[Senate Hearing 116-518]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 116-518

                     COVID-19: LESSONS LEARNED TO 
                     PREPARE FOR THE NEXT PANDEMIC

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                                   ON

     EXAMINING COVID-19, FOCUSING ON LESSONS LEARNED TO PREPARE 
                         FOR THE NEXT PANDEMIC

                               __________

                             JUNE 23, 2020

                               __________

    Printed for the use of the Committee on Health, Education, 
                         Labor, and Pensions
                         
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                         


        Available via the World Wide Web: http://www.govinfo.gov
        
                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
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            COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                  LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming		PATTY MURRAY, Washington
RICHARD BURR, North Carolina		BERNARD SANDERS (I), Vermont
RAND Paul, Kentucky			ROBERT P. CASEY, JR., Pennsylvania
SUSAN M. COLLINS, Maine			TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana		CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas		        ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska			TIM KAINE, Virginia
TIM SCOTT, South Carolina		MARGARET WOOD HASSAN, New Hampshire
MITT ROMNEY, Utah		        TINA SMITH, Minnesota
MIKE BRAUN, Indiana			DOUG JONES, Alabama
KELLY Loeffler, Georgia			JACKY ROSEN, Nevada

                                     
               David P. Cleary, Republican Staff Director
         Lindsey Ward Seidman, Republican Deputy Staff Director
                  Evan Schatz, Minority Staff Director
              John Righter, Minority Deputy Staff Director

                            
                            
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                         TUESDAY, JUNE 23, 2020

                                                                   Page

                           Committee Members

Alexander, Hon. Lamar, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State 
  of Washington, Opening statement...............................     4

                               Witnesses

Frist, William, M.D., Former U.S. Senate Majority Leader, 
  Nashville, TN..................................................     7
    Prepared statement...........................................     8
    Summary statement............................................    15
Khaldun, Joneigh S., M.D., MPH, FACEP, Chief Medical Executive 
  And Chief Deputy Director For Health, Michigan Department of 
  Health and Human Services, Lansing, MI.........................    16
    Prepared statement...........................................    18
    Summary statement............................................    22
Gerberding, Julie L., M.D., MPH, Executive Vice President And 
  Chief Patient Officer, Merck & Co., Inc., Co-Chair, CSIS 
  Commission on Strengthening America's Health Security, 
  Kenilworth, NJ.................................................    23
    Prepared statement...........................................    24
    Summary statement............................................    28
Leavitt, Michael O., Former U.S. Secretary of Health And Human 
  Services, Salt Lake City, UT...................................    29
    Prepared statement...........................................    30
    Summary statement............................................    36

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
    Senators Schumer and Murray, testing letter..................    69
    ASM Statement letter.........................................    71
    Health Equity Principles for State and Local Leaders in 
      Responding to, Reopening, and Recovering from COVID-19, 
      Robert Wood Johnson........................................    75
Bill Frist:
    A Storm For Which We Were Unprepared.........................    80
    Pandemic; The Economy's Silent Killer, Bill Frist Remarks 
      Dec. 8, 2005...............................................    86

 
                      COVID-19: LESSONS LEARNED TO
                     PREPARE FOR THE NEXT PANDEMIC

                              ----------                              


                         Tuesday, June 23, 2020

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:03 a.m., in 
room SD-430, Dirksen Senate Office Building, Hon. Lamar 
Alexander, Chairman of the Committee, presiding.
    Present: Senators Alexander [presiding], Burr, Collins, 
Cassidy, Roberts, Murkowski, Romney, Braun, Murray, Baldwin, 
Murphy, Warren, Kain, Hassan, Smith, Jones, and Rosen.

                 OPENING STATEMENT OF SENATOR ALEXANDER

    The Chairman. The Committee on Health, Education, Labor, 
and Pensions will please come to order. First, the usual 
administrative matters. This is a little like the theater 
announcements that we used to receive. We are getting used to 
those. We follow the advice of the attending physician and the 
Sergeant-at-Arms who have consulted with all the right people. 
We are seated at least six feet apart. That means there is no 
room for the public or the media here, but the media is 
participating, we hope, and we hope the public is as well. 
www.help.senate.gov is our website.
    Our witnesses are participating by video conference, which 
is a real change for the U.S. Senate and in some ways a very 
welcomed one because I think it makes it possible for us to be 
able to attract witnesses who have very busy schedules on the 
same day such as today. Some Senators are participating by 
video conference.
    Senators may remove their masks since we are 6 feet apart. 
I am grateful to the Rules Committee, the Sergeant-at-Arms, the 
Press Gallery, the Architect of the Capitol, the Capitol 
Police, our Committee staffs, and Chung Shek and Evan Griffis 
for all their hard work to help keep us safe. Senator Murray 
and I will each have an opening statement and then we'll turn 
to our witnesses who we thank very much for being with us 
today.
    Each witness, we would ask that you summarize your remarks 
in five minutes, which will allow more time for the large 
number of Senators who we expect to participate to present 
their testimony. We will have one round of questions for a five 
minute round.
    Less than four months ago, on March 1, the coronavirus 
situation was about this. At the end of February, there were 
79,000 cases around the world. Only 14 in the United States, 
except for 39 who had been brought home from overseas with the 
virus. By March the 2nd, there were two deaths in the United 
States. By March the 3rd, when we had a hearing, there were six 
deaths. And on March the 1st, on Sunday in the New York Times 
on the front page it said this, that most experts were far from 
certain that this virus would carry to all parts of the United 
States, and that with its top-notch scientists, ``modern 
hospitals and sprawling public health infrastructure, most 
experts agree the United States is among the countries best 
prepared to prevent or manage such an epidemic.''
    Well, even six weeks after the first virus was found in the 
United States, even the experts underestimated the ease of 
transmission and the ability of this coronavirus to spread 
without symptoms. These qualities made the virus, in the words 
of Dr. Fauci, ``my worst nightmare.'' In the period of four 
months, he said, it has devastated the world. This Committee is 
holding this hearing today because even with an event as 
significant as COVID-19, memories fade and attention moves 
quickly to the next crisis. While the Nation is in the midst of 
responding to COVID-19, the U.S. Congress should take stock now 
of what parts of the local, state, and Federal response to this 
crisis worked, what could work better and how, and be prepared 
to pass legislation this year to be better prepared for the 
next pandemic which will surely come.
    On June 9, I released a white paper outlining five 
recommendations for Congress to prepare Americans for the next 
pandemic. They were these. No. 1, tests, treatments and 
vaccines. Accelerate research and development. No. 2, disease 
surveillance. Expand our ability to detect, identify, model, 
and track emerging infectious diseases.
    No. 3, stock piles, distributions, and surges. Rebuild and 
maintain Federal and state stockpiles, and improve medical 
Supply surge capacity and distribution. No. 4, public health 
capabilities. Improve state and local public health 
capabilities. And finally, who is on the flagpole, who is in 
charge. Improve coordination of Federal agencies during a 
public health emergency. I have invited comments and responses 
in any additional recommendations for the Senate Committee on 
Health, Education, Labor, and Pensions to consider. I will 
share this feedback with my colleagues, both on the Democratic 
and the Republican side.
    This is not a new subject for any of the witnesses that we 
have today. 15 years ago the then Majority Leader of the U.S. 
Senate Bill Frist said in a speech at the National Press Club 
that a viral pandemic is no longer a question of, if but a 
question of when. He recommended what he calls a six-point 
public health prescription to minimize the blow, 
communications, surveillance, antivirals, vaccines, research, 
stockpile surge capacity. Senator Frist is one of our witnesses 
today and I am including in the record two of his speeches.
    Our next witness, Dr. Joneigh Khaldun serves as Chief 
Medical Executive and Chief Deputy Director for the Michigan 
Department of Health and Human Services, where she has worked 
to coordinate the state's response to COVID-19. Our third 
witness is Dr. Julie Gerberding, who served as Director of The 
Centers for Disease Control and Prevention under President 
George W. Bush. She helped lead preparedness efforts on the 
response to SARS, West Nile Virus, H5N1 Avian Influenza, and 
the rise of multi-drug resistant bacteria like MRSA.
    Another witness is Governor Michael Leavitt. He was 
Governor of Utah. He was Secretary of Health and Human Services 
and an Administrator of the EPA under George W. Bush. Following 
the emergence of H5N1 Avian Flu, Governor Leavitt increasingly 
focused his efforts on pandemic preparedness. As Secretary in 
2007 he said this 13 years ago, everything we do before a 
pandemic will seem alarmist, everything we do after a pandemic 
will seem inadequate. That is the dilemma we face, but it 
should not stop us from doing what we can do to prepare. 
Congress has passed legislation to prepare for pandemics 
before.
    During the last 20 years, four Presidents, Clinton, Bush, 
Obama, Trump, and several Congresses have enacted nine 
significant laws to help local, state, and Federal Governments, 
as well as hospitals and health care providers, to prepare for 
a public health emergency including a pandemic. Congress 
provided over $18 billion to States and Hospital Preparedness 
Systems over the last 15 years to help them prepare as well.
    In writing those laws, Congress considered many reports 
from Presidential commissions, offices of Inspectors General, 
the Government Accountability Office, and outside experts. The 
reports contained all sorts of warnings that the United States 
needed to address the following familiar issues, familiar by 
now, better methods to quickly develop tests, treatments, and 
vaccines, and scale-up manufacturing capacity, better systems 
to quickly identify emerging infectious diseases, more training 
for the health care and public health workforces, better 
distribution of medical supplies, better systems to share 
information within and among states and between states and the 
Federal Government. Many reports also warned that while states 
play the lead role in a public health response, many states 
didn't have enough trained doctors, nurses, and healthcare 
professionals, had inadequate stock piles, and struggled with 
funding challenges.
    In some instances, over-reliance on inflexible Federal 
funding contributed to these problems. Looking at lessons 
learned from the COVID crisis thus far, many of the challenges 
that Congress has worked to address during the last 20 years 
still remain. Additionally, COVID-19 has exposed some gaps that 
had not been previously identified. These include unanticipated 
shortages of testing supplies and sedative drugs which are 
necessary to use ventilators for COVID-19 patients.
    Memories fade, attention moves quickly to the next crisis. 
Four months ago, five months ago we were in the midst of the 
impeachment of a President. Today, that seems like ancient 
Roman history. That makes it imperative that Congress act on 
needed changes this year in order to better prepare for the 
next pandemic. I look forward to hearing from our witnesses and 
I would also appreciate the feedback we are receiving on the 
white paper. I will set a deadline for June 26 on that feedback 
so the Committee has time to consider it and to draft and pass 
legislation this year.
    Senator Murray.

                  OPENING STATEMENT OF SENATOR MURRAY

    Senator Murray. Well, thank you very much, Mr. Chairman, 
and I also want to thank all of our witnesses for joining us 
today. And of course thank our staff for wrangling the 
technology to make this hearing possible. I said before, we 
need to understand fully and exactly everything that has gone 
wrong in our response to COVID-19. Why and how we work to make 
sure we are never in this situation again. But I want to be 
absolutely clear from the start, reflecting on how we prepare 
for the next crisis is no substitute for responding to the 
crisis at hand, which has infected over 2 million people in our 
country, killed over a 120,000, and which continues to spread.
    Unfortunately, the White House is pretending this pandemic 
is over. President Trump has said it is fading even as several 
states see record case increases. Vice president Pence wrote an 
op-ed saying we are winning the fight and there isn't a second 
wave while experts like Dr. Fauci warn we aren't even through 
the first wave yet. Admiral Giroir has stepped down from his 
role leading testing efforts without being replaced, and 
President Trump is calling for less testing, even though we 
don't have anything close to the testing and tracing capacity 
we need to safely reopen our communities. It is not just 
officials in the White House who are sticking their heads in 
the sand.
    Leader McConnell and some Republicans have suggested there 
is less urgency to take further action since we gained some 2.5 
million jobs after losing more than 20 million jobs. You know, 
as a former preschool teacher, I can tell you even some of our 
younger students know that map doesn't add up. So I hope we 
don't just spend our time today talking about how to avoid 
mistakes in the next pandemic, but instead address the mistakes 
this administration is still making during this one and the 
ones they are at risk of repeating as the response to COVID-19 
continues. One lesson we have already learned, this crisis is 
no great equalizer, but rather a force which perpetuates and 
deepens the injustices that black communities, latino 
communities, tribal communities, people with disabilities, and 
so many others face.
    We have known for decades that our healthcare system treats 
some communities much worse than others, especially communities 
of color. Those disparities are caused by a long history of 
systemic racism and underfunding, and those in charge have a 
responsibility to acknowledge the problem and do everything 
they can to close that gap. This administration has not taken 
that responsibility seriously. At best, they turned a blind eye 
to the problem. At worst, they seem determined to make it worse 
as we have seen in the administration's irresponsible rule to 
allow discrimination in health care.
    We have also seen once again how desperately we need a 
national universal paid sick leave policy so workers can stay 
home and do what is best for their health and for public health 
without fear of losing their job or their paycheck. And we have 
learned how important it is the Department of Labor's 
Occupational, Safety and Health Administration is. They need to 
stop dragging their feet and finally make clear safety isn't 
optional by immediately issuing an emergency temporary 
standard. There are also several lessons We need to apply 
regarding vaccines.
    We cannot allow the Trump administration to bungle this 
like they have so much else. This pandemic will not end until 
we have a vaccine that is safe, effective, that we can widely 
produce and equitably distribute and that is free and 
accessible to everyone. So when it comes to developing a 
vaccine, we don't just need a fast process, we need a thorough, 
transparent, and science driven one. We need to know the 
process is free of political interest influence, especially 
after the hydroxychloroquine debacle. And the final COVID-19 
vaccine or vaccines truly meet the gold standard families have 
relied on for so long, which is why the administration needs to 
commit now to being fully transparent about the vaccine 
development and review process and about the data that is 
ultimately used to evaluate safety and effectiveness.
    We also need the administration to detail how it will 
produce and distribute vaccines everywhere to everyone. Even 
the incomplete data we currently have shown black, latino and 
tribal communities are disproportionally impacted by COVID-19 
and have significantly less access to testing than white 
communities. This is an injustice that we cannot repeat when it 
comes to vaccines nor can we afford to repeat delays like those 
the Trump administration caused by refusing to take 
responsibility for resolving coordination problems in the 
national supply chain.
    Instead, the Trump administration must work now to draft 
and release a comprehensive COVID-19 vaccine plan, the type of 
comprehensive plan we still haven't gotten on testing. One that 
addresses all of these questions and other barriers, like how 
do we fight misinformation and vaccine hesitancy? How do we 
strengthen our immunization infrastructure to ensure it is 
ready to meet this unprecedented challenge? How do we build 
global partnerships in this effort, instead of turning our back 
on the rest of the world, which not only betrays our American 
values but also puts people here at home directly in harm's 
way.
    Mr. Chairman, these are not questions we need to answer 
before the next pandemic starts, they are questions we have to 
answer before the current pandemic can end. I look forward to 
hearing our witnesses perspectives on all of these urgent 
issues today, and Mr. Chairman I hope in the future, very near 
future, this Committee will also be able to get the 
perspectives of several important members of this 
administration we have not heard from yet, Secretary Azar, 
Secretary Scalia, and Secretary DeVos.
    It is clear we have a lot more work to do to respond to 
this pandemic and I urge our Republican colleagues to come back 
to the table so we can work on this together because the 
challenges our Nation is grappling with right now, the public 
health crisis of COVID-19, the economic crisis this pandemic 
has set in motion, and of course the persistent systemic 
inequities driven by racism that this crisis has only 
exasperated are urgent. Our Nation cannot keep waiting. Thank 
you, Mr. Chairman.
    The Chairman. Thank you, Senator Murray. Each witness 
will--I would ask you to summarize your statement in five 
minutes so we will have more time for questions. I welcome our 
witnesses. It is a distinguished panel. We look forward to 
hearing from each of you. It is my privilege to introduce the 
first one. Senator Bill Frist, with whom I served and many of 
us served. He represented Tennessee for two terms in the 
Senate. He was the Majority Leader of the U.S. Senate. He 
served on this Committee in the U.S. Senate. He is a heart and 
lung transplant surgeon by training. First practicing physician 
to serve in the Senate since 1928.
    He now serves on several boards including the Robert Wood 
Johnson Foundation. He is senior fellow at the bipartisan 
policy center and chairman and founder of Health Nashville. In 
2005, and I am sure he will talk about this, he gave many 
speeches on the inevitability of a global pandemic and the 
importance of preparedness. I have submitted two of those 
speeches to the record during this Committee's May 7th hearing.
    Next, after Dr. Frist, we will hear from Dr. Joneigh 
Khaldun. Dr. Khaldun serves as the Chief Executive and Chief 
Deputy Director for Health of the Michigan Department of Health 
and Human Services. In this position she oversees the 
Population Health Medical Services, Aging and Adult Services, 
and Behavioral Health and Developmental Disabilities 
Administration for the State of Michigan. Dr. Khaldun has 
extensive experience in state and local Governments. Prior to 
her current role, she served as Director and Health Officer for 
the Detroit Health Department. She is a practicing emergency 
medicine physician.
    Our third witness is Dr. Julie Gerberding. She is Executive 
Vice President and Chief Patient Officer at Merck & Company, 
and serves as a Co-Chair of the Commission on Strengthening 
American Health Security at the Center for Strategic and 
International Studies. Dr. Gerberding served as the Director of 
the Centers for Disease Control, the CDC, from 2002 to 2009.
    Under her leadership CDC coordinated preparedness efforts 
and responses to several public health threats including SARS, 
West Nile Virus and Avian Flu. She played a key role in the CDC 
response to Anthrax attacks in 2001. Senator Romney will 
introduce our final witness, Governor Mike Leavitt.
    Senator Romney. Thank you. Mr. Chairman. I am happy to 
introduce my friend Mike Leavitt. Mike is actually the one who 
is most responsible for freeing me from the golden chains of 
the private sector. He got me to leave my position at Bain 
Capital and to come out help run the Olympic Winter Games of 
2002 in Salt Lake City. As such, he was my boss. He was the 
Governor of the State of Utah at the time and we became since 
then dear friends. He also was kind enough when I was running 
for President to lead my transition team.
    I am not sure I would have been a great president, but I 
would have had a great administration because he put together 
an extraordinary team and laid out a pathway to help our 
Country in numerous ways. Mike Leavitt, as you also have 
indicated, was a three-term Governor of Utah in the Bush 
administration. He served as Administrator of the EPA and then 
for several years as a Secretary of Health and Human Services.
    One of his priorities was to focus on pandemic preparation. 
He secured some $7 billion in funding with the Administration--
through the Administration and Congress to prepare for 
pandemics. Since leaving Government, he has founded a firm 
called Leavitt Partners. It is the premier healthcare 
consulting firm in the country, with hundreds of employees 
under his management as well as a private equity firm that he 
has built. It set an extraordinary record and he continues to 
contribute to our Country, my friend Mike Leavitt.
    The Chairman. Thank you, Senator Romney. Now we will begin 
with Senator Frist. Welcome, Senator Frist, back to your old 
Committee.

 STATEMENT OF WILLIAM FRIST, M.D., FORMER U.S. SENATE MAJORITY 
                     LEADER, NASHVILLE, TN

    Dr. Frist. Good morning, Chairman Alexander and the Ranking 
Member Murray, Members of the Committee. And it is great to be 
back to the halls in the Senate even if only remotely and to 
see so many old friends and colleagues. I do want to commend 
the Committee for placing a focus now on preparing for the 
inevitable biological and infectious diseases that absolutely 
will come in the future. As you mentioned, in December 8th of 
2005 at the National Press Club, I said in the very same speech 
I gave, in this body 15 years ago and repeatedly all across the 
country, I said a viral pandemic is no longer a question of if 
but a question of when.
    I even said it would come from China at the time. Grounded 
deeply in my own experiences as a physician in the Senate, 
being in China with a Senate delegation during the SARS 
pandemic in 2003, personally treating HIV, AIDS patients, 
responding to the Anthrax attacks, it was crystal clear then we 
were woefully unprepared for what was to inevitably come. In 
those talks, I proposed a specific six-point plan called a 
Manhattan Project of the 21st century to prepare the Nation. 
And during my time in the Senate, we laid the foundation with 
the Bioterrorism Act of 2002, Project Bioshield 2004, the PREP 
Act 2005, the Pandemic and All-Hazards Preparedness Act of 
2006, and subsequently, as you have outlined in your white 
paper, we have done more but this was not enough nor will it be 
enough.
    A little bit disappointingly, most of what I recommended in 
2005 remains undone. So for my recommendations, I use the exact 
same six categories I used then. No. 1, communication. We have 
got to clarify who is in charge in an emerging pandemic. Only 
then will we be consistent and be coordinated. The Federal 
response must be led at the National Security Council level to 
facilitate this whole of Government approach. CDC, the trained 
and experienced experts, should regain its position as the 
Nation's apolitical voice of public health.
    No. 2, surveillance. We must modernize our real-time 
domestic and international surveillance and threat detection 
system. This pandemic has laid bare our inability at the 
Federal level to track outbreaks with testing and reporting 
across the country. We must engage globally, diplomatically and 
economically.
    An outbreak anywhere in the world is a risk everywhere. It 
is a risk to every community in America. The ability of 
developing nations to detect, track and contain a novel virus 
will be inextricably tied to their capacity of their public 
health infrastructure, which is vitally dependent on U.S. 
support. Categories three and four were agents and vaccines, 
and as in 2005, we have a dangerously inadequate vaccine 
manufacturing base here within the United States. We must 
establish public, private partnerships with industry that are 
and can be sustained. For our supply chains including testing 
and vaccine development, the Federal Government must be re-
engineered to serve as a sort of control tower function.
    No. 5, I said then and now research and development. In my 
words in 2005, I called for massive R&D investment to create a 
biologically based Manhattan Project to help better defend us 
against naturally occurring, like we are seeing now, or 
accidental or intentional bioterror threats, including 
infectious disease. Categories of stockpiling and surge 
capacity were No. 6. The Federal Government should take the 
lead role serving as overlaying central repository paired with 
a well-structured surveillance system that would accurately 
track outbreaks to ensure that supplies are responsibly and 
appropriately distributed where the risk is greatest.
    In telemedicine, with which this Committee has dealt, I 
echo Chairman Alexander's recommendations that we, ``ensure the 
United States does not lose the gains made in telehealth.'' We 
must make permanent the majority of regulatory changes, with 
some modifications, in order to unleash this revolutionary 
power of virtual care delivery in America. I want to quickly 
touch on two other important areas, public health funding and 
vulnerable populations.
    For the funding, observing closely for the past 25 years, I 
conclude like our armed services defense, we must have 
predictable, consistent base funding for our public health 
security programs. Yes, health security is National Security so 
let's treat it as such. That is why I joined. Dr. Tom Friedman 
and others to advocate for the creation of a specific new 
health defense operations budget designation. This 
discretionary approach, with exempt from spending caps, a small 
number of critical pre-existing health security funding lines.
    Lastly, this whole concept of vulnerable populations of 
health equity, any pandemic preparedness response needs to 
comprehensively consider how to protect and care for the most 
valuable here at home and globally. And real quickly, I 
encourage the Committee to underscore this vital connection 
between the health of the world's most vulnerable and the 
security of Americans here at home, especially as you soon 
consider global access to immunization. Members of the 
Committee, thank you for having me here today. The work you are 
doing now will literally save lives in the future.
    [The prepared statement of Dr. Frist follows:]
                    prepared statement of bill frist
    Good morning Chairman Alexander, Ranking Member Murray, and Members 
of the Senate Health, Education, Labor, and Pensions Committee. Thank 
you for inviting me to testify at today's hearing, ``COVID-19: Lessons 
Learned to Prepare for the Next Pandemic.'' It is great to be back in 
the halls of the U.S. Senate--even if only remotely--and to see so many 
old friends and colleagues.

    I want to commend Chairman Alexander and Ranking Member Murray for 
placing a focus now on preparing for the biological and infectious 
diseases threats of the future. For too long, we have lurched from one 
public health crisis to another--retroactively appropriating emergency 
funds and so avoiding a large-scale pandemic through a great deal of 
American ingenuity and, sometimes, an even greater dose of good luck. 
But with COVID-19, our luck has run out.

    In 2005, in a series of speeches I predicted a global pandemic 
arising from China and proposed a six-part plan to prepare the Nation 
focused on: 1. Communication; 2. Surveillance; 3. Antiviral Agents; 4. 
Vaccines; 5. Research and Development; and 6. Stockpiling and Surge 
Capacity.

    On June 5, 2005 at Harvard University, I called for and outlined a 
greater than ``Manhattan Project'' for the 21st Century with ``no less 
than the creation, with war-like concentration, of the ability to 
detect, identify and model any emerging or newly emerging infection, 
natural or otherwise; for the ability to engineer the immunization and 
cure, and to manufacture, distribute and administer whatever may be 
required to get it done and to get it done in time. For some years to 
come, this should be the chief work of the Nation, for the good reason 
that failing to make it so would be to risk the life of the Nation.''

    On December 8, 2005 at the National Press Club, I said, ``A viral 
pandemic is no longer a question of if, but a question of when. We 
know--depending upon the virulence of the strain that strikes and our 
capacity to respond--that the ensuing death toll could be 
devastating.''

    My reasoning then for recommending a bold, comprehensive 
preparedness plan was first and foremost, to protect human life. But my 
second, as captured in my December speech's title: ``Pandemic: The 
Economy's Silent Killer,'' was to preserve economic stability when a 
pandemic inevitably came. I had the Congressional Budget Office study 
the impact of a severe pandemic on our economy, and they estimated a 5 
percent reduction in GDP. Tracking almost exactly, the International 
Monetary Fund's World Economic Outlook released in April estimated a 
5.9 percent decline in U.S. GDP for 2020--over a trillion dollars in 
losses.

    I share this not because my remarks were prescient of what was to 
come 15 years later, but as Majority Leader of the Senate, I failed to 
sufficiently make the case, and truly comprehensive pandemic 
preparedness legislation never passed. I had seen SARS firsthand on the 
ground (with a Senate delegation) in China in 2003, personally treated 
patients suffering the ravages of HIV/AIDS in Sub-Saharan Africa and 
here at home in my medical practice, lived through and helped navigate 
our response to the 2001 Anthrax attack on the U.S. Senate and our 
postal workers, and at the time of this 2005 proposal, shared global 
concerns about the deadly H5N1 avian influenza. But now that we all are 
living through what once was a predicted threat, my hope is the smart 
work of this Committee and others, combined with the will of the 
people, will make these needed changes a reality. I can assure you that 
new, more deadly viruses will raise their heads in the future. It's 
biology. They know no borders. And they kill.

    But we are not starting from scratch. As Senator Alexander's recent 
White Paper, ``Preparing for the Next Pandemic,'' clearly outlines, 
Congress has not wholly ignored this threat. Indeed, during my time in 
the Senate and as Senate Majority Leader, we enacted:

          The Public Health Security and Bioterrorism 
        Preparedness and Response Act of 2002 (``Bioterrorism Act,'' PL 
        107-188)

          The Project BioShield Act of 2004 (PL 108-276)

          The Public Readiness and Emergency Preparedness Act 
        of 2005 (``PREP Act,'' PL 109-148)

          The Pandemic and All-Hazards Preparedness Act of 2006 
        (PL 109-417)

    But these and all the well-intended legislation that followed 
failed to protect us. While 9/11 and the Anthrax attacks were a wakeup 
call, and while our Nation's leaders did respond and put in place 
funding and new important public health authorities, we didn't fully 
prepare for a pandemic--a simultaneous nationwide, indeed a worldwide, 
assault on every one of our citizens, our underfunded public health 
infrastructure, and our economy. We took some important steps and in 
many ways, the basic foundations from which we need to respond to a 
pandemic are in place. Now, we need to establish a clear chain of 
command coupled with a more systematized, coordinated response 
structure and power it with robust, sustained financial resources to 
enable our public health leaders to keep Americans safe.

    Most of what I recommended in 2005 in those speeches delivered 
around the country and in this body remains undone today, thus I 
outline my recommendations along the exact same six categories.
                            1. Communication
    As I said then, ``Number one is communicating with the public.'' To 
allay irrational fear, communication--of accurate, reliable, consistent 
information--must be the bedrock of every public policy response.

    From the outset of the COVID-19 crisis and continuing today, we 
have had mixed and contradictory messages on the severity of the 
outbreak, the differing roles of Federal, state and local government, 
the availability of tests, potential treatments, the appropriateness of 
masks, and timelines and approaches for reopening. This has 
unquestionably led to unnecessary viral spread, duplication of efforts, 
gaps in response, and loss of life. It's fixable.

    First, we must clarify who is in charge in a pandemic. The current 
response structure is broken. The Federal response should be led at the 
National Security Council level to facilitate a ``whole of government 
approach'', re-establishing the NSC'S Directorate for Global Health 
Security and Biodefense. The NSC should set out guidelines and ensure 
seamless coordination between and among departments, with regular and 
consistent pressure testing.

    Second, the CDC should regain its position as the Nation's 
apolitical voice of public health. The CDC has 20,000 health 
professionals who dedicate their lives to protecting Americans. The 
National Center for Immunization and Respiratory Disease has more than 
700 FTE staff who are experts in this area. They have spent decades 
working on the public health control of respiratory viruses. This 
Administration has sidelined the entire agency from their role in 
briefing the public, which has had a chilling effect on the information 
that could leave the agency and reach the public. CDC guidance has had 
to go through dozens of levels of review which in many cases took weeks 
instead of days. This led to confusion and uninformed improvisation at 
the state and local levels without strong Federal leadership.

    Third, we must make sure what is said at the Federal level 
coordinates and integrates well with the more regional needs, abilities 
and resources of state and local municipalities. This can be 
accomplished in part by strengthening the relationship between CDC and 
the Association of State and Territorial Health Officials (ASTHO). In 
times of infectious disease outbreak or pandemic, predetermined, 
clearly delineated emergency channels of communication, authority and 
action should immediately be implemented.
                            2. Surveillance
    Every moment counts. The sooner we detect, identify, and contain a 
viral threat, the better the health and economic prognosis will be. 
This pandemic has laid bare our inability, at the Federal level, to 
detect and track outbreaks across the country, and provide real-time, 
consistently formatted data to states and localities that can help them 
understand the threat, and in turn inform Federal and regional 
allocation of supplies and personnel. Compared to 2005, the tracking 
tools are much more sophisticated. But, just like then, we have waited 
until after an outbreak to develop and deploy much of this technology. 
Valuable time is lost as the virus aggressively continues to 
exponentially infect the world. Here we must think global to protect 
the safety and security of our families in our neighborhoods.

    That's why we need a real-time domestic and international threat 
detection system. Some experts have recommended a new epidemic 
forecasting center similar to the National Hurricane Center, which 
would function as a government-academic partnership to help guide 
decisions from National Strategic Stockpile needs and disbursements, to 
informing travel restriction decisions as novel viruses emerge, to 
providing states and localities real-time information to guide their 
public safety decisions in an outbreak.

    While not necessarily intuitive, a huge part of effective 
infectious disease surveillance is maintaining Federal support of 
global health. The next zoonotic disease transmitted from animals to 
humans will likely come out of Asia or Africa. The ability of 
developing nations to detect, track and contain a novel virus will be 
inextricably tied to the capacity of their own public health 
infrastructure, something that is vitally dependent on U.S. support. 
And their willingness to mutually share that critical infectious 
disease surveillance information and allow our scientists to reliably 
participate in its interpretation will depend on the integrity and 
trust of our diplomatic relationships.

    Our national health, when it comes to recurrent deadly viruses and 
pandemics, depends on global health.

    We typically commit about 1 percent of Federal resources to 
international assistance, but in our COVID-19 emergency packages, only 
one-tenth of 1 percent of funds have gone to help low-and middle-income 
countries in their COVID fight. We must recognize containing COVID 
globally is essential to halting its spread in the U.S., particularly 
as we begin to reopen our country for travel and business. (Indeed, New 
Zealand had just announced the eradication of COVID-19 when two 
infected U.K. travelers potentially reintroduced the virus, coming in 
contact with as many as 320 people.) To ensure a comprehensive Federal 
approach to global health security, Congress's fractured global health 
jurisdiction (which spans at least 10 different committee and 
subcommittee structures across both chambers) should be rectified by 
the establishment of separate bipartisan special committees or formal 
working groups that provide a coordinating, overarching vision for the 
regular committees of jurisdiction.

    The White House Office of Management and Budget should establish a 
senior staff role to ensure consistency of health security funding and 
management decisions across all agencies and accounts--domestic and 
international--as the George W. Bush administration did effectively.

    We cannot close our borders until a vaccine is developed and all 
300 million Americans are inoculated. Nor can we completely shut down 
our economy and livelihoods. So, while protecting our own people is 
first and foremost, supporting global response efforts are essential to 
keeping Americans safe.

    Viruses are indifferent to a country's borders. Surveillance must 
be global as well as domestic.
                 3. & 4. Antiviral Agents and Vaccines
    The development of a COVID-19 vaccine has quickly become the Holy 
Grail, and after record genome sequencing, our private sector is 
tackling this challenge with unprecedented innovation and remarkable 
speed.

    (In my personal opinion, I believe that the rapidly developing 
treatments of COVID-19 via anti-viral agents, monoclonal antibodies, 
and convalescent serum, coming this late summer and fall, will have the 
most dramatic impact on re-opening our economy, equal to or possibly 
more so than the long-awaited vaccine.)

    But had we invested years ago in speeding up the ``bug-to-drug'' 
development timeframe for the vaccines, it's possible this record 
timeline could have been halved. To that end, I strongly agree with 
Chairman Alexander's assessment that, ``Only the Federal Government can 
fund research at the scale necessary to create tests, treatments, and 
vaccines for a pandemic . . . '' It will take partnerships.

    What was true in 2005 is still true today: we have a dangerously 
inadequate vaccine manufacturing base in the United States. This must 
be rectified. Bottom-line: there's so little profit and so much 
uncertainly in vaccine manufacturing today. We must establish 
longstanding public-private partnerships with industry that are 
sustained and are not at risk of disappearing with each Appropriations 
cycle. We cannot expect the private sector to independently invest 
billions of dollars developing antivirals and vaccines for novel 
viruses that we hope we'll never need to use. That's not a sustainable 
business model.

    One approach that should be considered here is a model adopted 
recently by Civica Rx--an innovative, new nonprofit pharmaceutical 
entity that partners with health systems, insurers, and the Federal 
Government to prevent generic drug shortages by establishing stable 
supply chains, expanding domestic manufacturing, and entering into 
long-term supply contracts. Though its success is yet to be fully 
demonstrated, the model of shared responsibility among all stakeholders 
might be considered with drug and vaccine development and distribution.

    We should also consider options like the continuous manufacturing 
provisions in Senator Blackburn's Securing America's Medicine Cabinet 
Act, which would strengthen our ability to more quickly manufacture 
certain drugs at a lower cost and with better quality controls.

    Beyond investing in the science to create future treatments and 
vaccines for unknown threats, it is imperative that we act now to 
address the very real challenge we are about to face when a vaccine is 
developed. The same supply chain shortages and equity issues we 
witnessed with personal protective equipment (PPE) and testing 
components are about to be magnified when every nation in the world is 
simultaneously seeking the vaccine and the components needed to package 
and administer it, to protect their people.

    The Federal Government should serve a ``control tower'' function to 
address these inevitable, pending domestic supply chain issues. It must 
clarify which agency will be responsible for this vital function, 
boldly prepare them for it, and then give that agency the full 
authority and resources to act.

    Additionally, we must recognize when it comes to competing global 
interests, it is not a zero-sum situation. Today, exactly as we said in 
2005, we simply do not have the domestic manufacturing capacity in this 
country necessary to cover our own needs. The greater the capacity to 
produce a vaccine globally, the better off we are. Access must be 
addressed proactively before it is a politically explosive as well as 
economically and ethically catastrophic.

    While the World Health Organization Access to COVID-19 Tools (ACT) 
Accelerator has little chance of really corralling every player to 
share ``equitably'' before meeting their own needs, participation or 
cooperation now will at least be the point on which countries will 
judge one another. China will exploit the hole in U.S. engagement in at 
least two ways: providing products and access directly to countries and 
by pressing the idea that the global rules-based, capital system is the 
cause of any vaccine access failure. We should consider constructive 
ways to engage globally to counter this narrative, including 
participating in the Coalition for Epidemic Preparedness Innovations.
                      5. Research and Development
    I previously called for a massive R&D investment to create a 
``Manhattan Project for the 21st Century'' to help us better defend 
against naturally occurring, accidental, and intentional threats--
including infectious diseases. We must make long-term, multi-year 
investments here.

    For example, Project BioShield when it was enacted in 2004 was 
intentionally an advance ten-year appropriation, established to allow 
the government to guarantee a market for chemical, biological, 
radiological, and nuclear (CBRN) medical countermeasures. But since 
2014, there hasn't been an advance appropriation, and instead it is 
reliant on the annual appropriations cycle. That doesn't send a 
powerful message to the private sector.

    A meaningful investment here could, for example, go toward standing 
up public-private partnerships to ensure robust and timely diagnostic 
testing development to avoid repeating the test development mistakes of 
this spring.
                    6. Stockpiling & Surge Capacity
    This is unequivocally an area where we fell short. There was 
unnecessary confusion about Federal, state, and even hospital-level 
responsibilities in procuring PPE and testing supplies, which led to 
hoarding, drove up market prices, and pitted states and even hospitals 
against one another. And most importantly, our failure here put the 
lives of our frontline workers at risk. We would never ask our soldiers 
to go into battle without armor, and we should never send our 
healthcare first responders into a pandemic without PPE and other vital 
supplies.

    It is easy to point the finger, but the reality is our Natio1nal 
Strategic Stockpile--its contents, relationships between state and 
Federal, its distribution policy--has been neglected over the course of 
multiple administrations. States and health systems should make a good 
faith effort to create their own stockpiles, but realistically we must 
acknowledge that competing, short-term, state budget priorities will 
always win out over long-term preparedness planning. The Federal 
Government must take the lead role here, serving as a central 
repository. Ideally, paired with a well-structured domestic and global 
surveillance and wisely managed distribution system, our Nation could 
appropriately fortify our stockpile at early signs of a threat, and 
also accurately and sensitively track outbreaks to ensure supplies are 
rapidly distributed to those in greatest need. Stockpile resources 
should be stored regionally, with a transparent and operationally 
capable plan for distribution to local municipalities.

    In strengthening our Strategic National Stockpile framework, the 
Federal Government should stand up capabilities to map supply chain 
data--including where it is and how much there is (a Federal registry). 
Ideally, we would onshore some of these manufacturing capabilities, and 
for others preplan resilient measures to convert existing factories to 
supplies that may be needed. These will require Federal incentive or 
partnership to keep domestic production lines at the ready.

    Additionally, there needs to be more coordination between BARDA and 
the Stockpile. We need a resilient system that involves more ongoing 
input from experts on what is needed for the future, so we can 
strategically invest and fortify the Stockpile for the next, most 
probable threat, not the last one. Furthermore, both BARDA and the 
Stockpile would benefit from more financial resources.

    Being prepared also means training first responders, and ensuring a 
civilian volunteer corps to step in and help handle the surge. It means 
allocating adequate surge facilities--vaccination sites, treatment 
centers, laboratories, and morgues. I have specifically advocated for 
funding for an expanded contact tracing workforce and voluntary self-
isolation facilities, if needed utilizing vacant hotels, with Andy 
Slavitt, Scott Gottlieb and other public health leaders, recognizing 
that our ability to immediately trace and self-isolate at the sign of 
illness are of utmost importance today to public safety as we reopen. 
The current pandemic will rapidly accelerate tracking and tracing 
technology for the future, and it will improve with time though it's 
still just a bit too early in its development, practical application 
and general acceptance.

    The recommendations within each of these six categories are by no 
means exhaustive, and I know my colleagues on this panel will have much 
to add. A few additional areas I want to touch on are: (1) Public 
health funding; (2) Vulnerable populations and health equity; (3) 
Virtual care, and (4) Establishing a Coronavirus Commission.
                         Public Health Funding
    In just a few short months, we already spent more in the four COVID 
response packages than we have on the Iraq War.

    Researchers estimate that there is a $34 per capita gap between 
what is needed to assure the conditions that populations are healthy 
and our Nation's current public health investment--approximately a $10 
billion deficit. It is time we look at public health as part of our 
Nation's defense.

    Last month, I joined with Dr. Tom Frieden, former Senator Tom 
Daschle, Dr. Tom Ingelsby and others to advocate for the creation of a 
Health Defense Operations budget designation.

    Health Defense Operations--HDO--provides an increased, sustained, 
predictable base funding for public health security programs that 
prevent, detect, and respond to outbreaks like COVID or pandemic 
influenza.

    Congress is to be commended for the quick response to COVID-19 by 
providing critical emergency supplemental funding during the pandemic. 
But this funding in response to emergencies will not sufficiently 
protect us for the future. Supplemental appropriations are by their 
nature temporary. Future health and economic security can best be 
protected by changing the way we allocate funds to protect us all from 
health threats. We have all seen the limitations that caps and 
sequestrations cause for discretionary funding. We have seen that even 
mandatory funding doesn't ensure stable support as those funds are 
often siphoned off during calm periods when outbreaks are out of the 
news.

    We propose a new approach for specific public health programs that 
are critical to prevent, detect, and respond to health threats. We call 
this the Health Defense Operations (HDO) budget designation, and it 
would exempt critical health protection funding lines at the CDC, NIH, 
FDA the office of the Assistant Secretary for Preparedness and Response 
from the spending caps so our public health agencies can protect us.

    Specifically, Health Defense Operations programs will:

          be exempted from the Budget Control Act budget caps

          not be sequesterable for the length of the fiscal 
        year

          and be required to submit bypass budgets (Program--> 
        Agency--> Congress) ensuring there is an unvarnished look at 
        preparedness needs.

    This does not exempt these identified programs from the 
appropriations process, but rather exempts them from budget mechanisms 
that have eaten away at public health. We propose an $11 billion annual 
increase in funding for specific funding lines at CDC, NIH, FDA and 
ASPR, a comparatively small investment compared to prior COVID 
supplementals and our annual defense budget.

    The detailed recommendations I have outlined require a dependable, 
consistent funding source, and the Health Defense Operations budget 
designation can create a thoughtful cross-agency approach to funding 
diverse needs over time.

    An alternative approach would be to establish a Public Health 
Infrastructure Fund that would provide a mandatory stream of resources 
to states and localities to build public health capabilities while 
ensuring accountability. Ultimately, our public health infrastructure, 
as has become apparent to all over the past four months, has been 
woefully underfunded for years and we need a new budgetary approach to 
combat funding shortfalls.

    While I recognize that the HELP Committee does not appropriate 
these funds, robust public health infrastructure funding will be 
necessary if we are serious about effectively preparing for the 
inevitable next pandemic with incumbent loss of life.
                Vulnerable Populations and Health Equity
    The greatest strains of a pandemic fall on particular demographics 
because of specific economic, or social or health status. With COVID-
19, we continue to see a disproportionate burden of illness and death 
among racial and ethnic minority groups. Theses populations 
disproportionately work in front-line jobs that prevent them from 
staying home, are more likely to be uninsured or underinsured, live in 
densely populated areas and in multi-generational homes that make it 
harder to isolate when sick, rely on public transportation, and have 
serious underlying medical conditions. Any pandemic preparedness 
response needs to comprehensively consider how to protect and care for 
the most vulnerable. I recommend:

          States and the Federal Government collect and share 
        data on confirmed cases by race, ethnicity, disability and 
        income to understand what populations are being hit hardest and 
        why;

          States, in consultation with Federal health agencies, 
        establish protocols for intensifying testing in the highest 
        risk settings and among the highest risk individuals to ensure 
        early detection paired with contact tracing;

          States and Federal health agencies include 
        representatives from communities of color and other 
        marginalized groups to inform and shape pandemic response 
        decisions.

    We are living through a singular time in our Nation's history, and 
our preparedness policies should seek to end the barriers to health and 
well-being for communities of color, with the goal of health equity.
                              Virtual Care
    Necessity is the mother of all invention, and the explosion of 
telehealth and virtual care has been one of the most constructive 
advances to emerge from this crisis. I want to echo Chairman 
Alexander's recommendation that we ``Ensure that the United States does 
not lose the gains made in telehealth.'' The gains for the patient 
include convenience, affordability, and rapid access to quality care 
that is needed. The field of virtual health care, delivered from a 
remote location by text, phone or video has been accelerated by five 
years or more. And patients and the country will benefit in a 
transformative way.

    I am heavily involved in virtual care, beginning with my days 30 
years ago taking care of over a hundred transplant patients remotely. 
Today I serve on the board of two virtual health care companies, 
Teladoc Health (physical and mental health) and Smile Direct Club 
(dental health). Teladoc Health delivers care via telemedicine in 175 
countries and in more than 40 languages, partnering with employers, 
hospitals, and health systems. I have seen firsthand how our recent 
policy changes at the Federal and state levels have in an 
overwhelmingly positive way unleashed private sector innovation--
stepping in to address care gaps created by the pandemic's stay at home 
orders.

    To continue this progress, I recommend:

        1. Allow telehealth access regardless of patient and provider 
        location: Congress must act to modernize 1834(m) by removing 
        the geographic and originating site restrictions. By doing 
        this, all Medicare patients can access care outside of specific 
        geographic locations and outside specific brick-and-mortar 
        facilities.

        2. Allow HHS to determine appropriate telehealth services and 
        providers: Congress should give the Secretary of HHS the 
        ability to expand the list of eligible telehealth practitioners 
        and ensure the Secretary has the authority to determine 
        eligible telehealth services. Additionally, Congress should 
        make permanent the 80 new telehealth services that can be 
        reimbursed by Medicare.

        3. Allow federally Qualified Health Centers and Rural Health 
        Clinics to offer telehealth after COVID: 1834(m) limits the 
        types of ``distant sites'' for a provider to use telehealth. 
        The law does not allow FQHCs or RHCs, critical safety net 
        providers, to be reimbursed as distant sites. The CARES Act 
        changed this during the pandemic, but action must be taken to 
        ensure FQHCs and RHCs can reach their patients via telehealth 
        and receive appropriate reimbursement for their services.

    While the Administration has done a good job, there is a risk that 
broad telehealth deployment if not carefully designed could actually 
replicate barriers in place in the traditional health system that 
produce disparities. One glaring example is a bias in some of the new 
authorities that have been authorized for two-way video communications. 
We should treat all forms of communications equally, as long as doctors 
are able to meet the same standards of care. If we discriminate against 
telephone (without video) users, for example, we will leave behind 
rural communities without access to broadband as well as minority and 
other lower-income populations that may not have more expensive smart 
phones with two-way video capabilities. I urge CMS to continue to allow 
patient choice and physician discretion when it comes to technology 
post COVID. And as we move forward, we need to ensure that patient 
privacy and security are protected.

    Additionally, we have learned that in order to deploy vast networks 
of physicians to where they are needed, we must have a mechanism to 
address state physician licensure. Many states did that by waivers of 
various kinds, but it was a steep learning curve with no consistency.

    Finally, while I believe the majority of regulatory changes made to 
advance telehealth and virtual care during COVID should be made 
permanent, parity in payment is one that should be revisited following 
the crisis. Undoubtedly it was a needed change to motivate physician 
engagement and participation, but since some of the overhead costs are 
eliminated in virtual transactions, it will likely make sense to 
reimburse closer to 70 to 80 percent of in-person visits. Reimbursement 
parity laws completely remove telehealth savings to the patient.
                         Coronavirus Commission
    In closing, I have one final recommendation. After September 11, 
2001, we recognized that our country faced a new threat that required a 
new approach to our national defense. Without a doubt, the massive 
disruption caused by the COVID-19 pandemic makes clear we need to 
recalibrate again. A deadlier virus will cause devastation on an even 
more frightening scale.

    To further examine what parts of the local, state, and Federal 
response worked, and what could work better and how, we should form the 
coronavirus equivalent of the 9/11 Commission. We must do everything in 
our power to make sure our imperfect response is not repeated. It's a 
matter of saving lives.

    Thank you Chairman Alexander, Ranking Member Murray, and Members of 
the Committee for having me here today. The work you are doing now will 
literally save lives in the future--thank you for your tireless 
commitment to improving health in the spirit of bipartisanship.
                                 ______
                                 
                   [summary statement of bill frist]
    In 2005, in a series of speeches I predicted a global pandemic 
arising from China and proposed a six-part plan to prepare the Nation 
focused on: 1. Communication; 2. Surveillance; 3. Antiviral Agents; 4. 
Vaccines; 5. Research and Development; and 6. Stockpiling & Surge 
Capacity. Much of what I recommended in 2005 remains true today.

    1. Communication

          We must clarify who is in charge in a pandemic. The 
        Federal response should be led at the National Security Council 
        level to facilitate a whole of government approach.

          The CDC should regain its position as the Nation's 
        apolitical voice of public health.

          We must make sure what is said at the Federal level 
        coordinates and integrates well with the more regional needs, 
        abilities and resources of state and local municipalities.

    2. Surveillance

          This pandemic has laid bare our inability, at the 
        Federal level, to track outbreaks across the country, and 
        provide real-time data to states and localities. That's why we 
        need a real-time domestic and international threat detection 
        system.

    3. & 4. Antiviral Agents and Vaccines

          We have a dangerously inadequate vaccine 
        manufacturing base in this country. We must establish public-
        private partnerships that are sustained and are not at risk of 
        disappearing with each appropriations cycle.

          Furthermore, the Federal Government should serve in a 
        ``control tower'' function now to address pending supply chain 
        issues for when a vaccine is developed.

    5. Research and Development

          I previously called for a massive R&D investment to 
        create a ``Manhattan Project for the 21st Century'' to help us 
        better defend against naturally occurring, accidental, and 
        intentional threats--including infectious diseases. We must 
        make long-term, multi-year investments here.

    6. Stockpiling & Surge Capacity

          The Federal Government should take the lead role, 
        serving as a central repository. Ideally, paired with a well-
        structured domestic and global surveillance system, our Nation 
        could fortify our stockpile at early signs of a threat, and 
        also accurately track outbreaks to ensure supplies are 
        distributed to those in greatest need. Stockpile resources 
        should be stored regionally, with a transparent and 
        operationally capable plan for distribution to local 
        municipalities.

          Being prepared also means training first responders, 
        and ensuring a civilian volunteer corps to step in and help 
        handle the surge.

    Public Health Funding: Last month, I joined with Dr. Tom Frieden, 
former Senator Tom Daschle, Dr. Tom Ingelsby and others to advocate for 
the creation of a Health Defense Operations budget designation to 
provide an increased, sustained, predictable base funding for public 
health security programs. It would exempt critical health protection 
funding lines at the CDC, NIH, FDA, and ASPR from spending caps so our 
public health agencies can protect us.
                                 ______
                                 
    The Chairman. Thank you, Dr. Frist.
    Dr. Khaldun, welcome.


   STATEMENT OF JONEIGH S. KHALDUN, M.D., MPH, FACEP, CHIEF 
    MEDICAL EXECUTIVE AND CHIEF DEPUTY DIRECTOR FOR HEALTH, 
 MICHIGAN DEPARTMENT OF HEALTH AND HUMAN SERVICES, LANSING, MI

    Dr. Khaldun. Yes. Chairman Alexander, Ranking Member 
Murray, and Members of the Committee, thank you for the 
opportunity to speak with you today about Michigan's response 
to COVID-19 and how we can prepare for future pandemics. COVID-
19 has infected at least 61,000 and killed over 5,800 adults 
and children in Michigan. At our peak in April we identified 
over 1,500 cases and there have been 180 deaths each day. Due 
to the decisive and necessary actions of our Governor Gretchen 
Whitmer, as well as the sound judgment of our residents and the 
work of our local Health Departments, those numbers have 
declined by more than 80 percent. But let me be clear, this is 
not the time for victory laps.
    COVID-19 is still very present in Michigan and across the 
country. We simply cannot let our guard down on COVID-19. More 
than ever, leaders must be laser focused on protecting our 
communities and addressing the inadequacies in our public 
health infrastructure. So the greatest tragedy of this pandemic 
is how it has ravaged communities of color. Michigan was one of 
the first states to release COVID-19 data by race and 
ethnicity. In Michigan, just 14 percent of our population is 
African-American and they represent 31 percent of COVID-19 
cases and 40 percent of deaths. This is not unique to Michigan.
    Racial and ethnic minorities are disproportionately being 
inspected by and dying from COVID-19 across the country. These 
disparities cannot be explained by genetics. They exist because 
of institutional and structural racism that has deprived 
communities of color of adequate resources and opportunities 
for prosperity and optimal health. Indeed, racism is a public 
health crisis that must be met with urgency, funding, 
elimination of policies that perpetuate health inequities. If 
we truly care about the health of every individual in this 
country, we must ensure that there is equitable access to 
testing, treatment and vaccines for COVID-19 at no cost.
    We also need consistent and accurate messaging from the 
highest levels of the Federal Government. As a practicing 
emergency medicine physician and public health leader, I rely 
on swift, scientifically sound guidance from our Nation's 
leaders during the crisis. We need accurate and clear messaging 
from the White House about the true threat of the disease, how 
and when to get a test, and the importance of wearing masks and 
social distancing. Next, we must develop and implement a 
national testing strategy infrastructure.
    As a country, we did not expand access to COVID-19 testing 
at the rate needed to identify cases quickly with tragic 
consequences. Michigan has now built a testing network of 
nearly 70 labs and 250 testing sites and we conduct about 
14,000 test per day with the capacity to do more. I am grateful 
for the support of our Federal partners, but we still struggle 
with the limited number and types of supplies we receive from 
HHS and FEMA. To fill in the gap, we work non-stop to procure 
testing materials from the private market but supply 
constraints remain a limiting factor.
    A national procurement and testing strategy would have 
prevented state and local Governments from competing with each 
other and avoid one of the most outrageous realities of this 
pandemic, turning people away who should have been tested. 
Finally, we must invest in public health infrastructure at the 
Federal, state and local level. More than 25 percent of local 
public health physicians have been eliminated in recent years 
and Federal spending on public health and prevention is minimal 
and declining. These cuts hinder our ability to adequately 
respond to public health threats. I have experienced this 
firsthand.
    In my former role as Detroit's Health Commissioner, I lead 
the city's response to the largest hepatitis A outbreak in 
modern history, pulling a limited staff away from other 
critical public health work to quickly ramp up vaccination 
infrastructure. As Michigan's Chief Medical Executive, I 
scrambled to respond to the state's outbreak of Eastern equine 
encephalitis, a mosquito borne illness that infected and killed 
a record number of people and animals. Simultaneously, I had to 
pull together a team within weeks to respond to a mysterious 
vaping related illness without any additional funding or staff.
    My experience with COVID-19, unfortunately, is no 
different. Since March, we have had to take extraordinary 
measures to build data systems, armies of contact tracers, and 
set up testing infrastructure. To ensure the U.S. can 
adequately respond to this crisis and the next, we need long-
term investments in our public health departments and programs. 
Now is not the time to celebrate or to turn our focus away from 
COVID-19. If anything, we must get more aggressive, more 
aggressive in addressing health inequities, expanding testing 
and contact tracing, and ensuring our public health 
infrastructure is strong. Thank you for the opportunity to 
share Michigan's experience today.
    [The prepared statement of Dr. Khaldun follows:]
                prepared statement of joneigh s. khaldun
    Chairman Alexander, Ranking Member Murray, and Members of the 
Committee, thank you for the opportunity to speak with you today about 
Michigan's response to COVID-19, what steps need to be taken to protect 
the public health from this devastating disease, and how we can prepare 
for future pandemics.

    COVID-19 continues to ravage communities across the country, and 
Michigan has not been spared. Michigan identified its first two cases 
of COVID-19 on March 10, 2020, the same day that our Governor, Gretchen 
Whitmer, declared a state of emergency. By April 1, 2020, Michigan had 
identified 9,334 confirmed cases and 334 deaths from the disease. 
Governor Whitmer has taken a series of appropriate and decisive actions 
to protect the health of Michigan residents, including restricting 
gatherings and travel unless they were necessary to sustain or protect 
life, limiting healthcare activities that were not time-sensitive, and 
aggressively building up testing and contact tracing to contain the 
disease.

    As of June 20, 2020, Michigan had 61,084 confirmed cases, and 5,843 
deaths due to COVID-19. It has tragically killed people of all ages in 
our state, from as young as 5 up to 107. While our road has not been 
easy, we have made progress. Due to the Governor's actions, the sound 
judgment of most of our businesses and residents, and the work of our 
local health departments, Michigan has seen a significant decline in 
cases and deaths over the past several weeks. Our hospital systems, 
particularly those in southeast Michigan who were hit hardest during 
this pandemic, are now stable in bed availability, supply of personal 
protective equipment (PPE), and resources available to take care of 
their sickest patients. As of last week, Michigan was one of four 
states in the country on track to contain the disease, according to the 
public health experts at Covid Act Now. \1\
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    \1\ https://covidactnow.org/?s=53768.

    Because of this, Michigan is cautiously reopening the economy with 
robust safety protocols in place. \2\ But let me be clear: this is not 
the time for victory laps. COVID-19 is still very present in Michigan 
and we continue to respond to outbreaks across our state. There is no 
vaccine and much of the population has likely not been infected, 
meaning most people are not immune to the disease. There is no FDA-
approved antiviral treatment. And many states are still seeing 
increasing numbers of cases. In Michigan, I am preparing for the real 
possibility of a resurgence of cases in the fall during influenza 
season, which would be devastating for the health of our residents and 
could stretch our hospital capacity once more.
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    \2\ MI Safe Start Plan. May 7, 2020.

    For these reasons, we cannot let our guard down now on COVID-19. 
The COVID-19 pandemic is not over. As we move forward with fighting 
this disease, Federal, state, and local leaders must be laser-focused 
on protecting our communities from COVID-19 and addressing the 
inadequacies in our public health infrastructure.
                           Health Inequities
    The greatest tragedy of this pandemic is how it has ravaged 
communities of color. Michigan was one of the first states to release 
data on cases and deaths by race and ethnicity. In Michigan, a state 
where just 14 percent of the population is African American, 31 percent 
of COVID-19 cases, and 40 percent of deaths, are African American. 
Governor Whitmer swiftly responded to this information by establishing 
the Michigan Coronavirus Task Force on Racial Disparities, chaired by 
Michigan's Lieutenant Governor Garlin Gilchrist. \3\ I have the 
pleasure of serving on this task force alongside several other 
community, academic, and government leaders, and the task force has 
moved swiftly to identify causes and promote solutions to address these 
inequities.
---------------------------------------------------------------------------
    \3\ Executive Order 2020-55.

    The racial disparities in the effects of COVID-19 are not unique to 
Michigan. African Americans, Hispanics, and other racial and ethnic 
minorities across the country are disproportionately being infected by 
and dying from COVID-19. \4\ This is no surprise. Health disparities 
and inequities have plagued this country since its inception. To be 
clear, these disparities cannot be explained by genetics. Instead, the 
disparities exist because of institutional and structural racism that 
has deprived communities of color of adequate resources and 
opportunities for prosperity and optimal health. Indeed, racism is a 
public health crisis that must be met with urgency, funding, and the 
elimination of policies that perpetuate health inequities: policies 
like redlining, lack of investment in schools, and both implicit and 
explicit bias in the healthcare system.
---------------------------------------------------------------------------
    \4\ Garg S, Kim L, Whitaker M, et al. Hospitalization Rates and 
Characteristics of Patients Hospitalized with Laboratory-Confirmed 
Coronavirus Disease 2019--COVID-NET, 14 States, March 1-30, 2020. MMWR 
Morb Mortal Wkly Rep 2020;69:458-464. DOI: http://dx.doi.org/10.15585/
mmwr.mm6915e3.

    These policies have caused communities of color to be more likely 
to live in poverty, have inadequate housing, have poor access to 
healthcare, and work in lower paying jobs. \5\ This means that due to 
the nature of their employment, people of color have disproportionately 
been deemed ``essential'' during the COVID-19 pandemic, needing to 
leave their homes and interact with the public instead of having the 
privilege of safely working from home while maintaining health and 
other fringe benefits. Homelessness, multi-generational households, or 
unsafe living conditions make it difficult to effectively self-isolate 
and quarantine, allowing COVID-19 to rapidly spread. People of color 
are also more likely to have underlying health conditions that are 
often undiagnosed or poorly treated, putting them at higher risk of 
being severely affected and dying from COVID-19.
---------------------------------------------------------------------------
    \5\ US Bureau of Labor Statistics, Report 1082, Labor force 
characteristics by race and ethnicity, 2018. October 2019. https://
www.bls.gov/opub/reports/race-and-ethnicity/2018/home.htm.

    Strategies to fight COVID-19 and future pandemics must focus on 
eliminating barriers in access to healthcare. No one should worry about 
paying out of pocket for testing or treatment of COVID-19. Everyone 
should have access to health insurance, and our healthcare safety net 
which cares for the most vulnerable must be adequately funded. Vaccine 
distribution strategies should be data-driven and focus on those who 
are at highest risk of severe disease, with clear guidance in place to 
ensure communities of color have equitable access. Strategies should be 
employed that embed testing and vaccination distribution in 
communities--not only in doctor's offices or hospitals. The strong 
partnerships that state and local health departments have cultivated 
with communities over the years should be leveraged to address ongoing 
challenges with access to care. These partnerships will also be 
critical to overcoming the mistrust of the healthcare system that often 
exists in communities of color, fueled by historical inequities in 
treatment. \6\
---------------------------------------------------------------------------
    \6\ Armstrong, K et al. Distrust of the Healthcare System and Self-
Reported Health in the Unites States. J Gen Intern Med. 2006 Apr; 
21(4): 292-297. Available from: https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC1484714/.

    We also have to ensure access to adequate housing. Housing policy 
is health policy. In the short term that means safe places where people 
who have COVID-19 can self-isolate and longer term making sure people 
---------------------------------------------------------------------------
have access to affordable, healthy housing in safe neighborhoods.

    Finally, we must address implicit and explicit bias in our 
healthcare system. Research has shown that, once care is accessed, both 
implicit and explicit bias by healthcare providers contributes to 
health care disparities. \7\ One of the factors associated with 
implicit bias is how we are socialized. We all have implicit biases but 
often do not realize that they exist--assumptions about individuals and 
groups can cause medical providers to not use a patient's individual 
circumstances or objective data to guide clinical management. Explicit 
biases include those that are more explicitly racist, that may also not 
be fully recognized. This bias is known to impact health outcomes in 
communities of color and COVID-19 is no different. Implicit bias 
training should be a mandatory part of all health professional 
training, and medical schools and residency training programs should 
accelerate efforts to increase diversity in their classes.
---------------------------------------------------------------------------
    \7\ Institute of Medicine (US) Committee on Understanding and 
Eliminating Racial and Ethnic Disparities in Health Care; Smedley BD, 
Stith AY, Nelson AR, editors. Unequal Treatment: Confronting Racial and 
Ethnic Disparities in Health Care. Washington (DC): National Academies 
Press (US); 2003. Available from: https://www.ncbi.nlm.nih.gov/books/
NBK220358/.

                   Consistent and Accurate Messaging
    I have the utmost respect for my colleagues at the U.S. Centers for 
Disease Control and Prevention (CDC), and I have been grateful for 
their support since we first began building up Michigan's response to 
COVID-19 in January 2020. However, we have been challenged by the lack 
of consistent, science-based strategy and messaging from the White 
House. I am a practicing emergency medicine physician and have had the 
honor of serving as Baltimore's Chief Medical Officer, Detroit's Health 
Commissioner, and now as Michigan's Chief Medical Executive. As 
frontline clinicians and public health leaders, we rely on swift, 
scientifically sound guidance and messaging from our Nation's leaders 
and Federal public health experts during a crisis. This has not been 
the case since the beginning of this outbreak, with inconsistent and 
inaccurate messaging from the White House about the true threat of the 
disease and potential treatments. There should be a clear, accurate, 
and consistent message at the national level alerting people to the 
risks of the disease, how and when to get a test, the importance of 
contact tracing, and basic public health messaging relaying the 
benefits of wearing masks and practicing social distancing. As with 
previous outbreaks such as Ebola, or H1N1, we must make sure our 
Nation's top public health leaders are the face of this pandemic and 
are given full authority to swiftly implement the most scientifically 
sound practices and to communicate this information to the public.
              National Testing Strategy and Infrastructure
    As a country, we did not expand access to COVID-19 testing quickly 
enough. In the early stages of the pandemic in Michigan, individuals 
had to meet strict criteria, including having severe symptoms, or a 
clear history of travel to an impacted country, to access testing. Once 
they met that strict criteria and were tested by a healthcare 
professional, state and local public health leaders had to subsequently 
arrange for packaging and shipment of the patient's sample to the CDC 
lab, where the CDC then prioritized which samples were run. By early 
February, Michigan was working through the process to be able to run 
samples in our state laboratory, but that process was then halted as 
the CDC had to work through unexpected inconsistencies in the testing 
platform.

    By the end of February, Michigan's public health laboratory was the 
only laboratory in Michigan able to perform COVID-19 testing. On March 
10, 2020, when Michigan confirmed its first case of COVID-19, our 
laboratory only had enough supplies to run a few hundred tests a day 
for a few days. Weeks of delays and restrictions in testing meant we 
were not able to identify cases at the level and speed needed--with 
tragic consequences--as there were likely hundreds, if not thousands of 
cases in Michigan well before they were identified by testing.

    Since that time, through painstaking work, Michigan has built a 
testing system that now conducts about 14,000 tests per day. We are 
working toward a goal of 30,000 tests a day, or about 2 percent of 
Michigan's population per week, in line with recommendations of 
national public health experts. Nearly 70 laboratories in the state 
have validated testing for COVID-19, and about 250 test sites are 
currently operating. With this expanded capacity, Michigan has 
broadened testing criteria significantly, and we are focused on testing 
anyone who has symptoms, may have been exposed, or is most vulnerable 
to disease. The assistance of Michigan's National Guard and funding 
from the Paycheck Protection Program and Healthcare Enhancement 
(PPPHCE) Act as well as the Coronavirus Aid, Relief and Economic 
Security (CARES) Act have been vital supports in the state's testing 
strategy.

    I have greatly appreciated the support we've received from our 
Federal partners including, but not limited to those at the U.S. 
Department of Health and Human Services (HHS), the CDC, the Assistant 
Secretary for Preparedness and Response (ASPR), and the Federal 
Emergency Management Agency (FEMA). They have consistently answered our 
calls and Michigan is now regularly receiving testing supplies. 
However, we still struggle with the lack of detail provided on the 
timing, quantity, and type of supplies coming to the state, and often 
the supplies we receive are not compatible with the laboratory systems 
that exist in the state. This makes planning and coordination 
challenging.

    Early identification of cases and testing should have been an early 
priority at the Federal level. When it was clear in other countries 
that the disease could rapidly spread, the U.S. should have swiftly 
established a national testing strategy and set up clear testing 
criteria and infrastructure for state and local governments to easily 
obtain testing supplies. Instead, state and local governments were left 
to compete for limited supplies and people who likely had the disease 
were turned away from testing, resulting in the disease spreading like 
wildfire in our communities. Even today, Michigan is unable to meet its 
testing goal of 30,000 tests per day. Laboratories still struggle with 
a fragmented and inconsistent supply of test kits and laboratory 
reagents. Our hospital laboratories frequently run low on reagents and 
are still only able to test the sickest patients. Going forward, the 
Federal Government should institute a national supply chain strategy to 
resolve bottlenecks that no state alone can address--and ensure an 
ample supply of test kits and reagents.
Invest in Public Health Infrastructure at the Federal, State, and Local 
                                 Levels
    In its 1988 report, ``The Future of Public Health'', the Institute 
of Medicine expressed concern that, ``this nation has lost sight of its 
public health goals and has allowed the system of public health 
activities to fall into disarray.'' \8\ Despite this grave warning, our 
public health systems continue to struggle for the support and funding 
needed to ensure there is a robust, versatile, and flexible system 
available to protect and promote the health and well-being of our 
residents. Public health departments across the country are 
continuously asked to do more, with less. Between 2008 and 2017, more 
than 56,000 local public health positions were eliminated, which 
accounts for almost 25 percent of the workforce. \9\
---------------------------------------------------------------------------
    \8\ Institute of Medicine 1988. The Future of Public Health. 
Washington, DC: The National Academies Press. https://doi.org/10.17226/
1091.
    \9\ Trust for America's Health. What we are learning from COVID-19 
about being prepared for a public health emergency. Issue Brief, May 
2020. Accessed 18 June 2020 file:///C:/Users/HUdsonn2/Downloads/
TFAH2020CovidResponseBriefFnl.pdf.

    Nationally, less than three percent of the annual $3.6 billion 
spent on health is dedicated to public health and prevention, and this 
proportion has been decreasing since 2000. \10\ Funding from the CDC 
for public health preparedness and response has been cut by over half 
in the past decade. \11\ In fiscal year 2016, Michigan's per capita 
state funding from the CDC was $18.80 compared to the national average 
of $21.31. \12\ This places Michigan 43rd in CDC funding. \13\ These 
cuts have had a significant impact on our ability to adequately fund 
and respond to public health threats.
---------------------------------------------------------------------------
    \10\ Trust for America's Health. The Impact of Chronic Underfunding 
on America's Public Health System: Trends, Risks, and Recommendations, 
2020. Accessed 17 June 2020 https://www.tfah.org/report-details/
publichealthfunding2020/.
    \11\ Ibid.
    \12\ Citizens Research Council of Michigan. An Ounce of Prevention: 
What Public Health Means for Michigan. Report 403, August 2018. 
Accessed 17 June 2020 https://crcmich.org/wp-content/uploads/rpt403-
public-health-2.pdf.
    \13\ Citizens Research Council of Michigan. An Ounce of Prevention: 
What Public Health Means for Michigan. Report 403, August 2018. 
Accessed 17 June 2020 https://crcmich.org/wp-content/uploads/rpt403-
public-health-2.pdf.

    I have experienced this first-hand. As Detroit's Health 
Commissioner, I led the city's response to the largest Hepatitis A 
outbreak in modern history, pulling my limited staff and funding away 
from other critical public health work to quickly set up pop-up 
clinics, and worked with federally Qualified Health Centers and 
hospitals to make sure patients were appropriately screened and those 
at highest risk were vaccinated. In my role as Michigan's Chief Medical 
Executive, last year I had to quickly respond to the state's worst 
outbreak of Eastern Equine Encephalitis (EEE) ever recorded. This 
debilitating mosquito-borne illness infected many and ultimately killed 
six people and dozens of animals across the state. I had to scramble to 
set up a surveillance and mitigation strategy coordinated across 45 
---------------------------------------------------------------------------
local health departments in a matter of weeks.

    My experience with COVID-19 is no different. Since March 2020, our 
state and local health departments have had to take aggressive and 
extraordinary measures to expand contact tracing infrastructure--the 
bread and butter of any communicable disease response. We set up a new 
technological infrastructure that enables more effective management of 
contacts. We built our own contact tracing army--over 10,000 
Michiganders have volunteered to be contact tracers, approximately 500 
are deployed today, and we are moving quickly to hire surge staffing 
embedded in local health departments, using funds from the PPPHCE Act 
and the CARES Act.

    But the ability to respond to crises like these should be built 
into the public health system, not jerry-rigged as a global pandemic 
spreads like wildfire. We should not have to rely on volunteers or take 
staff away from other critical public health work to respond to 
emerging public health threats. Lack of ongoing investment in 
technology, surveillance, and staffing infrastructure means that state 
and local health departments are constantly improvising and building 
these systems during a response, resulting in dangerous delays in 
understanding disease spread and swiftly controlling it. To ensure the 
U.S. can continue to respond to COVID-19, safely reopen and sustain our 
economy, and respond to the next emerging threat, we need long-term 
investments in our public health departments and programs.

    Public health experts have been gloomily warning of our lack of 
preparedness for a global infectious disease pandemic for years. 
Unfortunately, COVID-19 has turned those warnings into a real-life 
public health nightmare, killing over 120,000 people in the U.S. and 
leaving under-resourced public health departments scrambling to provide 
a coordinated and robust response. It has further unveiled the tragic 
injustice of racial inequality in our society. But it is not too late 
to save the lives of hundreds of thousands more. We have an opportunity 
to make the next chapter in this crisis a success story brought about 
by strong Federal leadership making serious and sustained investments 
in public health infrastructure.

    Now is not the time to celebrate or turn our focus away from COVID-
19. We must still aggressively fight this pandemic and if we do not 
redouble our efforts many more people will unnecessarily die. As a 
country we must urgently address health inequities, expand testing and 
contact tracing, and make sure our public health infrastructure is 
strong. We must remain vigilant, hopeful, and committed to protecting 
the public's health.

    Thank you for the opportunity to share Michigan's experience.
                                 ______
                                 
               [summary statement of joneigh s. khaldun]
    COVID-19 has and continues to ravage communities across the 
country. As of June 20, 2020, Michigan had 61,084 confirmed COVID-19 
cases and 5,843 deaths. While we have made tremendous progress in 
slowing the spread of this disease in Michigan, we recognize that now 
is not the time for victory laps. COVID-19 is still very present in 
Michigan and we continue to respond to outbreaks across our state. 
Nationally, this destructive virus has killed over 120,000 people so 
far with no end in sight and has left under resourced public health 
departments scrambling to provide a coordinated and robust response in 
the absence of Federal leadership. It has also further unveiled the 
tragic injustice of racial inequality in our society. But it is not too 
late. With strong Federal leadership and strategic policy, we have the 
opportunity to turn this crisis around and prevent additional suffering 
and death.
                           Health Inequities
    Across the country, communities of color are disproportionately 
being infected by and dying from COVID-19. For example, despite making 
up only 14 percent of Michigan's total population, African Americans 
represent 31 percent of COVID-19 cases and 40 percent of deaths. This 
cannot be explained by genetics and has everything to do with 
institutional and structural racism that has consistently left 
communities of color without adequate resources and opportunities for 
prosperity and optimal health. Strategies to fight COVID-19 and future 
pandemics must focus on eliminating policies that perpetuate inequities 
and should ensure equitable access to health care, vaccines, education, 
employment, and housing.
                   Consistent and Accurate Messaging
    Since the beginning of the COVID-19 outbreak, Michigan has been 
challenged by the lack of a consistent, science-based Federal strategy 
and message about the true threat of the disease, mitigation 
strategies, and potential treatments. A clear, accurate, and consistent 
message is needed at the national level alerting people to the risks of 
the disease, how and when to get a test, the importance of contact 
tracing, and basic public health messaging relaying the benefits of 
wearing masks and practicing social distancing.
              National Testing Strategy and Infrastructure
    As a country, we were not prepared for COVID-19. We did not have 
the testing capabilities, testing supplies, or personal protective 
equipment needed to adequately respond. Governments and hospitals have 
had to compete for resources, often against the Federal Government. 
Combined with delayed and sometimes unusable supplies from our Federal 
partners, this created unneeded uncertainty in an already difficult 
situation. While things have improved, many of these issues continue to 
be a concern. We need a national strategy and leadership to ensure a 
smooth supply chain that makes sure the right supplies are arriving 
when and where needed.
                        Public Health Investment
    Nationally, less than three percent of the annual $3.6 billion 
spent on health is dedicated to public health and prevention, and this 
proportion has been decreasing since 2000. COVID-19 has shown the 
problems with this disinvestment. To ensure the U.S. can continue to 
respond to COVID-19 as well as the next emerging threat, we need to 
invest long-term in our public health departments and programs.
                                 ______
                                 
    The Chairman. Thank you, Dr. Khaldun.
    Dr. Gerberding, welcome.

   STATEMENT JULIE L. GERBERDING, M.D., MPH, EXECUTIVE VICE 
   PRESIDENT AND CHIEF PATIENT OFFICE, MERCK & CO., INC., CO-
   CHAIR, CSIS COMMISSION ON STRENGTHENING AMERICA'S HEALTH 
                    SECURITY, KENILWORTH, NJ

    Dr. Gerberding. It has been a long time since I have 
testified in front of the HELP Committee and it is good to be 
back, but I also thank you for your incredible leadership and 
all you do to protect the health of Americans. There is a lot 
of media claiming that this pandemic is the pandemic of a 
century, but I agree with Dr. Frist. I think this pandemic is 
the harbinger of things to come.
    While we focus on how we can mitigate its harm right now, 
we do have to peer into the future and accelerate our 
preparedness efforts and really take seriously this time what 
needs to be done to truly create a health security agenda for 
America. Now, I would like to just start with what we know for 
sure because we are still in a learning phase here. We know for 
sure this virus is incredibly transmissible. We know it causes 
great harm, serious morbidity and mortality especially among 
vulnerable people, and we know that it is going to continue to 
spread for many months to come.
    We are nowhere near the end of the mitigation phase of this 
crisis. We also know that shelter in place and quarantine can 
be successful in slowing down transmission, but that comes at a 
tremendous price to individuals and families as well as 
economies and global macroeconomic forces simply because it 
shuts down business and people don't have livelihoods and the 
economies don't have a base. Now, what don't we know? We don't 
know what we need to know about the virus, its interaction with 
the host, and how it is going to evolve over time. We don't 
know really how to calibrate our balance between opening our 
societies and resuming some important business functions and at 
the same time continuing social distance so that we can slow 
down spread. We don't know to what extent daycare, schools, and 
colleges contribute to community transmission and transmission 
of this virus to other more vulnerable people in society.
    Last but not least, we don't know if we can stop this 
pandemic with a vaccine. So let's talk a little bit about 
vaccine. If we want to end a pendemic, we are going to need a 
vaccine that is feasible and produced at large scale. We need a 
vaccine that ideally is successful in a single dose and we need 
a vaccine that we can reasonably predict will likely be 
effective and safe.
    Let me talk about why this is a stern taskmaster, the 
science of vaccinology in the context of COVID-19. First, with 
respect to efficacy. We need a vaccine that produces effective 
immunity, neutralizing the virus, preventing infection even 
among vulnerable, older or immunosuppressed people, and we need 
a vaccine that is durable so that protection lasts beyond a few 
weeks or months. And finally, of course, ideally, we would like 
to have a vaccine that is robust if the virus does change or 
evolve over time. But as high a bar as efficacy sets, we also 
need a higher bar for safety because we are going to be using 
this vaccine in some of the most healthy people as well as some 
of the most vulnerable people, including children and 
potentially even infants.
    We must not sacrifice safety for the sake of speed and I 
think that is going to be a very important component of our 
communication about the vaccine opportunity because people need 
to trust that the vaccine will be safe. We already have 
concerns that myths and lies about the safety of the products 
that are in progress are a deterrent to people's willingness to 
step up and accept immunization.
    While I am cautiously optimistic about the prospects for a 
vaccine, we are a long way from being able to promise the 
delivery date or the characteristics of what I suspect will be 
several vaccines that will have different effectiveness in 
different populations. So, Senator Frist outlined an incredible 
historic list of the six things that we need to do for future 
pandemics. That has been echoed in your white paper, Senator 
Alexander. It has been presented in various forms by the 
bipartisan Blue Ribbon panel, by the CSS Commission that you 
referenced earlier, as well as many after-action reports filing 
ongoing outbreaks during my tenure at CDC.
    All of these perspectives have some common themes, and 
first and foremost is the theme of sustained National 
leadership at the level of the National Security Council. But I 
want to highlight one other theme that Senator First brought up 
and that is the critical importance of sustained, long-term 
budgetary investment, ending the cycle of complacency in crises 
that we have been in for so many years and instead creating a 
budget process for our Nation's preparedness, and particularly 
for the CDC, which you characterized as an independent 
scientific organization that needs to function in an apolitical 
environment.
    We need to make sure that we find a budget mechanism that 
allows the sustained funding to not be subject to budget caps 
and not be something that gets involved in horse-trading when 
the budget balancing process rolls around every year. That 
alone would help us secure an ongoing progressive investment in 
preemptive preparedness that truly will change the game for 
Americans. So thank you for allowing me to testify and I look 
forward to your questions.
    [The prepared statement of Dr. Gerberding follows:]
               prepared statement of julie l. gerberding
    Chairman Alexander, Ranking Member Murray, and other Members of the 
Committee, thank you for the opportunity to appear today. Reviewing the 
lessons learned from COVID-19 and other past pandemics and preparing 
for the next pandemic is critical. Unfortunately, we can't expect this 
pandemic to be a ``once in a century'' event; it is a sobering 
harbinger of things to come. Thank you for your leadership in this 
critical area.

    Experts have predicted for years that a pandemic of this magnitude 
would occur, and significant progress has been made over the last 
decade in increasing our capabilities and readiness. Now that we are in 
the midst of the experience, while we must focus on the immediate task 
at hand, we can already see some of the vulnerabilities in our system 
that need to be addressed for the future. We must increase our posture 
of readiness for future infectious disease threats, with science, 
capability, and capacity in the U.S. and across the globe. We must 
ensure there is a robust market for innovation and continue 
collaboration, partnership, and strategic investments across the 
public-private continuum.

    As one of the very few companies that have continued to invest in 
both vaccines and anti-infective medicines, at Merck we know we have a 
special responsibility to help advance both vaccine and antiviral 
therapies as part of our overall COVID-19 response. We have been fully 
committed to developing an effective response to the COVID-19 pandemic 
since it was first recognized, and we know that success will require 
global collaboration among countries, companies, and other key 
stakeholders. Despite the unprecedented, rapid collaboration and 
investment from the biopharmaceutical industry, we will continue to 
have more lives lost to COVID-19.

    The development of a new vaccine is complex, time intensive, and 
carries no guarantees. It is estimated that only six percent of vaccine 
candidates get to the finish line and that is why only a small number 
of companies have continued to operate in this space.

    Manufacturing and distributing a vaccine under normal circumstances 
is exceedingly complex, requiring hundreds of steps, thousands of 
complex tests, all validated to ensure that every single vial has the 
identical high quality and safety. When we think about what will be 
needed to address the pandemic, we are talking about orders of 
magnitude beyond what we as an industry are currently doing and which 
truly exceeds the current global capacity.

    In order to meet this need, we must all appreciate that the 
biopharmaceutical collaborators are working at risk. In other words, we 
are making considerable investments in key elements such as 
manufacturing capacity before we typically would, before we know 
whether we even have a successful product--in many cases building a 
factory before we have fully developed the process at a smaller scale. 
As a result, we have to think carefully about how these decisions will 
impact other development programs and allocation of investments, 
including considering the inevitable opportunity costs.

    In the short-term, we can expect many more months of ongoing 
transmission risk, with many people at risk. This will be further 
complicated as we expect influenza season to confound the impact of 
COVID-19 on communities and health systems. Sheltering in place and 
social distancing have proven effective mechanism to slow the 
transmission of the virus and protect the health care capacity; 
however, it comes at a huge price. The economic, individual/family, and 
community hardships are real. At the same time, communities with less 
social distancing are beginning to demonstrate more transmission.

    I believe we need to find the right evidence-based balance between 
sufficient social distancing, including masks and avoidance of crowds, 
with prudent steps to resume business activities and more normal 
activities of daily life. This is imperative.

    We also need to address escalating levels of misinformation related 
to the pandemic and the public and individual health impact of future 
vaccines. We are continuously seeing dissemination of information that 
is inaccurate and/or misguided. This can be quite dangerous as it leads 
to questioning the safety and efficacy of vaccines, which we know are 
critical to containing this pandemic and preventing future ones. We 
have seen the erosion of trust in governments and health care workers, 
who will be conducting vaccination programs. Ultimately this 
misinformation and mistrust can lead to a troubling reduction in people 
choosing to receive vaccines.

    The current pandemic has only further emphasized the value of 
vaccines in preventing illnesses. We know that it is better to prevent 
an illness rather than treat it, but we are now living a stark example 
of that principle. As we look forward to a time when new vaccines and 
treatments are widely available, we must do more to ensure the adequate 
funding of prevention and immunization infrastructure in our health 
system more broadly. As this pandemic has shown very clearly, these are 
critical for health protection but also for national and economic 
security.

    Testing protocols for future pandemics will also be critical. The 6 
key priorities for testing are as follows:

        1. Test people with symptoms for diagnosis;

        2. Test people exposed to known/suspected cases;

        3. Test people in ``hotspots'' where transmission is 
        increasing;

        4. Routinely test people in locations known to be or likely to 
        be high risk (nursing homes, health care settings, prisons, 
        meat packing plants, etc.);

        5. Test to understand patterns of transmission risk and improve 
        policy decisions (e.g., in daycares, schools, campuses, etc.; 
        using antibody testing)--this is the essence of public health 
        surveillance;

        6. Deprioritize other ``general'' testing to unclog the system, 
        especially until the reliability of tests improves.

    Accelerating and enhancing health care surge capacity planning is 
also essential. This includes a multitude of critical activities, such 
as:

        1. Conducting a thorough supply chain assessment to understand 
        and address vulnerabilities;

        2. Examining how to best strengthen the Strategic National 
        Stockpile performance to be the most effective and efficient 
        during a pandemic (e.g., consider expansion of personal 
        productive equipment, ventilators, and other durable medical 
        equipment);

        3. Augmenting supplies of antibiotics, intravenous fluids, and 
        other medicines to sustain critical care;

        4. Formalizing augmented health care workforce contingency 
        plans (credentials across states, retirees, volunteers, 
        Department of Defense) and updating training;

        5. Institutionalizing telehealth and payment reforms; planning 
        for needed in-person primary care, maternal health, mental 
        health, substance abuse, and dental care clinics;

        6. Creating an interoperable pandemic health data network 
        (instead of local and state stand-alone networks);

        7. Engaging and incentivizing the private sector in planning 
        efforts;

        8. Exercising and improving plans with accountability from 
        partners to follow through on lessons learned.

    As we look forward, it is important to understand the key lessons 
that can and should be applied to help us better prepare for and 
respond to future pandemics. Vaccine development is complex and carries 
no guarantees; for this reason, we need to support the pursuit of 
multiple approaches.

    While the first step is clearly finding the one or more effective 
vaccines, we can't underestimate the challenges of successfully 
deploying those vaccines. The complexity of the situation on the ground 
and challenges faced by vaccinators in the Democratic Republic of Congo 
(DRC) with our Ebola vaccine have been unparalleled. The scope and 
scale of the vaccine distribution, delivery, and administration 
challenges for COVID-19 will be significantly greater and will require 
unprecedented partnerships amongst manufacturers, supply chain and 
logistics professionals, governments, community leaders, health care 
workers, and individual citizens.

    Key lessons we learned through our experience with Ebola that we 
can leverage moving forward include:

        1. Public-private partnerships can be very powerful and 
        effective, but also exceptionally complex and resource 
        intensive. Bringing a diverse set of collaborators together 
        requires trust and an ``eyes wide open'' effort with clear 
        roles, expectations, and accountability defined for each 
        collaborator.

        2. Regulatory requirements and regulatory-manufacturing 
        interplays are highly complex, requiring approval of both the 
        product and the manufacturing process at each manufacturing 
        facility for licensure. Accounting for these complexities 
        requires more standardization and rightsizing specifically for 
        preparedness goals, as well as better pre-work and 
        harmonization when moving forward.

        3. Numerous non-regulatory policies, such as trade, GMO, and 
        BSL requirements can act as barriers to the free flow of raw 
        materials and other component parts needed for vaccine 
        manufacturing and quality testing. If these can be identified 
        in advance, manufacturers and government officials can work 
        actively to address them before they result in manufacturing 
        delays.

    Preparing for tomorrow's pandemic requires a new health security 
doctrine. For the past two years, I have co-chaired with former Senator 
Kelly Ayotte the Center for Strategic International Studies (CSIS) 
Commission on Strengthening America's Health Security. Senators Murray 
and Young are part of the Commission. Other congressional Members 
include: Representatives Bera, Brooks, Cole, and Eshoo, in addition to 
several security experts. In November 2019, the Commission released the 
Ending the Cycle of Crisis and Complacency report. The report lays out 
several key steps that the Administration and Congress should take to 
create a sustainable basis for strengthening the health security of 
Americans.

    We began the Commission's work with a simple understanding: health 
security is national security, in a world that is increasingly 
dangerous and interdependent.

    Biological threats--outbreaks from natural, intentional, and 
accidental causes--are occurring more often and at the same time, the 
world is increasingly insecure, violent and disordered, and it is 
exactly in these danger zones where an increasing number of biological 
outbreaks occur.

    Globalization and the rise of international trade and travel mean 
that an outbreak in a disordered setting with a compromised health 
system can quickly become a pandemic, threatening the United States and 
the rest of the world. Policymakers increasingly recognize these 
threats can undermine the social, economic, and political security of 
nations.

    Unfortunately, this recognition occurs when a health crisis 
strikes--COVID-19, measles, MERS, Zika, dengue, Ebola, pandemic flu--
and U.S. policymakers rush to allocate resources in response. Yet all 
too often, when the crisis fades and public attention subsides, urgency 
morphs into complacency. Investments dry up, attention shifts, and a 
false sense of security takes hold.

    That realization led us to conclude: the U.S. Government needs to 
break the cycle of crisis and complacency and replace it with a 
doctrine that can guarantee continuous prevention, protection, and 
resilience. The Commission advocates for a package of strategic, 
affordable actions to advance U.S. health security.

    First and foremost, we recommend permanent health security 
leadership as a central pillar of the National Security Council (NSC) 
by a credentialed and qualified expert.

    Second, we need to invest directly and consistently, over the next 
decade, in the capacities of low-income countries. The best approach to 
protect the American people is to stop outbreaks at the source. The 
Global Health Security Agenda has a proven track record in building 
health systems and health security preparedness in low-and middle-
income countries, financed through a $1 billion Ebola emergency 
supplemental funding. We recommend sustaining that success, not 
disrupting or curtailing it.

    Create a new non-discretionary budget authority that assures 
sustainable investments independent of budget caps or the necessity of 
annual budget trade-offs.

    We recommend that the U.S. Government expand DTRA's geographic 
authorities to operate in all continents where health security threats 
exist. Furthermore, support for military overseas infectious research 
laboratories should be sustained. DOD biological research and 
development programs often focus on diseases not studied in other 
venues and result in medical countermeasures that would otherwise be 
delayed or not developed at all.

    Congress should require national, state, and local governments to 
conduct regular preparedness exercises with updates to Congress on 
strengths and identified gaps in capacity.

    The Commission also advocates that the U.S. Government strengthen 
and adapt programs and capacities to deliver health services in fragile 
settings that meet the special needs of acutely vulnerable populations, 
elderly, women, and children.

    It is also importation to prioritize a ``one health'' research 
agenda, including significantly augmenting research to understand the 
intersection of human, animal, and ecosystem factors that promote the 
emergence and spread of infectious diseases and how to reduce and 
contain these threats. This would include expanding the investment in 
animal and environmental health surveillance for infectious diseases, 
modernizing global public health infectious diseases data systems and 
tools, and seeking predictive insights and preemptive interventions, 
not just counter-measures and emergency response capabilities.

    The last area of priority concern is to plan strategically, with 
strong private-sector partners, to support targeted investments that 
will accelerate the development of new technologies for epidemic 
preparedness and response. We assert that the U.S. Government should 
directly invest in the Coalition for Epidemic Preparedness Innovations, 
or CEPI, an international alliance that finances and coordinates the 
development of new vaccines to prevent and contain epidemics.

    Again, thank you for the opportunity to testify in front of you 
today, and it is my sincere hope that we can work closely together to 
advance the U.S. health security agenda, so we are better prepared for 
the next pandemic.
                                 ______
                                 
               [summary statement of julie l. gerberding]
    We must increase our posture of readiness for future infectious 
disease threats, with science, capability, and capacity in the U.S. and 
across the globe. We must ensure there is a robust market for 
innovation and continue collaboration, partnership, and strategic 
investments across the public-private continuum.

    Unfortunately, recognition of the health security vulnerabilities 
tends to occur when a crisis strikes--COVID-19, measles, MERS, Zika, 
dengue, Ebola, pandemic flu--and U.S. policymakers rush to allocate 
resources in response. All too often, when the crisis fades and public 
attention subsides, urgency morphs into complacency. Investments dry 
up, attention shifts, and a false sense of security takes hold.

    The U.S. Government should examine package of strategic actions to 
advance U.S. health security:

          Permanent health security leadership as a central 
        pillar of the National Security Council (NSC) by a credentialed 
        and qualified expert.

          Invest directly and consistently, over the next 
        decade, in the capacities of low-income countries.

          Create a new non-discretionary budget authority that 
        assures sustainable investments independent of budget caps or 
        the necessity of annual budget trade-offs.

          Expand DTRA's geographic authorities to operate in 
        all continents where health security threats exist. Sustain 
        support for military overseas infectious research laboratories.

          Congress should require national, state, and local 
        governments to conduct regular preparedness exercises with 
        updates to Congress on strengths and identified gaps in 
        capacity.

          U.S. Government must strengthen and adapt programs 
        and capacities to deliver health services in fragile settings 
        that meet the special needs of acutely vulnerable populations, 
        elderly, women, and children.

          Prioritize a ``one health'' research agenda, 
        including significantly augmenting research to understand the 
        intersection of human, animal, and ecosystem factors that 
        promote the emergence and spread of infectious diseases and how 
        to reduce and contain these threats.

          Support targeted investments that will accelerate the 
        development of new technologies for epidemic preparedness and 
        response.

    It is also essential to accelerate and enhance health care surge 
capacity planning, including:

          Conducting a thorough supply chain assessment to 
        understand and address vulnerabilities.

          Examining how to best strengthen the Strategic 
        National Stockpile performance to be the most effective and 
        efficient during a pandemic.

          Augmenting supplies of antibiotics, intravenous 
        fluids, and other medicines to sustain critical care.

          Formalizing augmented health care workforce 
        contingency plans (credentials across states, retirees, 
        volunteers, Department of Defense) and updating training.

          Institutionalizing telehealth and payment reforms; 
        planning for needed in-person primary care, maternal health, 
        mental health, substance abuse, and dental care clinics.

          Creating an interoperable pandemic health data 
        network (instead of local and state stand-alone networks).

          Engaging and incentivizing the private sector in 
        planning efforts.

          Exercising and improving plans with accountability 
        from partners to follow through on lessons learned.
                                 ______
                                 
    The Chairman. Thank you, Dr. Gerberding.
    Welcome, Governor Leavitt.


STATEMENT OF GOVERNOR MICHAEL O. LEAVITT, FORMER U.S. SECRETARY 
        OF HEALTH AND HUMAN SERVICES, SALT LAKE CITY, UT

    Mr. Leavitt. Thank you, Chairman Alexander, and Ranking 
Member Murray, and the Members of the Committee. A special 
thank you to Senator Romney for that generous introduction. 
Only months into my service at the Department of Health and 
Human Services, Dr. Gerberding and I participated in an 
emergency briefing on the H5N1 Avian Influenza. We were told it 
was a virus with pandemic potential.
    The next morning a colleague of mine entered my office 
carrying a book. The book was entitled ``The Great Influenza: A 
History of the Pandemic of 1918'' written by John Berry. As he 
handed it to me, he delivered a message. It was, you need to 
understand this. He was right, not just for me, but for all of 
us. As I read the book and several others, as I saw briefings 
and learned from others, it quickly became evident to me that 
ultimately a pandemic would occur. And that is true today. We 
have it but we will have another and we need to be prepared. 
And at that point in time our country was unprepared. As the 
H5N1 continued to spread, as you indicated earlier Mr. 
Chairman, Congress was alerted and appropriated $7.4 billion. 
Several Members of this Committee will remember that well.
    Over the next three years, we undertook an aggressive 
effort to heighten our Nation's readiness for a pandemic. We 
sought to develop vaccine manufacturing inside the territorial 
boundaries of the United States. We wrote the national pandemic 
response plan. Congress passed legislation that has become a 
foundation of that plan, the PREP Act of 2005, Pandemic All-
Hazards and Preparedness Act of 2006.
    Those two bills, when added to Project Bioshield, which was 
passed in 2004, contain many of the legislative authorities 
that have been actually used in recent months. 54 pandemic 
summits were held in partnership with the Governors of each 
state and territory. There were three messages that were 
delivered at those summits, all three still critical even in 
the midst of a pandemic and certainly in the future. The first 
was just a reminder that pandemics happen. They are a biologic 
fact and a certainty. Pandemics occur, and when they do they 
obviously bring death and suffering and sweeping change.
    The dilemma is that they happen far enough apart that we 
forget, as people have made the point already. The second 
message was that pandemics happen and every generation has to 
prepare on their own or they will be complacent as well. And 
finally, everyone needs a pandemic plan. States need a plan, 
local Governments need a plan, businesses, churches, schools, 
hospitals, because a pandemic is different than any other 
disaster that we deal with. It is intensely local.
    In a terrorist event like 9/11 or a natural disaster like 
Katrina, the Federal Government's response is to call on 
unaffected states to send people and equipment to the disaster 
area. In a pandemic, those resources are to a large degree 
unavailable because they are needed at home. The message is 
clear that any state or any community that fails to plan 
thinking that somehow the Federal Government will ride to its 
rescue will be tragically mistaken, not because the Federal 
Government lacks the will, not because it lacks the wallet, but 
because the Federal response plan is based on focusing 
primarily on localized disasters.
    Gratefully, the H5N1 Avian Influenza did not become a 
pandemic but the process has taught us a lot and the lessons we 
need to learn are still true today. I will just highlight four. 
First, the need to clarify roles between states and national 
Governments in advance. Second, having a vaccine is critical, 
but it is only the beginning. While we have manufacturing 
capability, fill, finish and distribution priorities will 
inevitably be a problem and they still need planning.
    Third, providing situational awareness is a critical role 
of the Federal Government and principally CDC. The disease 
gathering--information gathering capability of the Federal 
Government needs investments and it needs modernization. And 
last, I will echo what my colleagues have said, pandemic 
preparation requires investment every year. Mr. Chairman, I 
look forward to our conversation.
    [The prepared statement of Mr. Leavitt follows:]
           prepared statement of governor michael o. leavitt
    Good Morning, Chairman Alexander, Ranking Member Murray, and 
Committee Members.

    Thank you for the invitation to appear before the HELP Committee 
again and for accommodating my remote participation.

    The topic of this hearing is of great importance to me personally 
and to the Nation. I am pleased that this Committee has the foresight 
to recognize that even while we are still in the midst of responding to 
COVID-19, now is, in fact, the right moment to be capturing the lessons 
we are learning through this public health emergency, so we haven't 
long forgotten them by the next one and to be looking ahead to how to 
prepare for the next pandemic.

    Before we turn to talk about the future, I want to acknowledge the 
significant losses we've experienced across this country over the past 
several months. For the families that have lost loved ones, I convey my 
greatest sympathies to you. For those who have felt the economic pain 
of job or income loss, I hope you are soon on the path to recovery. And 
to the heroes in the public and private sectors who have helped us 
respond to this emergency and keep essential businesses open to serve 
our communities, I thank you for your efforts. This pandemic has 
affected us all in profound and different ways, which is why we must 
learn from what we are experiencing today and take steps to set 
ourselves up for the best possible outcomes in the future.
    The Foundation of Preparedness is Laid Long Before an Emergency
    Shortly after becoming Secretary of the U.S. Department of Health 
and Human Services, the H5N1 avian influenza appeared to have pandemic 
potential. With support from President George W. Bush and Congress, my 
colleagues and I initiated an aggressive pandemic planning process. 
Part of our efforts involved energizing local and state preparedness by 
holding pandemic summits in 54 states and territories. These summits 
were full-throated efforts to sound the alarm and remind states and 
local communities that pandemics happen. When they do, there are no 
other natural or manmade disasters that can compare to their 
disruption. It was also an attempt to assure states understood that 
because the pandemic would unfold across the country at the same time, 
states and local communities also needed to prepare.

    The experience reminded me that pandemic planning is made even more 
difficult because anything you do to prepare in advance of a pandemic 
seems like an overreaction, and anything you say sounds alarmist. But 
after a pandemic starts, anything you have done to prepare seems 
inadequate.

    We are, as a Nation, understandably focused right now on mitigating 
the health and economic harm caused by COVID-19. However, while we 
focus on the pandemic in front of us, we can't miss this opportunity to 
reflect on the lessons of COVID-19 and apply those lessons, so we are 
more prepared for the next pandemic or public health emergency. 
Unfortunately, time is of the essence since the next pandemic event 
might be the second wave of COVID-19 this fall.

    As Chairman Alexander points out in his white paper, ``Preparing 
for the Next Pandemic,'' action often only comes in response to a 
threat. That is human nature. It can be challenging to focus citizens 
and policymakers on public health preparedness when they are focused on 
other pressing issues of daily life. If a snake isn't at your ankle, 
then you aren't thinking about it.

    The terrorist attacks on the United States on September 11, 2001, 
and the subsequent anthrax attacks ushered in a period of heightened 
awareness that homeland security and domestic preparedness are just as 
crucial to the Nation's safety as foreign policy and a combat-ready 
military. In the subsequent five years alone, Congress passed, and the 
President signed into law, the Bioterrorism Act (2002), Project 
BioShield (2004), the Public Readiness and Emergency Preparedness Act 
or ``PREP Act'' (2005), and the Pandemic All-Hazards and Preparedness 
Act (2006). Collectively, these laws provided necessary tools that have 
been deployed in the years since, and some specifically in response to 
COVID-19, including;

          Preparedness grants to help states and health care 
        providers prepare for and respond to public health emergencies;

          Authority for HHS to waive certain Medicare or 
        Medicaid requirements during national emergencies to provide 
        flexibility for hospitals and states to respond to a public 
        health emergency;

          Establishment of a multi-year Special Reserve Fund 
        and authority for HHS to enter contracts to procure medical 
        countermeasures before they are approved;

          The Hospital Preparedness Program, which to helps 
        hospitals buy tangible resources like ventilators, mobile 
        medical units, and pharmaceutical caches;

          Authority to the FDA to issue emergency use 
        authorizations, which allow the use of medical countermeasures 
        before FDA approval;

          Liability protections for companies, health care 
        providers, and others involved in the distribution and 
        administration of medical countermeasures in a public health 
        emergency, except in cases of willful misconduct;

          The Covered Countermeasures Process Fund to 
        compensate eligible individuals who suffer injuries as a direct 
        result of a countermeasure administered or used under a PREP 
        Act declaration.

          Establishing the Secretary of HHS as the lead Federal 
        authority for the public health and medical components of 
        responses to emergencies under the National Response Framework;

          Creating the position now known as the Assistant 
        Secretary of Public Health Emergency Preparedness (ASPR) to 
        coordinate HHS efforts to prepare for, respond to, and recover 
        from disasters and public health emergencies; and

          Creating the Biomedical Advanced Research and 
        Development Authority (BARDA) to fund the advanced research and 
        development of medical countermeasures.
    Cooperation by Federal and State Governments is Key to Response
    It is my perception that Members of this Committee, in general 
terms, share an aspiration for the United States to be prepared to 
prevent, mitigate, respond, and recover from a public health emergency, 
whether deliberate, accidental, or natural. I also sense there is 
consensus that both the states and the Federal Government have an 
essential role in that effort. So, the age-old dilemma of how to divide 
responsibility between state governments and the Federal Government 
seems to be very much at play.

    Having served as a Governor and a Cabinet Officer, I have come to 
understand that both the states and the Federal Government have 
different capabilities and roles to play. I dealt with this dynamic 
regularly because both the Department of Health and Human Services and 
the EPA had important missions and were heavily dependent on state 
partnerships to carry them out.

    On matters related to public health emergencies, I view the Federal 
Government as excelling in two areas. First, the Federal Government 
collects and distributes money. While public health is a core function 
of states, the Federal Government is a significant supporter of this 
state-based infrastructure. Second, the Federal Government provides 
leadership, support, and coordination to the states and local agencies 
that are the front lines of any response. As a practical matter, 
however, the Federal Government is challenged to execute uniformly 
across the entirety of this vast, diverse nation, and thus roles should 
be assigned with care. With those limitations, the Federal Government 
is highly dependent on states to meet emergency response needs.

    I saw this very clearly when Hurricane Katrina struck in 2005. Our 
Department's role was to aid victims after their evacuation or rescue. 
I quickly understood that the Federal Government's emergency response 
system is in no small measure the aggregation of multiples state 
emergency response capacities operating under Federal coordination. 
Emergency response was done differently in Arkansas than in Texas or 
Florida. But each in their way, the states got it done. If we had 
insisted on absolute uniformity, the effort would have failed.

    Shortly after Hurricane Katrina, we were required to prepare the 
Nation for a potential pandemic influenza. Once again, it became 
evident that the Nation's public health capacity was the aggregation of 
state and local public health organizations, acting with Federal 
coordination. Each state deployed its assets. Were some better than 
others? Yes. But the Federal Government simply does not and should not 
have sufficient capacity to deploy everywhere.

    All disasters are local. When it is a hurricane or flood, 
particular areas of the country become the focus. While the response is 
led at the local level, the Federal Government is needed, as noted 
above, to step in to provide funding as well as leadership and 
coordination in some cases. But a pandemic imposes a unique strain on 
our system of response since the emergency is happening on such a wide 
scale all at once and requires resources and coordination in different 
magnitudes of scale. Because of this, pandemic preparedness requires 
special preparation and attention, and so I offer up five 
recommendations for your consideration.
Define the Division of Duties Between States and the Federal Government 
                               in Advance
    Because of the Federal Government's involvement in many state 
domains, it should not surprise anyone that states have expectations 
that the Federal Government comes to the rescue, even in areas that are 
clearly state responsibilities. In a pandemic, there are times when the 
Federal Government cannot come to the rescue. Not because the Federal 
Government lacks a will or the wallet, but because many of the 
resources they would typically call on belong to the states. In a 
natural disaster like Hurrican Katrina, Federal emergency managers call 
other states and pay them to deploy their emergency response assets to 
the disaster area. In a pandemic, state resources are not deployable 
because they are needed at home.

    In the current pandemic, at times there was confusion by some on 
matters such as the purposes of the Strategic National Stockpile (SNS), 
the procurement of personal protective equipment (PPE), and who had the 
authority to make public health decisions. In the middle of a pandemic, 
emergency finger-pointing is unproductive and costly. Roles and 
responsibilities must be communicated clearly before an emergency 
occurs to encourage swift decisionmaking and response.

    In my view, there are some duties only the Federal Government can 
accomplish. For example:

          Support the research, development, and manufacture of 
        vaccines and medical countermeasures, and approve safe and 
        effective products;

          The stabilization of the economy through fiscal and 
        monetary policy;

          Managing relationships with other countries;

          Supplementing states and local governments with 
        emergency funding;

          Creating situational awareness by collecting data and 
        research from the states and giving it a big picture 
        perspective;

          Providing general guidance and assurance to the 
        American people; and

          Interstate and intercontinental transportation.

    There are also duties better handled by states and local 
authorities. Most of the state duties are execution-oriented. For 
example:

          Managing public health functions such as inspection, 
        data collection, workforce;

          Making risk framework decisions (e.g., Red, Orange, 
        Yellow, Green) in various areas;

          Management of health care delivery capacity;

          Communicating local conditions and guidance;

          Regulation of health care delivery;

          Conducting testing and contact tracing; and

          Public health enforcement.

 The Federal Government Must Ensure and Maintain Domestic Capacity to 
 Manufacture Vaccines for the Entire U.S. Population Within Six Months 
          of the Emergence of a Virus With Pandemic Potential
    Due to the unparalleled impact that a pandemic has on the health, 
economy, and security of the entire country, the Federal Government 
must ensure the capacity to domestically manufacture enough vaccines to 
protect all Americans. A pandemic virus does not stay within state 
lines. Just as the Federal Government must prepare to deploy military 
assets such as the Army Corps of Engineers when the U.S. homeland is 
attacked or devastated by a natural disaster, it must also prepare to 
develop and deploy life-saving countermeasures and vaccines. This 
understanding led President George W. Bush to make domestic vaccine 
manufacturing capacity a key pillar of the National Strategy for 
Pandemic Influenza.

    Unlike seasonal vaccines or routine immunizations, there is no 
commercial market for most medical countermeasures outside of a public 
health emergency. No state alone, or even a group of states, can create 
and sustain such demand. Only the Federal Government has the financial 
and practical capacity to lead this effort.

    Over the last two decades, Congress has taken steps to de-risk 
vaccine research and development by funding pre-clinical, clinical, and 
advanced research, giving the Federal Government authority and 
dedicated funding to procure countermeasures, and establishing 
liability protections.

    On November 1, 2005, President George W. Bush requested $7.1 
billion in emergency funding for pandemic influenza preparedness 
activities, of which $6.7 billion was for implementing the HHS Pandemic 
Influenza Plan. Over the next year, $5.6 billion of that request was 
funded by Congress and allocated to HHS. In June 2007, HHS used some of 
these funds to retrofit existing domestic manufacturing facilities of 
U.S.-licensed biologics for pandemic influenza vaccine production. Over 
the years, additional funding has gone to support the Centers for 
Innovation in Advanced Development and Manufacturing (CIADM) to build 
warm base manufacturing capacity through both new and converted 
facilities.

    These investments must be sustained over time, and unfortunately, 
they were not. As a result, we do not have the robust, warm base 
capacity we need for this and future pandemics. After initial Federal 
construction support, manufacturers bore the full cost and risk of 
maintaining these facilities. Several of the facilities were eventually 
sold and used to produce seasonal vaccines or as contract manufacturing 
facilities. They may eventually be made available for COVID-19 vaccine 
manufacturing.

    HHS has announced contracts with manufacturers to buildup domestic 
manufacturing capacity for both COVID-19 vaccines and therapeutics 
using funds recently appropriated by Congress. This is the right move, 
and I'm glad to see it's being done. But we need to take a longer-range 
view and not wait until a pandemic has already hit our shores before 
making these kinds of investments. This approach should be a 
centerpiece of a long-term preparedness strategy.

    There are several things that the Federal Government can do to 
increase and sustain domestic vaccine manufacturing capacity, 
including:

          Support the research, development, and domestic 
        manufacturing of seasonal influenza vaccines. Domestic seasonal 
        influenza vaccine platform technologies and manufacturing 
        facilities are the foundation of domestic pandemic vaccine 
        capacity. Increased domestic seasonal flu vaccine 
        infrastructure investments can be leveraged to produce pandemic 
        vaccines with similar scientific and platform technology 
        profiles. The Federal Government can further support the U.S. 
        domestic seasonal flu vaccine market through tax incentives, 
        reimbursement strategies, research, development, and 
        procurement contracts, and other public-private partnerships.

          Utilize a federally Facilitated Vaccine Portfolio 
        Strategy. A successful pandemic vaccine strategy is not ``one 
        shot, and you're done.'' Once a virus with pandemic potential 
        is identified, the Federal Government must utilize a portfolio 
        strategy to support parallel research, development, and 
        manufacturing of multiple vaccine candidates. To execute this 
        strategy, the Federal Government must have access to pre-
        designated domestic manufacturing facilities for each type of 
        vaccine candidate technology (such as Messenger RNA (mRNA), 
        cell, or egg-based) in multiple regions of the country. The 
        Federal Government can expand beyond the current CIADM program 
        by:

                Y  Funding the warm base maintenance required to keep 
                domestic vaccine manufacturing facilities, their 
                personnel, and their technology up-to-date and 
                pandemic-ready;

                Y  Entering into cost and risk-sharing agreements with 
                commercial and academic partners to co-manage domestic 
                vaccine manufacturing facilities;

                Y  Identify and pre-certify non-traditional contract 
                manufacturing facilities, such as animal vaccine and 
                agricultural biotech facilities, which can quickly 
                convert to a vaccine or vaccine-component manufacturing 
                facility in the event of a pandemic. Participating 
                facilities could receive additional compensation for 
                operating losses from forgoing manufacturing of their 
                traditional business lines.

          Leveraging Federal Contracting Authorities in New 
        Ways. While the Federal Government must ensure domestic vaccine 
        manufacturing capacity, it cannot do it without the cooperation 
        and innovation of the private sector. Most government contracts 
        to support medical countermeasures are quite simple. The 
        Federal Government gives money to one company for the research, 
        development, or procurement of a specific medical 
        countermeasure with demonstrated safety and efficacy for 
        delivery on a particular schedule. Producing a nationwide 
        supply of domestically manufactured pandemic vaccines requires 
        the support of more complex business relationships. For 
        example, the government may have several options for vaccine 
        components, manufacturing facilities, and fill and finish 
        capabilities. They need the flexibility to ``mix and match'' as 
        science and needs evolve. If a vaccine manufacturer's vaccine 
        candidate fails in clinical trials, there must be an ability to 
        use that same manufacturer's facility, and perhaps even their 
        personnel and supply chain to produce vaccines from other 
        manufacturers with successful vaccine candidates. HHS can use 
        their Other Transactions Authority (OTA), a widely used 
        mechanism by other agencies, to enter into contracts with a 
        consortium of companies to spread risk over several different 
        vaccine candidates. \1\ Other useful authorities exist under 
        DOD programs with similar interests.
---------------------------------------------------------------------------
    \1\ See generally, ``Rapid Medical Countermeasure Response to 
Infectious Diseases: Enabling Sustainable Capabilities Through Ongoing 
Public-and Private-Sector Partnerships: Workshop Summary (2016.)'' 
available at https://www.nap.edu/catalog/21809/rapid-medical-
countermeasure-response-to-infectious-diseases-enabling-sustainable-
capabilities.

          Recruiting Federal Employees with Vaccine 
        Manufacturing and Procurement Experience. Every day of my 
        tenure as Secretary of Health and Human Services, I was 
        impressed by the knowledge, expertise, and commitment to health 
        and public service of the HHS staff. They each bring valuable 
        expertise to their roles. One area that needs additional focus 
        is ensuring that the team tasked with managing and executing 
        the Federal domestic vaccine enterprise have technical 
        experience in vaccine manufacturing and procurement. A further 
        area of required expertise is familiarity with flexible and 
        complex contracting and procurement authorities that may 
        involve other departments and sophisticated performance 
---------------------------------------------------------------------------
        metrics.

          Understand That the U.S. Isn't the Only Vaccine Game 
        in Town. With the increase in global partnerships to develop 
        vaccines for use overseas, U.S. vaccine manufacturers have 
        several potential government and non-government partners to 
        choose to do business with. One executive from a COVID-19 
        vaccine manufacturer stated that they did not seek Federal 
        funding because ``Our focus was to move as quickly as possible, 
        and we really didn't want to . . . spend a month negotiating 
        with the U.S. Government.'' \2\ The domestic vaccine supply of 
        the United States is put at risk when U.S. vaccine 
        manufacturers begin to see contracts to manufacture vaccines 
        for foreign countries and global NGO's as more reliable options 
        than partnering with the Federal Government. The U.S. 
        Government needs to be a consistent, efficient, and transparent 
        contracting partner.
---------------------------------------------------------------------------
    \2\ See generally, ``BIO: What's the ROI on a COVID-19 vaccine? We 
have no idea, says Pfizer.'' by Arlene Weintraub, FiercePharma, June 
11, 2020. Available at https://www.fiercepharma.com/pharma/bio-what-s-
roi-a-covid-19-vaccine-we-have-no-idea-says-pfizer.

    We Need Modern Day Data Collection and Aggregation to Guide Our 
                                Response
    Detailed and accurate data is essential for the Federal Government 
to coordinate and states to execute a response to a public health 
emergency. The lack of an established process to share near real-time 
data electronically leads to duplicative, time-consuming processes at 
CDC and other Federal health agencies, to aggregate and organize data 
already stored electronically at the state, local, tribal, and 
territorial levels.

    There are currently two major types of datasets tracking the COVID-
19 outbreak: a Federal dataset run by the CDC, and state-based data 
sets. A recent survey showed substantial differences between state and 
Federal data on COVID-19 testing. According to the survey,

          28 states and the District of Columbia's test numbers 
        reported by the CDC fall within 10 percent of the total test 
        numbers reported by the states and only a few match precisely;

          22 states' test numbers reported by the CDC fall 
        outside the 10 percent range--and some of the discrepancies are 
        very large; and

          13 states' total test numbers reported by the CDC 
        diverge from state reporting by more than 25 percent. \3\
---------------------------------------------------------------------------
    \3\ See generally, ``Assessment of the CDC's New COVID-19 Data 
Reporting'' The COVID Tracking Project, May 18, 2020. Available at 
https://covidtracking.com/documents/CDC-Report-CTP.pdf.

    Some of this confusion comes from conflicting reporting 
requirements for laboratories and states, while a critical element is 
the lack of interoperable software capacity to collect and aggregate 
---------------------------------------------------------------------------
test results.

    While Congress appropriated $500 million to support improved public 
health data systems as part of the recent CARES Act (PL 116-136), money 
alone will not solve the problem. HHS should work with the private 
sector to acquire the software capacity to collect and aggregate test 
results submitted by state and local public health agencies but 
coordinated and maintained by the CDC. HHS should give guidance and 
technical support to the states so they can each collect and submit 
their data in a manner compatible with CDC's, to establish the near-
real-time biosurveillance system that is necessary to detect, identify, 
and model emerging infectious diseases.

    Better data faster means a better public health response. It also 
allows Federal and state governments to quickly predict how a disease 
will impact different populations and help identify high-risk 
individuals and communities that need additional interventions.
    We Should Modernize and Sustain Our Public Health Infrastructure
    The public health function of our state and local governments is 
being tested in many ways through the current public health emergency, 
and it is clear that it is in desperate need of modernization. In part, 
this is due to budget pressure at the state level to prioritize 
Medicaid spending or other health priorities over investments in public 
health. Public health is often a forgotten function of government, 
working quietly behind the scenes and not drawing attention to the part 
it plays when things are going well. But the COVID-19 pandemic has 
thrust public health into the spotlight, and it is now getting the 
attention it warrants.

    The CARES Act included funding to make essential upgrades to our 
public health infrastructure, and I hope that this funding is used 
wisely to help states and local agencies make long-term improvements. I 
believe that upfront investments in public health modernization at the 
state and local level save the Federal Government money over time. For 
example, if state and local public health agencies maintained the 
capacity to trace contacts for emerging infectious diseases and surge 
that capacity as necessary, Congress wouldn't need to come up with such 
large emergency supplemental appropriations to respond to every 
emergency. With a strong foundation of well-trained personnel, IT 
infrastructure, and surge capacity steadily funded, it wouldn't be as 
great of a strain to respond to a pandemic or any other health 
emergency.

    This is not just an issue for governments. Right now, many 
employees of large and small businesses alike are having their 
livelihoods threatened by the economic impact of COVID-19. There can be 
no real economic recovery until we have public health risk mitigated. 
This connection between public health and financial well-being provides 
strong incentives for employers and the business community to step up 
in new ways to partner with and support state and local public health 
agencies.
        Preparedness Needs to Have the Same Urgency as Response
    Finally, one of the goals of preparedness should be to identify 
potential threats and responses before they happen. Preparedness 
exercises must be done regularly at the Federal, state, and local 
government levels, as well as by the private sector, communities, and 
families. In many places, these exercises are a standard practice 
already, and I think that they should become more widespread, more 
frequent, and should focus on known and unknown threats. One of the 
things we did at our business was develop a continuity of operations 
contingency plan for a pandemic or economic downturn. We didn't know if 
either or both would happen, but when they did it allowed us to 
transition to remote work and take other quick measures to mitigate the 
impact of COVID-19 on our clients and employees. Similarly, I reached 
out to family members and encouraged them to develop preparedness 
plans.

    Right now, it feels a bit like we are walking out onto an icy lake. 
We're not sure how thick the ice is. So, you walk a few feet, stop, and 
pause, and get a sense of whether you feel comfortable or not, whether 
you hear cracking sounds. If you do, you move back, but if you don't, 
then you move forward. And that's where we are as a country. We have 
seen individuals and institutions scramble over the last few months to 
develop risk frameworks to guide public health and economic decisions--
essentially frameworks for how we safely walk across the icy lake. 
These are the ``Red, Orange, Yellow, Green'' and ``Phase 1, Phase 2, 
Phase 3'' decisions that Governors and Mayors must make. After the 
pandemic, these officials should be encouraged to preserve these risk 
frameworks so they can build on them in future emergencies. The 
specific details of any given plan may need to change, but the mindset 
of thinking in advance and gaming out a response should not.
                               Conclusion
    Thank you for the opportunity to address this Committee. I agree 
with Chairman Alexander that now is the time not just to respond, but 
to prepare. This pandemic is not over. New cases are still rising in 
some locations, and others that have seen a decrease may have a second 
wave in the fall or next year. That means we still have time to prepare 
for what this disease may bring and for future public health 
emergencies. As the Committee looks at different policy 
recommendations, I remind you to consider how the Federal, state, and 
local governments, as well as the private sector, communities, and 
individuals, can all play a role. We are ``all in this together'' in 
pandemic response and recovery but must now extend this mentality to 
preparedness as well.

    I look forward to answering any questions you have.
                                 ______
                                 
               [summary statement of michael o. leavitt]
    This pandemic has affected us all in profound and different ways, 
which is why we must learn from what we are experiencing today and take 
steps to set ourselves up for the best possible outcomes in the future.

    All disasters are local. When it is a hurricane or flood, 
particular areas of the country become the focus. While the response is 
led at the local level, the Federal Government is needed to step in to 
provide funding as well as leadership and coordination in some cases. 
But a pandemic imposes a unique strain on our system of response since 
the emergency is happening on such a wide scale all at once and 
requires resources and coordination in different magnitudes of scale. 
Because of this, pandemic preparedness requires special preparation and 
attention, and so I offer up five recommendations for your 
consideration.

    1. Define the Division of Duties Between States and the Federal 
Government in Advance.

    There are some duties only the Federal Government can accomplish:

          Support the research, development, and manufacture of 
        vaccines and medical countermeasures, and approve safe and 
        effective products;

          The stabilization of the economy through fiscal and 
        monetary policy;

          Managing relationships with other countries;

          Supplementing states and local governments with 
        emergency funding;

          Creating situational awareness by collecting data and 
        research from the states and giving it a big picture 
        perspective;

          Providing general guidance and assurance to the 
        American people; and

          Interstate and intercontinental transportation.

    There are some duties better handled by states and local 
authorities:

          Managing public health functions such as inspection, 
        data collection, workforce;

          Making risk framework decisions (e.g., Red, Orange, 
        Yellow, Green) in various areas;

          Management of health care delivery capacity;

          Communicating local conditions and guidance;

          Regulation of health care delivery;

          Conducting testing and contact tracing; and

          Public health enforcement.

    2. The Federal Government Must Ensure and Maintain Domestic 
Capacity to Manufacture Vaccines for the Entire U.S. Population Within 
Six Months of the Emergence of a Virus with Pandemic Potential.

    3. We Need Modern Day Data Collection and Aggregation to Guide Our 
Response.

    4. We Should Modernize and Sustain Our Public Health 
Infrastructure.

    5. Preparedness Needs to Have the Same Urgency as Response.
                                 ______
                                 
    The Chairman. Thank you, Governor Leavitt. And thanks to 
each of you. We will now begin a five-minute round of 
questions. I would ask the Senators and the witnesses to try to 
observe the five-minute limit. We have a lot of Senators who 
want to talk to these very distinguished witnesses. I will 
begin.
    When we are through, I am going to ask each of the 
witnesses to answer this question, if you were the king or the 
queen and you could do two or--let's say three things to be 
ready for the next pandemic, what would those three things be? 
Now, Dr. Frist I only have five minutes, but let me start with 
you with this question. Someone might ask, why are you taking 
time in the midst of this pandemic to talk about planning for 
the next one? How would you answer that question?
    Dr. Frist. Yes, I think the points are made. We need to end 
this pandemic. But, we don't know even when a second surge is 
going to come. So as much as we can do to prepare that 
infrastructure and the structure itself for the next pandemic, 
the next emerging threat, it will apply to what we are doing 
now.
    The sense of urgency is simply that we have identified 
pretty quickly in the last several months the needs that are 
out there, which we have talked about in this hearing thus far, 
and now is the time to go ahead in a parallel fashion, pass 
legislation, and I would add things like the telehealth hearing 
that you had the other day, good things you can do now which 
will make either a second surge preparation more adequate or 
another pandemic which will occur more tolerable in the future.
    The Chairman. Thank you. And as each of you said, memories 
are short and we will move on to the next issue if we don't 
deal with this one now. Now, let me go to Dr. Gerberding and 
Governor Leavitt first. Let's talk about manufacturing. Let me 
drill down on that a little bit. We dealt with manufacturing 
before. We built three manufacturing plants.
    Today, we have 10, 12, 14 of vaccines that are racing 
toward trying to produce several hundred million doses by early 
2021. Ideally, what sort of manufacturing capacity should the 
Federal Government have on hand, ready to produce these doses 
and to distribute them properly? Can we just rely on the 
private sector to do that or should we have our own 
manufacturing plants? I thought we did that with three 
manufacturing plants. Are they adequate? What happened, 
Governor Leavitt?
    Mr. Leavitt. As time has gone on and the urgency has 
diminished, we have seen the ongoing funding of those, 
particularly in the area of maintenance and keeping them warm--
we invested and I think properly invested in partnerships to 
enhance it. What I think we did not do adequately as a country 
over the course of time is maintain them in a way that they 
were warm and could be stood up quickly. I will also mention 
that we have a big challenge in being able to fill and finish 
and distribute that infrastructure.
    Yes, the private sector can in fact be very important in 
that process because that infrastructure exists, but planning 
how it will be distributed, who will get it first, etc. is a 
big need and it is one that will need to deal with, to Senator 
Murray's point, even now. So if we have time, and I know that 
the Department is likely working on this, but that is a 
critical need.
    The Chairman. Dr. Gerberding, you have seen it from both 
sides, the Government and now the private sector. Should we 
build manufacturing plants or pay for the private sector to 
build manufacturing plants for the future, or can we remodel 
those we now have? What should we do? What is a smart strategy 
in manufacturing for the Federal Government?
    Dr. Gerberding. One thing Senator to point out about the 
manufacturing that has been built in these partnerships is that 
was primarily targeting influenza, and influenza vaccine is a 
dual-purpose vaccine because of course we have seasonal flu 
every year and the idea would be they can call upon those 
seasonal flu operations to flex in the case of a pandemic as we 
did in 2009 when we were experiencing H1N1 pandemic. Broadly 
speaking, the few large manufacturers of vaccines that are 
still in business are nearly at capacity just to create the 
vaccines that we need for day-to-day purposes and immunizing 
our population against known threats.
    We clearly need an emergency capacity buildup. And in my 
view that is best done in private, public partnerships. We may 
get to a point, as we experiment with these 130 products that 
are in various stages of development for this pandemic, where 
we understand the concept of a platform approach, meaning that 
we can repurpose a given facility easily for the next problem 
that comes along and that we don't have to go back to ground 
zero and build a new each time a new and unfamiliar need for 
vaccine arises.
    I think a partnership model works best and we must not 
remove the incentives for the biopharmaceutical industry to 
continue to innovate. It is that innovation that has gotten 
this far this fast in this particular pandemic, but at the same 
time we can't invest at scale for 130 candidates. We have to 
make choices. And that is where the NIH----
    The Chairman. My time is up and I want to respect the five-
minute limit as interesting as the comments may be. Thank you.
    Senator Murray.
    Senator Murray. Thank you, Mr. Chairman. Thank you to all 
of our witnesses. Really appreciate your testimony today. Dr. 
Khaldun, the United States COVID-19 response has failed to keep 
black and latino families, Indian tribes, and other people of 
color healthy and safe. Disproportionately high numbers of 
people of color are becoming seriously ill or dying from COVID-
19.
    This tragic reality is driven in part by long-standing 
systemic racism and underinvestment in communities of color, 
which have contributed to significant health disparities, but 
it is also a result of this administration's failure to take 
these disparities seriously and devote attention and resources 
to the communities most in need of assistance. I am going to 
ask you today, what can we do to address the immediate impact 
of the pandemic on communities of color?
    Dr. Khaldun. Thank you, Senator Murray, for that question. 
So we in the state of Michigan have identified these 
disparities very, very early. The Governor actually announced 
quickly a task force to really understand why these disparities 
exist and then to develop specific recommendations for how we 
address them. So some of the things that we have done is making 
sure that testing is accessible in minority communities.
    We actually worked with the communities to bring testing to 
places where they normally wouldn't have access to care. We 
have also eliminated costs for a lot of our testing sites so 
you don't have to worry about it if you don't have insurance or 
even if you don't have a primary care doctor. A lot of our 
sites in Michigan for testing, you don't have to have a 
doctor's order in order to be able to get a test done.
    Then we have to think about all of the people who have been 
deemed essential during this pandemic and been coming out of 
their homes to have to work and how we can protect them. So 
making sure they are not allowed to lose their jobs and that 
they get supports at home so that they can be able to be as 
safe as possible.
    Senator Murray. Thank you. Obviously, we have to work on 
this. We can't ignore it as we have been doing and I think this 
is a really important point we need to think about not just for 
today, but moving forward, so thank you. Dr. Gerberding, we 
have a very robust system for evaluating vaccines.
    Unfortunately, we have seen some concerning polling already 
suggesting some Americans would not be willing to get a COVID-
19 vaccine. So the time to build that confidence is right now 
and a number of experts are expressing concern that President 
Trump's vaccine acceleration process known as Operation Warp 
Speed could undermined confidence in COVID-19 vaccine, 
particularly, if the public perceives that a vaccine was rushed 
out for political reasons or without rigorous review. What 
specific commitments should the administration make right now 
to build public confidence in a vaccine?
    Dr. Gerberding. There are two things that I would 
recommend, one is transparency about exactly what the safety 
assessments are and that involves the participation of the ACIP 
at the CDC, the FDA, and several of the other scientific 
organizations that have an oversight of that. The second thing 
that I would propose is that the safety be monitored by the 
National Academy of Medicine.
    This is something that has happened many years over the arc 
of childhood immunizations and when I for example had 
responsibility for administering the smallpox vaccination 
program for First Responders, it was the National Academy of 
Medicine that monitored the safety of that program and helped 
us identify very early that there was a safety signal. So I 
think involving the scientific community, credible experts, 
apolitical and orientation is really going to be a very 
important part of building this trust.
    Senator Murray. Okay. And a comprehensive plan, I would 
assume you would agree?
    Dr. Gerberding. Absolutely. Yes, absolutely.
    Senator Murray. Senator Frist, good to see you again. You 
have repeatedly emphasized the importance of strong public 
health funding and argued that insufficient public health 
investments have met state and local public health departments 
are responding to COVID-19 with, ``one hand tied behind their 
backs'' and you have argued for the creation of a $4.5 billion 
mandatory annual investment in public health infrastructure. I 
think this is something that is critically important and I want 
to ask you, if we were to create such a fund, how do you 
predict the U.S.'s response to the next infectious disease 
outbreak would look different than what we currently have?
    Dr. Frist. Well, I think all or many of the panelists have 
empathized this importance of the sustained funding and the 
public health infrastructure fund is one option to do that, one 
that I do support.
    A strong public health system can quickly alert us to 
problems. You can build resilient communities that are healthy 
and socially connected. It creates a reserve capacity to 
respond to an emergency of any kind which is why I co-authored 
that op-ed with Senator Daschle and the FDA Commissioner Andrew 
Von Eschenbach in support of what was a $4.5 billion public 
health infrastructure fund. It is really interesting.
    We have not consistently provided the type of funding this 
needed to build an ongoing strong public health system. If you 
look back at the Great Recession, frontline state and local 
health departments have lost more than 56,000 positions due to 
funding cuts. These are the people we need whether for contact 
tracing or epidemiology. They have been lost now over the last 
about 10 years.
    Strong predictable investments from the Federal Government 
will ensure that public health departments here on the ground, 
in your community are fully staffed and resourced and able to 
handle the needs of today's demand for things like the contact 
tracing force.
    Senator Murray. Okay. Thank you. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Murray. Senator Burr is 
next and for 17 years he has been busy writing many of the laws 
we are talking about today.
    Senator Burr.
    Senator Burr. Chairman, thank you. Thank you for that 
recognition. Senator Frist, Secretary Leavitt, Dr. Gerberding, 
Dr. Khaldun, welcome. We value the ability to pick your brain 
on this. I think this is probably the most important period in 
this pandemic it is when we begin to do the after action review 
and figure out what worked, what didn't work, what needs to be 
changed, and it is important that Congress go through this 
process.
    When we moved the last PAHPA reauthorization bill out of 
this Committee, I reminded my colleagues at that time, this was 
by no means the finish line and much work remained for us to be 
better prepared. Dr. Gerberding, you were in a unique situation 
at CDC and now in the private sector, but in your testimony, 
you advocate for a greater use of public-private partnerships. 
During our last HELP Committee hearing on the pandemic, I urged 
the CDC to put these types of collaborations in place so that 
we could leverage innovative technology companies and our 
ability to detect, to identify, and detract threats including 
emergency infectious disease.
    Given your experience at the helm at the CDC, why was the 
agency so ill-equipped to put these types of agreements in 
place before the pandemic and what would you recommend to CDC 
going forward as it relates to public, private partnerships?
    Dr. Gerberding. Thank you, Senator. And I must say I don't 
know what the CDC was or was not doing in collaboration with 
private sector partners. Just seeing it from the outside 
looking in, there has been a tradition of recognizing the 
importance of the private sector when I was there. We had desks 
in the Emergency Operation Center for a number of private-
sector entities that we recognized as important in the supply 
and stockpiling logistics and testing, etc.
    But I will also say that there are some complexities of 
working with the private sector and Government. And I just go 
back to what Governor Leavitt said in the context of planning 
for influenza pandemic where we recognized that the Federal 
Government has a critical role but we had learned then and what 
I think we are seeing now is that the private sector is 
powerful, and leveraging that power and those resources is 
essential to being able to scale a national response.
    Senator Burr. Well, I thank you for that. I think that the 
deficiency was most evident in testing and the inability for 
CDC to reach out to the private sector. Thank goodness PAHPA 
reauthorization allowed greater expansion of authorities by the 
directorate FDA to use emergency use authorizations to set up 
these public-private partnerships, and we have probably more 
capacity than is being utilized in testing nationwide today. 
One of the areas where efficiencies can be gained in vaccine 
manufacturing and production is through the use of platform 
technology, Dr. Gerberding.
    For example, Merck licensed the Ebola vaccine platforms 
being used to develop coronavirus vaccine. How can we enhance 
the coordination between innovators, BARDA, FDA to ensure that 
these platforms against these threats is as efficient as 
possible when the need arises? In other words, how do we keep 
these platforms as an approved entity and we only do the 
clinical proof on what we are trying to treat off the 
platforms?
    Dr. Gerberding. I think BARDA is well on its way to being 
able to accomplish that. I think CEPI is another model, the 
Coalition for Epidemic Preparedness Innovation. But what needs 
to happen is not necessarily having a focus on efficiency. We 
need to have a broader expectation that will invest in a lot of 
things that won't pan out. If we aim for efficiency, we are 
going to be slow and miss the boat. We need to be prepared to 
experiment, to try a broader array of things, and I continue to 
think that BARDA is critical to the coordination of all of 
that.
    Senator Burr. Thank you for that, Dr. Gerberding. This 
question is to my good friend, Mike Leavitt and Bill Frist. We 
did what I thought was revolutionary at the time with the 
investment in three flex manufacturing facilities for vaccines. 
And the testimony has been correct that they were designed for 
the annual influenza or some variation, at the time H1N1, H5N1, 
and they are very difficult to program over and surge in front 
of that vaccine for coronavirus. Can both of you give us what 
you think this Committee should do legislatively to encourage 
the creation of some type of multi-manufacturing facilities 
that can be utilized when the Federal Government feels a 
national need?
    Mr. Leavitt. I will respond quickly. First, just annual 
appropriation, supporting it when there is not a crisis is the 
first thing that has to happen because it is keeping facilities 
warm and keeping access to them during those periods that makes 
it possible when there is a need.
    Senator Burr. Senator Frist.
    Dr. Frist. Yes, and Senator Burr, again, thank you. I just 
17, 18 years ago I remember all the nights in the majority 
leader office as you helped put together BARDA so thanks for 
that. You know, I think it is going to come down a little bit 
to what Senator Murray asked about increased funding and how we 
do it. I am on record as supporting a mandatory appropriation 
about $4.5 billion fund but also I mentioned my testimony the 
HD, which is an annual appropriation which really comes to what 
Governor Leavitt talked about.
    An annual appropriation in a sort of an advanced category 
would allow you to fund it to BARDA individually, to NIH 
individually, discretionary funding, and to the NIH all three, 
but it would be annual and it would be annual appropriations 
with oversight by the U.S. Senate, by the Congress itself. That 
does have the advantage of this timeliness of incorporating 
science, what is needed at a particular time and guarantees 
that funding in a sustained way. So I would also encourage 
looking at that because that immediacy of what is needed to 
years from now is going to be very different as we just saw 
with flu vaccine manufacturing versus the current 
manufacturing.
    It is going to have to be flexible and it is going to have 
to be nibble, and you might consider, even though it is not 
directly in your Committee, that sort of annual appropriation 
oversight be able to support the type of public-private 
partnerships in this area of manufacturing.
    Senator Burr. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Burr. Senator Casey is 
next and he too has been very involved being the principal 
Democratic co-sponsor of the last reauthorization of the PAHPA 
bill, I believe.
    Senator Casey.
    Senator Casey. Mr. Chairman, thank you very much. And thank 
you for noting that, and I am grateful for the testimony of our 
witnesses and the wisdom and experience they bring to bear on 
these issues for this hearing. I wanted to start with Dr. 
Khaldun regarding what you have seen in a lot of what is in 
your testimony with regard to the challenges faced in the state 
of Michigan like so many other states. I know that Detroit, 
obviously one of the hardest hit cities in the country, just 
like all major cities, like Philadelphia have been hit, 
especially in the black community and that is true in so many 
of our urban areas.
    I know that in your testimony, I guess when you compare the 
percent of the population of African-Americans in Michigan, 
about 14 percent but 40 percent of the deaths and more than 30 
percent of the cases. In our state the death number, percent 
might be a little lower, but it far outstrips the percent of 
the population. We have had to date at least 1,368 deaths of 
black Pennsylvanians from COVID-19. So I have two questions, 
the first one is, how have the social determinants of health 
impacted people's ability to protect themselves and their 
families from the virus and from the COVID-19 disease?
    Dr. Khaldun. Well, thank you, Senator Casey. So absolutely, 
when you talk about the health disparities that we are seeing 
not just in Michigan, but across the country, those social 
determinants of health, so housing, transportation access to 
healthcare, poverty, those are things that we believe are 
really contributing to the disparities in COVID-19 as they 
contribute to other health disparities.
    Again, people who are of color are more likely to live in 
poverty. They have been more deemed as essential workers coming 
out of their house instead of being able to safely work from 
home, needing to take public transportation, living in crowded 
or perhaps unsafe living conditions making them more likely to 
spread COVID-19. So those are some of the things that we have 
seen in Michigan that we believe are contributing to the 
disparities.
    Senator Casey. I guess as well some, many I should say, 
African Americans are the ones who are on the frontlines and 
often the very front of the front line. Is that correct?
    Dr. Khaldun. Yes, that is correct, Senator Casey. So again 
going back to the fact that people of color are more likely to 
live in poverty and therefore more likely to have those lower 
wage jobs, some of our grocery store workers, bus drivers, 
those types of jobs. And those are the exact people that when 
across the country we had stay home or stay safe orders, a lot 
of those people were unable to stay at home. They had to come 
out and I believe that contributed to the disparities and the 
disparate numbers of deaths that we have seen.
    Senator Casey. Thank you, doctor. The second question I 
have is, we know that public health is driven at a very much a 
state and local level. But obviously this pandemic has reminded 
us that all levels of Government need the help of the Federal 
Government. And I guess when you step back and look at where we 
have been, what parts of the response so far do you believe 
require coordination and the convening power of the Federal 
Government?
    Dr. Khaldun. Yes, so I think that very early on, and first 
let me actually start by saying I really appreciate the support 
of my Federal colleagues at the CDC who since January has been 
really supportive of us at the state and local level in 
Michigan. But I do think that we should have had, as I said in 
my testimony, a more urgent testing response in our 
communities.
    Early on in my state labs, we were preparing in January 
actually to be able to perform the test, but we ran into delays 
and I am sure that in Michigan because of those delays, there 
were people who weren't tested and the disease was spreading 
before we even knew it. So I believe that a coordinated 
strategy at the Federal level would have helped us in that way. 
Also with PPE, we had to fight other states and even local 
Governments in being able to get access to PPE and it really 
delayed us and I think exposed many more people to the virus in 
Michigan.
    Senator Casey. Finally, Dr. Gerberding, I want to thank you 
for your help in Pennsylvania helping our citizens and our 
state to better understand what we have been up against and am 
particularly grateful for that. I guess in the 30 seconds we 
have, you spoken about an immunization infrastructure. Could 
you fill in for us, I know your testimony spoke to this, the 
kind of the who, what, when, where, the mechanics of that, who 
should be involved and what role the Federal Government should 
play?
    Dr. Gerberding [continuing]. Are just beginning to improve 
that for adolescents and adults but it is fragile and I think 
one of the most important things that is not getting enough 
attention right now is the fact that distributing this vaccine, 
even in the United States, is going to be incredibly 
challenging, making the decision about who goes first, how to 
allocate doses as they become available, and how to sustain 
that atmosphere of trust and willingness to step forward and 
receive it.
    The infrastructure for that is going to be local and that 
means that we need to support our local and State health 
officials in getting ready to make those really hard decisions 
and implement that really macro-program.
    Senator Casey. Thank you. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Casey.
    Senator Collins.
    Senator Collins. Thank you, Mr. Chairman. Dr. Frist, it is 
great to see you again. We have missed you. One of the lessons 
from the COVID pandemic is that our country is far too 
dependent on foreign manufacturing of drugs, diagnostics, and 
medical supplies. For example, about 80 percent of the basic 
components used in medicines, the active pharmaceutical 
ingredients, are coming from China and India for our U.S. 
market. The exact dependence remains unknown since there is no 
API registry. Well, what happened is just about the time that 
the COVID-19 epidemic hit the United States, India stopped 
exporting 26 APIs and finished drugs.
    The CARES Act includes portions of legislation that I 
introduced with Senator Tina Smith, the Meds Act, that includes 
greater reporting requirements on the sources of APIs as well 
as redundancy plants and tended to deal with shortages, but are 
there specific incentives that the Senate should consider 
specifically to encourage domestic manufacturing, including 
perhaps tax incentives or greater investment in FDA's emerging 
technology program?
    Dr. Frist. Thank you, Senator Collins. I think this whole 
coordination of procurement is huge and in the Committee's 
white paper, you talked about coordination, procurement as 
being a very clear and important Federal responsibility. As you 
pointed out, we have been inadequately prepared here. We have 
seen it day in and day out and we can do so much more to 
establish this resilient domestic right here at home 
manufacturing lines, detracting of supply chains, ensuring a 
robust support of the national strategic stockpile.
    The incentives will have to be financial. The real problem 
in these public, private, or the real challenge in these 
public, private partnerships is this lack of continued funding 
over time to adjust to the market, where on the private sector, 
they will be generous and they will be patriotic but at the end 
of the day, they do need to report fiscal responsibility. So we 
have to step in and whether it is with direct tax credits, 
whether it is with a funding stream by an artificial market 
that is set up over time, we do have to keep a revenue stream 
out there that is dependable, it is sustainable, and that is 
long term, and that is flexible because it will change year to 
year in terms of what those manufacturing, the specific 
manufacturing needs are.
    As for the testing itself, the tests are remarkable right 
now between the public-private partnerships and the private 
sector moving ahead and is being revolutionized before eyes in 
a very quick fashion. Now, it came too late. It came too late 
but now there is an encouraging more and more of that with some 
sort of financial incentive.
    Senator Collins. Thank you. Dr. Gerberding, last month the 
Aging Committee held a hearing on the impact of the coronavirus 
on older adults living in nursing homes. And that hearing 
reaffirmed my belief that a baseline test for all residents and 
staff, not just those that are symptomatic, is necessary to 
prevent outbreaks. COVID-19's impact on long-term care settings 
directly intersects with the stark racial disparities have we 
are seeing, and unfortunately, remarkably Maine has the 
Nation's worse COVID-19 racial disparity.
    Many of the worst outbreaks that have occurred in Maine are 
in nursing homes and the CDC reports that some 40 percent of 
those health care workers that have tested positive were 
identified as black or African Americans. As a former director 
of the CDC, what do you recommend as the best way for Congress 
to help address this racial disparity among those that are the 
frontline workers in our nursing homes?
    Dr. Gerberding. Thank you, Senator. Obviously we need to 
test symptomatic people and their context but to me the third 
most important reason to test are the people who are working in 
these known high-risk environments and clearly nursing homes 
are among those at the top of that list. Those are intrinsic 
hot spots and we need to test often and test everyone who comes 
and goes from those centers until such time that we can 
demonstrate that transmission has been contained.
    I can't say enough about how critical it is to not overlook 
the most vulnerable people and that includes the elderly people 
but also those who are vulnerable on the basis of underlying 
conditions and often that tracks with the racial and ethnic 
disparities that you are alluding to. It is a very difficult 
challenge. The solution to it is multifactorial.
    It really is a reflection of the social determinants of 
health as much as anything else and that is a long answer, and 
I know I have a short period of time, but the first step is to 
make the measurement clear and transparent so that we all have 
to stare it in the face and recognize that we are not 
successful until we deal with that challenge.
    Senator Collins. Thank you.
    The Chairman. Thank you, Senator Collins.
    Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman, having trouble 
with my mute button here.
    The Chairman. You are on now.
    Senator Baldwin. Great. Thank you. So I wanted to start by 
just reflecting that every Member of this Committee would love 
to be able to turn the page on the current pandemic and start 
planning for the next one, but the cases of COVID-19 and 
hospitalizations continue to rise and we can't divert our 
attention from the ongoing crisis. And I think it is very clear 
that the administration has not yet learned a critical lesson 
particularly about worker safety. Without enforceable worker 
safety standards, workers and their families are needlessly put 
at greater risk when they go back to work.
    Guidelines from the CDC have not been enough, and yet the 
Occupational Safety and Health Administration has failed to 
move forward with mandatory and meaningful rules for employers. 
In response to disturbing widespread reports of safety concerns 
leading to preventable illnesses and deaths, I introduced the 
COVID-19 Every Worker Protection Act. This bill would require 
OSHA frankly to do its job and to issue an emergency temporary 
standard that establishes a legal obligation of all workplaces 
to implement infectious disease exposure control plans that 
would keep workers safe during the COVID-19 pandemic.
    Dr. Khaldun, do you believe that giving employers clear and 
mandatory rules through an emergency temporary standard would 
help improve our public health response by protecting workers, 
their families, and their communities during a pandemic? And 
correlated with that, why is a focus on worker safety 
particularly important for communities of color and others who 
have been disproportionately impacted by COVID-19?
    Dr. Khaldun. Thank you, Senator. So, absolutely. The health 
and safety of our frontline workers has been incredibly 
important. I think it is really unfortunate that a lot of our 
frontline workers have been infected by or even died from 
COVID-19. In the state of Michigan, our Governor did issue an 
executive order that established robust protections for our 
workers so that is incredibly important. It goes back to these 
social determinants of health and the fact that communities of 
color are more likely to live in poverty and have these lower 
wage jobs. So again, they have had to come out of their homes 
instead of being at home during this pandemic, so it is 
incredibly important.
    The Chairman. Senator Baldwin, we have lost your signal and 
we will wait just a moment. See if we can regain it. If not, we 
will go back to you--why don't we move on to Senator Cassidy 
and then we will come back to Senator Baldwin, let her reclaim 
her time when ever she regains her internet signal.
    Senator Cassidy.
    Senator Cassidy. Thank you all for being here. I appreciate 
your service in the midst of an epidemic. I have got questions 
to begin with, with Mr. Leavitt and Dr. Gerberding. Let's kind 
of reflect on your past history, if you will.
    Dr. Gerberding, all of you are recommending lots more money 
for the Centers for Disease Control and public health, 
mandatory spending almost most of you. If you are not saying 
that specifically, it seems as if you wish it to be mandatory. 
There is a lot of folks out there that feel as if the CDC has 
not responded to the challenge with the money that they have 
been given and before significant more dollars are given, would 
like to see some sort of recommendations for reform. So some of 
the criticisms made, which I have made some of them by the way, 
whether it is right to make them are not, a little bit slow to 
the mark, laborious contracting with lots of red tape, a loss 
of focus, afraid to take bold action, and they misjudged 
terribly the rapidity by which the virus would spread 
throughout our community.
    Now, if we are going to ask to give them another $4 or $5 
billion and more and more and more, I think it is fair to say, 
is there reform that could be instituted, that you are just not 
putting more money into a system which is inherently not 
working well, but rather more money in system which is 
streamlined so that it can work better? What are your thoughts 
on that, may I ask?
    Dr. Gerberding. You know, I have known the CDC for a long 
time before and after I worked there and I can say that the 
scientists who are there are national treasures and the 
scientists who are there leading this pandemic are the same 
scientist that were there when I dealt with SARS. So I don't 
think it's a deterioration of the science or the scientific 
capability of the agency.
    I do think the scale of this response would test any public 
health agency as it has around the world, but I also do think 
that modernization is a word that really needs to be the 
framework for considering where do we go from here. One of the 
things that I would acknowledge, and maybe Governor Leavitt 
would like comment, is that when we did extensive rehearsal for 
influenza pandemic preparedness, again involving some of the 
very same people, we rehearsed everything except one thing, we 
didn't rehearse testing because in influenza you don't rely on 
the test to make the diagnosis and make the decisions. So the 
whole apparatus necessary to scale test to 300 million people 
was not something that we practiced and we made----
    Senator Cassidy. Let me ask, and I can concede that 
although it seems as if there could have been--because I 
understand in different times people were concerned about 
bubonic plague and other kind of exotic infectious diseases 
coming in, so it seems that testing could have been imagined as 
an issue, but there has so far not been a plan I have seen to 
actually go beyond mitigation into actual suppression. And so 
we have communities that have moved beyond litigation that 
should be in suppression, but again, we don't see the plan for 
that. So what would be your response to that?
    Dr. Gerberding. Well, I am not sure I could agree with you 
on the we have ended the mitigation phase and are into 
recovery. This virus is still not----
    Senator Cassidy. I am not speaking nationwide. I am 
speaking particular communities.
    Dr. Gerberding. But in every community the vast majority of 
people remain susceptible so they are only one visitor when 
travel away from exposure.
    Senator Cassidy. Which is why you need the suppression, I 
guess. Let me go to you, Dr. Leavitt--Mr. Leavitt, I am sorry. 
The defenders of the CDC said it actually put good stuff out 
there, but there is a review process that squashes it, and yes, 
they actually have thought ideas that would say Montana you are 
so low, we can move to a suppression strategy, but they float 
it, it gets killed.
    Now, I look at the interaction between CDC and HHS and the 
White House as a black box, but someone told me that the 
Congress should demand recommendations without review. Meaning 
that we get the recommendations for those, what that means, I 
didn't. That we get the recommendations unvarnished, not if you 
will kind of looked at through the political lens or through 
the lens of that which the administration wished to have. It is 
the pure scientists that Dr. Gerberding just kind bragged on. 
What are your thoughts on that?
    Mr. Leavitt. I am inclined to believe that Congress getting 
the facts in an unvarnished way is a good thing and that good 
ideas will be held up under scrutiny. I will point out that 
there are times when even within a Department or the Government 
there are conflicting missions. Testing is a good example. CDC 
had the mission of being able to get testing out quickly. FDA, 
it was about being accurate. Sometimes accurate and quick don't 
align, and in a situation like that, in an emergency situation 
that occurred. I too agree with.
    Dr. Gerberding, CDC is a treasure not just in the United 
States, but around the world in dealing with disease around the 
world. If you look at international organizations and lift up 
the hood, you will see at the heart of that are the scientists 
in CDC, and I know you are not intending to diminish that but 
it is--in an emergency, it is easy to be critical in an 
emergency. The reality is they need support.
    Senator Cassidy. I accept that but I think with Dr. 
Gerberding said about modernization, if we don't have 
modernization, it is going to be difficult to get people to 
support the more financially. I yield back.
    Mr. Leavitt. I totally agree with that, particularly in the 
data infrastructure. Our data infrastructure, the ability to 
collect data from the states in an almost real-time, be able to 
create situation situational awareness, that is one of the 
fundamental important duties of the Federal Government in a 
pandemic situation is to provide situational awareness.
    Senator Cassidy. Thank you.
    The Chairman. Senator Cassidy.
    Senator Murphy.
    Senator Murphy. Thank you very much, Mr. Chairman. Thank 
you to all of our witnesses. Senator Cassidy knows the high 
regard in which I hold him and he is not wrong that there needs 
to be reform at the CDC going forward and admission of the ways 
in which they didn't measure up. But let's just be a hundred 
percent clear here, the CDC is trying to do good work here. 
They are sending out regular guidance on the importance, for 
instance, of wearing masks as maybe the most evidence based 
method of preventing the spread of this disease.
    The President of the United States refuses to wear a mask. 
His top advisors refuse to wear masks. He says it is an attack 
on him politically for people to wear masks. The CDC develops 
guidance for individual industries and businesses to reopen. 
The White House then prevents that guidance from being 
dispensed to states because the White House doesn't want to 
take responsibility for the decisions made to reopen the 
country.
    I think the CDC needs to do some hard looking internally, 
but I also think that they have been prevented from doing the 
best work they could by this administration, this President. I 
appreciate the focus of this hearing moving forward, but any 
good fire department that has a house on fire and a house next 
door that is in danger of catching on fire does both, they put 
out the fire at the house that is engulfed in flames and they 
try to do work next door to prevent the next house from 
catching fire. We are not doing both in the Senate right now. 
We are holding a hearing on getting ready for the next pandemic 
and we are not taking up any legislation this work period in 
order to address the existing pandemic.
    I want to frankly direct some of my questions to our 
witnesses with respect to what we could be doing now, which I 
think also probably is part of the conversation about what to 
do moving forward. Dr. Gerberding, you referenced how important 
it was for us to join the international vaccine effort, CEPI. 
The Coalition for Epidemic Preparedness Innovations is a 
multinational public, private sector collaboration to develop a 
vaccine for COVID-19.
    It is also working on other vaccines as well. I agree with 
you. We should join CEPI as a mechanism to get ready for the 
next pandemic but we should join CEPI right now, correct? There 
is no reason to wait, especially given that they are doing most 
of their work as we speak on a vaccine for COVID-19.
    Dr. Gerberding. I completely agree with you, Senator.
    Senator Murphy. Just underscore why that is important. Why 
is it important for us to be in CEPI right now as they develop 
a COVID-19 vaccine?
    Dr. Gerberding. Well, CEPI is already funding many of the 
biopharmaceutical entities that are working on vaccines. So 
they have already reviewed and invested, but they also are 
positioned uniquely right now on a global basis to help 
adjudicate the allocation and the planning for how we are going 
to solve this global problem because we are not safe until 
everyone is safe.
    That means we have to be thinking about vaccine in the 
billions of doses not in the hundreds of millions of doses. So 
right now CEPI is probably the leading organization, together 
with many other partners, to provide the credibility and the 
scientific oversight to try to make sure we do that right.
    Senator Murphy. It is pandemic response malpractice for the 
United States not to be part of CEPI. All of our allies, all of 
our friends are part of this organization. And while we hope 
that it is our funding and our domestic programs that develop a 
vaccine, if it is a CEPI partner develops the vaccine, we want 
to be at that table. That is something we can do right now.
    Dr. Khaldun, we talked a little bit about supply chain and 
what we do moving forward to try to prevent the problems that 
happened this time around. But in my state, the supply chain 
crisis isn't history, it is present. We still can't get PPE at 
our nursing homes. I was just at a hospital testing site last 
week and they don't have enough cartridges to be able to do 
their quick turnaround tests. I just want to be clear, Dr. 
Khaldun, the supply chain crisis isn't fixed is it?
    Dr. Khaldun. That is correct. We still in our state have 
lab capacity to be able to do at least twice as many labs as we 
are doing now, but we are limited by the number of swabs and 
reagents. So that is absolutely still a challenge.
    Senator Murphy. I think this discussion is really 
important. I have argued from the beginning that you can't wait 
for the next pandemic to hit us in order to get ready, but we 
have not beat this pandemic. On Sunday, there were one 183,000 
new cases reported globally. That was the highest number of 
cases on any single day since the beginning of this pandemic. 
And that was Sunday.
    It was Sunday and we are going to break for a very nice 
July 4th recess for Members of Congress who still have jobs, 
who are largely still healthy without having passed any 
legislation to try to help states, help local, public health 
districts address an epidemic that is still present. We need to 
be able to do both and my worry, Mr. Chairman, is that we are 
not at least during this work period. Thanks for the 
opportunity to ask questions.
    The Chairman. Thank you, Senator Murphy.
    Senator Roberts.
    Senator Roberts. Thank you, Mr. Chairman. And thanks to all 
of the witnesses. I would like to thank Chairman Alexander, 
Senator Burr for working with me over the years to help address 
this issue, particularly during our work on something called 
Pandemic All-Hazardous Preparedness Act and response to the 
COVID-19 pandemic. We are making progress and in March Congress 
passed the CARES Act which included the Priorities Zoonotic 
Animal Drug Provision or PZAD. Everything has to be an acronym. 
This provides a pathway at FDA for expedited approval of animal 
drugs that have the potential to prevent or treat a zoonotic or 
vector-borne disease.
    This isn't new, Mr. Chairman. It isn't as if the dogs 
haven't been barking about this back in the day when I had the 
privilege of being chairman of the Emerging Threats Committee 
on the Armed Services Committee. We were in charge of the Nunn-
Lugar Program and we were allowed into secret cities in Russia 
at that particular time. Obviously, we are not now. But there 
was one that I visited called Obokensk. It is about 60 miles 
north of Moscow and it was there that we had a whole range of 
scientists and I saw warehouses full of pathogens. It was 
stunning. It was shocking.
    Everything from Ebola to Smallpox where there was no 
preparedness or no treatment, but the big one was hoof and 
mouth disease and these scientists were trying to weaponize 
these pathogens for an attack on a Nation's food supply. Well 
now we have seen that with COVID-19. Not exactly with regards 
to the livestock that we have but we have seen it in the 
packing houses and what it does to the food supply chain. So, 
and back at that particular time when Bill Frist was our 
Majority Leader, he was also our doctor with regards to every 
Senator.
    Bill, I still want to thank you for what you did for me 
with one malady that I was suffering from. Bill had no patience 
for patients that were a little reluctant and so he took me by 
the arm, arched me into the cloakroom, got Dr. Cameron on the 
line up at Johns Hopkins and made an appointment for me, not 
the next day but the following Monday at 7 o'clock in the 
morning.
    I then had the wonderful experience of enjoying 10 days of 
my life at Johns Hopkins. The view was nice in terms of 
Baltimore, but I didn't particularly want to end my days there 
which was not the case. Bill, thanks for everything that you 
have done for me and for a lot of Senators. The question I have 
is what are we doing now? One thing I want to point out, we 
have the National Bio Agriculture Facility, the replacement for 
Plum Island, at a level 4 lab at Kansas State University. It is 
a Consortium with other land-grant schools.
    Again, we are making some progress. That facility will be 
open in 2022, but it is open right now doing some work and 
additional work at Kansas State. Now, the question I have is, 
we used to have exercises and I know of three. The first one, I 
played the role of the President. We had a hoof and mouth 
disease outbreak. Started in Texas. By the time Oklahoma 
figured out, it was in North Dakota. All of our exports 
stopped. Our entire food supply chain stopped. We had to 
euthanize millions of head of cattle. It was something we never 
experienced before. I know that leaves two others.
    I am not sure we are doing that today and I don't know why 
we are not now. Now, we have a wonderful exercise with COVID-
19, it just happens to be real. Senator Frist I am going to ask 
you this question. What can we do, and this is for all the 
witnesses, to continue facilitating coordination between public 
health and agriculture sectors and improving our surveillance 
in these areas before we have an outbreak? Dr. Frist, please.
    Dr. Frist. You know, it is--one of the things that these 
pandemics bring out is a reason I was able in 2005 to be so 
certain that we would have an infection and I mentioned, I 
predicted it coming out of China or it could have come out of 
these congested areas in Africa, is this integration, this 
assimilation between human and animal. And if you look at the 
layout for the future, almost certainly the next virus will 
emerge through this chain of anergenic shifts and drifts to 
come between animals coming to humans. I didn't first 
appreciate it.
    But in 2001 when Anthrax hit our Capitol and about a third 
of Senate was moved out of their offices for a year, this 
symbiotic relationship and this focused understanding, this 
important understanding of the veterinary world with human 
health and I would also add with environmental health. It is 
all one health.
    We in our own ways are very isolated and insular and 
thinking silos. The only way to bring people together, to 
expand their thinking, their diversity of thinking in real time 
are these exercises in each should be built into every 
administration. It should be done on an annual basis. And from 
that we will be able to predict in almost exponential type 
thinking things like this need for testing, which we have 
missed in the past.
    Senator Roberts. I appreciate it. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Roberts.
    Senator Warren.
    Senator Warren. Thank you, Mr. Chairman. No, I have to be 
honest. I am puzzled by the topic of today's hearing which asks 
us to start preparing for ``the next pandemic.'' The next 
pandemic. What about the pandemic that is going on right now. 
You know, the last time I checked the U.S. was still fighting 
coronavirus and losing. Cases are rising rapidly over 20 states 
and hundreds of people are dying every single day. In 
Massachusetts, we learned firsthand just what happens when the 
Federal Government isn't prepared for a pandemic.
    Back in March, we asked the Federal Government for medical 
supplies. Weeks later, only a fraction of those supplies had 
arrived and the Federal Government was reportedly seizing 
shipments that were headed our way. Now, even as the cases have 
come down, supply chain problems persist. Doctors in Milton are 
using construction goggles as PPE and Massachusetts General 
Hospital told the Boston Globe that its supply chain was, 
``fragile.'' If we don't apply the hard lessons learned in 
Massachusetts, states like Florida and Texas and Arizona where 
cases are now rising are going to pay the price.
    Dr. Khaldun, Michigan has also experienced some of these 
supply chain problems. Since March, the Federal Government has 
implemented systemic ways to try to ensure that states with 
rising COVID caseloads will have all the masks and gowns and 
testing kits and other supplies that they need. Is that right? 
Is that what has actually happened in Michigan?
    Dr. Khaldun. I am grateful and thank you, Senator, for that 
question. I am grateful for the support of my colleagues at HHS 
and FEMA. They have been regularly sending us supplies. But 
quite frankly, they have not been enough. Some of the supplies 
that we have received have been expired. And so we still are 
working aggressively to try to make sure we have enough PPE for 
now and the potential second wave that we will probably see in 
Michigan come the fall.
    Senator Warren. Yes, it sounds like the very clear supply 
chain lessons that were learned by the states that were hit 
hard early on are just simply not being applied even though we 
are now more than three months into fighting this virus. So 
here is another one to focus on. As Massachusetts fought to 
reduce the spread of COVID-19, it developed a robust contact 
tracing program that is now the model for the Nation.
    Experts agree that contact tracing is essential to 
successfully contained coronavirus. So Dr. Khaldun, Michigan 
has also invested in contact tracing and tracking information, 
and 500 Michiganders, as I understand it, are already working 
on tracking these infections, but the state could use more 
support. So let me just ask you, do you need more resources for 
this work and do you think that we should have a nationwide 
contact tracing program to help states that are dealing with 
COVID-19 cases?
    Dr. Khaldun. Absolutely, Senator. So, yes, absolutely. I 
think we should have a Federal strategy for contact tracing. We 
have over 10,000 Michiganders who have volunteered to do this 
contact tracing, more than 500 of them are already deployed. We 
have additional paid staff throughout the state. What has been 
a hodgepodge of local, state and Federal Governments trying to 
support this. Some more support would actually be welcomed from 
the Federal level.
    Senator Warren. Well, I think--it is important for all of 
us to hear your voice on this. I appreciate it, Dr. Khaldun. 
You know we are nowhere near close to a national contact 
tracing program. The House has passed key provisions of the 
contact tracing legislation that I introduced with Congressman 
Levin from Michigan, but Republicans in the Senate have refused 
to provide states with the funds they need to trace coronavirus 
infections. So let's have one more turn of this.
    Let's talk about who is going to be hit the hardest if we 
don't learn the lessons of the past few months. In 
Massachusetts, we already know data. Data show that black and 
Hispanic people in the commonwealth are three times more likely 
than white people to contract COVID-19. So, Dr. Khaldun, if the 
Federal Government fails to right the wrongs of its early 
response to COVID-19, how will its failure impact people of 
color and other vulnerable communities that are at risk for the 
coronavirus infection?
    Dr. Khaldun. I think if we don't aggressively address those 
social determinants of health, so adequate housing, making sure 
people have access to health care, no out-of-pocket costs for 
testing, absolutely. African-American communities, latino 
communities, our tribal communities are going to be the ones 
that are hit the hardest so it is something that is very 
concerning for me.
    Senator Warren. Well, thank you very much, Dr. Khaldun. And 
thank you for your work. You know, there is going to be a time 
and place to take the lessons from this pandemic and apply them 
to the next one.
    But right now as COVID-19 cases top 2.3 million nationwide, 
our country can't look at the coronavirus pandemic as if it is 
an event from the past. 120,000 Americans are already dead and 
more are dying every day. We must expand contact tracing. We 
must secure our supply chain. We must protect communities of 
color and we must stop pretending that this pandemic is over. 
Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Warren. We will go to 
Senator Murkowski, I believe, and then we will go back to 
Senator Baldwin. Let her reclaim her time when we lost internet 
contact with her.
    Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman. I so appreciate 
this hearing. I happen to think it is very timely and I am not 
one that thinks that we are beyond this pandemic we are in the 
midst of it. But even while we are in the midst of an active 
pandemic, it is important to not only understand where we have 
been but where we are going.
    Governor Leavitt, I really appreciate the comment that you 
made in 2007 while serving as Secretary and you have repeated 
some of it in your opening testimony, everything we do before a 
pandemic will seem alarmist, everything we do after a pandemic 
will seem inadequate. This is the dilemma we face, but it 
shouldn't stop us from doing what we can to prepare and prepare 
every day for what we really don't know.
    Back home in Alaska, we have heard from our state officials 
and just from Alaskans around the state, what are the 
priorities as we are dealing with the here and now. It is still 
supplies and manufacturing, making sure that we have what it is 
that we need. Testing capacity continues to be a challenge, but 
we have been aggressive with that which I credit our state 
teams with but worrying about supplies.
    Consistent messaging, no different in Alaska than what we 
are seeing around the country. Levels of confusion, though when 
you are having mitigation strategies that are perhaps 
conflicting, that causes an issue of distrust from the public 
and we need to pay attention to that. But the one that I want 
to speak to and have questions about is the public health IT 
infrastructure. Our state reports that IT infrastructure for 
contact tracing is still lacking. What we are using is Excel 
spreadsheets and faxes as our main tool for their contact 
tracing efforts. We have 761 cases as of this morning. Over 250 
of those are active. Our teams have been working and staying on 
top of it but the article in the newspaper just yesterday is we 
are close to being maxed out.
    As we are thinking about that and recognizing that there 
are several proposals out there for a national contact tracing, 
TTSI, that the contact tracing, diagnostic testing, supported 
isolation, and the need to suppress or mitigate. So the 
question that I would have is, is whether or not we need to 
have a national contact tracing program or do you believe that 
we can focus our attention on bolstering the funding and the 
capacity of public health departments at the state and locality 
level.
    Because as I talk to Alaskans, they are saying, we think we 
have this. We want this support, financial support, but we 
don't know that we want a national program. So I would--I guess 
I would ask you, Dr. Frist and you Governor Leavitt for your 
views on that role with contact tracing because I think going 
forward this is going to be a key aspect to how we can stay on 
top of what we are dealing with. Your thoughts.
    Dr. Frist. Thank you, and just to prefix what I am saying, 
I think our second pandemic may come in about three months and 
that is why I do think it is important to do exactly what we 
are doing. Learn very quickly and then probably can but right 
now and then an after-action review will I am sure occur next 
year or two years or three years. On the contact tracing 
workforce, there has been a whole bunch of estimates out there 
as to what is needed.
    We know it is the most effective action at this standpoint 
and the workforce does operate under state and local 
management, even if it is a Federal program and it needs to 
expand to help control COVID-19. We have to. All of these 
studies have concluded that we must expand it. It is about 
180,000 people that are needed and can states do that? Probably 
not because states have had their public health infrastructure 
underfunded at the state and local level.
    A lot of them don't even have epidemiologist to the local 
communities much less contact tracers. And so I think we have 
to go out for Federal support this time around, maybe not next 
time around, until we have an effective vaccine that is on the 
market. If we see new cases, we are going to have to increase 
it.
    Massachusetts has done a great job. They hired and trained 
applicants quickly, got them out there. So Dr. Gottlieb and I 
and Andy Slavitt have proposed for this pandemic a Federal 
workforce, federally funded, and then allocation of that 
funding to the state so they can get it up and running today 
and we have that on record----
    Senator Murkowski. Thank you, Dr. Frist.
    Mr. Leavitt. Senator, I believe that a national strategy is 
required. It will require some local execution. Let me be 
deliberate about that. Clearly, we will need to have national 
funding to support this in the way that Senator Frist has 
articulated. Second, there has to be a national system that 
local input feeds into where standards are used and how data is 
collected so it can be rolled up quickly.
    There are components of local execution that are required 
but there is a clear need for national funding on this 
pandemic, as I agree with Senator Frist, public health has been 
malnourished over the course of the last almost 40 years, and 
we need to buildup that infrastructure. We can have a national 
system but it will require some execution by the local level, 
but ought to be done according to a set of national standards.
    Senator Murkowski. Thank you. Thank you both.
    The Chairman. Thank you, Senator Murkowski.
    Now, we will go back to Senator Baldwin.
    Senator Baldwin. Thank you, Mr. Chairman, and I apologize 
for the interruption in internet service, but I am glad to be 
back with the panel. My first question, of course, related to 
urging OSHA to issue an emergency temporary standard that would 
be enforceable and mandatory as workplace reopen. And I think 
especially about schools that are preparing to start in-person 
classes again, K through 12 and higher education and their 
needs. But I want to move to the companion issue of these 
shortages that we have been seeing in the very things that 
would likely be contained in an emergency temporary standard 
that OSHA should promulgate.
    Just as the administration has failed to issue these 
enforceable standards to protect workers, they have also failed 
to provide the leadership needed to take decisive action. For 
example, ramping up production of testing and testing supplies, 
other needed equipment, PPE here in the United States. Some 
have touched on this already, but it is why I introduced with 
Senator Murphy the Medical Supply Transparency and Delivery 
Act.
    What it does is unlock full authority of the Defense 
Production Act to increase the production of critical supplies 
including PPE as well as the supplies needed for testing. So 
Dr. Khaldun, I directed my first question to you and I will 
follow-up also with you. Can you describe how shortages of 
testing supplies or PPE have hindered your state's efforts to 
respond to the current pandemic?
    Dr. Khaldun. Yes. So, as I said earlier Senator, in the 
beginning we had to delay testing in our state even when our 
state lab was able to do tests initially. We could only do a 
few hundred and then there were very strict criteria at the 
beginning were only the sickest could actually get access to a 
test while the disease spread in our state.
    We still have, for example, our hospital labs. They are 
still only able to test the sickest patients because they have 
challenges with reagents and a lot of our community testing 
sites also still have challenges with reagents and testing 
swabs. Again, I am grateful for what we have received, but 
often when we receive supplies from the Federal Government, 
they actually don't match up with that what our labs are 
actually able to run so we can't even use them. So it is still 
absolutely a concern.
    Senator Baldwin. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Baldwin. Sorry that we 
lost you there for a while. But thank you for sticking with us. 
Senator Romney.
    Excuse me, Senator, Kaine.
    Senator Kaine. Thank you, Mr. Chairman. Thanks to the 
witnesses, especially to Secretary Leavitt. When I was Governor 
of Virginia, we were dealing with H1N1 and then Secretary was a 
great partner with the administration. I associate myself with 
comments of all my colleagues that we got a current challenge, 
we have to plan for the future one. Just the magnitude of the 
current challenge, last week in the United States the number of 
new COVID-19 cases increased by 25 percent over the previous 
week. And that shows that the current challenge is getting 
worse not better, but we do have to plan for the future.
    One of the things I want to do is take advantage of this 
experience to talk about the future. So first topic to the 
witnesses, every pandemic would likely be a little bit 
different but it seems like there is a template that the 
successful nations have used to deal with COVID-19. And the 
template is aggressive early testing and contact tracing to 
find those who are ill, the isolation of people who have COVID-
19, and immediate treatment of those folks.
    Do you agree that those four elements early testing, 
contact tracing, isolation, treatment should be a template that 
we should prepare to use in future pandemics?
    Mr. Leavitt. I will respond Senator Kaine. Those are--what 
we have collectively come to know as social distancing 
measures. They are they constitute the only medical 
intervention that we have absent a pandemic--or absent a 
vaccine, excuse me. And the reality is that is likely to be the 
case in any pandemic situation. We will be without a vaccine 
for a time. So that is a fundamental. It is a public health 
basic. What we do have to remember is that any medical 
intervention has side effects and this has side effects.
    If I were to take pain medication, for example, I would be 
told you can't use this too long and you can't use too much of 
it or you are going to have other problems develop. We are 
obviously trying to find the balance now in this medical 
intervention that we have used, absent having no vaccine.
    The answer is yes, but there is going to be a limit to 
which we can use them as a practical matter without having the 
side effects of the economy that we have experienced, the side 
effects of the social logic damage that is becoming more 
evident.
    Senator Kaine. You have anticipated my next question, 
Secretary Leavitt. The side effects on the economy. I was 
having this conversation with Chairman Rich in the Foreign 
Relations Committee last week because we had a similar hearing 
about the global aspects of the pandemic. And he pointed out 
that the aggressive testing and contact tracing, some nations, 
some cultures accepted maybe a little bit better than would be 
accepted here. We were talking about South Korea.
    I responded and I said that is true, it might be hard for 
people here to accept contact tracing but because South Korea 
did that early they didn't then have to use the heavy hand of 
Government to shut the economy down. South Korea's unemployment 
rate has gone up by about 1 percent. Because they isolated sick 
people, they didn't have to do the large economic shutdown that 
the United States had to. So the basic measures we talked about 
are not only good public health measures, they are also 
measures to protect the economy.
    I want to move to one element of these basics and that is 
testing. I am very concerned about this and you have all talked 
about it, particularly Dr. Khaldun, the difficulty of doing 
testing and mission because of an adequate supplies and mixed 
messaging. Over the weekend, the President said he had 
instructed his administration to slow down testing because he 
thinks increased cases is bad.
    I am going to be clear about this, increasing number of 
cases is bad, increasing deaths is bad, increasing 
hospitalizations is bad, but the idea that you would slow down 
testing because you didn't want to find out if people are sick 
is just grotesque. The Chairman, the Ranking Member of the 
Committee, Senator Murray and Senator Schumer, wrote a letter 
to Secretary Azar that I would like to introduce for the 
record, Mr. Chairman, if I could.
    The Chairman. So ordered.
    [The information referred to can be found on page 69 in 
Additional Material.]
    Senator Kaine. Pointing out that $14 billion that has been 
provided by Congress for testing has yet to be obligated by the 
Administration. I am deeply worried that there is a bias 
against testing because we don't want to know bad news. I have 
been puzzled, we are in the fifth month of the pandemic, why 
hasn't the Administration issued national guidance about how 
many tests we should do. The website of the CDC, instructions 
to colleges doesn't even mention the word testing and I believe 
there is either a fear of finding out how bad this is or a 
desire to not be held accountable for falling short of testing 
guidelines.
    As I conclude, I will just point out, we heard from Admiral 
Giroir a month ago, May 12, and we sort of had to drag out of 
him, what would be an appropriate national testing goal for the 
beginning September when schools are going back in and he said 
40 to 50 million tests a month, which is 1.3 to 1.7 million 
tests a day. At that time in May 12 we were doing between 
300,000 and 400,000 tests a day. Now more than a month later we 
are at 500,000 test a day.
    If Admiral Giroir is right and we have to do between 1.3 
and 1.7 million tests today in September and many experts say 
it is higher, I have grave doubt about whether this 
administration is going to enable our country to do that if we 
are only at 500,000 on June 23. With that, thank you, Mr. 
Chairman.
    The Chairman. Thank you, Senator Kaine.
    Senator Hassan.
    Senator Hassan. Well, thank you, Mr. Chairman, and thank 
you to all of the witnesses for being here today. As I looked 
at your bios, I am realizing that the combined years of public 
service sitting before us is extraordinary and I thank you all 
for your service. There will be time for thorough review of 
everything that went wrong with the Administration's response 
to the current pandemic.
    Our Nation can better prepare for future pandemics by 
reversing cuts to public health and preparedness funding, re-
engaging with international partners, and ensuring that key 
Federal positions are occupied by qualified staff. However, we 
are in the middle of a pandemic now. COVID-19 continues to 
spread quickly through the United states even as many European 
nations have gotten their outbreaks under control. America has 
4 percent of the world's population yet 25 percent of the 
overall deaths from this endemic and 20 percent of new daily 
cases being reported.
    In my home state, the toll in our nursing homes continues 
to be extraordinary, 80 percent of the deaths in New Hampshire 
have been in long-term care facilities. Our primary focus must 
be on strengthening the Federal response to the current 
pandemic that is still raging across our country.
    I want to start with a couple of questions to Dr. Khaldun. 
Dr. Khaldun, in the early stages of the pandemic Michigan's per 
capita testing for COVID-19 was below the national average. 
Since then, you have been able to not only ramp up testing and 
become one of the few states that have an infection rate of 
less than 1 percent among those being tested.
    What specific steps were critical to addressing those 
initial challenges in your state and what Federal support is 
needed to help other states replicate your approach by 
expanding testing capacity, improving demographic data 
collection from testing sites, and using that data to quickly 
respond to potential outbreaks?
    Dr. Khaldun. Thank you for that question, Governor. It has 
certainly been a massive effort and response not only from our 
state and local health departments but our procurement team in 
the state, our Michigan National Guard. There are many, many 
people who have contributed to us being able to respond, going 
from just a few hundred tests today to now about 14,000 a day. 
We have focused on how after we bring in testing into 
communities.
    Working with community partners. We have made sure that 
when we do our contact tracing, we have updated and have to do 
again, building the plane while we are flying it, updating our 
contact tracing platforms so that we can effectively isolate, 
understand who has potentially been exposed and isolate them as 
quickly as possible.
    Again, it has been a massive effort but I would not say 
that we are necessarily winning in Michigan. We are still 
seeing outbreaks across the state and we continue to work hard 
to expand testing.
    Senator Hassan. Well, that is helpful. Are there particular 
things you think the Federal Government can do?
    Dr. Khaldun. Yes, I again I have been really pleased that 
we have been working with our Federal partners on testing 
supplies, but often we don't know when those testing supplies 
are going to come, and when they come with their less than what 
we expected to get or they are not even useful. So we need 
really a clear strategy from the Federal Government on 
supplies, when we will get them, so that we can actually plan 
on the state and local level for how we will get those supplies 
out.
    Senator Hassan. Well, thank you. I also wanted to follow-up 
with you on another issue. In April, you wrote a letter to 
clinicians across Michigan highlighting the fact that African 
American residents comprise 40 percent of COVID-19 deaths 
statewide despite making up only 14 percent of the state's 
population.
    This is a disparity that you have talked about a little bit 
today and it is a disparity we have seen across the Nation 
during this pandemic and in overall health care and outcomes. 
What types of dedicated investments from Congress are needed to 
give state and local Governments across the country the support 
they need to improve health and wellness in communities of 
color and work toward eliminating these health disparities 
during the pandemic and beyond?
    Dr. Khaldun. We really have to focus upstream and talk 
about those social determinants of health. So housing policy is 
health policy. We have to make sure communities of color who 
are disproportionately living in poverty have access to healthy 
and safe housing. Making sure they have access to health 
insurance and expanding Medicaid across the country would be 
important.
    No one should have to pay out-of-pocket costs for testing 
or treatment or a vaccine. And to make sure there is equitable 
distribution across this communities to make sure that we are 
addressing disparities. I also talked about implicit and 
explicit highest in our health care system. Again, many people, 
it has been well documented that these disparities exist, that 
is why I sent the letter as well.
    Senator Hassan. Thank you very much and thank you, Mr. 
Chairman.
    The Chairman. Thank you, Senator Hassen.
    Senator Smith.
    Senator Smith. Thank you, Mr. Chairman and Ranking Member 
Murray, and to all of you for being here today. I want to start 
by associating myself with the comments of my colleagues who 
made on the really important point that we have so much work 
right now to address the existing pandemic that we are dealing 
with and living through right now. And I especially am 
concerned about how COVID-19 is exacerbating existing health 
disparities and the systemic racism that is literally deadly 
for black and Hispanic and native communities in my state and 
all around the country. But here is one example that really 
shows what this means in real life.
    Recently an obstetrician in Minnesota shared a story about 
a black Minnesotan a Liberian immigrant, a pregnant woman who 
went to the emergency room because she thought she had 
complications with her pregnancy related to COVID-19. So she 
goes to the emergency room and not once, not twice, not three 
times, but four times. The first three times she is turned away 
because even though she is COVID positive, it was determined 
that she wasn't sick enough to be admitted to the hospital. Two 
days later, she returns for a fourth time and she is so sick 
that an emergency cesarean is performed in a last-ditch effort 
to save her and her child and they both died. She wasn't 
believed and she died.
    Now, implicit bias healthcare is kind of a policy wonkish 
term, but this is what it means when bias and racism and 
disparity kills people. I know that we have talked a lot about 
what this disparity means when it comes to COVID, but Dr. 
Khaldun, I want to ask you this question. What can we do so 
that black women are not turned away from getting the health 
care that they need when it comes to COVID?
    Of course, I have to acknowledge that we know that maternal 
mortality rates for African American women in our country are 
three or four times higher than they are for white women even 
without the complexities of COVID. What can we do to address 
that problem?
    Dr. Khaldun That is right. We experience that disparity 
when it comes to maternal and infant mortality in the state of 
Michigan. Even an African-American baby is twice as likely to 
die before its first birthday than a white baby and in the 
state and some of the things that we can do is really make sure 
that, I believe that we should have mandatory implicit bias 
training for all health professionals students.
    I think that our health professional schools should all 
work to expand diversity in their students. I also think, and 
this is some of the work we are working on with our partners in 
Michigan, we have to make sure that those best practices when 
it comes to hemorrhage bundles and just the top quality care 
for OB care really implemented across hospitals, even those 
hospitals that take care of the most impoverished women, we 
have to make sure there are high standards set and that 
everyone has access to equitable care.
    Senator Smith. Thank you for that. I agree with you on 
that. I think that those are the kinds of things we need to do 
all of the work we need to do to diversify our health care 
system. And also make sure that we have community based care 
available for women and that would be I would think would be 
the same when it comes to COVID. Let me ask you this question, 
Dr. Khaldun. What should we be doing better in order to make 
sure that our public health messages are reaching communities 
of color and are relevant and appropriate for black and brown 
latino communities, indigenous communities who are a very 
important part of our, my work here in Minnesota also.
    For messaging, those community partnerships are incredibly 
important. That is some of the work we have done here in 
Michigan. Again, with our coronavirus racial disparities task 
force, we are working very closely with community members to 
make sure that the messages that we are putting out are 
resonating and that we use those community like those trusted 
community leaders to get accurate messaging out into the 
community. Those partnerships are critical. We can't do this 
alone and we shouldn't be only doing it from a state and local 
Government perspective.
    Senator Smith. Right. I think that is so right and it 
brings me to my last point here, which is that in order for 
that to work, those community organizations and need to have 
capacity and local public health agencies need to have 
capacity. And I know that you worked at the local level as well 
at the state level.
    Right now in Congress, we are having a debate about how 
urgent it is that we get emergency resources to state and local 
Governments right now in order to help make sure that this 
response happens. And so could you just answer briefly, I just 
have a second left, on how important it is you think from where 
you sit that we get that state and local aid to Governments 
right now as we are dealing with this epidemic.
    Dr. Khaldun. That is right. Our state and local Governments 
absolutely have been underfunded for her decades, especially 
our local health departments. They often don't have even one 
epidemiologist. So funding at the state and local level are 
incredibly important for COVID-19 and other critical public 
health work.
    Senator Smith. I think it is why so many of us supporting 
the Heroes Act funding to get emergency aid to state and local 
Governments. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Smith. Senator Jones. We 
will go back to Senator Jones. Senator Rosen.
    Senator Jones. I am sorry. I had problems with the mute 
button. Mr. Chairman, can I go forward?
    The Chairman. Okay, we will go to Senator Jones.
    Senator Jones. Thank you. Thank you, Mr. Chairman. I really 
appreciate this hearing and I hope we have more to be honest 
with you. I don't think this is a topic that can be handled in 
just one hearing and I hope our other committees in the Senate 
will likewise have hearings on their respective jurisdictions 
about lessons learned from this pandemic. I would like to first 
go to my Northern neighbor, Tennessee neighbor, Senator Frist 
and talk a little bit more about manufacturing. I know Senator 
Alexander asked about it.
    Senator Collins, Senator Murphy mentioned it as well. But 
the focus I want to talk about is really on PPE, masks, gowns, 
those kind of things. We have--I really--it seems to me that we 
have had not only a shortage now, we are going to continue to 
have a shortage in the future. We have got to rebuild our 
national stockpile, but also keep that replenished as our 
stockpile ages. We have seen in Alabama supplies sent from the 
national stockpile that were 10 years past expiration dates, 
that were rotted. So it seems to me that one of the things that 
we can do is try to incentivize, and you mentioned that in your 
testimony.
    I have a bill pending called the Build Healthcare Equipment 
and In America Act to try to give those tax incentives to 
companies to either repurpose existing facilities, stand up new 
facilities, and also give some help or infrastructure such as 
broadband in areas that might not have it.
    In addition to the tax incentives, I was caught by your 
statement that we have got to help with markets, long-term 
markets, maybe even I can't remember the exact phrase, might 
have been artificial markets. So in addition to the tax 
incentives like I have got in my bill, what can we do to create 
those markets? Because I just think we are going to be, even 
when we are out of this pandemic, we are going to be living in 
a new world in which more masks, more gowns, more shields are 
going to be needed for businesses, schools, and healthcare 
workers going forward. So, how can we do that in addition to 
the incentives?
    Dr. Frist. Thank you. We deal in pandemics, remember virus 
occur. They don't all become pandemics. So when we talk about 
pandemics, we were talking about something that explodes and 
then it goes around the country to multiple places. That is the 
global emphasis of if there is an outbreak anywhere, it is 
important here. The markets does come in part to stockpiling 
but in addition it extends this whole concept of what we are 
dealing with is a rare but certain event, a rare but certain 
event.
    The rarity is hard for Congress to deal with because of the 
attention span of Congress, having spent a lot of time in the 
room that you are in, and that is where it is important to have 
timelines that are 10 years or 15 years. Markets tend to look 
day-to-day and therefore this will artificial market means that 
we have to have some side, sort, of the tax credits could do 
it, but some sort of public funding that will guarantee a 
market over that 10, 15 year period when that certain event, 
that certain pandemic will occur. Your higher point is on the 
stockpiling and it too, and the CDC we talked about 
modernization which I agree with, but we also need to modernize 
the stockpile.
    There is still a lot of debate. Is it a Federal 
responsibility or do we push it upon the states? States, 
because they have to balance their budgets, are not--because of 
the immediate demands of the constituents, is not going to be 
able to do it. So the stockpiles need to be not just 
implemented at one point in time, but they, just like we have 
to have these exercises every year, have to be looked at year 
to year as to the current threats or risks that are being 
determined by our communities of science, those scientist at 
the CDC.
    If we do that, we can have regional stockpiles coordinated 
with an overlay at the Federal Government, with great 
coordination, better coordination, going back to Governor 
Leavitt's plans with the states is to the immediacy of what 
needs to be in that stockpile and then the markets design 
around that. The Federal Government itself can't go out and 
build these factories. It has got to have to be people who are 
in the business who can change with science, change with the 
time, change with the biology in real-time.
    Senator Jones. Great. Thank you, Senator, I appreciate 
that. Governor Leavitt, let me ask you real quick in my 
remaining seconds here, I completely agree that we need to do 
more investing in public health, but in your testimony you 
mentioned that Medicaid funding crowds out state budgets for 
public health funding and I would like for you to just explain 
briefly what you mean by that. Are you suggesting that we 
should cut Medicaid and that would help public health funding 
because it seems to me in my state more Medicaid is better for 
public health than less.
    Mr. Leavitt. Senator, let me just say that public health 
generally has been starved for resources for probably 30 or 40 
years and the budgets have just continued to go down. There is 
a direct correlation, it is just a fact, I am not making--
drawing the causation. I am just saying there is correlation 
here that Medicaid budgets have dramatically gone up.
    When I was first Governor I think Medicaid was 6 percent of 
the budget. It would probably be 20 percent in the state that I 
was Governor now. Public health as a percentage of that is gone 
down. We have just undernourished it and I am worried about 
that. I don't think that every--it is a local function. It is a 
state function. Right now it is being driven and funding 
primarily by Federal dollars. I think that is not a good idea 
in the long term. So I am just advocating that states need to 
be to pay attention to their public health infrastructure as 
well.
    Senator Jones. Right. Thank you. Thank you, Mr. Chairman.
    The Chairman. Thank you, Senator Jones.
    Senator Rosen.
    Senator Rosen. Well, good morning everyone and thank you, 
Mr. Chairman for bringing this important hearing and of course 
Ranking Member as well and everyone on the panel for all of 
your work in the past and your comments about how we can plan 
for not just a global pandemic but all those smaller kinds of 
prices that we may have that we have to plan for you even if 
they are regional.
    I do believe that it is really important to keep up with 
research in order to understand this virus because scientists 
around the globe are frantically working to gain a better 
understanding of COVID-19. How the virus specifically attacks a 
patient's immune system, what treatments work, how to best 
prevent infection. To make sure we do not have gaps in research 
and information in how the virus impacts a wide range of 
patients, I introduced along with Senator Rubio the Ensuring 
Understanding of COVID-19 to Protect Public Health Act.
    This bipartisan bill would direct the NIH to conduct a 
longitudinal study of patients that includes diversity among 
gender, race, ethnicity, geography, and age, and many other 
things. We are looking at both the short-term and long-term 
impacts along with interventions.
    This would be reported publicly on a regular basis so that 
all researchers and public health officials have the latest 
information. So Dr. Khaldun, as a public health official 
directly dealing with the current pandemic, what challenges 
have you faced in getting comprehensive information about the 
latest research on COVID-19, and could you please speak to how 
not having robust data available hurts not only ongoing 
research but patient care?
    Dr. Khaldun. Yes. So we all are learning about this virus. 
Obviously, it is a new virus. So we are all learning how it 
responds in the human body and who is the most impacted, but 
absolutely it would be great to have more research to look at 
the disparities and why those disparities exist, to look at how 
it even impacts children. We are seeing this mysterious disease 
in children as well. So absolutely the research and the data 
would be incredibly important to advancing this response.
    Senator Rosen. Building on that, what recommendations would 
you have for us, maybe in Congress or others, how can we make 
it easier for doctors and public health officials to get this 
comprehensive data? Updates are coming in rapidly. I want to 
avoid, what--I really want to avoid these gaps that we seem to 
be having in the data between states and counties and cities, 
etc., etc.
    Dr. Khaldun. Yes, I think we need uniform surveillance and 
data systems across the country. We at the state, we have our 
own data system, the locals often are doing their own, and then 
we have kind of a hodgepodge of ways that we get data to the 
CDC and we have recently updated that.
    We absolutely need more data. It would be great to have, I 
would say, more coordination and updating when the CDC does 
come out with guidance or research to make sure that our state 
and local Governments get that as quickly as possible. Some 
more coordination and better surveillance will be important.
    Senator Rosen. From the CDC?
    Dr. Khaldun. The CDC.
    Senator Rosen. Thank you. I want to move on and talk a 
little bit about telehealth. Of course last week we had a great 
hearing on telehealth. It showed how vital this tool is for 
caring for patients not only during the pandemic but also 
after. So of course along with many of my colleagues, we 
support continuing the flexibilities for telehealth 
reimbursement that we have allowed through Medicare through the 
passage of the CARES Act, and I want to tell you I think it has 
been fantastic in Nevada. We have a model health company that 
will send a paramedic or a nurse to a patient's home and use 
telehealth to connect with the physician to treat the patient.
    They do a history and physical, they take the vital signs, 
they may do blood work right there, and then can speak with the 
physician. If the situation is more serious, they can get the 
patient to a hospital or to a follow-up kind of an urgent care 
situation. So again, Dr. Khaldun, from your experience during 
this pandemic, how do you think that telehealth has really 
improved patient outcome and people's ability to receive care?
    Dr. Khaldun. Telehealth has been incredibly important to 
maintaining our health care system during this response, and I 
actually hope that we don't go backward, that we continue to 
use the lessons we have learned with this response as we move 
forward. We have expanded access in our state to telemedicine 
and telephonic visits, including authorization for 
teledentistry, OT, PT, speech therapy as well.
    It has been incredibly helpful with our health care system, 
and I hope we learn from those lessons.
    Senator Rosen. I hope we do too. Thank you. I appreciate 
you being here today.
    The Chairman. Thank you, Senator Rosen. If the witnesses 
will stay with us another 10 minutes, we will conclude the 
hearing. Senator Murray, do you have closing remarks?
    Senator Murray. Well, thank you, Mr. Chairman. You know, I 
just have to say COVID-19 has killed more than 120,000 people 
in the country and sickened more than 2 million. None of us 
would have said that 4 months ago. And we just have to just say 
this is stunning. I mean, especially when I heard Vice 
President Pence last week, ``our whole of America approach has 
been a success and the Nation's response to COVID-19 is a cause 
for celebration.''
    I mean, we are in a pandemic that has just stunned this 
Nation and we should not be ignoring that or talking 
nonchalantly about it. I will ask Dr. Khaldun to just comment, 
based on your experience in Michigan, would you characterize 
the Federal Government's response as a cause for celebration? 
Is it time to declare mission accomplished?
    Dr. Khaldun. Absolutely not, Senator. We are in the middle 
of a pandemic. We are still seeing outbreaks across the country 
and increasing cases. So we definitely should not be 
celebrating right now.
    Senator Murray. Yes, and I don't think so either. So Mr. 
Chairman, thank you for this hearing. I really do appreciate 
all of our witnesses for taking the time to join us today and 
share your expertise. While it is clear we still have a lot of 
work to do to prepare for the next pandemic, it is even more 
apparent to me that there is a lot more that has to be done 
right now to respond to this one, because despite what we heard 
from the White House, this crisis is far from over.
    Several states are seeing record setting new case counts. 
There are many steps that we need to be taking as soon as 
possible to fight COVID-19. We need to increase testing not 
decrease it like we continue to hear President Trump suggest. 
We need to take steps to pave the way for a safe, effective 
vaccine that is free and accessible nationwide. And we need to 
take steps to address the harmful health disparities that are 
being compounded by this crisis.
    Of course we have to address racial injustice not just in 
health care but in so many other ways as well. So as we 
continue to focus on that, I would like to ask consent to 
submit for the record an outline of health equity principles 
from the Robert Wood Johnson foundation, Mr. Chairman.
    The Chairman. So ordered.
    [The information referred to can be found on page 75 in 
Additional Material.]
    Senator Murray. I really hope we continue to talk about 
this and build on this conversation today not just with future 
hearings and discussions but we need to take, Congress needs to 
take, immediate action so our country can deal with the crisis 
at hand. Thank you.
    The Chairman. Thank you, Senator Murray. And thanks for 
your cooperation and that of your staff in scheduling the 
hearing. In a moment, I am going to ask each of our four 
witnesses if they can summarize in about 60 seconds the top 
three things they would do now to prepare for the next pandemic 
if they were the king or the queen of the United States, but 
first, let me make a couple of comments. Several of my 
colleagues have wondered why in the middle of a pandemic we 
would be thinking about how to prepare for the next one.
    Well, I think Senator Frist made that argument very 
eloquent, as eloquently as did other witnesses. It is because 
our experience has been, we haven't been able to adequately 
take the steps that we need to take to prepare for the next 
pandemic if we wait till the current one is over. Over the last 
20 years, we have had four Presidents, two Republicans, two 
Democrats, several Congresses earnestly working on this 
subject. They have passed nine different major laws.
    I mentioned what those were before, but it was after 
Anthrax and after SARS and after the flu pandemic and after 
Ebola, the attention of Congress on difficult issues was on 
other matters. The same thing happened in the states where 
hospitals and states allowed their stockpiles to be diminished 
because other matters demanded more budgetary considerations. 
So I would ask my colleagues, when do you think would be a 
better time to ask the U.S. Congress, for example, to build a 
manufacturing plant for vaccines that we for many years might 
not even use. Probably during this pandemic is the best time to 
get the attention of the Congress for such a use.
    Or when would be a better time to accelerate research for 
testing and treatments, if we can think of ways that would 
speed and accelerate those testing and treatment for the next 
pandemic? Or when will be a better time to do the appropriate 
funding for the Centers for Disease Control to do data 
surveillance? Or when would be a better time to look at our 
stockpiles and our Hospital surges than while we are in the 
midst of them? When would it be a better time to talk about 
strengthening funding for state and local public health 
departments, which Governor Leavitt said have been going 
downhill for 40 years in terms of funding? Well if we haven't 
been able to do it for 40 years, why not try doing it in the 
midst of a pandemic. When would be a better time to consider 
who ought to be on the flagpole?
    It is not going to be easy to accept the recommendation of 
Dr. Gerberding and the commission that recommended putting 
someone in the NSC in charge or to improve coordination of 
Federal agencies in other ways. And when would be a better time 
to do what is probably the most difficult recommendation that 
many of you have made which is create a funding stream that is 
automatic, that is mandatory at a time when the Federal 
Government has such a big deficit.
    The reason we are doing this today is because we are in the 
midst of these problems and our eyes will be clearer on what 
the solutions may be and our wills will be better and we have 
an notoriously poor record of short memories when it comes to 
doing everything we need to do. We have tried but we have not 
obviously done some of the things that we need to do. So in my 
view, and I think in the view of at least several of the 
witnesses and many others, now is the time to do those few 
things that we know must be done for the next pandemic while 
our attention is focused on these matters.
    A couple of other comments before I ask our witnesses for 
their concluding remarks, one was I appreciate Dr. Gerberding's 
comment about asking the National Academy of Medicine to become 
involved in transparency for the vaccines. I think that is a 
very good idea. And that is what they are for. And I think 
their opinion about the safety of a vaccine would go a long way 
toward dispelling any worries about it. And the other comment I 
want to make was on contact tracing. Of course contact tracing 
is essential and of course Federal funding is essential but we 
have already done the Federal funding.
    I mean Congress gave states $150 billion, all of which 
could be spent on contact tracing. In addition to that, that 
was a month ago. And then in addition to that, Congress gave 
states another $11 billion as part of a $25 billion testing 
package that was expressly for the purpose of contact funding 
if the state chose to use it that way. We specifically decided 
not to tell states to use it that way but they could use it 
that way.
    That is plenty of money to hire all the contact tracers 
that you need. I mean according to one estimate by professional 
firm, an average salary for a contact tracer might be $37,000. 
And if that were the case, the cost of a 100,000 would be $3.7 
billion, a lot less than the $11 billion that was specifically 
allocated to states for the purpose of hiring contact tracers 
if they chose to use it.
    Senator Blunt, who is the Chairman of the Appropriations 
Committee for Health and I wrote a letter to CDC asking to make 
that clear to Governors that they have that money and many 
states have not spent their $150 billion that we gave them 
earlier. This is an allowable expense there.
    Yes, we need Federal funding for contact tracing. Yes, they 
are important. Yes, it might be 100,000, 150,000, 180,000 but 
we have already appropriated that money and states ought to use 
it and many already are now. To conclude the hearing, let me 
ask the four witnesses, even though they have already said this 
in their testimony, if they were in charge and they could do 
three things this year to get ready for the next pandemic, what 
would those three things be? Senator Frist, maybe begin with 
you.
    Dr. Frist. Thank you, Mr. Chairman. The pandemic is growing 
around the world. And as I said, an break anywhere is a risk 
everywhere so we got to think globally. We need to test more. 
Continue to focus on the vulnerable populations as we talked 
about here and around the world. I too endorse Senator Murray's 
under underscoring of the Robert Wood Johnson Foundation 
principles.
    My three things are No. 1, we need to establish to invest 
in long-term partnerships. Age and partner with the private 
sector to develop the diagnostic tests and treatments, 
vaccinations. No. 2, put in place a budget mechanism to ensure 
public health funding does not disintegrate when memory of this 
pandemic fades.
    I mentioned the health defense operations budget in my 
prepared statement. And No. 3, telehealth. It works. It allows 
social distancing and clinical care to be delivered. And for 
the future, it is convenient. It is affordable. And for the 
future of health, it will be transforming.
    The Chairman. Thank you, Dr. Frist.
    Dr. Khaldun.
    Dr. Khaldun. Thank you, Chairman, for the opportunity to 
speak today. The three things I would focus on are one, 
disparities, two, surveillance, testing, and tracing, and 
isolation. And then, funding of state and local health 
departments. When we talk about disparities, we have to talk 
about housing. Everyone should have access to affordable and 
healthy housing. We have to invest in communities of color, so 
education and jobs, access to healthcare we have to focus on, 
so funding for the health care safety net, our federally 
qualified health centers who provide this care in these 
communities. We have to buildup, as has already been talked 
about, the testing capabilities, the contact tracing 
capabilities.
    We are grateful for the funding that we received in the 
State of Michigan but it also needs to be long-term funding and 
not just come up when we have an emergency. And then finally, 
we must invest in long-term infrastructure in our state and 
public health departments.
    As has been said before, many of them only have one 
epidemiologist or no epidemiologist, and we are always building 
these responses on the fly. This needs to be something that is 
long term as far as funding for state and local health 
departments. Thank you.
    The Chairman. Thank you.
    Dr. Gerberding.
    Dr. Gerberding. Thank you. I certainly support what Senator 
Frist said and stand by the recommendations of the CSIS report 
as well. I will emphasize three things one is a national 
vaccine plan that includes not only the science and the 
development and the manufacturing piece in collaboration with 
the private sector, but also the allocation, uptake, and 
monitoring piece because we know this is in our future and we 
are not ready for it yet.
    The second thing I would say is that we are coming into a 
high probability of jointness of ongoing COVID in the context 
of influenza, and we need to exercise health care surge under 
that scenario. Again, including the supply chain and the 
private sector in that process so that we can understand how to 
create more robust supply and hopefully really improve 
immunization rates for influenza this season at a time when we 
need it now more than ever.
    The last thing I would just re-emphasize is the importance 
of the budgetary authority that allows for sustained investment 
not just at the Federal level and CDC, but through our state 
and local health departments. You can't plan for preparedness 
in one year cycles any more than you can plan for the 
Department of Defense to be prepared for that kind of security 
in a one-year timeframe. We need long-term, sustained, 
progressive accountability and measures for progress. Thank 
you.
    The Chairman. Thank you.
    Governor Leavitt.
    Mr. Leavitt. Unless you think I cannot count, I am going to 
give you four. The first is to advance in clarity on the 
division of labor between state and Federal Government and the 
pandemic. States need to be with that, armed with a clear 
understanding of their role and the Federal Government, its 
role. Second, rejuvenating the public health infrastructure, as 
others have stated, is not only important in a time of pandemic 
but in the health system where working toward value of the 
social determinants of health will play a dual role and an 
important role, and will have ongoing benefit in both in and 
out of a pandemic. Third the HHS, CDC data modernization.
    It is a critical piece of infrastructure that needs to be 
put in place in advance. We should be working on it now. It can 
be valuable in three months from now as well as in three years 
from now. and finally, again the echo, annual appropriation on 
emergency management not just episodic funding.
    The Chairman. Thank you, Governor Leavitt. Thanks to each 
of our four witnesses. As I listened to the priorities, I am 
reminded again, most of those recommendations will help with 
the current pandemic, all will help with the future pandemic, 
and in my opinion, they will all be easier to pass and turn 
into law during this current pandemic then they will be if we 
wait a year or two and try to compete with other priorities of 
the moment.
    The hearing record will remain open for 10 days. Members 
may submit additional information for the record if they would 
like. I have also invited comments and responses and any 
additional recommendations in response to my white paper 
preparing for the next pandemic for our Committee to consider. 
I will fully share those recommendations that I receive with my 
colleagues, both Democrat and Republican. The deadline for 
submitting those comments is 5 p.m. this Friday, June 26. 
Comments may be sent to pandemic preparedness at 
help.senate.gov.
    [The information referred to can be found on page 69]
    The Chairman. This is our fourth hearing this month on the 
COVID-19 pandemic. We have had one on going back to school, one 
on going back to college, we have had one on telehealth, we 
have had this one, and then we will meet again at 10 a.m. on 
next Tuesday, June 30th for an update on progress toward safely 
getting back to work and back to school and our witnesses will 
be Dr. Fauci, Dr. Hahn, Admiral Giroir and Dr. Redfield. Thanks 
again to our distinguished panel of witnesses, to the Senators 
who participated, to the staff who helped put this together. 
The Committee will stand adjourned.

                          ADDITIONAL MATERIAL

                           Letters of Support

                               United States Senate
                                                      June 21, 2020
The Hon. Alex Azar, Secretary
U.S. Department of Health and Human Services,
200 Independence Avenue,
Washington, DC.

    Dear Secretary Azar:

    We write to express concern regarding the distribution of funds 
Congress allocated for COVID-19 testing and contact tracing, including 
for providing testing to the uninsured. Congress provided more than $25 
billion to increase testing and contact tracing capacity \1\ and $2 
billion to provide free COVID-19 testing for the uninsured by paying 
providers' claims for tests and associated items and services (such as, 
office or emergency room visits needed to get an order for or to 
administer a test). \2\, \3\ While it has been months since these funds 
were first appropriated, the Administration has failed to disburse 
significant amounts of this funding, leaving communities without the 
resources they need to address the significant challenges presented by 
the virus. The United States is at a critical juncture in its fight 
against COVID-19, and now is the time for an aggressive and fast 
response. This Administration will put our country at grave risk if it 
tries to declare an early victory, leave lifesaving work undone, and 
leave resources our communities desperately need sitting untouched.
---------------------------------------------------------------------------
    \1\ https://www.Congress.gov/bill/116th-congress/house-bill/266/
text.
    \2\ https://www.Congress.gov/bill/116th-congress/house-bill/6201/
text.
    \3\ https://www.Congress.gov/bill/116th-congress/house-bill/266/
text.

    Regarding funding for ramping up testing and contact tracing 
capacity, the Administration has full discretion to spend, as it sees 
fit, more than $8 billion of the $25 billion provided by Congress. With 
COVID-19 cases spiking in numerous states, the Administration has not 
released a plan to distribute this funding. It is critical that the 
Administration disburse the $8 billion immediately with an emphasis on 
addressing two major unmet needs: contact tracing and collecting data 
---------------------------------------------------------------------------
on COVID-19 racial and ethnic disparities.

    The country's current contact tracing workforce is inadequate to 
deal with the new spike in COVID-19 cases. Leading public health groups 
say state and local governments need $7.6 billion to quickly scale up 
contact tracing, including $4.8 billion to hire at least 100,000 
contact tracers. \4\ Meanwhile, other experts believe the country needs 
closer to 300,000 contact tracers. A bipartisan group of experts 
proposed last month that $46.6 billion is needed to contain the spread 
of COVID-19--including $12 billion for expansion of the contact tracing 
workforce. \5\
---------------------------------------------------------------------------
    \4\ https://www.naccho.org/uploads/full-width-images/Joint-Public-
Health-Contact-Tracing-Workforce-Request-4.30.20-FINAL.pdf.
    \5\ https://apps.npr.org/documents/document.html?id=6877567-
Bipartisan-Public-Health-Leaders-Letter-on.

    Dr. Scott Gottlieb, who served as Commissioner of the Food and Drug 
Administration under President Trump, said recently that, ``Right now, 
we haven't been able to trace [spread of the virus] back to the source 
because we don't have all that track and trace work in place. And so 
that's a challenge for public health officials.'' \6\ Yet despite this 
urgent need, the Centers for Disease Control and Prevention (CDC) has 
not even awarded nearly $4 billion in funding at its disposal that 
could be used for public health surveillance, and state, local, tribal 
and territorial surveillance and contact tracing efforts.
---------------------------------------------------------------------------
    \6\ https://www.washingtonpost.com/news/powerpost/paloma/the-
health-202/2020/06/15/the-health-202-u-s-isn-t-ready-for-the-contact-
tracing-it-needs-to-stem-the-coronavirus/5ee6528b602ff12947e8c0d7/.

    Additionally, the effort to gather COVID-19 data on race and 
ethnicity is woefully inadequate. Recent reports found that 52 percent 
of reported cases are missing information on race or ethnicity, 
preventing public health officials from knowing where to target 
interventions in communities of color. \7\ Even with these low 
reporting frequencies, the data we do have indicates that the 
disparities are vast. By its own admission, the Trump administration 
must change its approach to this issue. CDC Director Robert Redfield 
acknowledged that the Administration's paltry initial report to 
Congress on demographic data fell short, saying that ``I want to 
apologize for the inadequacy of our response.'' \8\ Brett Giroir, HHS 
Assistant Secretary for Health and former coronavirus testing czar, 
said ``We're flying blind until this comes in. We can't develop a 
national strategy to reach the underserved, or know how well we're 
doing, until we have the data that shows us if we're reaching them or 
not.'' \9\ Communities of color ravaged by COVID-19 cannot afford to 
wait any longer for a better approach.
---------------------------------------------------------------------------
    \7\ https://www.politico.com/news/2020/06/14/missing-data-veils-
coronavirus-damage-to-minority-communities-316198.
    \8\ https://www.politico.com/news/2020/06/04/coronavirus-robert-
redfield-racial-disparity-cdc-301223.
    \9\ https://www.politico.com/news/2020/06/14/missing-data-veils-
coronavirus-damage-to-minority-communities-316198.

    Regarding funding to provide free testing for the uninsured, to 
date, media reports note that ``only $10.8 million, or 0.5 percent of 
the $2 billion Congress set aside to help providers pay for COVID-19 
testing for uninsured patients, has been approved to be paid during the 
first two weeks of the program's operation.'' Recent news reports note 
that slow distribution of these funds may be caused by technical flaws 
with the portal for submitting claims, a lack of awareness about the 
availability of the funds, and coding issues. No patient should avoid 
seeking medical care because they are worried they cannot afford it--
especially in the midst of a pandemic, in which reluctance to seek care 
because of cost endangers the health of others. Congress appropriated 
these funds in large part because we know that patients often forego 
recommended tests and treatments because of cost. \11\ The need for 
these funds is made even more acute by the Trump administration's 
sabotage of our health care system, leaving increasing numbers of 
Americans uninsured. Even before the pandemic began, the U.S. Census 
Bureau reported that the number of Americans without health insurance 
rose by about 2 million in 2018. Even the number of uninsured children 
increased. \12\
---------------------------------------------------------------------------
    \11\ https://www.norc.org/PDFs/
WHI%20Healthcare%20Costs%20Coverage%20and%20Policy/
WHI%20Healthcare%20Costs%20Coverage%20and%20Policy%20Issue%20Brief.pdf.
    \12\ https://khn.org/news/number-of-americans-without-insurance-
rises-in-2018/.

    The pandemic has exacerbated this trend. After the start of the 
pandemic, the Kaiser Family Foundation estimates that as many as 27 
million people may have lost employer-sponsored insurance between March 
1 and May 2, many of whom may be eligible for an automatic special 
enrollment period. \13\ Further, the Trump administration has refused 
to open a national special enrollment period to make it easier for 
patients and families to sign up for comprehensive coverage, while 
continuing to promote ``junk'' short-term plans that are allowed to 
discriminate against people with pre-existing conditions and are not 
required to cover the essential health benefits, like prescription 
drugs.
---------------------------------------------------------------------------
    \13\ https://www.kff.org/coronavirus-covid-19/issue-brief/
eligibility-for-aca-health-coverage-following-job-loss/.

    This funding is also important to addressing health disparities. As 
of 2018, nonelderly Black, Hispanic, American Indian and Alaska Native, 
and Native Hawaiian people and Pacific Islanders are more likely to be 
uninsured than white people. \14\ This lack of access to care is one 
factor that contributes to the worse health outcomes experienced by 
communities of color with respect to COVID-19. \15\
---------------------------------------------------------------------------
    \14\ https://www.kff.org/disparities-policy/issue-brief/changes-in-
health-coverage-by-race-and-ethnicity-since-the-aca-2010-2018/.
    \15\ https://www.cdc.gov/coronavirus/2019-ncov/need-extra-
precautions/racial-ethnic-minorities.html.

    Funding to cover the cost of testing for the uninsured is also 
critical to support health care providers. The American Hospital 
Association estimates that, over a 4-month period from March 1 to June 
30, hospitals will experience $202.6 billion in losses. The rise in the 
uninsured population contributed to a 13 percent increase in bad debt 
and charity care in March of this year compared to the prior year. \16\
---------------------------------------------------------------------------
    \16\ https://www.aha.org/guidesreports/2020-05-05-hospitals-and-
health-systems-face-unprecedented-financial-pressures-due#:-
:text=Discussion,of%20%2450.7%20billion%20%20month.

    We call on you to immediately disburse the remainder of the $25 
billion in funds to ramp up testing and contact tracing capacity, as 
well as to make sure providers are aware of and able to easily access 
the $2 billion that Congress appropriated to provide testing for the 
---------------------------------------------------------------------------
uninsured. Thank you for your urgent attention to this matter.

            Sincerely,
                                        Charles E. Schumer,
                                     United States Senator.
                                              Patty Murray,
                                     United States Senator.
                                 ______
                                 
           Statement from the American Society for 
                                       Microbiology
                                                      June 23, 2020

    On behalf of our 30,000 members in the United States and around the 
world, the American Society for Microbiology (ASM) thanks Chairman 
Lamar Alexander, Ranking Member Patty Murray, and Members of the Senate 
Health, Education, Labor, and Pensions (HELP) Committee for holding 
this hearing to review lessons learned from past global infectious 
disease outbreaks and the current COVID-19 pandemic, and to discuss how 
we can better prepare for future pandemics. We also wish to express or 
appreciation to the Chairman for issuing a white paper on this subject 
with a call for comments. This is an important first step to ensuring a 
better response in the future, and ASM looks forward to providing more 
specific comments to the Committee.

    As soon as the public health emergency subsides, Congress and the 
Administration must initiate a high-level, broad-based, comprehensive 
and scientific review of the COVID-19 response through either a Federal 
commission or a qualified, nonpartisan entity such as the National 
Academies of Science, Engineering, and Medicine. This process should 
also be forward-looking and make cross-cutting recommendations on how 
the United States can better prepare for future public health 
emergencies, including funding needs and policy changes. By fully 
understanding what went well and what did not during this most recent 
pandemic, we can help thwart, or at the very least minimize, the 
effects of the next pandemic.

    Attached is a stakeholder letter dated March 30, 2020 spearheaded 
by ASM and signed by 38 additional national and international 
organizations, calling for a science-based review. ASM believes a high-
level, comprehensive pandemic response review should make 
recommendations to do the following:

      Ensure global collaboration and open lines of 
communication with our international partners;

      More rapidly scale up laboratory testing capacity in 
order to get tests to those who need them;

      Ensure a steady supply chain of materials to labs and 
hospitals to mitigate shortages;

      Clearly and effectively communicate practical, science-
based information and guidance to stakeholder entities and to the 
public; and

      Reduce patient access barriers so that all who need 
testing can get testing.

    The current crisis has brought to light a number of barriers, 
challenges and shortcomings in our ability to respond to a public 
health emergency. Some of these were the results of ``real-time'' 
decisionmaking, while others exposed systemic breakdowns, chronic 
underfunding, and a lack of resources that were years--if not decades--
in the making. These cut across multiple agencies and span levels of 
government from Federal, to state, to local authorities.

    While ASM members in clinical laboratories have the most immediate 
connection to the current crisis, our members work in several areas 
that will be critical to a long-term strategy to head off future 
pandemics. These include conducting basic biomedical research, vaccine 
development, and service delivery in clinical laboratory settings.

    ASM stands ready to work with you to help improve the systems we 
have in place today and to develop the solutions that will help address 
tomorrow's challenges.

    ASM reiterates our commitment to assisting the Committee, its 
Members, the Congress, the White House Coronavirus Task Force and the 
agencies as the U.S. continues to respond to the COVID-19 pandemic. 
More information from ASM on nCov2019: https://asm.org/Press-Releases/
2020/COVID-19-Resources.

    The American Society for Microbiology is one of the largest 
professional societies dedicated to the life sciences and is composed 
of 30,000 scientists and health practitioners. ASM's mission is to 
promote and advance the microbial sciences.

    ASM advances the microbial sciences through conferences, 
publications, certifications and educational opportunities. It enhances 
laboratory capacity around the globe through training and resources. It 
provides a network for scientists in academia, industry and clinical 
settings. Additionally, ASM promotes a deeper understanding of the 
microbial sciences to diverse audiences.
                                                    March 30, 2020.
The Hon. Richard Shelby, Chairman
Committee on Appropriations,
U.S. Senate,
Washington, DC.
The Hon. Patrick Leahy, Vice Chairman
Committee on Appropriations,
U.S. Senate,
Washington, DC.
The Hon. Roy Blunt, Chairman
Subcommittee on Labor, HHS, Education,
Committee on Appropriations,
U.S. Senate,
Washington, DC.
The Hon. Patty Murray, Ranking Member
Subcommittee on Labor, HHS, Education,
Committee on Appropriations,
U.S. Senate,
Washington, DC.

    Dear Chairman Shelby, Vice Chairman Leahy, Chairman Blunt and 
Ranking Member Murray:

    We, the undersigned organizations representing millions of 
individuals working to address the unprecedented challenges SARS-COV-2 
has presented to our society, our healthcare system, and our economy, 
are committed to working with Congress and the Administration to 
address the pressing needs associated with the novel coronavirus (SARS-
COV-2) and COVID-19.

    We are writing to request that, as soon as the immediate public 
health emergency subsides, Congress and the Administration initiate a 
high-level, comprehensive review of the COVID-19 response through 
either a Federal commission or a qualified, nonpartisan entity such as 
the National Academies of Science, Engineering, and Medicine. This 
process should also be forward-looking and make cross-cutting 
recommendations on how the United States can better prepare for future 
public health emergencies, including funding needs and policy changes. 
By fully understanding what went well and what did not during this most 
recent pandemic, we can help thwart, or at the very least minimize, the 
effects of the next pandemic.

    Specifically, such a review should recommend the most effective 
ways to:

      Ensure coordination and collaboration across and amongst 
Federal agencies and with state and local authorities;

      Clearly and effectively communicate practical, science-
based information and guidance to stakeholder entities and to the 
public;

      Build public health capacity, including at the local, 
state and tribal health department levels;

      Rapidly scale up laboratory testing capacity in order to 
get tests to those who need them;

      Ensure a steady supply chain of materials to labs, 
clinics, hospitals and workplaces to mitigate shortages;

      Protect the most vulnerable in our communities by 
reducing patient access barriers to testing and health care services; 
and,

      Facilitate global collaboration to ensure that responses 
are based on real-time, accurate information.

    The current crisis has brought to light a number of barriers, 
challenges and shortcomings in our ability to handle a public health 
emergency. Some of these were the results of ``real-time'' 
decisionmaking, while others exposed systemic breakdowns that were 
years--if not decades--in the making. These cut across multiple 
agencies and span levels of government from Federal, to state, to local 
authorities.

    While public health professionals, health departments, clinical 
laboratories, clinics and hospitals have the most immediate connection 
to the current crisis, a comprehensive, well-planned approach will be 
critical to a long-term strategy to head off future pandemics. A 
comprehensive approach includes medical research and development, 
social, behavioral and economic considerations, corporate partners to 
ensure product and service delivery, small businesses, universities and 
research institutions, as well as healthcare professions.

    We stand ready to work with you to help improve the systems we have 
in place today, and to develop the solutions that will help address 
tomorrow's challenges.

            Sincerely,
                                                 1,000 Days
                                                       AABB
                             American Academy of Pediatrics
                American Association for Clinical Chemistry
        American Association for the Advancement of Science
               American Association of Colleges of Pharmacy
                      American Association of Immunologists
  American Institute for Medical and Biological Engineering
                         American Public Health Association
                    American Society for Clinical Pathology
                          American Society for Microbiology
                             American Society for Nutrition
        American Society for Pharmacology and Experimental 
                                               Therapeutics
                              American Society for Virology
                             American Society of Hematology
          American Society of Tropical Medicine and Hygiene
    Association for Professionals in Infection Control and 
                                               Epidemiology
                  Association of American Cancer Institutes
                       Association of American Universities
            Association of Maternal & Child Health Programs
                          Association of Population Centers
                  Association of Public Health Laboratories
          Association of Public and Land-grant Universities
                                        Biophysical Society
                            Coalition for the Life Sciences
  Federation of Associations in Behavioral & Brain Sciences
                            Foundation for Vaccine Research
                       Global Health Technologies Coalition
                     Infectious Diseases Society of America
   National Association of County and City Health Officials
                                    National Safety Council
                                   OSA, The Optical Society
                          Population Association of America
                                           Research!America
                 Society of Infectious Diseases Pharmacists
                                             Susan G. Komen
         The Society for Healthcare Epidemiology of America
                                 Trust for America's Health
                                      Vaccinate Your Family
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                  A Storm for Which We Were Unprepared
    Bill Frist, M.D.

    The American Mind

    Essay--04.13.2020

    Senator Bill Frist saw it coming years ago.

    Senator William Frist, M.D. is a nationally acclaimed heart and 
lung transplant surgeon and the former Majority Leader of the U.S. 
Senate. In 2005, during his tenure in Congress, he delivered the 
Marshall J. Seidman Lecture for the Department of Health Care Policy at 
Harvard University. In this strikingly prescient speech, he foretells 
the possibility of a viciously deadly pandemic and calls for action to 
defend against that eventuality on a vast scale. Though his warnings 
went unheeded, we are honored to publish his words now as part of our 
ongoing efforts to understand and counteract COVID-19 and its effects.

    I am a physician and a surgeon who by accident of fate finds 
himself in the halls of power at a time of dangers for his country and 
the world, the most compelling of which are exactly those a physician 
is trained to recognize and fight. To me it seems no more natural to be 
a United States Senator, and in my case the majority leader of the 
Senate, than it did to Harry Truman, who spent so many hard and 
unambitious years as a farmer and then found himself in such a place 
and at such a time as he did. And, like him, as someone who comes from 
the outside, and for whom the perquisites of power appear strange and 
irrelevant, I have asked myself what my purpose is as a public servant, 
what my obligations are, and what high precedents I should follow.

    After some thought, I have determined my purpose, I know my duty 
and obligations, the precedents to honor, and why--neither history nor 
life itself being empty of example. Just as a surgeon must follow a 
purely objective course and a general must look at war with a cold and 
steady eye, a statesman must operate as if the world were free of 
emotion. And yet, to rise properly to the occasion, the surgeon must 
have the deepest compassion for his patient, the general must have the 
heart of an infantryman, and the statesman must know at every moment 
that the cost of his decisions is borne, often painfully, by the 
sovereign population he serves--all as if the world were nothing but 
emotion. The difficulty in this is what Churchill called the 
``continual stress of soul,'' the rack upon which the adherents of 
these professions, if they meet their obligations well, will of 
necessity be broken.

    In balancing objectivity with emotion, the practical with the 
moral, the smooth operation of power with its homely and human effects, 
one is driven to consider first things and elemental purposes, and this 
consideration makes clear that the guiding star of statesmanship is not 
aggrandizement of the state or the furtherance of a philosophy or 
ideology, and neither glory nor ambition nor accumulation of territory 
or riches. Rather, the guiding star must be the fact of human 
mortality, and the first purpose of a public official a simple watch 
upon the walls. We are charged above all with assuring the survival of 
the Nation and protecting the lives of those whom we serve and who have 
put us in our place, entrusting us with this gravest of 
responsibilities.

    Whether leading a small nomadic band, captaining a ship, or at the 
head of a huge industrial nation, the task is the same. It is not 
merely that which can be accomplished with sword and shield, but, 
rather, the exercise of courage, sacrifice, and judgment, in the 
preservation of the life of a nation in its people as families and 
individuals. And as if by design, this task becomes in its execution a 
principle that unites the powerless and powerful in an unimpeachable 
equality.
                        Clear and Present Danger
    In times of peace and prosperity, whole nations sometimes willfully 
forget that we are mortal, and the forgetfulness then can rule beyond 
its natural life even in the face of war and pestilence, when by all 
accounts the star of mortality shines in air cleared of the luminous 
distractions of peace.

    Like everyone else, politicians tend to look away from danger, to 
hope for the best, and pray that disaster will not arrive on their 
watch even as they sleep through it. This is so much a part of human 
nature that it often goes unchallenged. But we will not be able to 
sleep through what is likely coming soon--a front of unchecked and 
virulent epidemics, the potential of which should rise above your every 
other concern. For what the world now faces it has not seen even in the 
most harrowing episodes of the Middle Ages or the great wars of the 
last century. And not only are we unprepared for rampant epidemics, we 
have not taken sufficient note of the fact that though individually 
each might be devastating, they are susceptible of either purposeful or 
accidental combination, in which case they could be devastating almost 
beyond imagination.

    The history of pathogens advances in parallel with and is no more 
static than our own, with which it is always intertwined, even if at 
times invisibly. Sometimes it rushes forward with great speed and 
breathtaking evolutionary vigor, and sometimes it rests in slow 
backwaters. When, in 1967, the U.S. Surgeon General declared that we 
had won the war on infectious diseases, we thought the slack water 
would last forever. But that war had never ended other than in wishful 
thinking.

    Even now we accept as normal, because it is normal, that more than 
a quarter of all deaths--fifteen million each year--are due to 
infectious diseases. Three million children die every year of malaria 
and diarrheal diseases alone, one child every 10 seconds. As sobering 
as this may be, we have been nonetheless in a quiescent stage of the 
mutability of pathogens, a hiatus from which they are now poised to 
break out. When viral diseases evolve normally--such as in the typical 
course of the human influenza virus undergoing small changes in its 
antigenicity and killing an average of 500,000 people annually 
throughout the world--it is called an antigenic drift. When they emerge 
with the immense power derivative of a jump from animal to human hosts 
followed by mutation and/or recombination with a human virus, as in the 
influenza pandemic of 1918-1919, in which 500 million people were 
infected and 50 million died, including half a million in the United 
States, it is called an antigenic shift.

    To have believed with the Surgeon General forty years ago that the 
great advances of biological science were capable of permanently 
suppressing infectious disease was to have been unaware that these 
triumphs were appropriate only to one phase in the life of a 
continually evolving enemy whose natural rate of evolution and 
adaptation is far greater than our own. Shifts are the result of 
random, fortuitous, and unavoidable changes. Human population increase, 
concentration, and spread, intensification of animal husbandry, and 
greater wealth in developing countries bring animals both wild and 
domestic into closer contact with ever-larger numbers of people. War, 
economic catastrophe, and natural disasters subdue active measures of 
public health. The unprecedented use of antibiotics builds 
unprecedented resistance. Travel, trade, and climate change bring into 
contact disparate types and strains of disease. And as a consequence of 
all this, microbes evolve, mutate, and find new lives in new hosts.

    The annual toll of infectious diseases worldwide--including four 
million from respiratory infections, three million from HIV/AIDS, and 
two million from waterborne diseases such as cholera--is a continuing 
and intolerable holocaust that, while sparing no class, strikes hardest 
at the weak, the impoverished, and the young. But this is just a 
beginning, in that the evidence strongly suggests that we are at the 
threshold of a major shift in the antigenicity of not merely one but 
several categories of pathogens, for never have we observed among them 
such variety, richness, opportunities for combination, and alacrity to 
combine and mutate. HIV, variant Creutzfeldt-Jakob disease (mad cow), 
avian influenzas such as H5N1, and SARS are merely the advance patrols 
of a great army forming out of sight, the lightning that however silent 
and distant gives rise to the dread of an approaching storm--a storm 
for which we are entirely unprepared. How can that be? How can the 
richest country in the world, with its great institutions, experts, and 
learned commissions, have failed to make adequate preparation--when 
preparation is all--for epidemics with the potential of killing off 
large segments of its population?
                         Precedent and Presage
    To see what lies on the horizon one need only look to the 
relatively recent past. I have a photograph of an emergency hospital in 
Kansas during the 1918 influenza pandemic. People lie miserably on cots 
in an enormous barn-like room with beams of sunlight streaming through 
high windows. It seems more crowded than the main floor of Grand 
Central Station at five o'clock on a weekday. In this one room several 
hundred people are in the throes of distress. Think of 2,000 such rooms 
filled with a crush of men, women, and children--500,000 in all--and 
imagine that the shafts of sunlight that illuminate them for us almost 
a century later are the last light they will ever see. Then bury them. 
That is what happened.

    How would a nation so greatly moved and touched by the 3,000 dead 
of September 11th react to half a million dead? In 1918-1919 the 
mortality rate was only 10 percent, which seems merciful in comparison 
to the near 100 percent rate common to hemorrhagic fevers. Nor is 
influenza nearly as infectious as, for example, smallpox. How, then, 
would a nation greatly moved and touched by 3,000 dead, react to five 
or fifty million dead?

    Smallpox is just one of many threats. During the cold war, the 
Soviet Union, which stockpiled 5,000 tons annually of biowarfare-
engineered anthrax resistant to 16 antibiotics, also produced massive 
amounts of weaponized smallpox virus just as universal immunization had 
come to a halt. As a result of conditions prevalent during the 
dissolution of the USSR, it is impossible to rule out that quantities 
of this or other deliberately manufactured pathogens such as anthrax, 
pneumonic plague, tularemia, etc. may find or may have found their ways 
into the possession of terrorists such as bin Laden and al-Zarqawi. 
Although the United States has put up enough--questionable--smallpox 
vaccine for the entire population, it has neither the means of 
distribution nor the immunized personnel to administer it in a 
generalized outbreak, nor the certainty that the vaccine would be 
relevant to a specific weaponized strain of the virus. Ring vaccination 
would be useless if the pathogen were released at many sites 
simultaneously, and in such a circumstance hospitals and the now 
nonexistent auxiliary means of relief would be quickly overwhelmed.

    Panic, suffering, and the spread of the disease would intensify 
as--because people were dead, sick, or afraid--the economy ceased to 
function, electrical power flickered out, and food and medical supplies 
failed to move. Over months or perhaps years, scores of millions might 
perish, with whole families dying in their houses and no one to 
memorialize them or remove their corpses. Almost without doubt, the 
epidemic would spread to the rest of the world, for in biological 
warfare an attack upon one country is an attack upon all. Every vestige 
of modernity would be overturned. The continual and illusory flirtation 
with immortality that is a hallmark of scientific civilization would 
shatter, and we would find ourselves looking back upon even the most 
difficult times of the last century as a golden age. Despite the common 
wisdom, humanity has not moved beyond this kind of scenario. Of late it 
has moved unnecessarily and gratuitously toward it.

    Any number of unknown viruses for which at present there is neither 
immunization nor cure are at this moment cooking in Asia and Africa, 
where they arise in hotbeds of densely intermingled human and animal 
populations. We are in unexplored territory. Economic and environmental 
changes in Asia have forced wilderness-deprived waterfowl to alight to 
feed amid farm animals in newly dense populations due to recently 
acquired wealth and dietary expectations, in a culture in which live 
poultry is brought to market. The reassortment of viral DNA as a result 
of this mingling is so frenzied that it is only a matter of time until 
the emergence of a virus unequaled in transmissibility and virulence. 
The epidemiological calculus of flu is notoriously volatile due to the 
unknowns of rapid reassortment. We do know now, however, that the 
incidence of H5N1 has been underestimated, that North Korea may be at 
the cusp of an Avian Flu crisis, and that we are woefully underprepared 
even for a virus that we can foresee, much less for one that we cannot.

    No such viruses have yet reached critical mass or leapt from the 
channels imposed by their inherent limitations, environmental 
obstacles, and deliberate actions to contain them. But the evidence I 
have seen, the patterns of history, and new facts such as rapid, 
voluminous, and essential travel and trade; the decline of staffed 
hospital beds; and a now heavily urbanized and suburbanized American 
population dependent as never before upon easily disrupted networks of 
services and supply, lead me to believe that--especially because 
vaccines, if they could be devised, would not be available en masse 
until six to nine months after the outbreak of a pandemic--the 
imminence of such viruses might result in the immensely high death 
tolls to which I have alluded.

    It is true that none of these viruses has yet spread 
geometrically--instantly and irrevocably overcoming health care systems 
and pulling us backward across thresholds of darkness that we long have 
believed we would never cross again. And yet this they might do--either 
entirely on their own or as a result of intentional human intervention. 
No intelligence agency, no matter how obsessively and repeatedly 
rearranged, and no military, no matter how powerful and dedicated, can 
assure that a few technicians of middling skill using a few thousand 
dollars' worth of readily available equipment in a small and apparently 
innocuous setting cannot mount a first-order biological attack. It is 
possible, for example, to unite the prairie-fire infectiousness of 
smallpox with the almost absolute fatality of Ebola fever. It is 
possible simply and inexpensively to synthesize virulent pathogens from 
scratch, or to engineer and manufacture prions that, introduced 
undetectedly over time into a nation's food supply, would after a long 
delay afflict virtually the entire population with a terrible and 
uniformly fatal disease. Unfortunately, the permutations are so various 
that the research establishment as now constituted cannot set up lines 
of investigation to anticipate even a small proportion of them. Never 
have we had to fight such a battle, to protect so many people against 
so many threats that are so silent and so lethal.

    But is it reasonable to assume that anyone might resort to 
biological warfare? Indeed it is. Al-Qaida has declared that, ``We have 
the right to kill four million Americans--two million of them children 
. . . [and] it is our right to fight them with chemical and biological 
weapons.'' In Al-Istiqlal, the weekly of Islamic Jihad, we read that 
``it is the duty of Muslims to act in any possible way to acquire 
weapons of mass destruction, starting with nuclear weapons and ending 
with chemical and biological weapons.'' It is hardly necessary, 
however, to rely upon stated intent. One need only weigh the logic of 
terrorism, its evolution, its absolutist convictions, and the evidence 
in documents and materials found in terrorist redoubts.

    Those who equate terrorism with its targets and take false comfort 
in attributing to the terrorist the moral status and restraint of his 
victim should consider that for more than half a century at least eight 
countries have possessed a collective arsenal of, at times, not only 
scores of thousands of nuclear warheads but the virtually ineluctable 
means of delivering them. Still, apart from the first and only use of 
nuclear weapons, in every trying condition, in crisis and in war, in 
victory and in defeat, not one has been detonated except in test. Who 
would gamble that if the terrorist enemy possessed even a single 
nuclear charge, he would fail to devote all his resources to its 
detonation in the midst of the maximum number of innocents? And though 
not as initially dramatic as a nuclear blast, biological warfare is 
potentially far more destructive than the kind of nuclear attack 
feasible at the operational level of the terrorist, and biological war 
is itself distressingly easy to wage.
                         Rising to Meet the Day
    I ask again how it is that nowhere is anyone prepared either for 
naturally occurring epidemics of newly emergent diseases or those that 
are deliberately induced? It would take whole encyclopedias to dwell on 
what has not been done and the inadequacy of what little has been done, 
but a hint may be accurately conveyed by the fact that the Nation's 
largest biocontaminant unit with fully adequate quarantine and negative 
air is a ten-bed facility in Omaha, or by the absurdity of a recent 
announcement from the Washington Hospital Center that in ``implementing 
plans for handling any disaster that might effect our capital,'' and 
``to deal with the worst in biological, chemical, and natural 
disasters,'' it has built, ``a multi-use, 20-bed ready room'' (emphasis 
mine).

    We may have built a 20-bed ready room, but there is on the horizon 
a silent wave that is coming at the world, and, if we do nothing, it 
will sweep over us invincibly. My duties as physician and public 
official having fused, I propose that we take the measure of this 
threat and make preparations to engage it with the force and knowledge 
adequate to throw it back wherever and however it may strike. It need 
not be invincible and we need not fall to our knees before it. Means 
adequate to the success of a defensive plan are present in great 
profusion. Whereas the approaching biological shift is gathering force 
like a massing army, providence has massed an army to meet it. Having 
themselves expanded geometrically, the life sciences have come to the 
threshold of a great age, and to cross it they need only encouragement 
and a signal from the body politic to put their resources in play.

    We are not without weapons in this war. They are present in the 
stupendous material and intellectual wealth of the civilized world, 
which, despite current divisions of action and opinion, has everything 
to lose in common. They are present in the approximately $30 trillion 
per annum combined gross national products of just NATO and Japan. They 
are present in the great stores of science and technology amassed over 
thousands of years of civilization; in the many hundreds of 
universities, advanced research institutions, and hospitals; in the 
private sector's ruthless focus, which, though frequently condemned for 
its lack of humanity, may yet be the instrument that saves humanity. 
They are present in the special temperament and brilliance of 
individual scientists; in the magnificent light that comes of the 
surprising and ingenious application of new technologies; and in the 
vigor, intelligence, and decency of free and unoppressed peoples.

    The nature of the threat being mortal and reaction to it heretofore 
irresponsible and inadequate, I propose--entirely without prejudice to 
the necessity and absent the diminution of the means to disrupt, 
defeat, and confound the aggressor by force of arms--an immense and 
unprecedented effort. I see not an initiative on the scale of the 
Manhattan Project, but one that would dwarf the Manhattan Project; not 
the creation of a giant, multi-billion dollar research institution, but 
the creation of a score of them; not merely the funding of individual 
lines of inquiry, but of richly supported fundamental research, a 
supreme effort in hope of universal application; not the fractional 
augmentation of medical education but its doubling or tripling; not a 
wan expansion of emergency hospital capacity, but its expansion, as is 
necessary and appropriate, by orders of magnitude; not to tame or 
punish the private sector, but to unleash it especially upon this task; 
not the creation of a forest of bureaucratic organization charts and 
the repetition of a hundred million Latinate words in a hundred million 
meetings that substitute for action, but action itself, unadorned by 
excuse or delay; not the incremental improvement of stockpiles and 
means of distribution, but the creation of great and secure stores and 
networks, with every needed building, laboratory, airplane, truck, and 
vaccination station, no excuses, no exceptions, everywhere, and for 
everyone.

    I call for no less than the creation, with war-like concentration, 
of the ability to detect, identify, and model any emerging or newly 
emerging infection, natural or otherwise; for the ability to engineer 
the immunization and cure, and to manufacture, distribute, and 
administer whatever may be required to get it done and to get it done 
in time. For some years to come, this should be the chief work of the 
Nation, for the good reason that failing to make it so would be to risk 
the life of the Nation.

    It could be very costly, yes, but it is the kind of thing that, 
once accomplished, is done. And it is the kind of thing that calls out 
to be done, and that, if not done, will indict us forever in the eyes 
of history. In diverting a portion of our vast resources to protect 
nothing less than our lives, the lives of our children, and the life of 
our civilization, many benefits other than survival would follow in 
train, not least the satisfaction of having done right. If the process 
of scientific discovery proceeds as usually it does, diversions of 
money, energy, and effort into the construction of a vast public and 
private research and medical system capable of intercepting and 
defeating the worst natural or terroristic epidemics would very likely 
bring as well a magnificent offshoot--understanding diseases that we do 
not now understand and finding the cures for diseases that we cannot 
now cure. If the laws of supply and demand have not been repealed--and 
they have not--the heretofore unequaled abundance of medical goods and 
services would contribute to solving the problems of financing health 
care--and it would do so the old-fashioned way, by paying for it. And, 
as always, disciplined and decisive action in facing an emergency can, 
even in the short run, compensate for its costs--by adding to the 
economy both a potent principle of organization, and a stimulus like 
war but war's opposite in effect, which would power the productive life 
of the country into new fields, transforming the information age with 
unexpected rapidity into the biotechnical age that is to come--and all 
this, if the Nation can be properly inspired in its own defense and 
protection, perhaps just in time.

    Rest for a moment what may be your astonishment at the scale of the 
initiative I have proposed, and allow a conservative Republican from 
Tennessee, who is by nature skeptical of government action, to affirm 
the root conservative principle that if the life of the Nation is 
potentially at risk no effort should be judged too ambitious, no price 
too high to pay, no division too wide to breach.

    We have built great cities, dams, and aqueducts. We have built the 
interstate highway system, bridges, canals, fleets, armies, and a world 
of structures the cost of which defies expression. We have decided upon 
going to the moon and then done so in a few short years. Can we not, 
then, build this thing, and take these steps, to protect our lives and 
the lives of our children, to evade mass death and alleviate the 
greatest suffering that man has ever known, that comes to all classes, 
all races, all ages? Have we been so blinded and confused that we 
cannot see the single most important challenge before us, and the 
single greatest opportunity?

    I am aware that what is now required has not been asked since the 
eighth of December, 1941. And I am aware of the difficulties. But I 
know as well that however much it may be shunted aside by the ordinary 
and the profane, a deep understanding of mortality, second to none, is 
present in the people--who are not superficial, who are not to be 
dismissed, and from whom an almost miraculous collective wisdom has 
arisen whenever it has been needed. It arose at the time of the 
American Founding, to create a republican democracy despite the 
militant opposition of the world's greatest empire. It arose when the 
premise of the founding, that all men are created equal, was turned 
into reality even though to do so meant the bloodiest war in the 
Nation's history. It arose in the world wars and the cold war, when the 
Nation fought and persevered for a century, with patience, devotion, 
and generosity, not merely for the sake of its narrow interests--which 
some could not even see--but out of principle. I believe that despite 
their imperfection the sinews of the American people are intact, and I 
believe that the sinews of our allies and their great civilizations are 
intact as well.
                       America on the Front Lines
    Especially since September 11th, awareness of mass biological 
warfare has been at the edge of the popular imagination, but seems to 
have escaped political will. Blind and chattering elites have dismissed 
the concerns of the public, or failed to hear them, as if there were a 
set of facts, a certitude of result, or some infallible wisdom with 
which to support this dismissal. But no such facts exist and the 
certitude of those who would discount the danger is just a pose spun 
from thin air. Failure to foresee, to prepare for, and to forestall 
bioterrorism and a biological shift is a failure of statesmanship that, 
until remedies are found and action taken, is also a personal failure 
for everyone in a high and responsible position--even the highest, 
especially the highest, including the president, and including me. In 
this regard the people are ahead of their leaders and possessed of more 
common sense. They know, quite frankly, that we are as vulnerable as 
hell, and that no one is really doing anything about it.

    The persistent inaction is especially gratuitous in light of the 
fact that the magnitude of the issue should have the power to heal many 
a breach and cross many an ideological chasm. For those who hold that 
attention to moral questions is illusory and impractical, and for those 
who protest that devotion solely to practical matters is amoral, here 
is the urgent fusion of both, that cannot be dismissed as either, even 
if until now it has been perceived and neglected as if it were neither. 
As in crises of times past, left and right, modernists and 
traditionalists, the old world and the new, can agree that the 
protection and preservation of human life on a massive scale is the one 
goal in their philosophies that will enable their every other principle 
to seek its every other action.

    Conservative predilection and purely empirical observation lead me 
to believe that what I have proposed, though universal in effect, 
cannot be brought to fruition as a universal scheme. The World Health 
Organization is essential, but it works best as an expression of the 
power and resolution of nations. For the Nation is yet the highest 
level of effective organization, and, paradoxical as it may seem, a 
worldwide defense against biological catastrophe would be strongest 
were it erected at the national level, in a loose confederation with 
unavoidable duplications but with, nonetheless, the organic development 
among countries of an efficient division of labor.

    In this the United States is as blessed as it has been since its 
beginnings. We are the wealthiest, freest, and most scientifically 
advanced of all societies, the first republican democracy, the first 
modern state. And although we have suffered criticism of late and to no 
small degree because of our awkwardness as a young nation, we have been 
willing since our Founding and are willing still to pursue certain 
ideals. Though not infrequently condemned from the precincts of 
cynicism, America has mostly left cynics in its wake, sometimes after 
saving them from floods that they themselves have unleashed.

    Do not discount America or dismiss its resolution. Our 
imperfections are accompanied by fine qualities and beliefs of which we 
will never be ashamed and from which we have no intention of recoiling. 
We believe in government with the consent of the governed, and in the 
sanctity of the individual. We have as a nation by and large rejected a 
mechanistic view of human nature in favor of a belief in the soul and 
the grace it may be granted. (If there is no soul, what is the basis of 
human equality in law or morals, given that we are unequal in all other 
ways?) This belief to which we hold firm is descended from our 
founding, which occurred at a time of miraculous poise in human history 
when science and reason were in uncontradictory balance with faith; 
when in America the freshest optimism the world has ever known was 
tempered by a view of human nature unsurpassed in its clarity and 
caution.

    Lest this seem too abstract, consider that when we found ourselves 
in violation of our elemental principles we suffered through many years 
of fratricidal warfare to put them right. Both sides fought with 
inimitable courage, and the side--of which I am a son--that was reduced 
to waste and ash, rose from its ruins to fight a greater battle, a 
battle with itself, finally to embrace the principles it had opposed.

    From the blood of my fathers and in my blood itself I have not 
merely a vision of ruin, waste, and ash, but the certain knowledge, a 
vivid memory that has of late been refreshed and confirmed. This is not 
the last time you will hear from me, but today I have tried to impress 
upon you the urgency I feel in the matter of the immediate destiny not 
only of America but of the world, for pandemics know neither borders, 
nor race, nor who is rich nor who is poor, they know only what is 
human, and it is this that they strike, casting aside the vain 
definitions that otherwise divide us.

    It is my pre-eminent obligation as a public servant and my sacred 
duty as a physician to ask you to support the essence of my proposal. 
In respect of human mortality, for the sake of your own families and 
children, for the honor and satisfaction of doing right, and to sweep 
away the inexcusable prevarication that has accumulated since the great 
shock of September 11th, I bid you join in this declaration. May God 
preserve us all, and may our actions and foresight make us worthy of 
His preservation.
                                 ______
                                 
        remarks as prepared for majority leader bill frist, m.d.
                 Pandemic: The Economy's Silent Killer
                          National Press Club
                            December 8, 2005

                              Introduction
    Imagine a cigarette carelessly flung on the edge of a scorched and 
brittle forest. Un-extinguished, the cigarette smolders in the leaves 
until it catches flame. The winds blow in, sparks are carried afar, the 
thirsty limbs ignite. A forest fire is born.

    When the elements are aligned, the path of a global pandemic is 
similar.

    Think of a fast-moving, highly contagious disease that wipes out 50 
million people. Half a million in the U.S. The killer pandemic claims 
more victims in 24 weeks, than HIV-AIDS has claimed in 24 years.

    In the United States--the most developed nation in the world--
bodies pile up in the streets. There aren't enough morticians to bury 
the dead. Nor are there enough doctors and nurses to tend to the sick.

    Normal life stops. The churches close, the schools shutter. 
Communications and transportation grind to a halt.

    The public succumbs to hysteria and panic. Police protection fails. 
Order decays. Productivity dives.

    Sounds like science fiction, doesn't it? But what if I told you, it 
already happened? What if I told you it was the pandemic flu that swept 
across America and around the globe in 1918?

    Or if I told you that this glimpse into the past might just be a 
preview to our future?
                                  ***
    A viral pandemic is no longer a question of if, but a question of 
when.

    We know--depending upon the virulence of the strain that strikes 
and our capacity to respond--that the ensuing death toll could be 
devastating.

    In recent weeks, the growing death toll of the avian flu and the 
mounting drumbeat of discussion have placed the virus under the 
microscope of the public eye. Yet--like all stories--it too will shift 
from center stage. The public will have had their fill. The danger will 
seem removed.

    But while the story may recede from the cover of Newsweek or the 
centerfold of Time, I know that a threat that strikes at our very 
mortality--as this does--must not recede to the backdrop of public 
concern.

    As a physician, a heart surgeon, my life has centered on 
mortality--the preservation of life.

    Similarly, as public officials, the mortality of mankind should be 
our first, and if necessary, only concern. Measured against everything 
we consider from day to day--budgeting, taxes, judges, pensions--your 
mortality, the care and protection of human life, is the most 
fundamental responsibility entrusted to us.

    Which is why we will not look away from what may come.

    Today I ask you to walk forward with me to a future where an avian 
pandemic strikes. (It's almost Christmas . . . think of the Ghost of 
Christmas Future.) As we look to that future, let's zero in on a 
critically important aspect that has received almost no focus to date--
the pandemic's impact on our economy.

    ``When a pandemic strikes, exactly how devastating will the 
economic fallout be?''

    That is the question I'll answer today.

    But before we fast-forward to the future, let's quickly rewind.

    ``Exactly what is this avian influenza?''

    The year is 1997. The place, Hong Kong.

    The culprit: the H5N1 strain of the avian flu, a highly contagious 
virus primarily affecting wild waterfowl. The birds are a natural 
breeding ground for the virus--they can carry the virus without 
symptoms, spreading it far and wide.

    In 1997 the dynamics shift. The virus that has affected only 
animals so far spreads to 18 people in Hong Kong. A third of them die.

    By slaughtering the region's entire poultry stock--1.5 million 
birds--Hong Kong authorities quickly stem the spread of disease.

    But to scientists and public health officials, it is the first shot 
heard round the world. The Hong Kong outbreak signaled that the H5N1 
strain had satisfied two of three prerequisites for a pandemic:

        1st: the H5N1 strain was a novel type of virus, to which no 
        human being has any pre-existing immunity.

        2nd: The virus could reproduce in humans and cause serious 
        illness.

    The only remaining requirement--not yet fulfilled--is human-to-
human transmission.

    For the final element to fall into place, it will require little 
more than the shuffling of a few genes between the animal and human 
forms of a virus (--a phenomenon known as an antigenic shift.)

    The resulting mix will be totally unfamiliar to the human immune 
system which normally fights infections--meaning that human beings will 
have no natural immunity to it. More alarming, the right mix of genes 
could allow for sustained human-to-human transmission: an avian 
pandemic would launch to life.
                                  ***
    Since the 1997 outbreak, the avian flu has progressively and 
relentlessly spread across 16 countries. From Hong Kong, the virus has 
stretched its tentacles into Thailand, South Korea, Vietnam, Japan, 
Cambodia, Laos, Indonesia, China, Malaysia, Russia, Kazakhstan, 
Mongolia, Turkey, Romania, and Croatia--infecting 135 humans, and 
killing 69 (in five countries--Cambodia, China, Indonesia, Thailand, 
Vietnam). \1\
---------------------------------------------------------------------------
    \1\ From 2003 to present. Deaths have occurred in Cambodia, China, 
Vietnam, Thailand, and Indonesia.

    With each outbreak, the signs are increasingly clear that a 
---------------------------------------------------------------------------
pandemic is looming.

        1st: it's found a permanent ecologic niche among domestic ducks 
        in rural Asia.

        2nd: it's increased the range of species it can infect--moving 
        to cats and tigers.

        3rd: it's grown more robust, rendering itself resistant to 1 of 
        2 types of anti-flu drugs.

        4th: it's shown the ability to mutate rapidly, with the 
        propensity to acquire new genes.

    Last, it's demonstrated that it can infect humans directly.

    With each person that the virus infects, the more likely it is that 
genetic re-assortment will occur, and a pandemic will arise.
                      Possible Pandemic Scenarios
    A second fundamental question: ``How severe will that pandemic 
be?''

    To forecast the economic impact, it's a question we must answer.

    The most frequently cited, deadliest pandemic in recent history was 
the 1918-1919 Spanish influenza.

    The flu infected between a quarter and a third of all Americans, 
and killed half a million (2-3 percent of those infected). Worldwide, 
40 to 50 million people died.

    Unlike the seasonal flu, the 1918 influenza preyed on and killed a 
younger, healthier demographic, the most productive segment of our 
population--as opposed to the elderly, the weak, and the very young. In 
the United States, the pandemic was so acute that the average lifespan 
was shaved-off by 10 years.

    ``So, will an avian pandemic today be more severe or less severe 
than the 1918 avian flu?''

    We don't know.

    Scientists who believe that the coming pandemic will be LESS severe 
cite the dramatic 20th century advances in science and medicine. We 
have far more sophisticated tools for surveillance, the ability to 
design vaccines, and better treatment options like antibiotics for 
secondary bacterial infections.

    Those who believe that we're MORE vulnerable today argue (perhaps 
even more persuasively) that the world is much more densely populated 
which facilitates rapid spread. They cite that the population is 
comprised of a higher proportion of elderly; that our dependence on 
just-in-time delivery systems would wreak greater disruption; and last 
that a million people living today with preexisting compromised immune 
systems (by cancer therapy) means a more susceptible host.

    This line of reasoning--that a pandemic would be worse--is 
compounded by the fact that the world today is so tightly 
interconnected through travel, trade, and on-line communication--a 
factor that could greatly amplify the spread of fear, panic, and even 
the virus itself.

    Whatever the outcome, this latter argument speaks to an undeniable 
truth. When facing the prospect of a modern pandemic, no longer are we 
battling the rapidly spreading virus alone, but the repercussions of 
disease in a world where everything is interdependent.

    ``But,'' you say, ``1918 is a long time ago.''

    ``Is there a modern example of a viral outbreak that we can learn 
from?''

    And the answer is yes--the 2003 outbreak of the SARS virus.
                       SARS is our Best Benchmark
    SARS, though not a pandemic, demonstrated--for the first time 
ever--the profound sensitivity of the modern global economy to a 
contagious, spreading, infectious disease.

    The SARS virus infected only 8,000, and killed just 774 (remember 
the annual seasonal flu kills 30,000 in America every year). BUT what 
we learned was that the global reaction to this newly emerged virus was 
disproportionately greater than the actual virulence of the disease. 
\2\
---------------------------------------------------------------------------
    \2\ Economic Risks Associated with an Influenza Epidemic, Bio-Era.

    From an economic standpoint, SARS taught us that when a modern 
---------------------------------------------------------------------------
pandemic emerges, it will generate two waves of reaction.

    The first economic wave leads to the INDIRECT costs to the economy. 
It will be propelled by fear, confusion and misunderstanding, and a 
lack of confidence in the authorities' ability to respond.

      In the early stages of the SARS outbreak, fear and 
uncertainty led to a dramatic 30-80 percent decline in tourism in East 
Asia in the spring of 2003. GDP fell by an astounding 2 percent in the 
second quarter.

      In Hong Kong, airline passenger arrivals dropped by two-
thirds in April 2003. (as compared to the month before). Retail sales 
fell 8.5 percent for the quarter.

      Foreign direct investment in Asia plummeted.

      And in Canada--where fewer than 500 people were 
infected--the country suffered more than $1 billion in economic losses. 
\3\
---------------------------------------------------------------------------
    \3\ Economic Risks Associated with an Influenza Epidemic, Bio-Era.

    The second economic wave is caused by the DIRECT impact of the 
disease. It represents the hit the economy takes from hospitalizations, 
deaths, lost productivity, and a consequent slowdown in the flow of 
goods and services. In SARS, these DIRECT economic losses--from the 
medical treatment costs and lost productivity--accounted for only 1-2 
percent of the $30-50 billion in total damages. \4\
---------------------------------------------------------------------------
    \4\ Economic Risks Associated with an Influenza Epidemic, Bio-Era.

    SARS taught us that the indirect impacts--from fear, 
misunderstanding, and a lack of confidence in a community's (or a 
nation's) ability to respond--must be addressed when forecasting the 
economic impact of a pandemic.
                               CDC Study
    ``What current economic studies have looked at the impact of a 
modern avian pandemic on the US economy?''

    The data are very limited.

    The most cited--and until today--the most recent study is the 1999 
report by the CDC (Centers for Disease Control and Prevention). The 
study, however,--conducted 4 years before the SARS outbreak--was 
incomplete. It measured only the DIRECT medical and health costs to the 
economy: hospitalizations, outpatient visits, and deaths.

    Assuming an attack rate of 15-35 percent, the CDC predicted that:

          38-89 million people would become clinically ill;
          18-42 million would require outpatient care;
          314,000-734,000 people would be hospitalized; and
          89,000-207,000 people would die.
          Their conclusion: The estimated cost to the U.S. 
        economy would be a 1 to 2 percent drop in GDP ($71-$166 billion 
        loss in 1995 dollars).
                       Projected Economic Effects
    But that's just the DIRECT costs.

    ``What would the TOTAL economic impact be?

    To shed light on that answer, I asked my economic advisers, the 
Congressional Budget Office, to provide a comprehensive analysis of the 
economic impact of a pandemic on the U.S. economy.

    Our CBO study looked at two scenarios--a severe pandemic (much like 
the 1918 pandemic) and a mild pandemic. For a severe scenario, the CBO 
assumed a 2.5 percent case fatality rate, and for a mild scenario they 
assumed a 0.1 percent case fatality rate.

    I will focus my remarks on the severe scenario:

          30 percent of the population is infected (90 million 
        Americans)
          2 million people die.

    CBO assumed that:

          The pandemic would last for 3 months.
          And 30 percent of the workforce would become ill and 
        miss 3 weeks of work

    The supply side economic impacts would include:

          A shrinking of the labor force due to illness and the 
        death of 1 million labor force participants;
          A disruption of the supply chain due to shutdowns in 
        transportation; and
          A shortage of health care personnel and quality 
        medical care for flu-and non flu-related illnesses.

    The supply side impacts can be roughly correlated to direct 
losses--from lost productivity, illness, and death.

    CBO concluded that these supply side impacts would cause the 
Nation's GDP to decline by a full 3 percent in the year the pandemic 
occurs.

    And then there is the demand side of the equation.

    The impacts to demand would also be astounding:

          Voluntary quarantining would reduce turnout at 
        restaurants, shopping malls, sporting events, churches and 
        schools.

          Demand would fall by 80 percent in entertainment, 
        arts, recreation, restaurants, and lodging (for 3 months).

          Retail trade would fall by 25 percent.

          The demand for medical and hospital services would 
        surge.

          And, a fear of travel, coupled with government-
        imposed restrictions, would lead to a dramatic decline in 
        domestic and international travel.

    These demand-side impacts can be roughly characterized as indirect 
economic losses, (and they reflect the public's fear, misunderstanding, 
and lack of confidence in authority). CBO concluded that these indirect 
losses would cause the Nation's economy to fall by an additional 2 
percent!

    Thus, together, the supply and demand impacts would result in a 5 
percent reduction in GDP.

    This is a $675 billion hit (in 2006 dollars) to the U.S. economy.

    These are huge numbers. This scenario suggests that a severe 
influenza pandemic would have an impact on the U.S. economy that is 
slightly larger than the typical recession experienced since World War 
II. On average those recessions lowered real GDP 4.7 percent.

    (The CBO study also reports results for a milder pandemic of the 
1957 and 1968 variety. The analysis found that the impact on the 
economy would be a 1.5 percent drop in GDP--1 percent on the supply 
side and 0.5 percent on the demand side.)

    Similar to what the SARS experience brought to light, the CBO 
scenarios suggest that fear, misunderstanding, and a lack of confidence 
and trust in authority may have almost as much impact on the economy as 
the direct toll of sickness and death.
                       Public Health Prescription
    A $675 billion hit to the economy is--without question--a grim 
prognosis. But our hands are not tied. In fact, the policy implications 
become crystal clear. By immediately outlining and implementing a 
specific policy prescription, we can minimize not only the direct 
economic effects of a pandemic, but perhaps more significant, greatly 
reduce the costly indirect effects of panic, fear and paralysis.

    There are 6 steps we must take.

    1. Communication

    Number #1 is communicating with the public.

    To allay irrational fear, communication must be the bedrock of 
every public policy response. Communication--of accurate, reliable, 
consistent information--isn't an option--it is the antidote--the 
vaccine for irrational fear. (Think Katrina.)

    Failing to effectively communicate with the public--both before and 
during the pandemic--would be analogous to having a fire escape plan 
for your home, but neglecting to share the plan with your family. You 
don't want your family jumping out the window when there's a ladder 
under the bed. To minimize losses, you not only create an emergency 
plan, you tell people about it--again and again and again..

    Prior to the pandemic--today--we must organize a communications 
structure with representatives from public health, law enforcement, 
military, and government to serve as the liaison to the public. It must 
be grounded in trust and reliability. During an outbreak, the 
communications structure should update the public every 6-8 hours on 
what they need to know--educating them on symptoms, cases, deaths, 
outbreak locations, and when and where to find care.

    2. Surveillance

    Second is surveillance. Remember the forest fire? We must stomp on 
the sparks before they ignite. The sooner we detect, identify and 
contain avian flu--in animals and in humans--the better the economic 
prognosis will be. That's why we need a real-time international threat 
detection system. And that's why I've proposed $1 billion to build it. 
By developing rapid testing technology, by training more 
epidemiologists, by enhancing our global partnerships, and by helping 
developing nations compensate farmers for livestock culled we can 
contain the flames before they spread.

    3. Antiviral Agents

    Third are antiviral agents. Antiviral agents (and believe it or not 
there are only two) are the only front-line therapeutic tool we 
currently have to treat the avian flu, and slow its spread. But the bad 
news is, our current supply is inadequate. Today we have 4.3 million 
courses of Tamiflu stockpiled. That's enough to treat less than 2 
percent of the U.S. population. We must increase that number to provide 
Tamiflu for at least 25 percent of the population. A five-day course of 
Tamiflu for 75 million Americans would cost approximately $1.35 
billion--a tiny fraction of the economic impact of a full-blown 
pandemic.

    4. Vaccines

    Vaccines are our best line of defense--for prevention. Yet, 
unfortunately, until we identify the strain--which we can do only when 
sustained human-to-human transmission occurs--we cannot begin to 
produce a targeted, fully effective vaccine. With our current grossly 
inadequate vaccine manufacturing capacity, it could take as long as a 
whole year to achieve ``bug to drug''--that's the window of time 
between first identifying the specific strain and manufacturing a 
vaccine available for distribution. In a time of pandemic, that's an 
unacceptable wait.

    We have a dangerously inadequate vaccine manufacturing base in this 
country. Why? Bottom-line: there's so little profit and so much 
uncertainly in vaccine manufacturing today.

    30 years ago there were 24 vaccine manufacturers. Today there are 
only 5 . . . and only 1 on U.S. soil (Sanofi Pasteur).

    In the United States we have 18,000 (not millions) doses of a test 
vaccine stockpiled, and 22 million more on order--enough to treat 11 
million people--clearly far less than we need.

    How do we grow our manufacturing base?

          We can immediately begin by increasing the annual 
        market for the seasonal flu vaccine. The most we've ever sold 
        in a year is 83 million doses, but by recommending that a 
        larger percentage of the population receive the annual vaccine, 
        we can increase the demand for vaccines and incentivize 
        manufacturers to enter the market.

          We should target tax credits to increase 
        manufacturing capacity, streamline regulations, and offer 
        balanced, sensible liability protection for manufacturers to 
        make these life-saving emergency medicines.

          Together these will lay the groundwork for a quicker 
        ``bug-to-drug'' timeframe.

    5. Research and Development

    5th is research and development.

    Vaccines and antivirals our best tools for the present. But 
research is our best hope for the future. We must harness the best 
minds in academia, and in the public and private sectors. We need to 
bring them together to form a ``Manhattan Project for the 21st 
Century'' which can help us better defend against naturally occurring, 
accidental, and intentional threats--including infectious diseases.

    One example is targeted research for a cell-based flu vaccine. By 
investing in cell-based manufacturing technology, rather than relying 
on antiquated egg-based technology, the window for bug to drug can be 
cut from a year to less than 6 months. With tens of thousands of people 
dying every week, every moment counts. (When tens of thousands of 
people are dying every week, every moment will count . . . ?)

    6. Stockpiling & Surge Capacity

    6th, we need to stockpile and prepare for surge capacity.

    If identification and vaccine manufacture represents the ``bug-to-
drug'' portion of the equation, stockpiling of medicine and surge 
capacity represents the ``drug-to-person'' side--that is, to respond 
with medical treatment.

    Our current health infrastructure simply and unequivocally lacks 
the capacity to respond effectively to a severe pandemic. We don't have 
the number of hospital beds, ventilators, health care personnel, 
morticians, vaccines, antivirals, or communication networks we need. 
All would be overwhelmed.

    Being prepared means training first responders, and ensuring a 
civilian volunteer corps to step in and help handle the surge. It means 
allocating adequate surge facilities--vaccinationsites, treatment 
centers, laboratories, and morgues. Has your community done so?

    Our goal should be building a stockpile of antiviral agents for 75 
million people, and putting in place a specific plan to deliver them. 
As soon as an effective vaccine is available, we must begin 
stockpiling, with the objective of having 300 million vaccinations--
enough for every American.
                               Conclusion
    We know that a pandemic influenza is no longer a question of if, 
when.

    While there is no way to predict when an avian pandemic will occur, 
what we CAN predict, what we DO know, is the cost of being under-
prepared.

    The study I report on today sends a strong message.

    A $675 billion potential hit to our economy--almost half of which 
is brought on by factors which CAN be eliminated by planning--gives us 
every reason to act now with a prescription, and immediately implement 
the course of action. Now is the time to act.

    The six-point prescription is simple--communication, surveillance, 
antivirals, vaccines, research, stockpile/surge capacity. We have the 
intellect, the ingenuity, the tools, the knowledge to minimize the 
blow.

    Science and technology afford us the power to allay the direct 
effects. Sound public policy--grounded in communication and 
information--renders us the ability to ease the indirect effects.

    My duty as an elected official, and as a doctor, is to ensure that 
we begin filling that prescription today. Our economy, our Country, our 
lives depend on it.
                                 ______
                                 
    [Whereupon, at 12:39 p.m., the hearing was adjourned.]

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