[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]


                     REPURPOSING THERAPEUTIC DRUGS
                         FOR COVID-19: RESEARCH
                      CHALLENGES AND OPPORTUNITIES

=======================================================================

                                HEARING

                               BEFORE THE

                     SUBCOMMITTEE ON INVESTIGATIONS
                             AND OVERSIGHT

                                 OF THE

                      COMMITTEE ON SCIENCE, SPACE,
                             AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             JUNE 19, 2020

                               __________

                           Serial No. 116-74

                               __________

 Printed for the use of the Committee on Science, Space, and Technology
 
 [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]


       Available via the World Wide Web: http://science.house.gov
       
                               __________
                               

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
40-634PDF                  WASHINGTON : 2021                     
          
--------------------------------------------------------------------------------------       

              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

             HON. EDDIE BERNICE JOHNSON, Texas, Chairwoman
ZOE LOFGREN, California              FRANK D. LUCAS, Oklahoma, 
DANIEL LIPINSKI, Illinois                Ranking Member
SUZANNE BONAMICI, Oregon             MO BROOKS, Alabama
AMI BERA, California,                BILL POSEY, Florida
    Vice Chair                       RANDY WEBER, Texas
LIZZIE FLETCHER, Texas               BRIAN BABIN, Texas
HALEY STEVENS, Michigan              ANDY BIGGS, Arizona
KENDRA HORN, Oklahoma                ROGER MARSHALL, Kansas
MIKIE SHERRILL, New Jersey           RALPH NORMAN, South Carolina
BRAD SHERMAN, California             MICHAEL CLOUD, Texas
STEVE COHEN, Tennessee               TROY BALDERSON, Ohio
JERRY McNERNEY, California           PETE OLSON, Texas
ED PERLMUTTER, Colorado              ANTHONY GONZALEZ, Ohio
PAUL TONKO, New York                 MICHAEL WALTZ, Florida
BILL FOSTER, Illinois                JIM BAIRD, Indiana
DON BEYER, Virginia                  FRANCIS ROONEY, Florida
CHARLIE CRIST, Florida               GREGORY F. MURPHY, North Carolina
SEAN CASTEN, Illinois                MIKE GARCIA, California
BEN McADAMS, Utah                    THOMAS P. TIFFANY, Wisconsin
JENNIFER WEXTON, Virginia
CONOR LAMB, Pennsylvania
                                 ------                                

              Subcommittee on Investigations and Oversight

                  HON. BILL FOSTER, Illinois, Chairman
SUZANNE BONAMICI, Oregon             RALPH NORMAN, South Carolina, 
STEVE COHEN, Tennessee                   Ranking Member
DON BEYER, Virginia                  ANDY BIGGS, Arizona
JENNIFER WEXTON, Virginia            MICHAEL WALTZ, Florida
                         
                         
                         C  O  N  T  E  N  T  S

                             June 19, 2020

                                                                   Page

Hearing Charter..................................................     2

                           Opening Statements

Statement by Representative Bill Foster, Chairman, Subcommittee 
  on Investigations and Oversight, Committee on Science, Space, 
  and Technology, U.S. House of Representatives..................     8
    Written Statement............................................     9

Statement by Representative Frank D. Lucas, Ranking Member, 
  Committee on Science, Space, and Technology, U.S. House of 
  Representatives................................................    10
    Written Statement............................................    11

Written statement by Representative Eddie Bernice Johnson, 
  Chairwoman, Committee on Science, Space, and Technology, U.S. 
  House of Representatives.......................................    12

                               Witnesses:

Dr. Peter Lurie, President, Center for Science in the Public 
  Interest
    Oral Statement...............................................    13
    Written Statement............................................    16

Dr. James Finigan, Director of the Respiratory Centers of 
  Excellence, National Jewish Health
    Oral Statement...............................................    24
    Written Statement............................................    26

Dr. Rick L. Stevens, Associate Laboratory Director for Computing, 
  Environment and Life Sciences, Argonne National Laboratory
    Oral Statement...............................................    29
    Written Statement............................................    31

Dr. Benjamin Rome, Associate Physician, Brigham and Women's 
  Hospital; Postdoctoral Research Fellow, Harvard Medical School
    Oral Statement...............................................    39
    Written Statement............................................    41

Discussion.......................................................    59

 
                     REPURPOSING THERAPEUTIC DRUGS
                         FOR COVID-19: RESEARCH
                      CHALLENGES AND OPPORTUNITIES

                              ----------                              


                         FRIDAY, JUNE 19, 2020

                  House of Representatives,
      Subcommittee on Investigations and Oversight,
               Committee on Science, Space, and Technology,
                                                   Washington, D.C.

     The Subcommittee met, pursuant to notice, at 1:30 p.m., 
via Webex, Hon. Bill Foster [Chairman of the Subcommittee] 
presiding.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

     Chairman Foster. Without objection, the Chair is 
authorized to declare recess at any time.
     Before I deliver my opening remarks, I wanted to note the 
unusual circumstances under which we're meeting today. Pursuant 
to Resolution 965, today, the Subcommittee will be meeting 
virtually. This is not how any of us would prefer to perform 
our duties, but remote work is unfortunately a necessity at the 
current moment and a reflection of the part we all have to play 
in slowing the spread of COVID-19.
     In light of this remote format, I want to offer some 
reminders to the Members about the conduct of the hearing. 
Members should keep their video feed on as long as they are 
present at the hearing. Members are responsible for muting and 
unmuting their own microphones, and please keep your 
microphones muted unless you're speaking. You know, much as we 
love your family dog [audio malfunction].
     And finally, if Members have documents they wish to submit 
for the record, please email them to the Committee Clerk, whose 
email address was circulated prior to the hearing.
     Well, good afternoon and welcome to the first virtual 
hearing of the Committee on Investigations and Oversight. 
Today, we're discussing a critical issue: research into 
repurposing of existing therapeutic drugs for COVID-19 
treatment, as well as the scientific basis for the Federal 
Government's evaluation of such drugs.
     I appreciate our witnesses being here under these unusual 
circumstances, but these are very important issues, and we look 
forward to your testimony.
     Today's hearing revolves around one of humanity's most 
promising tools in its public health response to the current 
pandemic: repurposing existing therapeutic drugs to treat 
COVID-19. The appeal of repurposing existing therapeutics is 
obvious. These drugs have already been developed, they have 
already been manufactured, and in some cases can quickly be 
accessed in large quantities. And for drugs that have already 
been approved to treat other diseases, a certain amount of 
safety data is often available to regulators.
     In the absence of any COVID-19 vaccine or novel treatment, 
existing therapeutics could potentially offer critical 
assistance for severely ill patients and bridge the gap until 
more prevention and treatment options become available. But 
with great promise comes great concerns. Since existing 
therapeutics rest at our fingertips and have demonstrated 
benefits in other circumstances, it can be all too easy in the 
midst of a pandemic to cut corners and to seek shortcuts to 
longstanding regulatory processes, and we can't allow that to 
happen. The evaluation process to repurpose approved drugs is 
there for a reason: to ensure that existing therapeutics, which 
could carry significant health risks for COVID-19 patients, are 
assessed through the prism of scientific and medical data and 
sanctioned on the basis of factual evidence regarding safety 
and efficacy in their new context. And while the process itself 
should be flexible and as fast as possible, the integrity of 
the process must be firmly upheld.
     The research community's evidence-based evaluation of 
existing therapeutics must be paramount, and political 
considerations must never enter into the equation for any 
specific treatment. If politics is allowed to interfere, 
scientific research may be distorted, patients may be placed at 
risk, and the faith of the public in our whole public health 
mechanism may be shaken.
     Unfortunately, we're seeing the consequences of some 
political interference in the controversy surrounding two 
existing therapeutic drugs, chloroquine and hydroxychloroquine. 
In March, the FDA (Food and Drug Administration) issued an 
emergency use authorization (EUA) for these drugs as COVID-19 
treatments. The scientific evidence to support this decision 
was dangerously thin, but the political considerations were 
clear. And our President became the world's loudest cheerleader 
for both drugs. Researchers, experts, and former FDA officials 
all questioned the decision for lacking a sufficient scientific 
basis.
     And now, nearly 3 months later, the FDA just this week 
revoked the emergency use authorization, acknowledging the 
clinical data showing the drugs, quote, ``may not be effective 
to treat COVID-19'' and that, quote, the ``potential benefits 
for such use do not outweigh the known and potential risks.'' 
This is a clear example of the dangers of allowing political 
considerations to distort what should be a scientific process 
reliant upon unbiased scientific evaluation.
     This hearing will explore the importance of supporting 
scientific research into repurposing existing therapeutics as 
COVID-19 treatments and the cost of neglecting science when 
politics intrudes. The research community is currently engaged 
in a heroic effort to explore as many therapeutics as possible 
in the search for a COVID treatment. The Federal Government 
supports many of these efforts, but there may be more that we 
can do as policymakers to provide researchers with the funding 
and the conditions that they need to make progress. And there 
may also be more that we can do to uphold the integrity in the 
role of science as the foundation for Federal efforts in this 
area.
     Our witnesses bring diverse perspectives with deep 
experience in these areas. I look forward to learning from them 
about the most effective way for the Federal Government to 
support research into repurposing existing therapeutics for 
this pandemic and probably--unfortunately, probably for the 
next one. Well, thank you all.
     [The prepared statement of Chairman Foster follows:]

    Today's hearing revolves around one of humanity's most 
promising tools in its public health response to the current 
pandemic: repurposing existing therapeutic drugs to treat 
COVID-19. The appeal of repurposing existing therapeutics is 
obvious. These drugs have already been developed; they have 
already been manufactured, and in many cases can quickly be 
accessed in large quantities; and for drugs that have already 
been approved to treat other diseases, a certain amount of 
safety data is already available to regulators. In the absence 
of any COVID-19 vaccine or novel treatment, existing 
therapeutics could potentially offer critical assistance for 
severely ill patients and bridge the gap until more prevention 
and treatment options become available.
    But with great promise comes great temptation. Since 
existing therapeutics rest at our fingertips and have 
demonstrated benefits in other circumstances, it can be all too 
easy in the midst of a pandemic to cut corners and seek 
shortcuts to longstanding regulatory processes. We cannot allow 
this to happen. The evaluation process to repurpose approved 
drugs exists for a reason: to ensure that existing 
therapeutics, which could carry significant health risks for 
COVID-19 patients, are assessed through the prism of scientific 
and medical data and sanctioned on the basis of factual 
evidence regarding safety and efficacy in their new context. 
While the process itself should be flexible, the integrity of 
the process must be firmly upheld. The research community's 
evidence-based evaluation of existing therapeutics must be 
paramount, and political considerations must never enter into 
the equation for any specific treatment. If politics is allowed 
to interfere, scientific research may be distorted, patients 
may be placed at risk, and the faith of the public may be 
shaken.
    Unfortunately, we are seeing the consequences of political 
interference in the controversy surrounding two existing 
therapeutic drugs, chloroquine and hydroxychloroquine. In 
March, the FDA issued an Emergency Use Authorization for the 
drugs as COVID-19 treatments. The scientific evidence to 
support this decision was dangerously thin, but the political 
considerations were clear: President Trump had become the 
world's loudest cheerleader for both drugs. Researchers, 
experts, and former FDA officials all criticized the decision 
for lacking a sufficient scientific basis. Now, nearly three 
months later, the FDA just this week revoked the EUA, 
acknowledging clinical data showing that the drugs ``may not be 
effective to treat COVID-19'' and that the ``potential benefits 
for such use do not outweigh its known and potential risks.'' 
This is a clear example of the dangers of allowing political 
considerations to distort a process reliant upon unbiased 
scientific evaluation.
    This hearing will explore the importance of supporting 
scientific research into repurposing existing therapeutics as 
COVID-19 treatments, and the costs of neglecting science when 
politics intrudes. The research community is currently engaged 
in a heroic effort to explore as many existing therapeutics as 
possible in the search for a COVID treatment. The federal 
government supports some of these efforts, but there may be 
more we can do as policymakers to provide researchers with the 
funding and the conditions they need to make progress. There 
may also be more we can do to uphold the integrity of the role 
of science as the foundation for federal efforts in this area. 
Our witnesses bring diverse perspectives with deep experience 
on these issues. I look forward to learning from them about the 
most effective way for the federal government to support 
research into repurposing existing therapeutics, now and for 
the next pandemic.

     Chairman Foster. And the Chair will now recognize Mr. 
Lucas, the Chair of the Full Committee, for an opening 
statement.
     Mr. Lucas. Thank you, Chairman Foster, and thank you to 
our witnesses for their participation today.
     The COVID-19 pandemic is unlike anything we've faced since 
the 1918 Spanish flu. In those days, we had very few tools to 
slow the spread of the virus, develop treatments, or produce a 
vaccine to make ourselves immune to it. Thankfully, that has 
changed. Our Nation's research enterprise, including 
government, academia, and industry, is the expertise, 
resources, and talent needed to fight this pandemic. The work 
they're doing to model the virus, screen potential treatments, 
and engineer new medical equipment is truly lifesaving.
     We have supercomputers, advanced manufacturing techniques, 
and even advanced photon sources being used to fight COVID-19. 
From PPE (personal protective equipment) manufacturing and new 
vaccine developments to repurpose existing therapeutics, 
America's scientific community has heeded the call to action.
     An excellent example of the public-private collaboration, 
leveraging technology to fight a common cause, is the COVID-19 
High-Performance Computing Consortium. Though this OSTP (Office 
of Science and Technology Policy)-led collaboration, COVID-19 
researchers can access the world's most powerful computing 
resources to run complex models and develop large numbers of 
calculations at astonishing speeds. By leveraging these 
computing resources and deploying artificial intelligence (AI) 
and machine-learning techniques, researchers can determine 
which drugs have the potential to be repurposed against COVID-
19 at a speed and scale previously unthinkable. Technology will 
continue to play a critical role in saving lives and preventing 
the spread of COVID-19. And our Federal research enterprise 
must have access to the resources and the technology necessary 
to do their jobs and to do it well.
     That's why I introduced the ``COVID Research Act of 
2020'', which would create an interagency working group and 
establish a national strategy to address infectious diseases. 
Additionally, this bill authorizes $50 million for DOE's 
(Department of Energy's) infectious disease research program 
over the next two years. Working together with NASA (National 
Aeronautics and Space Administration) and the NSF (National 
Science Foundation), this program gives us the ability to 
utilize the Federal Government's computing resources to respond 
to infectious diseases.
     Our national labs have already demonstrated the value of 
using high-performance computing and advanced research 
facilities to model novel coronavirus, understand its effects 
on human cells, and predict its spread. I'm pleased to learn 
that there is work underway at Argonne National Lab that is 
particularly relevant to repurposing therapeutics to fight 
COVID-19.
     And thank you, Dr. Stevens, for being here today. I look 
forward to learning more about this important work.
     And, more broadly, I'd like to extend my thanks to the 
entire scientific community, researcher after researcher, lab 
after lab pivoting immediately to fight COVID-19 when it 
reached our shores.
     When I began serving as Ranking Member of the Committee, I 
said one of our most important responsibilities is to tell the 
story of science and to make sure our constituents understand 
the tremendous research being done and why it matters to the 
next generation of Americans. This story in particular, how 
American scientists, researchers, and engineers responded to 
COVID-19 is one everyone should know, and I hope my colleagues 
will use this hearing as one more opportunity to share this 
work.
     And with that, Mr. Chairman, I yield back.
     [The prepared statement of Mr. Lucas follows:]

    Thank you, Chairman Foster. And thank you to our witnesses 
for your participation today.The COVID-19 pandemic is unlike 
anything we have faced since the 1918 Spanish flu. At the time, 
we had very few tools to slow the spread of the virus, develop 
treatments, or produce a vaccine to make ourselves immune to 
it. Thankfully, that has changed.
    Our nation's research enterprise, including government, 
academia, and industry, has the expertise, resources, and 
talent needed to fight this pandemic. The work they're doing to 
model the virus, screen potential treatments, and engineer new 
medical equipment is truly lifesaving.
    We have supercomputers, advanced manufacturing techniques, 
and even advanced photon sources being used to fight COVID-19. 
From PPE manufacturing and new vaccine development to 
repurposing existing therapeutics, America's scientific 
community has heeded the call to action.
    An excellent example of public-private collaboration 
leveraging technology to fight a common cause is the COVID-19 
High Performance Computing Consortium. Through this OSTP-led 
collaboration, COVID-19 researchers can access the world's most 
powerful computing resources to run complex models and perform 
large numbers of calculations at astounding speeds.
    By leveraging these computing resources and employing 
artificial intelligence and machine learning techniques, 
researchers can determine which drugs have the potential to be 
repurposed against COVID-19, at a speed and scale previously 
unthinkable. Technology will continue to play a critical role 
in saving lives and preventing the spread of COVID-19. And our 
federal research enterprise must have access to the resources 
and technology necessary to do their jobs, and to do it well.
    That's why I introduced the COVID Research Act of 2020, 
which would create an interagency working group and establish a 
national strategy to address infectious diseases. Additionally, 
this bill authorizes $50 million for DOE's Infectious Disease 
Research Program over the next two years. Working together with 
NASA and NSF, this program gives us the ability to fully 
utilize the federal government's computing resources to respond 
to infectious diseases.
    Our National Labs have already demonstrated the value of 
using high-performance supercomputing and advanced research 
facilities to model the novel coronavirus, understand its 
effects on human cells, and predict its spread. I'm pleased to 
learn that there is work underway at Argonne National Lab that 
is particularly relevant to repurposing therapeutics to fight 
COVID-19. Thank you, Dr. Stevens, for being here today. I look 
forward to learning more about this important work. And, more 
broadly, I'd like to extend my thanks to the entire scientific 
community. Researcher after researcher and lab after lab 
pivoted immediately to fight COVID-19 when it reached our 
shores.
    When I began serving as Ranking Member of this Committee, I 
said that one of our most important responsibilities is to tell 
the story of science and make sure our constituents understand 
the tremendous research being done, and why it matters to the 
next generation of Americans.
    This story in particular--how American scientists, 
researchers, and engineers responded to COVID-19--is one 
everyone should know, and I hope my colleagues will use this 
hearing as one more opportunity to share this work.
    I yield back.

     Chairman Foster. Thank you. And if there are Members who 
wish to submit additional opening statements, your statements 
will be added to the record at this point.
     [The prepared statement of Chairwoman Johnson follows:]

    Thank you, Chairman, Foster, and thank you to all of our 
esteemed witnesses for appearing before the Subcommittee today. 
It is so important to learn from experts about these critical 
issues because the threat of COVID-19 has not diminished. I 
have seen in recent days, in Dallas and throughout the state of 
Texas, how precarious our situation truly is and how we all 
must reinforce our commitment to combating the pandemic. It has 
been clear from the beginning and it remains clear today: 
science-based policymaking, rooted in facts and guided by the 
best efforts of the scientific community, is the key to 
overcoming this challenge. I am glad that today's hearing can 
help inform the federal government's response to the pandemic 
in the months to come.
    Repurposing existing therapeutics for COVID-19 treatment 
would be an important tool in the world's pandemic toolkit. 
Until a vaccine emerges, we must do everything possible to 
develop treatments that can save lives, and it makes a great 
deal of sense to evaluate drugs that have already been approved 
in other circumstances. I have been encouraged by the immense 
effort and resources that America's research community has 
dedicated to this cause. The federal government should be doing 
everything in its power to promote these research efforts, and 
I am eager to learn how we can do more to support the research 
community's critical work.
    I also want to better understand how the federal government 
can work with the research community to prepare for the next 
pandemic. There may be opportunities for the federal government 
to collaborate with the research community on broad issues such 
as prioritizing certain drug candidates, efficiently deploying 
limited resources, and coordinating efforts among the vast 
network of research institutions engaged in this work. These 
questions must be approached in a deliberative manner, and we 
should start to consider them now so that we are better 
prepared next time.
    As we think about these issues, we must never lose sight of 
the paramount importance of upholding scientific integrity at 
all times. Repurposing existing drugs in the midst of a 
pandemic carries high stakes, and federal policymaking must be 
done the right way, based solely on thebest available science 
and free from any political interference. The controversy 
surrounding the FDA's Emergency Use Authorization for 
hydroxychloroquine demonstrates all too well the damage that 
can occur when political considerations inappropriately 
influence the process. The government's actions to address the 
nation's needs during this public health crisis must only be 
guided by scientific evidence--never political pressure.
    The research community is rising to the challenge of COVID-
19, and I have no doubt that it will continue to perform 
magnificently. Thank you again to all of the witnesses. I yield 
back.

     Chairman Foster. At this point I'd like to introduce the 
witnesses. Our first witness is Dr. Peter Lurie. Dr. Lurie is 
the President of the Center for Science in the Public Interest 
(CSPI), a nonprofit health advocacy group based in Washington, 
DC. Before joining CSPI, he held several positions at the Food 
and Drug Administration, including a stint at the--as the FDA's 
Associate Commissioner for Public Health Strategy and Analysis. 
He served nearly 8 years as a top official of the FDA.
     Our next witness is Dr. James Finigan. Dr. Finigan is the 
Director of the Respiratory Centers of Excellence at National 
Jewish Health, the Nation's leading respiratory hospital. He's 
also the Medical Director of the Lung Cancer Screening Program 
at the National Jewish Health. Dr. Finigan is a pulmonologist 
with a research focus on lung cancer and injury.
     Our third witness is Dr. Rick Stevens. Dr. Stevens is the 
Associate Laboratory Director for Computing, Environment, and 
Life Sciences at Argonne National Laboratory. He also serves as 
the leader of Argonne's Exascale Computing initiative. He's 
worked at Argonne Lab since 1982.
     Our final witness is Dr. Benjamin Rome. Dr. Rome is an 
Associate Physician at Brigham and Women's Hospital in Boston, 
Massachusetts. He's also a Postdoctoral Research Fellow at 
Harvard Medical School. Dr. Rome's academic research focuses on 
the FDA approval process for drugs and medical devices, as well 
as the effect of Federal policies and regulations on drug 
pricing and utilization.
     As our witnesses should know, each of you have 5 minutes 
for your spoken testimony. Your written testimony will be 
included in the record for the hearing. And when you've all 
completed your spoken testimony, we will begin with questions. 
Each Member will have 5 minutes to question the panel. And if 
there is time, we may be able to have a second round of 
questions from those Members who are in attendance.
     And we'll now start with Dr. Lurie.

            TESTIMONY OF DR. PETER LURIE, PRESIDENT,

           CENTER FOR SCIENCE IN THE PUBLIC INTEREST

     Dr. Lurie. Well, thank you, Chairman Foster, Ranking 
Member Lucas, and other Committee Members, for inviting me to 
testify on this important topic. For this testimony, I'm 
defining repurposed drugs as approved drugs for which a second 
indication for COVID-19 is sought. Some other witnesses may use 
other definitions.
     Unfortunately, the unmistakable allure of repurposed drugs 
is not enough on its own. Effectiveness for one condition does 
not guarantee effectiveness for a second even closely related 
condition. Target populations may be demographically and 
medically different, and so even the existing safety databases 
may have only limited relevance. The product may be 
administered in different doses or by different routes than for 
the first condition.
     So, let's look at two repurposed drugs. The antimalarial 
drugs chloroquine and hydroxychloroquine, which I'm considering 
together, would likely have languished well down the list of 
candidates for COVID-19 had they not been catapulted to 
prominence by President Trump's comments. On March 21st, the 
President described them as, quote, ``one of the biggest 
gamechangers in the history of medicine'' and later stated that 
he was taking the drug himself, the ultimate celebrity 
endorsement.
     On March 28th, under pressure from the Administration, FDA 
granted the drugs an emergency use authorization, EUA, but the 
evidence provided for this EUA was less than that provided for 
many previous EUAs.
     Eventually, the scientific process played itself out with 
several observational studies that demonstrated either no 
benefit from the drugs or even indicated that mortality rates 
were higher. FDA issued a warning that the drugs cause life-
threatening arrhythmias. And finally, there were two randomized 
controlled trials, the gold standard for scientific evidence. 
The first suggested that the product was ineffective in 
preventing infection among those exposed to the virus, and the 
second, that it was also ineffective in treating SARS-CoV-2 
infection itself. On June 15th, FDA revoked the EUA.
     What can we learn from this embarrassment? Well, first, we 
should adhere to accepted methods of drug discovery even in a 
pandemic. It is the painstaking process of conducting 
randomized control trials that ultimately produces definitive 
evidence even if it is definitive evidence of lack of 
effectiveness.
     Second, the patients in the President's phrase did have a 
lot to lose. Life-threatening arrhythmias were fairly common. 
Even patients without COVID-19 suffered as those needing 
hydroxychloroquine for its FDA-approved conditions had 
difficulty obtaining the drug due to increased demand.
     Finally, the President's announcements distorted the 
overall research effort for COVID-19. It is inconceivable that, 
left to their own devices, scientists would have designed over 
150 randomized controlled trials assessing the effectiveness of 
these drugs. How many more promising drugs were left unstudied 
or understudied as researchers pivoted to address the 
headlines?
     A second problematic repurposed drug is famotidine, an 
over-the-counter heartburn drug also known as Pepcid, a 
seemingly unlikely drug for COVID-19. One of its primary 
advocates is a Boston physician named Dr. Michael Callahan, who 
was also a consultant on the Staff of the Assistant Secretary 
for Preparedness and Response, ASPR, Dr. Robert Kadlec. Under 
Dr. Kadlec's direction, Dr. Callahan, having advocated for the 
drug, assisted a pharmaceutical company and a hospital to 
prepare an application for funding to ASPR to conduct a trial 
of famotidine. Shortly thereafter, Dr. Kadlec ordered a hefty 
$21 million contract to these entities. Senior officials were 
cut out of the granting process.
     There are two other prominent drugs worth mentioning here. 
The first, remdesivir, is the only drug so far proved effective 
against SARS-CoV-2, but it is not a repurposed drug at least in 
my definition. Rather, it is an unapproved drug with known 
antiviral activity demonstrated to be effective in a study 
funded by NIH (National Institutes of Health).
     The second drug, dexamethasone, is the first drug to 
reduce mortality in patients with COVID-19. Whether it's a 
repurposed drug is a matter of definition as it's long been 
approved but is often considered as a general treatment for 
severe respiratory illness based on its anti-inflammatory 
activity and is not directed to SARS-CoV-2 itself.
     But the benefits of these two drugs were demonstrated the 
old-fashioned way, through rigorous, randomized controlled 
trials. Interestingly, the dexamethasone results are derived 
from the same British study that reported the ineffectiveness 
of hydroxychloroquine. That trial is very large and able to 
test multiple candidate therapies simultaneously. In contrast, 
the clinical trials effort in the United States has been 
fragmented and poorly prioritized, resulting in many relatively 
small studies often testing the same drugs with some patients 
struggling--some studies struggling to enroll patients.
     In conclusion, so far in this pandemic, effective 
treatments have not been identified by anecdote, by wishful 
thinking, by Presidential pronouncement, or by questionable 
contracting practices. They were identified instead by the 
fair, transparent, and systematic application of the very 
scientific principles that for decades have delivered so many 
safe and effective treatments. But when we departed from these 
principles, precious time was lost, resources were squandered, 
and some patients paid with their lives. Thank you.
     [The prepared statement of Dr. Lurie follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
     Chairman Foster. Thank you. And our next witness is Dr. 
Finigan, now recognized for 5 minutes.

                 TESTIMONY OF DR. JAMES FINIGAN,

              DIRECTOR OF THE RESPIRATORY CENTERS

             OF EXCELLENCE, NATIONAL JEWISH HEALTH

     Dr. Finigan. Thank you. I would like to thank the Members 
of the Subcommittee for inviting me to speak on my experiences 
as a clinical investigator during the COVID-19 pandemic. I am a 
pulmonary and critical care physician at National Jewish Health 
in Denver, Colorado, where I see patients in our pulmonary 
clinic and intensive care units. National Jewish Health is the 
leading respiratory hospital in the Nation and is the only 
facility in the world dedicated exclusively to medical research 
and to the treatment of patients with respiratory, cardiac, 
immune, and related disorders. We work with several hospitals 
in Colorado, including our flagship St. Joseph Hospital, to 
provide pulmonary and critical care medicine and have 
established respiratory institutes in New York in partnership 
with Mount Sinai Health System and in Philadelphia with 
Jefferson Health.
     I have close to two decades of basic, translational, and 
clinical research experience and currently help lead our COVID-
19 clinical research program. Responding to this pandemic has 
required a complete reorientation of our clinical and research 
programs at National Jewish. Clinically, we reorganized our 
workforce and physical plant to diagnose and treat COVID-19 
patients while simultaneously planning for the worst-case 
scenario. For our research operations, it meant halting 
existing studies and starting up new studies as quickly as 
possible, all with much of our staff working remotely. Many of 
these studies are basic science investigations to identify new 
targets for treatment.
     At National Jewish Health, we've gone from zero COVID-19 
clinical studies to 10 or more therapeutic trials in various 
stages of development over the past 12 weeks. Prior to 
embarking on any specific research study, each trial requires a 
number of time-consuming steps, including formal protocol 
review, assessment of our ability to perform the trial as 
designed, determination of any conflicts with ongoing trials, 
budget negotiation, and agreement on contracting terms. This 
process ordinarily takes 3 months or longer. During this 
crisis, we've been able to cut that time to a few weeks. For a 
pharmaceutical company or other study sponsor, this process 
must be repeated at every study site. As an example, the 
recently published remdesivir study had 60 sites.
     And reflecting on our experience at National Jewish Health 
during this pandemic, I believe three points should be 
highlighted. First, to rapidly deploy clinical trials of new or 
repurposed drugs, a pre-existing, organized network of research 
sites is essential. The recently announced NIH-led ACTIV 
program is an example of this. ACTIV stands for Accelerating 
COVID-19 Therapeutic Interventions and Vaccines. It is a 
public-private partnership to create a collaborative framework 
for prioritizing vaccine and therapeutic candidates and 
streamlining clinical trials using existing clinical methods.
     Another example is the Prevention and Treatment of Acute 
Lung Injury, or PETAL network. PETAL is an NIH-funded network 
of academic medical centers dedicated to studying acute lung 
injury and the acute respiratory distress syndrome, the disease 
caused by SARS-CoV-2. This network has been repurposed to study 
the clinical features and possible treatments of COVID-19. For 
the past month, the PETAL network developed and launched two 
research protocols, and both studies will likely be completed 
in the coming weeks. Networks like these can be used in 
collaboration with industry as a platform to launch quickly new 
studies on promising treatments.
     Second, we need ongoing investigation of SARS-CoV-2 and 
COVID-19 to understand the virus and mechanisms of this 
disease. Much of this research will be what we call preclinical 
studies, bench research in cells and animal models to expand 
our understanding of COVID-19 pathophysiology. However, this 
can only exist if we maintain a robust national medical 
research mission and infrastructure.
     Dividends from this kind of research are not always 
immediately apparent. However, a basic understanding of the 
underlying science of this disease will drive development of 
new therapeutics moving forward both for this pandemic and to 
prepare us for the next one. These studies can help identify 
which new drugs are most promising and can inform a rational 
strategy for prioritizing drugs for clinical trials.
     Third, another pandemic is likely in our future. What that 
will be we don't know, but we should be planning now on how to 
incorporate a full research operation into any future pandemic 
response. I've been impressed with the research community 
reaction to this crisis. However, even with this effort, an 
organized national response was not launched until several 
months into the pandemic. Coordination of what research will be 
performed and how it will be executed, the respective roles of 
organizations such as the FDA, NIH, CDC, BARDA (Biomedical 
Advanced Research and Development Authority), as well as 
industry, should be considered prospectively. Research is as 
important to defeating this pandemic and being ready for the 
next one as personal protective equipment, intensive care 
units, and ventilators. Thank you.
     [The prepared statement of Dr. Finigan follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
     Chairman Foster. Thank you. That was beautifully timed. 
The Chairman appreciates the accuracy of your time estimate and 
will now recognize Dr. Stevens for 5 minutes. Whoops, Rick, 
mute.

                TESTIMONY OF DR. RICK L. STEVENS,

                 ASSOCIATE LABORATORY DIRECTOR

         FOR COMPUTING, ENVIRONMENT AND LIFE SCIENCES,

                  ARGONNE NATIONAL LABORATORY

     Dr. Stevens. OK. I thought they were going to unmute me. 
So, thank you, Chairman Foster, Ranking Member Lucas, and 
Members of the Subcommittee, for inviting me here to talk about 
our work relating to COVID-19. My group and collaborators work 
primarily in the development of methods for high-performance 
computing and artificial intelligence applied to problems in 
biology and medicine, so let me talk a little bit about what 
we're doing.
     I should say that I'm speaking for Argonne, myself and for 
Argonne. I'm not speaking for the Department of Energy. My work 
focuses on applying high-performance computing methods to 
problems in science and medicine, and I've worked in this 
combination space for over 25 years. And related to COVID-19, 
I'm the co-PI (principal investigator) on a DOE, CARES Act-
funded, nine-laboratory consortium project that is working on 
molecular design for COVID. As part of that effort, we're 
looking at repurpose-able drugs, as well as de novo compounds.
     Now, let me tell you a little bit about the virus and why 
it--why this drug search process is actually challenging. The 
virus is a single-stranded RNA (ribonucleic acid) virus. It 
codes for about 30 proteins. About 2/3 of those proteins 
commandeer host cell machinery to make copies of the virus, and 
about 1/3 of them are involved in packaging and formulating the 
virus. Of those proteins, there's perhaps 10, maybe a little 
bit more than that in the virus that the virus codes for that 
are plausible drug targets. The virus proteins also interact 
with the host. Perhaps as many as 300 protein interactions 
appear to occur, and a number of those host proteins could also 
be drug targets.
     Now, it's also important to know this virus is very 
closely related to SARS-1, and so since around 2003 the 
scientific community has had access to information about its 
genome and its proteome and has been working on this. And 
thanks to the DOE light sources and light sources elsewhere, we 
have very detailed atomic structural maps of these proteins, 
and in the last few months we've acquired more of these 
structural maps. But what's not known is essentially how 
existing drugs interact with these virus targets. That has not 
been the subject of large-scale computational work prior to now 
and has not been the study of large-scale experimental work.
     So, what I'm working in and my collaborators at the 
University of Chicago and at the nine national laboratories 
that are collaborating with us are really looking at how we can 
apply high-performance computing to scan not only the 2,500 or 
so licensed drugs worldwide and the 7,000 or so drugs that are 
in the pipeline but literally billions of molecules that we 
know can exist.
     Now, in this effort, it's also critical to recognize the 
three main infrastructures that we're using. We're using 
supercomputers, the fastest machines in the world that exist at 
the DOE labs like at Argonne and at Oak Ridge. The famous 
Summit computer at Oak Ridge is a workhorse for us but also 
machines that the NSF supports. We also use the light sources. 
These are critical for determining structures of proteins and 
for determining structure with molecules, potential inhibitors, 
bound into these proteins so we can understand their mechanism 
of action.
     And the third resource that's critical for this effort is 
the NIH-funded biocontainment laboratories, the regional 
biocontainment laboratories that were stood up after 9/11, 
after the scare--after the anthrax scare and concern about 
emerging pathogens, and these exist at various locations in the 
country. The one that is close to me is the H.T. Ricketts lab 
operated by the University of Chicago here at Argonne. We're 
also using the Regional Biocontainment Laboratory that's at the 
University of Tennessee Health Sciences Center. Those centers 
are critical because they can work on active virus, virus 
that's--viruses are not alive, but viruses where we can look at 
the entire lifecycle and whole cell assays and animal-based 
assays.
     So, essentially, what our program is, is to use the 
computers to search for molecules, including all the 
repurposing drugs. They get scored on each individual molecular 
target. The drugs that appear to have high potential get 
forwarded to our experimental collaborators where they get 
assayed biochemically and then ultimately through whole cell 
assays.
     I should point out one more thing. There's lots of advice 
we could give about future pandemics, but one thing that's 
holding us back, that's holding back the scientific community 
right now is the lack of biochemical assays for these specific 
virus protein functions. The National Institutes of Health are 
investing in development of these assays. They have the NCATS 
(National Center for Advancing Translational Sciences) program 
working on that. The national laboratories are also investing 
in assay development, but that is a major bottleneck. In the 
future, we need to invest in assays up front. They need to be 
stockpiled. They should become part of the national critical 
infrastructure and made available to these biocontainment 
laboratories so that, in the future, rapid screening can happen 
on any new outbreak. And I'll leave it at that. Thank you.
     [The prepared statement of Dr. Stevens follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
     Chairman Foster. Well, thank you. Well, at this point 
we'll begin our first round of questions, and the Chair will 
recognize himself for 5 minutes here.
     Dr. Rome and Dr. Lurie, you know, there have been--there's 
been mention of the--what is being set up in Europe and 
internationally and as opposed to what has happened in the 
United States in terms of the coordination of the large number 
of clinical trials. Can either of you say little bit about what 
we get right that's gotten--you know, that's better or worse 
than what's done in other countries and other international 
collaborations and whether we're insufficiently or more than--
or sufficiently connected to those?
     Dr. Lurie. Let me let Mr.--Dr. Rome answer because, sir, I 
think you neglected to give him the chance to read his 
statement.
     Chairman Foster. Oh, goodness. My apologies. My apologies. 
Thank you, Dr. Rome. I was fumbling multiple windows here and 
neglected, so--and thank you for that, Dr. Lurie.
     All right. Dr. Rome, you're now recognized for 5 minutes.

                TESTIMONY OF DR. BENJAMIN ROME,

       ASSOCIATE PHYSICIAN, BRIGHAM AND WOMEN'S HOSPITAL;

                 POSTDOCTORAL RESEARCH FELLOW,

                     HARVARD MEDICAL SCHOOL

     Dr. Rome. Thank you. Sorry about that. So, Chairman 
Foster, Ranking Member Lucas, and Members of the Subcommittee, 
thank you for inviting me. I'm a practicing primary care 
physician and a health policy researcher at Harvard Medical 
School and Brigham and Women's Hospital in Boston. I'm a member 
of the division of pharmacoepidemiology and pharmacoeconomics 
and the Program on Regulation, Therapeutics, and Law for 
PORTAL, an interdisciplinary research group that studies 
prescription drug development, regulation, use, and cost. I am 
honored to be here today to talk with you about the process for 
studying and approving repurposed drugs during the COVID-19 
pandemic.
     Drug development can be a lengthy process, and repurposing 
several medications with existing data about safe use in humans 
allowed clinical trials to begin early in the pandemic. As a 
result, just 4 months after the first COVID-19 patient was 
reported in the United States, several high-quality clinical 
trials have provided solid evidence relating to at least four 
drugs, two of which have proven effective: dexamethasone, a 
low-cost generic corticosteroid that can be readily prescribed 
by clinicians; and remdesivir, an antiviral that has not yet 
been approved for any indication by the FDA but is now 
available under an emergency use authorization.
     However, we have also witnessed examples of how the 
process for testing and approving drugs can go awry, as 
exemplified by the case of hydroxychloroquine. We should learn 
from our past missteps as we move forward, and our experiences 
so far suggest four key actions Congress should take.
     First, Congress should hold all government agencies and 
officials accountable for making statements and acting based on 
the best available scientific evidence. Hydroxychloroquine was 
widely touted by President Donald Trump and was issued an 
emergency use authorization by the FDA based on preclinical and 
limited anecdotal evidence that turned out to be unreliable. 
These actions led to widespread use of the drug, which exposed 
patients to risk, led to shortages at pharmacies, and diverted 
attention and resources that might have been dedicated to other 
potential therapies.
     Second, Congress should invest heavily in high-quality 
clinical trials which are necessary for determining whether 
drugs are safe and effective. Notably, most of the high-quality 
evidence generated so far during the pandemic has resulted from 
public funding, including the U.S. Government in the case of 
remdesivir and the United Kingdom Government in the case of 
dexamethasone.
     While the pharmaceutical industry will continue to have a 
role to play, the Federal Government's leadership and 
involvement are crucial, particularly for repurposed drugs 
which industry may have little or no financial incentive to 
study. However, such public investment should be made with the 
assurance that any medications that are found effective will be 
priced fairly and distributed equitably to patients who need 
them. No American should be prevented from accessing 
potentially lifesaving treatment for COVID-19 due to cost.
     Third, Congress should invest in a public health 
infrastructure and national clinical trial network that can 
help shape the research agenda, facilitate research across 
multiple sites, and limit duplicative efforts. In several 
European countries, government and academics have collaborated 
on large clinical trials that test multiple repurposed drugs 
simultaneous. A prime example is the RECOVERY Trial based out 
of the University of Oxford. This trial has already provided 
useful information about the lack of effectiveness of 
hydroxychloroquine and the effectiveness of dexamethasone.
     Finally, Congress should amend the process by which the 
FDA issues emergency use authorizations or EUAs. The level of 
evidence required to meet the standard of an EUA should be 
clarified. And to increase transparency, Congress should compel 
the FDA to make all related data public at the time that the 
EUA is issued.
     As new evidence emerges, the FDA should be directed to 
apply the same standards for revoking an EUA as was required 
for issuing it. EUAs should be accompanied by a clear and 
transparent plan for how the drug will be fairly and equitably 
distributed to patients, something that was lacking for both 
hydroxychloroquine and remdesivir.
     Finally, issuance of an EUA should be accompanied by 
collection of data on treated patients to gain additional 
insight about the drug's safety and effectiveness.
     Our experiences so far studying repurposed drugs during 
the COVID-19 pandemic have shown that we need not choose 
between rigorous scientific evidence and speed. We can have 
both. As our fight to control the COVID-19 pandemic continues, 
Congress must assure that we uphold a drug approval process 
that follows the science and promotes the practice of evidence-
based medicine.
     In a recent viewpoint published in the New England Journal 
of Medicine, Dr. Jerry Avorn and I argued that, quote, ``The 
health of individual patients and the public at large will be 
best served by remaining true to our time-tested approach in 
clinical trial evidence and drug evaluation.'' Thank you.
     [The prepared statement of Dr. Rome follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
     Chairman Foster. Thank you. And my apologies again for 
having skipped your testimony in the order. That's, I guess, 
the danger that occurs when I've read your testimony in advance 
and feel less need to hear it directly from you.
     And so I guess I will repeat my question, which is largely 
directed at your testimony to say a little bit more about the 
differences in the way things are being done internationally 
versus in the United States and what lessons we might learn 
from that.
     Dr. Rome. Thank you, yes, I am appreciative. So, the--your 
question is a good one. We have had two successes in this 
pandemic so far with dexamethasone and remdesivir. One was 
primarily driven out of the United States, but the other, 
dexamethasone came from funding from other countries. And I can 
say that most of the large clinical trials that are being 
conducted, especially the ones that were started very, very 
early in the pandemic and are likely to get us results in a 
timely fashion, were led by our peers in Europe and other 
countries. And definitely the United States should, in going 
forward in this pandemic and in future pandemics, lead those 
efforts and become a leader in the world for running these 
sorts of clinical trials.
     Chairman Foster. Now, in the case of the drug that worked, 
the anti-inflammatory that worked in England, was that funded 
by the manufacturer? Because one of the things that worries me 
here is that if all--if the majority of our clinical trials are 
funded by manufacturers, you will naturally--they will prefer 
drugs for which they have an intellectual property or a 
manufacturing position in and that we may forgo equally 
promising drugs that are, for example, off patent or just 
become generic drugs. And is that handled differently in other 
countries than the United States or are essentially all trials 
worldwide funded by the manufacturer?
     Dr. Rome. No, not all trials are funded by the 
manufacturer. And the trial out of Oxford was funded by the 
U.K. Government. Dexamethasone is a generic drug. There's very 
little skin in the game for any manufacturer to conduct a 
clinical trial, and that's likely to be true of many of these 
repurposed drugs, which may be older, off patent, generic 
drugs, which are widely available and great for patients but 
not necessarily a good investment from the perspective of a 
manufacturer.
     But not only that, the clinical trial for remdesivir, 
which is still a patented drug owed by Gilead, the key clinical 
trial upon which we are using the drug and an EUA was based was 
funded by the U.S. Government, by the NIAID (National Institute 
of Allergy and Infectious Diseases), and so--and this is a case 
where Gilead should have been running the key clinical trials 
and instead ran a clinical trial testing two different doses of 
the medication against itself and leaving the key clinical 
trial to come to the U.S. Government. And they have a patent on 
that drug and can financially benefit from it when it--or if 
and when it gets FDA approved.
     Chairman Foster. Thank you. Yes, Dr. Lurie, any comments 
on what's done internationally versus the United States and 
lessons we might learn?
     Dr. Lurie. Well, I think what Dr. Rome said is spot on the 
money. Unfortunately, things have been to a certain extent 
delegated to the pharmaceutical industry and even to individual 
academic institutions in this country. What we really need is 
somebody to coordinate the whole thing. I know that the NIH 
would like to do that. I know that the British Government has 
done so very successfully, particularly in the Recovery Trial, 
but we need a stronger hand on the rudder, somebody to 
prioritize the drugs, figure out the ones that matter the most, 
and then do proper trials on them.
     I guess I'd add it to what Dr. Rome said in the following 
way. It's tempting in the setting of a pandemic to say that we 
need to cut corners, but actually, the pandemic is almost the 
best place to stick with the usual game plan because there are 
so many patients, I'm sorry to say, and the disease makes you 
ill so quickly, I'm sorry to say, that there's more than enough 
statistical power for people to do the randomized controlled 
trials which we expect drug approval to be based upon.
     So, let's stick with the methods that work. Let's not use 
the pandemic as some excuse for corner-cutting or for 
deregulation.
     Chairman Foster. All right. So, yes, that's interesting. 
Do you think that there may be opportunities that we're 
overlooking for sort of lightweight outpatient clinical trials? 
You know, you can imagine to have a quick but scientifically 
valid look at hydroxychloroquine, for example, if you had any 
one of the--some fraction of the large number of people who 
have tested positive were immediately given the option of being 
screened and just on an outpatient basis given that we could've 
rapidly understood and, you know, with a lot of safety concern. 
Are there opportunities there we should think about?
     Dr. Lurie. I think there are, but so far if you look at 
the totality of the research that's been done, most of it is 
based on the inpatient setting, and that makes a certain kind 
of sense. These are the sickest patients after all. They're the 
patients in whom you can demonstrate benefit most easily. So, I 
agree there's opportunity, but I don't mean that as a criticism 
of the research enterprise to date.
     Chairman Foster. All right. And that exceeds my 5 minutes, 
and so I'd like to recognize Representative Lucas--Chairman 
Lucas for 5 minutes.
     Mr. Lucas. Thank you, Mr. Chairman.
     Dr. Stevens, could you provide us with an example of a 
cutting-edge research capability unique to the Argonne National 
Lab and how it is helping researchers work forward toward 
repurposing existing drugs to treat COVID-19?
     Dr. Stevens. Well, the--probably the best example is the 
use of the advanced photon source to quickly within a few days, 
assuming we can get a good crystal, produce a new structure of 
a viral protein bound to a drug. This is critical to understand 
whether or not the target is in fact the target that the drug 
is working on to understand how it changes the structure of the 
protein, how it might interrupt its function, so that's a 
pretty unique capability. There's only a handful of places in 
the United States and the world that can do that and can do it 
quickly.
     And after the pandemic became apparent and Argonne went 
into a lowered level of operation, we kept the advanced photon 
source up, and we kept that team working on determining protein 
structures critical to the virus. That's a really good example.
     Mr. Lucas. Well, could you, along those lines, explain how 
Argonne National Lab is working collaboratively with other 
research entities toward identifying COVID-19 drug candidates?
     Dr. Stevens. So, we have a nine-lab consortium that 
includes Argonne, Oak Ridge, Berkeley, Brookhaven, Los Alamos, 
Livermore, Sandia National Laboratories, SLAC, and Pacific 
Northwest Labs, nine labs all working together. We are using 
large-scale computation to computationally screen drugs, 
billions of drugs--or billions of potential drugs. All the 
existing drugs and billions of molecules that can become 
potential drugs. The drugs that look interesting from a 
computational standpoint are immediately procured and turned 
over to experimentalists that can assay the drug to determine 
if it is a viable inhibitor of function.
     And for things that succeed at that functional screen are 
forwarded to whole cell assays that can test full virus 
replication. Things that would succeed there would get passed 
on to animal models and then passed on for additional 
refinement and development. But I point out that it takes a 
large team to do this with virologists, physicians, medicinal 
chemists, computer scientists, and so on, and because of that 
large team--in fact, an important strategy is to consider 
repurposing existing drugs alongside new compounds. Existing 
drugs are of particular interest to clinicians due to them 
already being available.
     Mr. Lucas. As I mentioned earlier, my bill, H.R. 6599, 
focuses on collaboration among Federal agencies and aims to 
create a national strategy for any infectious disease outbreaks 
we face in the future, and certainly we will face those in the 
future again, as the Chairman alluded to. Are there any other 
collaborations that we're not thinking about that would help 
you, Dr. Stevens?
     Dr. Stevens. Well, we--early on, we established a 
collaboration between the DOE national labs, and the NIH, which 
has laboratory activities and research groups, so there's 
linkage. I think what's needed in the framework of your bill is 
a sustained, ongoing network of research collaborations that's 
consistently working on problems and is sharing data, sharing 
research, sharing assays, sharing information and would involve 
the DOE, it would involve the NIH, it probably would involve 
NSF resources in some cases, the DOD (Department of Defense), 
essentially all the players that are necessary for integrated 
public health in this country--some kind of ongoing 
collaboration around emerging threats.
     Mr. Lucas. One last question, Dr. Stevens. Is there 
anything Congress can do to help scientists and researchers 
like yourself do their jobs more efficiently during this 
pandemic and bring us one step closer to ultimately a cure?
     Dr. Stevens. I believe that the current activity is 
exactly what's needed. The funding--the ongoing funding support 
for these new efforts is of course critical, extend that 
longer. We're not out of this pandemic yet. I believe the 
interagency coordination process is working quite well. I 
believe that the institutions have put together structures to 
support this. Within the Department of Energy, for example, 
they created the National Virtual Biotechnology Lab 
coordination process across all the national labs in the United 
States to drive them toward a coherent COVID-19 strategy, so I 
believe that's working. So, continued support for that level of 
activity is what I recommend.
     Mr. Lucas. Thank you, Doctor. Thank you, Mr. Chairman. I 
yield back.
     Chairman Foster. Thank you. And I will now recognize 
Representative Bonamici for 5 minutes.
     Ms. Bonamici. Thank you, Mr. Chairman. Can you hear me?
     Chairman Foster. Yes.
     Ms. Bonamici. Terrific. Well, thank you to Chair Foster 
and Ranking Member Lucas and really for--to our witnesses 
today. Thank you for your expertise.
     We know that COVID-19 is disproportionately affecting 
black, Latinx, indigenous, and other people of color and that 
they are contracting the disease and dying at alarming rates. 
And as researchers develop studies and carry out trials, the 
Administration and Congress can and must address these 
disparities and do all we can to encourage or require research 
that's deliberately inclusive of all demographics and 
effectively addresses these inequitable outcomes.
     Recruiting patients to participate in research we 
understand can be challenging even under ideal settings, but 
trials can fail if there's a lack of patient enrollment. There 
are valid reasons why a patient invited to take place in a 
study may not trust medical researchers or feel comfortable 
participating. And even once a willing participant is 
identified, there can be barriers to their inclusion.
     A recent Politico article talked about physicians who were 
conducting NIH-funded clinical trials for remdesivir at sites 
in Boston, New York, and Atlanta. They faced language barriers 
in recruiting patients with limited English proficiency. They 
didn't have consent forms in Spanish. They had to work with 
translators by phone to explain the study and get consent and 
took extra hours per patient.
     So, I know, Dr. Lurie, you mentioned this. Do the 
witnesses all agree that it's important to have diverse 
representation in studies and trials? Do you all acknowledge 
that that's important?
     Dr. Lurie. Well, if I may go, I most certainly do. I've 
not seen specific information about recruitment and how it 
might vary by ethnicity so far in this pandemic, but I do know 
that this is not an equal-opportunity virus. At all stages of 
this disease, African Americans and other people of color are 
at a distinct disadvantage. They're more likely to be exposed 
to the virus in that they're more likely to be living in 
crowded living conditions, more likely to be working in 
meatpacking plants, more likely to be in prison, more likely to 
be healthcare workers at the front lines of exposure to the 
virus.
     After that, they very often have difficulty gaining access 
to treatment in part because of lack of health insurance, and 
then within the hospital, you know, the outcomes have not been 
equal across ethnic groups perhaps because of significant 
underlying health care--health conditions as well.
     So, all the way across----
     Ms. Bonamici. I appreciate that. I'm going to ask--I don't 
mean to interrupt, Dr. Lurie, but I'm also going to ask you and 
Dr. Finigan, are there strategies to get diverse representation 
in testing and trials? And, if not, what could not only the 
government but what can the medical community do? Do you have 
suggestions on how to build trust in the communities that may 
have been historically excluded from government-funded 
research? I want to get your thoughts and also Dr. Finigan.
     Dr. Lurie. Well, Dr. Finigan, go ahead.
     Dr. Finigan. Thank you. So, first off, you're correct. So, 
I would--I have seen firsthand in the COVID-19 pandemic where 
we--there have been examples of people who were not recruited 
adequately or were not recruited because there was a language 
barrier, there was not an appropriate consent form. That was 
particularly challenging for people who only spoke Spanish. One 
important thing to note is that there's often--there's always a 
time window in which you can recruit somebody, so, you--
typically, you can't recruit somebody into a study in an 
unlimited time window, that you may have to do it within, let's 
say, 24 or 48 hours of them being positive, and so there's a 
little bit of a race against the clock in this. And so those 
kinds of barriers really can have significant meaning. I think 
those things need to be taken into account ahead of time.
     It is relatively common that African Americans, Latinos, 
nonwhites are sort of underrepresented in studies, and so being 
ready for that kind of thing ahead of time to make sure they 
can get adequately enrolled, all the resources are available to 
them, those things are critical. I know of studies where they 
got those kinds of resources, those consent forms, but it 
happened weeks into the trial, and so you lost time, you lost 
patients.
     And the other critical piece there that I think you're 
also getting at is that's a lost opportunity for that person to 
be in a trial. Our goal is to give every patient the 
opportunity to enroll in a trial if they want to. And if you 
can't enroll them because there's not an adequate consent form, 
let's say, that's a missed opportunity for that patient, and 
they may lose the chance of being in a trial, let's say, on 
remdesivir where there's a potential benefit.
     Ms. Bonamici. I appreciate that. And there was just an 
article this morning in Axios Health Newsletter that there's 
all this--now there's talk this week about this steroid that's 
been hailed as a breakthrough treatment, but there's also 
evidence, according to the Chair of Pharmacology at Johns 
Hopkins University School of Medicine that African Americans 
may respond differently to this type of steroid. So, it's so 
critical that we address this issue because, as we know, COVID-
19 doesn't discriminate based on somebody's race. I mean, it's 
disproportionately affecting people of color.
     And real quickly, Dr. Finigan, we know that repurposing 
existing drugs is an attractive option because medications have 
already gone through testing. Can you tell us more about how 
preclinical testing in clinical trial phases can be safely 
accelerated if the drug has already been approved for another 
use?
     Dr. Finigan. So, there are--so there are different ways 
this can be done, but I think the key is to have sort of 
integrated networks so you can hit all the phases at once. So, 
as has been described, there are things you can do, Insilico, 
in a computer where you can try to rationally identify drugs. 
So, for example, I was a part of a study where one of our 
investigators built essentially a Google program where you 
could put in drugs and then put in the kind of drug you wanted 
or the kind of protein you wanted to target, and then this 
computer program would sort of spit out the drug that you 
wanted, and then you could marry that to an assay that you 
could do in a lab where you might have, let's say, 500 little 
wells, and you could test different drugs in each one of those 
wells. And so being able to marry those different things 
together and being able to do that and then rapidly move that 
into an animal model, those things are important, to have that 
whole spectrum represented. Whether or not that requires one 
institution or multiple institutions is important.
     And I think, as was said earlier, having these assays sort 
of ready to go is important, and so thinking about what these 
might be, they often have to do with toxicity, whether or not 
they kill cells or something like that, those are the things 
that need to be thought about ahead of time so they can be 
ready to go.
     Chairman Foster. OK. So, I'm afraid I have to----
     Ms. Bonamici. OK. My--yes, my time is expired. I yield 
back, Mr. Chairman, thank you.
     Chairman Foster. That's all right. And we'll have a little 
bit of forbearance with Representatives who are coming in on 
the telephone because they can't see the timer.
     And we'll now recognize Representative Biggs for 5 
minutes.
     Mr. Biggs. Thank you, Mr. Chairman, and thanks, Ranking 
Member Lucas, and thank you to each Member of the panel. This 
has been very interesting.
     And as we're trying to develop vaccine or cures for the 
COVID, I see we're moving fairly rapidly. It looks like we're 
moving rapidly. And I appreciate Dr. Lurie talking through 
this, maintaining some standards and normalcy.
     But I guess my question that I want to ask here is, as we 
go through this and we accelerate these processes, can you 
address, and I'll just open it up to whoever wants to answer 
this. How can we maintain scientific rigor while we're 
accelerating the development of vaccines and curatives? And 
each one of you have nibbled around the edges here, but I'm 
wondering if there's any way that you see that we can maintain 
that scientific rigor that's so necessary if we're going to 
really get a handle on this?
     Dr. Lurie. Well, you know, I think the playbook is clear. 
The playbook is the playbook that we've had for decades, the 
playbook that has produced effective therapy through following 
that very playbook, through keeping to strong standards. So, 
all I think we really need to do is to coordinate better, 
obviously speed things up the way researchers collectively have 
decided to do by turning their attention to this. And if we 
keep our standards up, I like to think that ultimately we'll 
have the products that we need.
     Mr. Biggs. Well, and so that gets me to Dr. Rome, who I 
think mentioned something I'm in total agreement with if you'd 
maybe expand on that. You said in EUAs one of the things that 
we need to do is be more transparent. And so, Dr. Rome, if you 
would just address that, how we do that and how can we best be 
more transparent?
     Dr. Rome. Yes, thank you. I totally agree. Transparency is 
key with EUAs. We had two examples of EUAs or emergency use 
authorizations so far during this pandemic, so 
hydroxychloroquine and chloroquine was the first one. That was 
based on very little evidence. But when the EUA came out, it 
wasn't clear what evidence the FDA had considered, and it sort 
of--only later did we sort of learn a little bit about what 
they--what was going through the minds of the folks at the FDA.
     With remdesivir, we had a top-line result published by the 
clinical trial, but we--not until 3 weeks later did we have the 
full data that was released in the New England Journal of 
Medicine. And during those 3 weeks the drug was already being 
shipped out to hospitals and humans, and we didn't know 
necessarily how to best target the drug toward particular 
patients or if there was--and we had a limited supply.
     So, absolutely, transparency is key. The FDA should make 
decisions in a consistent way that meet the standard. The 
standard for any EUA is that it is reasonable to believe, based 
on the totality of evidence, that the drug is likely to be 
effective. So, that reasonable-to-believe standard needs to be 
enforced. When new data comes out, we need to reassess. And we 
need the--whatever data that the FDA is using to make those 
decisions should be public at the same moment that the EUA 
letter is issued.
     Mr. Biggs. Great. Thank you. And I'm just going to go to 
Dr. Stevens. Dr. Stevens, you mentioned that although 
repurposing existing drugs may be a fast route to possible 
treatments, it's highly likely that we're going to still need 
purpose-built drugs for treating COVID-19. Can you expand on 
how the work that you're doing at Argonne be leveraged by 
pharmaceutical companies to help develop purpose-built drugs 
specifically?
     Dr. Stevens. Yes. So, what the team is doing is we are 
trying to produce a set of qualified leads. That would be 
compounds that show some promise in the computational work, 
they show some promise in initial functional assays and initial 
whole cell assays but are not fully refined as drugs. These 
would be compounds that we would essentially handover to the 
pharmaceutical industry and say here's all the data that we've 
computed and that we've measured on these compounds and let 
them take it from there.
     And this--that kind of handoff has been discussed between 
the labs and pharma, and it's the kind of thing that pharma is 
very interested in because you think of the--the drug and all 
the processes is a giant funnel, and at the top of the funnel 
you've got billions of possible molecules out of the--out of 10 
to the 60th possible drug molecules, we know of a few billion 
of them that we've thought about in some sense, and we have to 
narrow that down to handfuls, you know, 10's or 20's of 
compounds the pharmaceutical industry can take and do more 
advanced studies on, can refine and improve the molecules, 
improve their safety, improve their effectiveness, improve the 
therapeutic window.
     And so what we're doing in the public sector is 
essentially that big top part of the funnel and reducing it 
down in a very public way, in a very open way, to set of 
priorities that they can then take and invest private money 
into drugs. That's the strategy.
     Mr. Biggs. Right. Thank you. And with that, Mr. Chairman, 
I'll yield back.
     Chairman Foster. Thank you. And I will now recognize Mr. 
Beyer for 5 minutes.
     Mr. Beyer. Thank you, Mr. Chairman, and thanks, all of 
you, for being with us.
     Let me begin with Dr. Rome. One of the things in your 
testimony you said it's imperative that we establish a clinical 
trial network. Does one not already exist, and isn't that part 
of the function of NIH to have established that over the years?
     Dr. Rome. Thank you for the question. Yes, so, certainly, 
we have small networks of clinical trials, and I think that Dr. 
Finigan could probably speak to this more as a trialist 
himself, but I would say that the NIH does in fact do direct 
research itself in some cases, as was the case in remdesivir. 
But in other cases it will outsource to academics. And, as was 
already mentioned, when a study is done at multiple sites, 
there's a lot of regulatory things that need to happen. You 
need to assure safety of the clinical trial through 
institutional review boards, and that can take a long time.
     And so by--what I think the--where I think the efforts 
need to be is, you know, clinical trialists and scientists are 
ready to go and want to act. What needs to be cut down on are 
the things that are super important like maintaining patient 
safety, but the time to do those things and the time to 
correlate across different sites can definitely be cut down on 
by investing further in those infrastructures.
     Mr. Beyer. The vision has to be that there is an existing 
national network of clinical sites, say, 50, 100, 300, that in 
a future crisis, click, you turn it on.
     So, to Dr. Finigan, you mentioned that at National Jewish 
Health you're working on delineating the structure of the 
protein. Why would an individual hospital do that rather than 
the national labs that have all the--you know, the big 
computing machines, the neutron devices and the light devices?
     Dr. Finigan. You know, I mean, it has to--so it has to do 
with a couple things. No. 1, ability and interest. We have 
people who have that ability and can do it. And, as I said, 
everything is sort of reoriented toward COVID-19, so everybody 
in the hospital dropped what they were doing and started to do 
new things directed toward COVID-19. So, people who had that 
ability here worked on that.
     I think it also speaks to a little bit of a lack of 
coordination of how this would be attacked from the beginning, 
and so from the beginning there was not a sort of--at least not 
a publicly announced kind of strategy that was clear to 
everybody in terms of how things were going to happen, how 
things were going to get laid out from sort of basic science, 
understanding some of those basic facts to driving it into 
clinical trials, and that creates a fair amount of duplication.
     And an example of that, just to answer the question you 
brought up earlier, there are clinical networks that have 
existed, and there are lots of them that still exist. It's just 
that it took several months to utilize those for COVID-19. They 
sat not being used for COVID-19 trials for a period of time, 
and now they're starting to get used. And so it may not be 
creating a new network. It just means understanding that these 
things exist and you have a strategy ready to go that you're 
going to use.
     Mr. Beyer. Great, thank you. Thank you. Dr. Stevens, I was 
fascinated by the notion that the COVID--you know, the RNA 
translates into 30 specific proteins. You understand the 
structure, how they're folded, that 10 to 20 of them are what 
creates this issue. And you talk about purpose-built. Is it--
are you thinking or is it possible to think--and I think 
mathematically with your supercomputers about how to tear apart 
one of those 20 proteins?
     Dr. Stevens. Well, we're building both physics-based 
models and AI models to essentially design--custom design 
inhibitor molecules for each of those proteins using the power 
of supercomputing. I mean, that's what the community that can 
do this type of biophysical modeling and AI is working on. 
There are many groups that are collaborating on this task, and 
I believe in the near future--I can't say exactly how long this 
will take--we will have new compounds that are the result of 
this process that will go into the experimental screening 
pipelines.
     Mr. Beyer. But do you have to disrupt more than one of 
those 20 proteins to make a----
     Dr. Stevens. Yes, you have to. If you look at state-of-
the-art antiviral therapies, often they're a cocktail of drugs, 
and so we think the best strategy is probably a multiple 
therapeutic mix that would go after multiple targets, maybe a 
target that would help in blocking viral entry, one that might 
block replication, one that might block some host process that 
is a problem, and so forth. And so you would probably end up at 
the end of the day with a mixture of compounds in a future 
drug--or future drug treatment.
     I think it's really important, though, to say that to 
develop the kind of drugs that we're imagining will take a long 
time. If you think about in the case of HIV, it took many, many 
years before there were effective HIV therapies, over a decade, 
and while we're moving faster, and we have better tools, this 
is a very hard problem. And while the scientific community has 
been working the last few months in a kind of crisis mode on 
this, they can't work in crisis mode for many years, and so we 
have to put institutional structures around this to get it 
done.
     Mr. Beyer. Thank you very much. And I yield back, Mr. 
Chairman.
     Chairman Foster. Thank you. I'll recognize Representative 
Wexton for 5 minutes. Mute. Whoops, microphone. Mute. You're 
muted.
     Ms. Wexton. Shame on me. Hi. Thank you, Mr. Chairman, for 
yielding and for not charging me my 5 minutes quite yet. And to 
the panelists for joining us today, this is a really 
fascinating discussion, and I'm glad to be here for it.
     You know, the controversy surrounding the FDA's EUA for 
hydroxychloroquine has caused a lot of people to question the 
scientific integrity of FDA's process, and so the policymaking 
especially during this pandemic. Dr. Lurie and Dr. Rome, could 
you please give us your general assessment of the rigor of FDA 
policymaking and public communications regarding the 
repurposing of therapeutic drugs during this pandemic and then 
what needs to be done better, if anything?
     Dr. Lurie. Well, I certainly agree that it has been a 
disappointment, and I don't think it's because of the career 
officials in FDA, who I believe are completely committed to 
scientific integrity and proper regulatory procedures in this 
pandemic. But I do think that people have turned out to be 
susceptible to political pressure.
     The hydroxychloroquine example is frankly an 
embarrassment. The standard for approving the EUA was 
considerably below what it was in previous EUAs, and I say this 
based on talking to people who granted EUAs in previous 
Administrations. And so, in the end, that turned out to be a 
black eye for the agency.
     Another embarrassment I think has turned out to be 
antibody tests where for a while the agency allowed these 
products to come on the market without even an EUA. And then 
that turned out to be a disaster when it turned out that they 
were plagued by false positives, so now they have an EUA.
     What I hope is that from the combination of those two 
experiences we'll get a proper use of the EUA process, which I 
think we are now seeing for remdesivir, and I sincerely believe 
and hope that my former colleagues at FDA will be able to stand 
up to the political pressure, because it is certainly searing.
     Ms. Wexton. And Dr. Rome, how about you?
     Dr. Rome. Yes, thank you for the question. I think what 
you're getting at is actually an issue that has come up again 
and again, which is sort of the standards of evidence sort of 
required for any drug approval even before COVID-19, which 
traditionally were statutorily supposed to be based on sort of 
substantial evidence, so it means that traditionally that meant 
two clinical trials, two large randomized clinical trials to 
make sure that even if one trial got the answer wrong, that we 
wouldn't get it wrong twice. And that has changed over time.
     There are many drugs now that are expedited through the 
FDA process, and that's something that needs to be considered. 
And that's sort of the background for when--you know, when 
COVID-19 came, we've already experienced the fact that 80-plus 
percent of drugs are approved through some expedited pathway 
may be based on more limited evidence than that traditional two 
clinical trials. So, during COVID-19, we've relied, you know, 
on the EUA to sort of cutoff the FDA approval process and act 
before the FDA sort of carefully considers all the evidence.
     It makes total sense, and certainly time is of the 
essence, but to your point, we actually have very little 
experience using EUAs in--for drugs. It was done during a swine 
flu pandemic of 2009, 2010. There, a drug was issued an EUA, 
and the--but data that later came out from the clinical trials 
showed that the drug was not actually effective for the type of 
patients the EUA was issued for.
     Now, we have hydroxychloroquine and remdesivir, so we've 
maybe hit one out of three potentially that we don't know the 
full story on remdesivir, but certainly this is the time for 
Congress to take a look at the way the EUAs have been utilized 
and tune up the regulations on the FDA to make sure it's done 
appropriately in the context of the speed that's needed.
     Ms. Wexton. So, in this final minute I guess my question 
is also there's going to be a lot of financial incentives for 
various firms to get their drugs through this EUA process and 
get them approved. What--how does the FDA assess and eliminate 
conflicts of interest in its drug approval process, make sure 
that there's no conflicts in the decisionmaking process?
     Dr. Lurie. Well, I--quite frankly, the process is infected 
with conflict of interest, and there's not very much that can 
be done about it in the following sense. We accept the idea 
that drug trials, trials of diagnostics and vaccines, are 
conducted in general by the manufacturers themselves, and so 
it's a given that there will be that kind of conflict of 
interest in that the companies will come in with an interest in 
depicting the data in the way that best suits them.
     But that's where the FDA comes in. That's where the FDA's 
review of the actual data itself, which no other country in the 
world claims to do, that's where that kind of review, that kind 
of insulating of the reviewers from the manufacturers is so 
important. And that's the way it's managed. But it's a given 
that most of the time the studies will be done by the 
manufacturers themselves.
     Ms. Wexton. Thank you very much. I see my time has 
expired, and I will yield back.
     Chairman Foster. Well, thank you. And I will now recognize 
Representative Perlmutter to unmute and----
     Mr. Perlmutter. Thanks, Mr. Chair. And to the panelists, 
thank you all for your testimony. I've been watching you all 
listen and watch each other, and it's been interesting.
     So, the first question I have--and, Dr. Finigan, you 
brought up a couple networks, and you say there are networks in 
place, but they really didn't get activated promptly. So, you 
talked about ACTIV and you talked about PETAL I guess, sort of 
the acronyms for these things. And to everybody but start with 
you, Dr. Finigan, a pandemic comes, we see this thing starting 
to roll, how is there--is there some lead agency, is it CDC, is 
it NIH, is it BARDA, is it--who is it that says to these 
networks, OK, everybody's got to jump to whether it's hospitals 
or the laboratories or who says ``get going?''
     Dr. Finigan. So, I think to a certain degree the exact 
agency that does it doesn't matter. I think it just needs to be 
understood out of time. And so whether or not it is the NIH or 
BARDA, it--you know, or another agency, I don't think really 
matters. It's just a function of thinking ahead of time and 
knowing ahead of time that these networks exist and that you 
want to put them into action and especially in a situation like 
this where you actually have some lead time. So, we knew about 
this pandemic for some time, and we could have been planning 
it, and so it doesn't necessarily matter that it's the CDC or a 
different agency. Whichever agency, let's say, funds that 
network or if you need to bring in more than one network and 
you might need to have cross agency, those things just need to 
be thought of ahead of time.
     Other aspects like how you would do consenting for 
patients and those things also should be thought of ahead of 
time so that that can be streamlined as quickly as possible for 
when you need to utilize those networks.
     Mr. Perlmutter. So, Dr. Stevens, when were the labs sort 
of kicked into gear on this thing?
     Dr. Stevens. The labs started to self-organize around the 
1st of March ahead of the official proclamations. We have a bit 
of internal flexibility at the labs and we used that 
flexibility to get started. That's why the labs exist, to do 
large-scale science, interdisciplinary, and so--and we're used 
to taking initiatives on our own, taking our own initiatives, 
so the labs started talking to each other, we started arranging 
computer time, we started pulling together teams actually long 
before the pandemic was declared. And DOE headquarters was very 
supportive that we were already moving.
     And so I think the community--I think the others would--
panelists would agree. The community saw this coming and 
started to do things that they could do within the realm of 
their degrees of freedom of action, and the agencies then came 
up to speed to start resourcing things. So, I think, you know, 
it all sort of happened in parallel.
     Mr. Perlmutter. So, to all of you, from our--so our 
Science Committee we have a little bit of jurisdiction with 
respect to hospitals but not a lot, but we do have definitely 
jurisdiction over the laboratories. So, is there any connection 
in these networks that you talked about, Dr. Finigan, or you 
talked about the nine labs that you're collaborating with, Dr. 
Stevens? Is there any connection between sort of these hospital 
networks and our laboratories? Are you guys talking to each 
other?
     Dr. Stevens. Not so much. The Department of Energy 
typically doesn't get involved in clinical research. Our 
laboratory doesn't have ongoing internal projects related to 
clinical work. This is largely due to the distinctions between 
the different agencies that fund that work. We do have a lot of 
collaborators in universities, and so the way in which we--and 
I personally have a joint appointment at the University of 
Chicago where I have colleagues in clinical trials and I have 
funding from NIH and connections to clinical work via my 
university appointment and from talking to those people so, 
personally, we have contacts. But, institutionally, the 
Department of Energy, typically, the DOE laboratories that they 
support aren't involved in clinical work.
     Mr. Perlmutter. All right. Well, let me turn to Dr. Rome 
for my last 45 seconds. So, at Harvard--so National Jewish 
collaborates with lots of hospitals, the University of 
Colorado, a bunch of other stuff. Harvard obviously 
collaborates with everything around the world. When did your 
medical school and when did you sort of--or how--get engaged in 
this thing, I mean, the minute we heard about it from China or 
how did that go?
     Dr. Rome. I agree with what's been said that the 
scientific community acted early, but acting early involves 
having information, and I think the information comes from the 
top in this case. The information out of China was challenging, 
I think, for medical professionals to understand, and so by the 
time in March that people started to gear up here, that might 
have been unfortunately pushed earlier had the Administration 
and everyone else in the government sort of set the ball moving 
and pushed for action earlier on.
     Mr. Perlmutter. And I guess I was remiss to say Dr. 
Finigan helped me on a telephone town hall where we had 10,000 
people on the line, and so I just wanted to mention that and 
thank all of you for your testimony today. I really appreciate 
it.
     Chairman Foster. Well, thank you all. At this point I 
guess there's probably enough Member interest for another round 
of questioning for those Members who wish, and so we can 
quickly--all right. Mr. Perlmutter and Beyer. OK. So, this may 
be a brief round of questions here, but I would like to follow 
up on a couple of points.
     The--Dr. Finigan, you sort of mentioned the idea, the 
concept that there--instead of having to replicate the approval 
of the remdesivir trial at 60 different locations, that there 
could be some single point of approval. And are you--is it 
realistic to expect that individual institutions will buy into 
that mechanism, that they'll be willing to outsource the 
approval of a clinical trial that may or may not, you know, be 
safe, which is one of their concerns?
     Dr. Finigan. So, the answer is no, they're not going to 
give it up, but I think there's things you can do ahead of time 
to make it go much faster. So, what happens with a trial like 
the remdesivir trial or other trials that we have going on is 
an industry sponsor in these instances reaches out to us, asks 
us if we want to be a part of it. We say yes, and then there--
at that point you begin the back-and-forth of we get the 
protocol, we read it, it goes through our process, we have to 
approve it and make sure it's safe, we have to discuss the 
budget, we need to make sure we have to do it. While we're--
they're doing that with us, they're doing that individually at 
all the different sites. If we spend, let's say, 3 weeks 
working on it and then decide we can't do it, that's wasted 
time for everybody.
     So, if this--so if you have a network like, let's say, the 
PETAL network that I mentioned, this exists already in place. A 
lot of that work has been taken care of already, and so a lot 
of that immediate work and legwork in terms of getting things 
approved and contracting and budgeting, that stuff might be 
taken care of. And so you can imagine a situation where a drug 
company might say I have a drug, I think it's promising, I want 
to use this federally funded network and maybe there's some 
mechanism by which they have to pay in to use that to help keep 
that funded but allows them to very rapidly get their drug out 
there and not have to go through the process every time.
     Chairman Foster. All right. And so, yes, you touched on 
the issue of getting the commercial incentives right, because 
that must be very delicate in this because, you know, obviously 
if a drug company can get the Federal taxpayer to pay for a 
clinical trial for a drug that they'll eventually make money 
on, you know, say this is something which is a currently 
unapproved use, you'd think that there ought to be a mechanism 
in place somehow to have the drug--the Federal taxpayer, you 
know, have some benefit from the fact that they paid for this 
trial.
     And are there countries anywhere that have a different 
model that might be more effective for dealing with the--you 
know, the commercial interest to fund trials, or do they just 
fully federalize it and there's a big pot of money that--and a 
group of scientists who decide what is the most scientifically 
promising and allocate some fraction of the clinical trials 
that way?
     Dr. Finigan. So, I can't speak to what happens very 
knowledgeably in other countries. I'll let other people address 
that if they know that. What I will say briefly is that there 
are some examples of--I don't know if it's quite public-private 
partnerships but, for example, in cystic fibrosis, the Cystic 
Fibrosis Foundation, which really sort of regulates a lot of 
the trials that happen in cystic fibrosis in kids and adults, 
partnered with an industry sponsor on new drugs so that they 
could rapidly get those drugs sort of tested, and then those 
were successful and approved, and so the drug company and the 
Cystic Fibrosis Foundation both benefited from that. And I 
think that's an example that could be replicated in other 
instances. And I'll let others talk about other countries.
     Chairman Foster. Dr. Rome, any comments?
     Dr. Rome. Yes, I guess I would say that I don't know of 
another country sort of to your question of sort of how that 
balance is made other than other countries do a much better job 
negotiating for value-based prices of drugs so that we do not 
sort of double pay, paying sort of through the roof for 
clinical research to develop the drug and then secondarily for 
high prices, so that's one comment.
     The other is that not just in COVID-19, again, I mentioned 
the example of remdesivir, which is exactly what you said. A 
government is funding the late stage sort of clinical trial 
development. That occurs in one in four drugs that have been 
developed over the last decade where the Federal Government is 
involved late in the development of a drug. And almost every 
drug has some sort of Federal involvement in the early stages 
of development, so this is absolutely a problem. It's going to 
be highlighted in COVID-19, and it's going to affect how the 
drugs are able to be accessed by patients once we have to--you 
know, once patients and insurance companies have to pay for 
them, so it's definitely something that needs to be addressed.
     Chairman Foster. Well, thank you. And I think one of the 
most potentially tragic outcomes is that promising drugs just 
won't get looked into that should if you don't set this up 
right. All right.
     And at this point I'm happy to recognize Chairman Lucas 
for 5 minutes of additional questions.
     Mr. Lucas. Mr. Chairman, I will yield back but simply note 
our constituents out in the countryside are frantically looking 
for ways to protect themselves from this or cures to address 
it. I'd like to think that all the discussion here today about 
the challenges we face to this point, still the underlying 
issue is we're making progress, diligently working to address 
the needs of our constituents, and that they should have faith 
in the institutions both inside and outside the Federal 
Government that are working together, healthcare industry 
included, to try and address their needs, needs that are 
brought on through issues by no fault of their own, just the 
world we live in at this time.
     And with that, Mr. Chairman, I yield back.
     Chairman Foster. Thank you. And I'll now recognize 
Representative Beyer for 5 minutes.
     Mr. Beyer. Thank you, Mr. Chairman, very much.
     Dr. Stevens, in your testimony you talked about us paying 
attention in the long term to emerging pathogens. How do you 
define emerging pathogens? Does someone have to get sick before 
we do it? And given the billions of different viruses that are 
out there, what constitutes an emerging one?
     Dr. Stevens. Well, it's--there are several definitions, 
but the one that I think most people would agree with, it's 
pathogens that are relatively new to science, so these could be 
pathogens, zoonotic pathogens that are endemic in wild animals, 
maybe in places people don't normally live, and as humans, 
human development, and economic development pushes large 
numbers of people closer to these previously wild areas, 
there's lots of opportunity for contact with these animal 
species, and new pathogens can emerge that way. That's the 
primary mechanism.
     If you think over the last couple of decades, the viral 
pathogens, Ebola, Zika, SARS, COVID-2--SARS-CoV-2, these have 
all emerged from animal reservoirs, and so my recommendation is 
that we mount a scientifically based international program to 
surveille wild populations, understand their microbiomes, the 
natural viruses that coexist with them, and study them. We have 
the technology for doing that. We could easily sequence these 
things. We can produce the structures. We can get ahead of the 
curve. We can understand the reservoirs much better than we do 
currently, and that would leave us more time to be ready for 
the next one.
     Mr. Beyer. Thank you. You also mentioned that there are 10 
million molecules available for experimental validation. Well, 
you can't--are you--and you talked about the windowing, the 
funneling.
     Dr. Stevens. That's right.
     Mr. Beyer. Is the first funnel going to be a mathematical 
one, the physical one rather than experimental----
     Dr. Stevens. Well, the top of the funnel occurs in some 
theoretical sense as every molecule that's possibly drug like 
is about 10 to the 60th. The drug companies and the academic 
community have an understanding of maybe 4 to 5 billion 
molecules. Of that, maybe 10 million are something I can get my 
hands on in a couple of weeks. Of course, synthetic chemists 
can make new things roughly in that timeframe as well, so it 
would be conceivable to create ahead of time panels, that is, 
collections of molecules that are ready but essentially 
standing by in the freezers.
     And if you have an emerging outbreak and you develop 
assays quickly, you could screen a very large set of molecules 
in a few months and have a lot of possible leads to chase down. 
And combining that with computation would create a much better 
situation in terms of future therapeutic development, and 
that's something I think the community would be very excited to 
work towards.
     Mr. Beyer. Excellent. Thank you. And it is amazing trying 
to get your arms around 100 million molecules.
     One last question. Dr. Rome, your fourth point was making 
improvements to FDA's EUA process, and you talked about the 
bullets, clarifying and standardizing transparency, equitable 
distribution, and then patient outcome data. Is this something 
that should be done regulatorily or is this a perfect piece of 
legislation for the House Science Committee?
     Dr. Rome. So, the FDA has the ability to do some of these 
things but has not done so. They have the ability to collect 
information about the drugs, but they're not required to and--
other than adverse event or safety reporting of sort of major 
events like deaths that occur from the drug, so that has 
happened, but further data has not been required as part of the 
EUAs. The FDA has broad authority to write into the EUA sort of 
what it wants in terms of requirements, but certainly those 
requirements--you know, that sort of broad authority could be 
better regulated by Congress by sort of more directing and 
saying when you issue an EUA, these are the things that we 
think are necessary.
     And we've learned a great deal about what would be 
helpful. I would say, again, more transparency at the outset so 
that physicians who are using the drugs from an EUA have access 
to data, you know, not just the data that's, you know, on the 
internet but actually like the raw data, the published studies.
     Mr. Beyer. And you wouldn't think that we were guilty of 
micromanagement if we led that?
     Dr. Rome. I mean, I think that these things need to 
happen, and so I think if Congress wants to step up and say 
that for all future EUAs that these are some tweaks that we 
think are necessary, I think that's reasonable. I would say the 
EUA is not just to drugs. The EUA applies to diagnostics, 
testing equipment that has been mentioned before, ventilators, 
other things. So, again, drugs are a minority of cases over the 
history of the EUA that have been--where it's been used, so we 
only have really three examples, two of which, you know, are 
for this pandemic alone. So, we are--you know, I do think it's 
time to reevaluate how that was used and decide if change--
small changes, legislative changes need to be made.
     Mr. Beyer. All right. Thank you very much. Mr. Chairman, I 
yield back.
     Chairman Foster. Thank you. And I'll now recognize 
Representative Perlmutter for 5 minutes.
     Mr. Perlmutter. Just one question, and start with you, Dr. 
Lurie. Anybody can jump in. The serologic tests, the antibody 
tests I guess, there are a whole bunch of them. Some have been 
approved, I guess, and some have not been approved. So, going 
to the diagnostics that you were talking about, Dr. Rome, did 
we do this right or not or is there now sort of doubt about 
these tests and their validity? Dr. Lurie?
     Dr. Lurie. Well, in referring to the antibody tests 
specifically, I don't think that has been well-handled by FDA. 
I think that, feeling the pressure to press ahead, they gave 
the antibody tests a free pass to begin with, not even 
requiring an EUA for them. And it didn't take long for evidence 
to mount that, particularly in low-prevalence populations, 
certain of these tests could actually produce more false 
positives than true positives. And I think that first the 
agency took a look at what they'd done and then they slapped an 
EUA upon them giving the companies 10 days to comply. I don't 
know how many of them have met the EUA requirements at this 
point, but I expect that certain of those products will just 
disappear because they couldn't meet the standards.
     So, again, what I'm sorry to say has happened is that the 
FDA has been--you know, they're kind of flip-flopping or, if 
you like, course-correcting, you know, to try and get this 
exactly right. They've made some mistakes. Hopefully, it will 
be better going forward.
     Mr. Perlmutter. OK. Thank you. I don't know if anybody 
else has any comments. I just want to thank the panel, and I'm 
happy to yield back to you, Mr. Chairman.
     Chairman Foster. Well, thank you. And I--you know, I have 
to say that I was a little bit surprised when the antibody 
tests came out so flawed, that there was no one responsible for 
making--for--in the government for establishing a test panel 
that you run every one of the proposed tests against just blood 
samples of positive and negative people that would be just 
prepared and at least given to every manufacturer to test 
against and report their results. And, you know, that seems 
like the sort of infrastructure that should exist somewhere in 
the future when this sort of thing happens.
     And I was also fascinated by Representative Beyer's 
suggestion of potential legislation coming out of this, that 
there may be something sensible that could be done there. And, 
let's see, I can--now can--have about one remaining minute of 
Representative Perlmutter's time, so I'd just like--Dr. 
Stevens, how leaky is the funnel? How often do you see a drug 
that works wonderfully in practice and not at all in theory?
     Dr. Stevens. Well, it usually means our theory is wrong, 
so we have to go back and fix the theory if that happens. The 
funnel is pretty leaky in the sense that things fall out that 
we have to filter out because we're using approximate rules 
often to do this. But, you know, most of what we look at 
doesn't work. I mean, that's the reality of drug development. 
Most compounds don't work. And so it is a needle-in-a-haystack 
type of problem, and occasionally, you will find drugs that 
defy our, you know, initial view, but those usually don't come 
from the computational process because we filter those out. 
They would come through physical screens and natural products, 
for example, and then you have to go back and rethink them. So, 
you need combinations of both. This can't all be 
computationally driven. As I mentioned before, large chemical 
libraries that would be screened in public I think is another 
resource that we need as infrastructure.
     Chairman Foster. All right. Well, anyway, I just want to 
thank all of our witnesses at this point before bringing the 
hearing to a close. It's very important. And keep thinking, as 
you're doing your daytime job here, what changes you'd like to 
see in place for the next pandemic because I think that's going 
to be a big part of our job is to try to preserve the attention 
span of Congress so that we're better prepared.
     I guess someone smart once said you go to war with the 
army you have, and next time--next pandemic I'd like a slightly 
better army. And just thank you all for being part of the army 
that we have.
     So, the record here will be open--remain open for 2 weeks 
for additional statements from Members for any additional 
questions that the Committee may ask the witnesses, and the 
witnesses are now excused, and the hearing is adjourned.
     [Whereupon, at 3:04 p.m., the Subcommittee was adjourned.]

                                 [all]