freezer when one of these fright-
ening pathogens does emerge. That will speed up our ability to act
quickly.
Dr. GOTTLIEB. I will just add briefly, doing a clinical develop-
ment, clinical trial in a setting of an outbreak of a deadly pathogen
is exceedingly difficult, and that is something that we could be
planning for right now. How are we going to construct clinical
trials of products that we want to test?
They are standing up a randomized trial of an antiviral drug in
China right now that was stood up very quickly. The question is,
Are we going to be able to gather information from that that could
inform a regulatory decision here in the United States if we ulti-
mately want to license that product for this disease?
So thinking through how to stand up that infrastructure and get
that in place in a setting of a public health crisis can greatly has-
ten the development timeline, and that is what we were able to do
with the Ebola vaccine, where we were able to stand up a random-
ized trial in Western Africa to turn over the data caught on that
product very quickly.
Senator CARPER. Thanks to all of you. Thank you so much.
Chairman JOHNSON. Senator Scott.
OPENING STATEMENT OF SENATOR SCOTT
Senator SCOTT. First of all, thanks to each of you for what you
have done in your prior jobs and what you are doing now.
There have been reports that the coronavirus may live up to 9
days on a surface. I have the call in to the CDC to get their feed-
back, but do you have any views on that and whether that is pos-
sible?
25
Dr. GERBERDING. That is relevant in case contaminated objects
prove to be a source of transmission, which would be highly un-
likely and not an epidemiologic factor in most cases of respiratory
virus transmission.
You have to distinguish between finding the virus, meaning
maybe there is deoxyribonucleic acid (DNA) there, dead or alive,
versus the virus is alive and present in sufficient quantities to be
infectious. Those are two very different things. I personally am not
focused on environmental contamination as a source of this. I think
it is much more likely to be droplet and potentially aerosols, and
that is kind of what we are seeing on the ship in the Japanese har-
bor.
Senator SCOTT. Anybody else? Anybody else have a different
view?
Dr. GOTTLIEB. The data with coronavirus shows typically that it
is probably a couple hours where you can get transmission from
what we call ‘‘fomites,’’ which is a contaminated surface, touching
it and then touching your face.
There have been some studies that have looked at transfer of the
virus under really ideal circumstances that are unlikely to exist in
nature that shows that it could be several days.
I think for most purposes, we should assume that the virus has
the capacity to live on a surface for a couple of hours. So you could
get transfer from what we call a ‘‘fomite.’’
That is why I think one of the roots of transmission that we
should be very concerned about is touching. It is not necessarily
wearing face masks that is going to provide the best protection for
individuals. It is going to be washing your hands and using an al-
cohol sanitizer appropriately.
Senator SCOTT. So we import quite a few things from China: ag
products, food products, processed food, seafood, grains, even live
animals. Do you think we are doing all the right things with regard
to reviewing what comes in and deciding what should not be
coming in until we get more information about how this
coronavirus—the transmission of it?
Dr. GOTTLIEB. I think from a regulatory standpoint, Senator,
that my focus would not necessarily be on the virus cross-contami-
nating inanimate object and coming in. So a ship package, I would
have a very low level of concern around that as a route of trans-
mission.
I think the bigger concern right now with respect to the imports
coming in from China is just the lack of oversight of manufac-
turing. We pulled out our own inspectors from the country. You
have to believe that their regulatory apparatus is stretched right
now and not providing the same level of oversight, and I think it
does behoove us to think of how we are going to backstop that with
other kinds of approaches like greater import sampling. It is not
an perfect substitute for having inspectors on the ground, but it is
a substitute. We need to think about how we adapt the regulatory
process and take a different risk-based approach to looking at some
of these products that are still coming in that consumers here in
the United States still need.
Senator SCOTT. Those inspectors, what agencies have inspectors
over there?
26
Dr. GOTTLIEB. I know FDA does. I am sure other agencies as well
have inspectors in China but not necessarily looking over FDA-reg-
ulated products.
As best I know, based on the public reporting, the U.S. FDA in-
spectors were recalled from the country based on the new travel
guides from the State Department, and so we do not have them on
the ground.
Senator SCOTT. Taiwan is not allowed, I guess, to be a member
of the World Health Organization (WHO). By Communist China
not allowing Taiwan to be a member, how has that impacted their
ability to defend themselves against coronavirus, which they are a
lot closer to it than we are?
Dr. GOTTLIEB. Taiwan has not been part of the working groups
of the WHO. It has been a question for our Ambassador, Andrew
Bremberg, over there, but I think it is highly unfortunate that
China has continued to try to assert their political prerogatives in
a setting of this crisis in terms of how they treated Taiwan.
So a lot of people have asked me why do not we receive reporting
from Taiwan. It is because the Chinese are baking the Taiwanese
numbers into their own estimates because they do not see it as an
independent nation. So that has certainly been unfortunate. We
can add to a long list of things I think the Chinese government has
done here that has made our response more difficult, probably the
most significant of which was not admitting that there was human-
to-human transmission until January 20 on the same day that they
disclosed that they had 14 health care workers that were infected.
Senator SCOTT. How comfortable are you with the numbers that
are coming out of China? You read reports that they are signifi-
cantly underreporting the number of cases, and there is a lot of
anecdotes that the number of deaths are way, way, way higher. Do
you have any feel for that?
Dr. GOTTLIEB. I will turn to Dr. Gerberding as well.
I do not trust the reporting in China, and I also believe that the
China numbers reflect the most severe cases. So we are getting a
skewed view of the case fatality rate and how severe this is.
I suspect that if you were able to bake in all the mild to mod-
erate cases or asymptomatic cases, the case fatality rate would go
down. It could still be quite high. I mean, even a case fatality rate
of .2 or .5 could be catastrophic if this is highly contagious and
spreads around the world.
But I almost believe that the issues of the reporting from China
are not as relevant right now to how we perceive this epidemic and
potential pandemic because we now have experience in Singapore,
Japan, Hong Kong that is going to tell us a lot more about how this
virus is going to spread around the world.
We now know this is epidemic in China, and whether it con-
tinues to grow or does not, that is not going to affect as much
whether or not this becomes pandemic as what is happening in
those other nations right now where the cases have already been
exported.
I will say, though, if China does take the brakes off of some of
the measures that they have taken—and they seem to be making
some noises about that because they are worried about the eco-
27
nomic impact—that could hasten the rate at which more cases get
exported out of China.
Senator SCOTT. Thank you.
Chairman JOHNSON. Senator Harris.
OPENING STATEMENT OF SENATOR HARRIS
Senator HARRIS. Thank you, Mr. Chairman.
I want to thank the panel for being here. Your experience in past
public health emergencies and crises is exceptional and I think im-
portant to understanding how we should respond to the
coronavirus virus.
However, the American people also, Mr. Chairman, need to hear
from the officials who are currently responsible for addressing this,
and we need a public hearing with current government officials as
soon as possible. It is critical to my State of California.
I have spoken with some of the current officials and asked them
why they are not here today, and they did not have a good re-
sponse for why they are not. In fact, they went on to say, ‘‘Well,
we have to take time to prepare talking points.’’ The American peo-
ple deserve them to be here this morning.
That being said, Dr. Gerberding, thank you for your service. The
coronavirus outbreak demonstrates, obviously, how important it is
that we respond and be prepared to respond to a public health
threat. Yet just this week, President Trump released the Fiscal
Year (FY) 2021 budget that cuts funding for the CDC and NIH,
which you have mentioned would be the first responder or most re-
sponsible for dealing with a pandemic, and so these are obviously
critical agencies that must response and need to respond to the
coronavirus.
So this is one in a long line of attacks on our country’s public
health system that we have seen over the past 3 years from trying
to repeal the Affordable Care Act (ACA), to restricting the way
science can inform government decisions, to slashing our invest-
ments in global health.
So my question to you, as a former CDC Director and especially
during the SARS epidemic, you must recognize, obviously, the im-
portance of a strong public health system to guard against infec-
tious disease threats. As Congress considers the next fiscal cycle,
what public health programs would you prioritize to ensure that
our country is prepared to address an outbreak, this outbreak, and
any future outbreaks?
Dr. GERBERDING. Thank you for your question. It is a question
that has been asked for many years, and it is frustrating to have
to answer it for many years.
I will put on my hat as the chair of the Center for Strategic and
International Studies commission because that is basically the
question we asked as well: Where should investments be made to
improve our global health security? I can share this with you.
Other Members of Congress have participated in its development.
But specifically with respect to the CDC, I think the whole sys-
tem of public health has been left behind as more and more of our
health resources have gone into care delivery, and we have under-
invested in prevention and preemptive care, including the pre-
paredness, to mention of that.
28
I also think that it is a small world, and we need to have a cadre
of people who are trained to be deployed to places like the DRC
when there is an outbreak there so that we can lend our expertise
and our competency in safe ways to be helpful at containment
when the problem is somewhere else.
The third issue really relates to what Dr. Gottlieb was dis-
cussing, and that has to do with our laboratory network. Across the
public health system, we depend on the Laboratory Response Net-
work in situations like this, and they have made dramatic steps
over the past 10 years or so. But there is much more to be done
there, and we have to keep up with the state of the science.
I totally agree with point-of-care diagnostics for emergencies. We
have a lot of work to do to really buildup the public health system,
and the great thing about it, it is not just sitting there idly waiting
for an outbreak. We can use it for ordinary care as well. So it has
a dual purpose, and I think those are investments that make sense.
Senator HARRIS. So to your point that you have made these rec-
ommendations before, to what do you attribute the lack of
progress?
Dr. GERBERDING. I think we have a general mindset that under-
values health promotion and prevention, and I include prepared-
ness in that dimension. When something happens, as a Nation, we
are very competent at making an emergency investment and step-
ping up in the crisis to get miraculous things accomplished, but we
do not sustain it. It is complacency crisis.
Senator HARRIS. But what you are describing goes to the very
core of the point of the public health model, which tells us preven-
tion——
Dr. GERBERDING. Promotion, preparedness.
Senator HARRIS. It is the smartest and cheapest way.
Dr. GERBERDING. Absolutely.
Senator HARRIS. Then if the sniffles take on, early intervention,
but if we are dealing with it in the emergency room, it is too late,
and it is too expensive.
So this is not a new concept, and I am just at a loss to under-
stand why we have not made progress, then.
Dr. GERBERDING. I would love to follow up with you in a deeper
conversation than that because it is a complicated cultural issue in
our country, but I think it also has to do with just generally the
tendency to have wishful thinking that a bad thing is not going to
happen.
Individuals do that when they smoke cigarettes or do things that
they know are bad for their health, but I think as a society, we
have a similar challenge.
Senator HARRIS. Can you talk with me, based on your experience
and your thoughts about how we can better, what is the system in
place? Because I am having a difficult time getting it, even when
I have talked to current government officials, about the system for
Federal funding and how it is distributed to State and local govern-
ments who in the current crisis, the coronavirus, and in past cir-
cumstances, it is not happening as it should. There seems to be a
distribution of responsibility but not a distribution of resources to
the State and local governments.
29
Dr. GERBERDING. I do not have any insight into how that is hap-
pening with the coronavirus situation. So I cannot respond in a
contemporaneous way.
Generally, the funding mechanism waits for emergency supple-
mental to come, and then it is distributed according to population
and other parameters across the public health system.
I do not think that is the optimal solution. I think we need to
have these systems and the support in place.
A major vulnerability, in my opinion, it gets back to what we
were discussing earlier, and that is that our health system has so
little surge capacity in it. Hospitals are not going to build that
without investment. We have to support hospital surge capability.
Senator HARRIS. Because in my State, for example, there are
large counties like Los Angeles and smaller counties like San Be-
nito that just simply do not have the resources that are necessary
to address the issue, and they are sitting there waiting for reim-
bursement, with no clear indication of when they are going to get
it and what will be reimbursed. Their work includes a number of
things, but all of the work is being done by local officials, not Fed-
eral officials.
Dr. GERBERDING. At the end of the day, it is the front line. I am
a licensed physician in your State and work at San Francisco Gen-
eral Hospital. So I am well aware of what you are talking about.
Senator HARRIS. Thank you for your work.
Ms. CLOWERS. Senator, may I add something about on the fund-
ing?
Senator HARRIS. Please.
Ms. CLOWERS. There are three core programs that fund State
and local activities, two of which are CDC. One is Administration
for Strategic Preparedness and Response (ASPR). We have looked
at the funding over time. From about 2003 to 2017, each year that
those programs in total, starting in 2003, awarded about $1.4 bil-
lion. It has decreased to about $1 billion now. So what we have
heard from State and local officials, they really do then rely on the
supplemental funding that is provided, and about that timeframe,
it has been $2.9 billion for Zika, Ebola, and other types of diseases.
The concerns with the supplemental funding, while it does en-
able the surge capacity that is needed, often the timing is off, and
so it is too late.
Senator HARRIS. Right
Ms. CLOWERS. The other mechanism that has been used is re-
programming, which we have heard the Secretary recently an-
nounce. Again, that gets the money out quick as needed, but again,
what we have heard from State and local officials is that that is
essentially robbing Peter to pay Paul. It takes money away from
the routine preparedness, and then it delays and disrupts the prep-
arations at that level.
Senator HARRIS. Thank you.
Thank you, Mr. Chairman.
Chairman JOHNSON. Senator Rosen.
OPENING STATEMENT OF SENATOR ROSEN
Senator ROSEN. Thank you, Mr. Chairman, and thank you for
being here today for the work that you have done.
30
I want to agree with you and Senator Harris that we need the
current administration here, not just to address today’s issue on
coronavirus, but our future preparedness and our readiness. It is
very important.
We talk a lot about our large population centers when we have
a potential pandemic like this one, but our community hospitals
and clinics, just like you alluded to, they are on the front lines, par-
ticularly those in our underserved urban areas and our remote and
rural areas.
Nevada, we have 300,000, about 10 percent of our population, liv-
ing in frontier and remote rural areas, and so we need guidance,
and we need staff that is well trained to have the right equipment
ahead of time.
So for Dr. Gerberding and Dr. Borio, what Federal investments—
where can we target these most effectively to ensure our local rural
providers have what they need to respond, not just to a large-scale
epidemic, but to mass casualty, a natural disaster? Those also have
an impact on public health and the system to respond.
Dr. GERBERDING. As we said a minute ago, the front line is local.
I do not think it is realistic for every health facility and every pro-
vider to be fully up to speed on every emerging infection that could
occur. So we have to think about a hub-and-spoke model.
What is most important for every provider is to have the ability
to be quickly updated if there is something new and emerging so
that a training system is in place, the information system can
quickly get information out to people, and they know what to do
when the first patient appears in the emergency room with a sus-
picious diagnosis or something that is suspicious for an emerging
infectious disease threat, and then that we have the capacity to get
advice and refer or transport the person to a facility that has the
more advanced infection control and care, just like we do for other
complex medical problems.
But the problem is reaching the front line in a reliable and sys-
tematic way, and that requires a system of ongoing education and
training that is incomplete, as you have pointed out.
I will let you talk a little bit about the medicine.
Dr. BORIO. I will just add that I agree that with the tiered ap-
proach, because that is probably most of complex medical delivery
occurs, anyway, right? So not every hospital can do the most com-
plex procedures.
But the funding has been approximately, ball park, $250 million
a year, and it is being filtered through State public health systems.
This funding is very necessary for planning purposes, but it is just
not sufficient to really achieve preparedness. We need to find a way
to go from planning to actual preparedness.
It is going to require more expectations, I think, on part of the
Federal Government coupled with resources to fulfill those expecta-
tions, but we cannot stress enough how important that prepared-
ness at the hospital level is.
Senator ROSEN. Do you think that we can potentiate using the
telemedicine capabilities between our urban hospitals that are very
well equipped to our rural providers that are out there? How do
you think that we could best put some funding into that mecha-
31
nism to be sure that out in smaller communities we have some of
those issues taken care of?
Dr. BORIO. It is clear that today’s system does not leverage the
most innovative technology that exists in the marketplace, and
telemedicine is—it is hard to imagine that we are going to achieve
the level of preparedness that we need to in the absence of explor-
ing more of those technologies that include telemedicine and tele-
health.
We see some progress in that regard, some increase in uptake in
the medical care system, but a lot more could be done to leverage
those technologies for preparedness.
Senator ROSEN. So I think that needs to be part of the funding
stream perhaps as well?
Dr. BORIO. Absolutely.
Senator ROSEN. Thank you. I yield back.
Dr. GERBERDING. Could I just add one thing? Because when we
are having this conversation about how do we build a cascade of
preparedness, I want to go back in time to the efforts that were
made when I was still at the CDC. Secretary Mike Levitt at the
Department took on the issue of pandemic preparedness, heart and
soul.
We went to every Cabinet Secretary in government and sat with
the book about the 1918 pandemic, outlined sections of it that were
relevant, and had conversations about what their Cabinet could be
responsible for and contribute.
Secretary Levitt also took those of us in the Department who
were involved to every State in the Nation and met with the Gov-
ernor, the head of education, faith-based, you name it. The commu-
nity of experts assembled in every State and then had an exercise
about what they would need to do in their State, and in many
States, that exercise cascaded down into cities.
So it brought attention to exactly what you are talking about. It
is local, and if we do not build that preparedness into the system,
we have kind of lost the game.
Senator ROSEN. We need to bring FEMA into some of these con-
versations too as we talk about whether it is a mass casualty, a
natural disaster, a hurricane, an earthquake, something else that
can happen that could leave some of our communities unprepared
in the same way as for this. So maybe FEMA needs to come into
this conversation training as well.
Ms. CLOWERS. Absolutely. It will require all agencies at Federal,
State, and local, as well as the private sector, and that was one of
the reasons why we called for a National Biodefense Strategy,
which was issued in 2018, and for the first time does lay out a
process for enterprise-wide strategy that looks at all the threats in
an integrated way, because we cannot have the fragmentation both
of understanding, trying to collect information, and integrating in-
formation, prioritizing risk. That must be done in a strategic fash-
ion.
Senator ROSEN. Thank you.
Chairman JOHNSON. Senator Hawley.
OPENING STATEMENT OF SENATOR HAWLEY
Senator HAWLEY. Thank you, Mr. Chairman.
32
Thanks to all of you for being here.
I think a version of this question may have been asked, but I
would like to hear the answer with my own two ears. Ms. Clowers,
I will direct it to you, but anybody is welcome to answer.
When it comes to the number of cases that China is reporting,
what is our assessment of the accuracy of these reports, both in
terms of infections and deaths, and how do we rate these statistics
in terms of trustworthiness?
Ms. CLOWERS. I would agree with the other witnesses in terms
of we should look at those numbers with some questions in terms
of reliability of both the number of deaths as well as the reproduc-
tive index.
Senator HAWLEY. Go ahead, Doctor.
Dr. GERBERDING. I would say one could worry about obfuscation
of information, but I think more to the point, it is who is being test-
ed. If the asymptomatic or mildly ill people are not coming forward
or not being tested, then we are obviously missing the rest of the
iceberg.
Dr. GOTTLIEB. Yes. I think that is a critical point that we are
probably overestimating the case fatality rate right now because we
are only testing more significant illness, and it is probably the case
that a lot of people who have mild to moderate illness just are not
even presenting to the system anymore, now that they have locked
down the entire Hubei Province.
The issue right now, the questions that we need to grapple with
right now are it is clear this is epidemic throughout China. Is it
becoming epidemic in other parts of China? So the reporting in the
other provinces is important, what is happening in Beijing.
But even more important than that, it is going to be what is hap-
pening in Singapore, Japan, Hong Kong. Why do not we have any
cases in Malaysia? There has to be imported cases into Malaysia.
They are just not finding them. What is happening in Western Af-
rica? There has to be imported cases in to Africa, given all the con-
nections. What is happening here?
There is probably spread that we are just not detecting yet, and
I think that the situation in China, we are going to quickly have
learned as much as we are going to learn from China, and we are
going to start to focus our attention on these other regions what
is becoming epidemic or at least there is sustained community
transmission and where then reporting is a lot better, including
Singapore, which has done exquisite reporting on their cases.
Senator HAWLEY. What do we know about the rate of reported
infections in terms of the curve, the derivative curve, if you like?
Is it still bending up at a pretty fast pace?
Dr. GERBERDING. Right now, a true epi-curve, exactly what you
are asking for, has not really been created.
What we do see are the number of reported cases, but we do not
see the curve in terms of when they started. So that is the frustra-
tion that I have. I cannot be an epidemiologist without an epidemic
curve, but I think just kind of crudely looking at the numbers as
they have climbed up day to day, we are still on the upslope of the
curve for sure.
Senator HAWLEY. Go ahead, Dr. Borio.
33
Dr. BORIO. They may not have enough diagnostic test kids to test
everybody who may need to be tested. So we may see a certain
number reporting because that is all they could test for that day.
Dr. GOTTLIEB. Yes. The reports out of the Hubei Province a num-
ber of days ago was that they had the capacity to test 6,000 sam-
ples a day. So if you figure that there is at least a couple of sam-
ples per patient, their testing capacity was limited somewhere
around 3,000, which is why we got a week worth of reporting of
3,000 new cases, probably. I think that had something to do with
it.
Senator HAWLEY. Yes. Go ahead, Dr. George.
Dr. GEORGE. I would also add that we have a resource problem
now too. In China and possibly elsewhere, if you have a limited
number of diagnostic tests, you are not necessarily going to use
those to test the people that have already passed away.
So our understanding of the entire outbreak out in China is lim-
ited by the resources that they have as well. It is not just a lack
of desire on the part of the Chinese government to report.
Senator HAWLEY. Thank you. That is very helpful.
Just on the resources point and turning our focus here domesti-
cally to the United States, what measures are we taking, whether
it is masks, whether it is kits, whether it is other supplies that we
are going to need, if we were to see a significant uptick in cases
here? What measures are we taking to make sure that we are fully
and amply prepared?
Dr. GERBERDING. I think it is important to remember that we
have a Strategic National Stockpile, which is an enormous res-
ervoir of medical equipment, supplies, medicines, vaccines, et
cetera, strategically situated around our country. So that is our
first line of defense that would have to come into play if we were
experiencing a major surge in requirements.
The stockpile is not limitless, and as we have already heard, the
supply chains who are replenishing it will be very marginal at best.
So I do not think it is a solution, but it will definitely help us buy
some time.
Senator HAWLEY. Does anyone else have anything to add to that?
[No response.]
Can I just pursue with you, then, a worst-case scenario? Dr.
George, maybe I will direct this to you in the first instance, but
anybody is welcome to answer.
Based on what we are seeing in the region, in the Pacific re-
gion—Japan, South Korea, and all of East Asia—at the end of the
day, what are the worst-case scenarios that we face here domesti-
cally in the Continental United States based on what we know
now?
Dr. GEORGE. I think we have to look and see what is happening
in these other countries and assume the same thing is going to
happen here, especially when we do not understand exactly how
the disease is behaving and all of its characteristics. It is some-
thing that we can do here.
I think we have to learn some lessons from some previous out-
breaks as well. During H1N1, the government had assumed that
pandemic influenza would start somewhere else, and in fact, there
34
is debate as to whether it started in the United States or in Mexico
or both sort of at the same time. So we need to learn from those.
But I think it is also important for us to be looking at the new
cases and the clusters that we are seeing throughout the world in
places where we would not necessarily expect to see them. There
is a cluster in France now, for example, and I think that should
inform what we are doing here and what we are planning for.
I do not think we should be planning for the onesie-twosie cases
that we have been seeing thus far in the United States. I think we
have to plan for something larger.
Senator HAWLEY. When you say larger, you mean what poten-
tially?
Dr. GEORGE. I think that we have to plan for the possibility that
we have thousands of cases.
In the schools of public health, they often train us to look at the
data that you have been provided, and assume that you do not
have all the data. Even here in the United States, you do not have
a comprehensive set of data and then multiply. So we are often
taught to multiply by seven or eight times what you have been
told. For every one case you see, there are seven or eight out there
that you do not.
So that means, actually, we would be looking at hundreds of
thousands of cases. I think that is the scale at which we should be
planning.
Dr. GOTTLIEB. The strategy seems to be try the slow introduction
of the virus as much as possible to push off the time at which we
are going to start to see outbreaks in this country, hope that the
summer provides some kind of backstop, because you typically do
not see coronavirus transferring as efficiently in the summer, al-
though that does not seem to be the case here—it is 90 degrees in
Singapore right now—and hopefully buy yourself enough time to
get to a vaccine or some kind of therapeutic.
So that is not an unreasonable strategy right now, given what we
do not know and what we do not have, but it does behoove us to
think about how are we going to try to develop a technology that
could be a backstop here if this does become endemic, meaning this
becomes part of the normal mix of viruses that propagate, or we
start to see very large outbreaks in the United States that we do
not have sufficient capacity to contain and control.
Senator HAWLEY. Last question, Mr. Chairman.
Surely, this has been asked, but again, I will ask it, just since
you raised it, Dr. Gottlieb. Where are we in terms of a therapeutic
or an antiviral for this strain?
Dr. GOTTLIEB. I will just comment briefly, and Dr. Gerberding
has far more insight into this. There is one drug, remdesivir, that
has been in the media that is manufactured by a company called
Gilead that is currently in investigator-led studies in China.
There are two studies ongoing, one in mild and moderate pa-
tients, about 300 mild to moderate patients, and another study in
about 450 severe patients.
If you believe that part of what is killing people with coronavirus
might be an inflammatory response to the virus itself, there is a
question of whether or not simply intervening at the point when
someone becomes very ill to block further viral replication is going
35
to be beneficial at that point. It might actually do more harm by
killing a lot of virus that then causes, then sort of potentiates the
inflammatory response.
So there is a lot we do not know, and I do not think that we can
just sort of hang our hat on the idea that we are going to have an
effective antiviral here. It might be difficult.
Dr. GERBERDING. I would just add that this week, the WHO
hosted a meeting of all of the parties who are involved in drugs or
vaccine development for this entity and looked at what can be done
to accelerate and support.
There are mechanisms to get that ball started in January, very
fast in January, Coalition for Epidemic Preparedness Innovations
(CEPI), which is this private-public partnership that funds early
stage development work for pathogens that could cause pandemics.
They funded three companies just within weeks of recognizing that
this problem was emerging. So the work is getting off to a good
start.
NIH is obviously priming the pump here, but the reality is it
takes time. It is 2020. The work on the Ebola vaccine for the emer-
gency response in Africa took a couple of years to really wrap up
and get submitted to Federal agencies for approval, even though
there is an ongoing outbreak there. We did not get our final U.S.
license until December 2019.
So we have to be realistic about the timeline, even when pres-
sured with emergency situations.
Senator HAWLEY. Thank you very much.
Thank you, Mr. Chairman.
Chairman JOHNSON. Before I turn it over to Senator Peters, I
think this might be a good time to try and put these things into
perspective with facts because this is what I am trying to sort out.
You started out, Dr. Gottlieb, talking about contagion versus
virulence. In 2003, SARS had a little over 8,000 cases worldwide,
8 in the United States, had about a 10 percent death rate. In 2009,
we had H1N1. Again, in the public perception, everybody is scared.
You have SARS. You have H1N1. You had 200 million cases world-
wide, 60.8 million in the United States, and a lot of people died,
150- to 500,000 people. But that is kind of true of seasonal flu as
well, right? Then you had MERS in 2012, 2,500 cases worldwide,
2 in the United States, with a death rate of 34 percent. Ebola, a
virus different than kind of flu.
Now you have coronavirus. It is looking to me a little bit more
like H1N1, maybe more contagious, maybe not as virulent. Can you
just kind of put it into—I know we do not know much about this,
but where does this all fit in, in terms of seasonal flu? Was H1N1
that much different than a normal seasonal flu, just a different va-
riety that sounded scary?
Dr. GOTTLIEB. H1N1 was a novel influenza that people did not
have cross-immunity to. So it was highly contagious because of
that.
I think it is hard to make an estimate on where coronavirus is
going to sit in that continuum.
I think the concern that you are hearing from us and public
health officials is that this could sort of occupy that sweet spot be-
tween being contagious enough that it transfer very efficiently but
36
still virulent enough that when distributed over a very large popu-
lation, it causes a lot of death and disease.
To put it in perspective, influenza has what we call an ‘‘R-
naught,’’ meaning how many new cases are infected for every case
that you have of about 1.5, I believe, 1.3, 1.5. It is 1.28.
It looks like based on the modeling that has been done, the R-
naught here is going to be somewhere between 2 and 3. So this is
much more infectious. The case fatality rate——
Chairman JOHNSON. That grows geometrically too, right?
Dr. GOTTLIEB. Yes.
The case fatality rate in normal influenza is .1 or less. A severe
strain might be .1. Sometimes it is a little less than that.
The case fatality rate here right now, the estimates are it is
about 2 percent. That is probably based on underreporting of the
mild to moderate cases. So that is probably going to come down,
but it might still be .2 or .5 percent. Now, that does not sound like
a lot, but that is devastating. If you have something that has an
R-naught of 2 to 3 and a case fatality rate of .2, that could be quite
devastating.
I will say that I think we are going to know much more in the
next 2 weeks as we examine what is happening in Singapore and
what is happening on a very unfortunate cruise ship, because we
are going to get a better estimate of how many people with disease
actually progressed to severe disease.
So far in Singapore, with 50 cases identified—and I believe that
they are doing a good job of identifying their cases—eight are in
the ICU. That is deeply concerning to me.
Chairman JOHNSON. Talk a little bit more about Singapore.
Again, you have the flu season. It gets cold. People are confined
versus in the summer months. Talk a little bit about why you are
simply concerned about Singapore.
Dr. GOTTLIEB. Because, first of all, it is warm right now. So you
should not see efficient transfer.
Second of all, Singapore has about 3.4 million travelers from
China a year. We have about 3 million. So on a statistical basis,
there is no reason to believe that if Singapore got implants of this
virus, we did not. You would expect them to be identified earlier
in Singapore, a very dense island nation, city-State. You would ex-
pect those viruses to be identified sooner there than it would be in
a big country like ours. But it does suggest, at least to me, that
we probably have some community spread right now that we just
have not identified yet and will identify it in time, hopefully in
time to intervene to prevent further propagation and make sure
that we contain the small outbreaks.
Chairman JOHNSON. One of the questions I did not get ade-
quately answered from my standpoint when I was talking to—and
by the way, in defense of the current administration, they are not
ignoring us. There has been a lot of interaction. Another briefing
here starts in about 5 minutes, where DHS and CDC will be there.
But in my discussions, I did not get a real clear answer. I think
I finally did, but I am still—who is following up?
Let me start it this why because I might have been you, Dr.
Gerberding. I think it was in your testimony. You talked about the
fact that you really did not think these travel restrictions are really
37
going to be particularly effective. It sounds good. It seems like the
responsible thing to do, but in the end—or did I read that from
somebody else? Somebody in an article or in testimony really kind
of toned out——
Dr. GEORGE. Senator Lieberman said it, actually, that perhaps at
first, there is something to be said for travel restrictions. But be-
yond a certain point, especially with all the travel that has oc-
curred, the 5 million people we believe left Wuhan before any trav-
el restrictions were imposed, et cetera, travel restrictions are not
going to remain the sole way to try and control all this.
Chairman JOHNSON. OK. So do people agree with that or dis-
agree with that? Does somebody want to answer?
Dr. GERBERDING. If you start with the concept of containment
very early on, yes, it makes sense to do everything possible to con-
tain a new pathogen in an area.
Once you start seeing sustained community transmission else-
where, the horse is out of the barn, and that strategy is no longer
likely to have an impact.
Chairman JOHNSON. One of the questions I had is—so we have
identified these—for example, we have a case in Madison. We know
the flight. So I was asking, ‘‘Are we contacting everybody on that
flight? Are we contacting passengers three rows to end, and who
is doing that?’’ because I know CDC does not have the personnel.
CBP does, and this is where we are talking about the whole of gov-
ernment. Who is going to actually follow up?
Dr. GERBERDING. So this goes back to the question earlier about
the public health system. When there is a situation like that, a
travel exposure, potentially, it is the local and State public health
department that identify the case and begin the process of working
with the airline to contact passengers. This is a routine that our
Division of Quarantine at CDC does routinely coordinate, but the
shoe-leather aspect of it is at the State level. That is why we need
to support them.
Dr. GOTTLIEB. I would also add, Senator, our system is excellent.
CDC does an excellent job of, once we identify a case, doing that
track and trace and that containment in the quarantine where nec-
essary.
I think what we should be worried about is not the cases that
we know about. It is the cases we do not know about, and there
are certainly cases we do not know about.
Chairman JOHNSON. Explain yourself a little bit more. That
statement confused a little bit.
Dr. GOTTLIEB. We should not assume that the 13 cases that we
have identified—and I think 10 of them were travel related, people
who came directly from China and imported the virus into the
United States—that we just managed to find all 10 people coming
in from China who happen to have coronavirus, especially since we
know that there is mild to moderate people or maybe even asymp-
tomatic, but certainly people with mild to moderate disease who
can transmit the disease.
We have to believe that over the course of the month or 6 weeks
that this was epidemic in China, people came over from China, and
we just did not identify them. Some of the modeling out of the
United Kingdom (UK) suggests that we are capturing about 25 per-
38
cent of the cases at best. So for every case we identify, there are
three or four that we did not identify. At least some of those cases
probably are propagating virus at a local level, but not enough
cases have accumulated yet to be identifiable.
Chairman JOHNSON. Again, I do not want to downplay this at all,
but I also do not want to overhype it.
I remember when we had the Ebola outbreak, and people were
projecting a million cases of Ebola. In the end, we are so fortunate.
It was confined to a couple tens of thousands.
When will we know that we are out of the woods on this? Are
we talking in 6 to 10 weeks, we ought to pretty well know whether
we have something that is out of control?
Dr. GERBERDING. I would say yes. It is unfolding as we speak.
We will be able to understand if there are more serious cases be-
cause of the numbers that Dr. Gottlieb has pointed out. As you
said, the exponential spread, if we are seeing a transmission that
is not detected because most cases are mild and not being tested,
we will know it soon because we will begin to see more cases. They
will not be directly linked to travel to China. They will be in people
who were exposed to someone who has traveled to the endemic
area.
Chairman JOHNSON. Seasonal flu kind of starts petering out
when?
Dr. GERBERDING. It is very variable. Early spring, generally
speaking. It is still actively being transmitted now. So we are not
out of the woods on that one yet either.
Chairman JOHNSON. But our concern is coronavirus may not de-
cline as other normal seasonal flus in terms of what we are looking
at Singapore.
Dr. GOTTLIEB. If you look at the medical literature, you would ex-
pect the coronavirus not to transfer in the warm months, and I
think people are hoping that we can prevent enough transmission
that you get into the summer and that is a backstop, and then
maybe we are dealing with this again in the fall. But by then,
hopefully, we have a better strategy and maybe even a candidate
vaccine.
But the situation in Singapore is concerning because it is warm
there right now, and it seems to be transferring. We do not know
the full scope of it, but they do seem to have some level of commu-
nity spread right now.
Chairman JOHNSON. We have reason to believe that we should
be able to develop an effective vaccine so that in a year from now,
we should be protected by this?
Dr. GOTTLIEB. I will also add, it is 60 degrees in Wuhan right
now.
Dr. GERBERDING. Another aspect of the seasonality is that the
coronavirus—is that human beings are used to dealing with the
four sort of cold-like viruses are upper-airway viruses. This is a
lower airway disease, and so I do not know that I would want to
predict any seasonal impact on its transmission pattern.
If you go back to 1918, we think of influenza as being a winter
disease, but that was not the case with the 1918 pandemic, so lots
of uncertainty, and we just need to be careful not to jump to any
conclusion too early.
39
Chairman JOHNSON. Again, I really appreciate the time you
spent answering all of our questions here. There are a lot of ques-
tions, obviously, that remain, and we will continue to press.
I will again say I am disappointed that we did not have DHS and
CDC or HHS here. I am going to leave now and go to the briefing
where they will be present. The public has a right to know these
things. So, again, information to me is going to be helpful here.
With that, I will say that the record will remain open for 15 days
until February 27th at 5 p.m. for the submission of statements and
questions for the record. This roundtable is adjourned.
[Whereupon, at 11:36 a.m., the Committee was adjourned.]
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