[Congressional Record Volume 166, Number 127 (Monday, July 20, 2020)]
[Senate]
[Pages S4267-S4270]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. ALEXANDER:
  S. 4231. A bill to strengthen and sustain on-shore manufacturing 
capacity and State stockpiles, and to improve the Strategic National 
Stockpile; to the Committee on Health, Education, Labor, and Pensions.
  Mr. ALEXANDER. Mr. President, our great country has developed a 
dangerous habit when it comes to pandemics. Public health experts call 
it panic, neglect, panic.
  In 2007, after the emergence of the Asian flu, former Utah Governor 
Mike Leavitt, who was then the Secretary of Health and Human Services, 
put it this way:

       Everything we do before a pandemic seems alarmist. 
     Everything we do after a pandemic will seem inadequate. This 
     is the dilemma we face, but it should not stop us from doing 
     what we can to prepare.

  That was Governor Mike Leavitt.
  Fifteen years ago, then-majority leader of the U.S. Senate, Dr. Bill 
Frist, told me and told our committee--he made 20 speeches predicting 
this--that a viral pandemic was no longer a question of if but a 
question of

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when. Now, this is in the 2005-2006 era, 15 years ago.
  He recommended then, Dr. Frist did, what he called a six-point public 
health prescription to minimize the blow: communication, surveillance, 
antivirals, vaccines, research, stockpile/surge capacity.
  Four Presidents of the United States and several Congresses have done 
some of what needed to be done to prepare for pandemics but not enough 
of it. There is substantial agreement on all sides about what to do. 
There is even more agreement that, if we wait until this pandemic is 
over to do it, we will fall into the familiar cycle of panic, neglect, 
panic.
  So the obvious thing for this Congress to do now, this month, while 
we are in the middle of a pandemic, while we have our eye on the ball, 
before we lose our focus, while we are spending $4 trillion or more 
mostly to repair the damage caused by this pandemic, is that we should 
authorize and spend the few billions that it takes to be prepared for 
the next pandemic.
  That is why I am introducing today the Preparing for the Next 
Pandemic Act, and that would take three of the most obvious steps about 
which there is near universal agreement: One, make certain that we have 
and maintain sufficient manufacturing capacity within the United States 
to produce tests, treatments, and vaccines so that we don't have to 
rely on manufacturing plants in China and India or any foreign country.
  Now, how difficult is that to decide? Do we really want our vaccines 
made in China or India or any other foreign country? So shouldn't we do 
something now to make sure that--for the next pandemic as well as this 
one--we produce them here?
  Two, make sure that Federal and State stockpiles have sufficient 
protective equipment--masks, gowns--ventilators, and other absolutely 
essential supplies so that we don't run out during this pandemic or the 
next one. Now, how controversial could that be? Do we really want to 
run out of masks and protective equipment in the next pandemic or in 
what remains of this one?
  Three, create more authority for the Federal Government to work with 
private companies to maintain more supplies and manufacturing capacity 
for products that are needed during a public health emergency.
  We have the strongest, best, most creative private sector in the 
world. Why would we not want our government working with it as much as 
it possibly could to save our lives during this pandemic and the next 
pandemic?
  The act also does the one thing that all of the experts with whom we 
have talked say is essential: Make sure there is a steady stream of 
money for the next 10 years so there is no lapse in preparedness. I 
would propose that we do this with 10 years of advance appropriations; 
in other words, that we appropriate this year $15 billion and spend it 
over 10 years--that is $1.5 billion a year--so Congress will be able to 
continue its oversight and make certain that our manufacturing plants 
onshore are kept up to date and that State stockpiles in Alaska, 
Tennessee, and every State and the Federal stockpile are not depleted 
during tough budget times, which we know will surely come, just as 
surely as we know the next pandemic will come.
  On June 9, I released a white paper on steps I thought Congress 
should take before the end of the year in order to get ready for the 
next pandemic. I am not a medical expert. So the main purpose of my 
white paper, as chair of the Senate's Health Committee, was to elicit 
recommendations to Congress from the experts that we could consider and 
act on this year. We asked the experts to get their ideas in by June 
26.
  I asked for recommendations in five areas:
  No. 1, tests, treatments, and vaccines; how do we accelerate research 
and development?
  No. 2, disease surveillance; expand our ability to detect, identify, 
model, and track emerging infectious diseases.
  No. 3, stockpiles, distribution, and surges; rebuild and maintain the 
Federal and State stockpiles and improve the medical supply surge 
capacity and distribution; in other words, make sure we have masks and 
gowns and ventilators so the hospitals are ready if something happens.
  No. 4, public health capabilities; improve State and local capacity 
to respond. Most of our public health is taken care of not here but by 
our State and local public health departments.
  Finally, who is on the flagpole? That is improving coordination of 
Federal agencies during a public health emergency.
  Our committee, the Senate's Health Committee, received 350 responses 
from leading public health experts around the country. They had many 
recommendations for short-term and long-term proposals to address 
future pandemics. As my staff and I reviewed these proposals and other 
feedback, I asked us to focus on targeted ideas that would generate 
broad bipartisan consensus and help address some of the most pressing 
issues that we are facing today.
  That led us to three strategic areas: One, sustaining onshore 
manufacturing--22 responses mentioned that. Two, creating and 
sustaining the State stockpiles--23 mentioned that. Improving the 
Federal stockpile--24 mentioned that.
  These are recommendations from public health experts and bipartisan 
leaders who have convened the experts. Some of those from whom we heard 
included Dr. Frist; Governor Ridge, who is cochair of the Bipartisan 
Commission on Biodefense; former Senator Joe Lieberman, cochair of that 
same commission; Dr. Julie Gerberding, former Director for the Centers 
for Disease Control and Prevention; Andy Slavitt, who during the Obama 
administration was the Acting Administrator of the Centers for Medicare 
and Medicaid Services. They all said basically the same thing when it 
came to these three priorities.
  So I introduced today the Preparing for the Next Pandemic Act in 
three parts: One, onshore manufacturing, which provides new, sustained 
funding--$5 billion over 10 years, half a billion a year--to maintain 
sufficient onshore manufacturing for tests, treatments, and vaccines so 
that, when a new virus emerges, we have a facility in this country 
ready to manufacture these products as quickly as possible.
  Two, State stockpiles, which provides new, sustained funding--$10 
billion over 10 years; that is $1 billion a year--so States can create 
and maintain their own stockpiles of supplies, like masks and 
ventilators, with help from the Federal Government.
  Now, this would be done with some restrictions because what really 
happened before was that a lot of the States and some of the hospitals, 
because they had budget shortages, said: Well, we can deplete our 
stockpiles and save some money. So they saved some money, but when the 
next pandemic arrived, we weren't ready, the stockpile wasn't full, and 
people suffered because of that.
  Finally, Federal stockpiles. This legislation improves the Federal 
Strategic National Stockpile by allowing the Federal Government to work 
with private companies to maintain additional supplies and 
manufacturing capacity so we are even better prepared for the next 
pandemic.
  Now, there is more to do to be ready for any future pandemic, but 
these are three steps that we ought to do right now, this month, as 
part of whatever COVID-19 phase 4 legislation we can agree upon.
  In our Senate Health Committee hearing on June 23, this is what 
former Senate Majority Leader Dr. Bill Frist had to say about the need 
for sustained funding to better prepare for the next pandemic:
  We do have to keep a revenue stream out there, Dr. Frist said, that 
is dependable, that is sustainable, that is long-term, and that is 
flexible. What we are really dealing with is a rare but certain event, 
said Dr. Frist, and the rarity is hard for Congress to deal with 
because of the attention span of Congress, and that is where it is 
important to have timelines that are 10 or 15 years out.
  Markets tend to look day to day, said Dr. Frist. Therefore, this 
means we are going to have to have some sort of public funding that 
would guarantee a market over that 10-year or 15-year period when that 
certain event, that certain pandemic, will occur.
  Now, there is precedent for what I am proposing today. In 2003, 
Senator Judd Gregg of New Hampshire--in fact, he

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used to stand at this desk and make excited and well informed speeches, 
and I used to sit right there and listen to him, and he was one of our 
best U.S. Senators--was chairman of the same Health Committee that I am 
chairman of today. He then recognized, in 2003, the need for a clear, 
long-term commitment from the Federal Government to prepare for public 
health emergencies like COVID-19.
  That year, Congress passed what we called Project Bioshield with the 
leadership of Senator Gregg, Congressman Hal Rogers, Senator Cochran of 
Mississippi, and others. The legislation provided $5 billion in advance 
appropriations to be used over the next 10 years to buy treatments and 
vaccines for threats like anthrax and smallpox.
  Reflecting on that experience in an editorial earlier this year, 
Senator Gregg wrote: ``In this instance, Congress actually anticipated 
a serious issue and began addressing it effectively.''
  ``Congress actually anticipated a serious issue and began addressing 
it effectively.'' Well, why doesn't Congress do that again? If it 
worked before, why don't we do it again? Why don't we make sure that 
the next time we have a pandemic, our manufacturing plants aren't in 
China or India? We can do that with a very modest amount of money, 
compared to the trillions of dollars that we are talking about for 
other things.
  At our June 23 hearing, speaking about Federal efforts to build 
manufacturing capacity to respond to a pandemic flu, Governor Leavitt 
said: ``What I think we did not do adequately as a country, over the 
course of time, is maintain those manufacturing plants in a way that 
they were warm and could be stood up quickly.''
  In other words, we have had this idea before. We supported building 
new manufacturing plants, but we lost interest in it--panic, neglect, 
panic. And they weren't warm, said Governor Leavitt, when the time came 
that we needed them.
  Regarding stockpiles, Dr. Frist said, we need ``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.'' That is what Dr. Frist said 
at our hearing. And he said it 15 years ago.
  Former Director of the Centers for Disease Control and Prevention, 
Dr. Judy Gerberding, said at our hearing:

       In the face of an unprecedented public health crisis like 
     the coronavirus, we have seen the Strategic National 
     Stockpile deliver some promising innovations but at the same 
     time discovered areas where there is room for improvement. . 
     . . The COVID-19 pandemic provides us an opportunity to make 
     pragmatic changes; we must act now to avoid becoming 
     complacent and finding ourselves in the same position when 
     the next pandemic occurs.

  Panic, neglect, panic.
  There is also broad agreement about some additional steps Congress 
needs to take to prepare for the next pandemic, including disease 
surveillance, restoring support for our State and local public health 
systems--Governor Leavitt said they have been seriously underfunded for 
the last 30 or 40 years--and better coordination of pandemic response.
  I don't propose to deal with those three things today, but I do 
intend to keep legislation to better prepare for future pandemics on 
the top of the congressional to-do list until it is done.
  In this internet age, attention spans are short. Even with an event 
as significant as COVID-19, memories fade, and attention moves on 
quickly to the next crisis. That makes it imperative that Congress act 
on needed changes this year in order to better prepare for next 
pandemic, which might be in 20 years or might be next year or next 
month. The only thing we know for certain is that it will come.
  Let us not succumb to the familiar, dangerous habit of panic, 
neglect, panic. At least Congress can take these three steps to keep 
vaccine manufacturing on our shores and stockpiles supplied now while 
the pandemic has our attention, while we have our eye on the ball.
  Mr. President, I ask unanimous consent to have printed in the Record 
a copy of the summary of responses the Health Committee received in 
response to the white paper that I released on June 9
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

Summary of Responses to ``Preparing for the Next Pandemic'' White Paper

                      (By Senator Lamar Alexander)

       On June 9, Chairman Alexander released ``Preparing for the 
     Next Pandemic,'' a white paper with five recommendations to 
     address future pandemics based on lessons learned from COVID-
     19 and the past 20 years of public health preparedness. The 
     main purpose of the white paper was to elicit recommendations 
     and feedback from experts who have studied public health 
     preparedness that Congress could consider and act on this 
     year. The Committee received over 350 responses to specific 
     questions posed by the white paper and more broadly on the 
     topic of public health and medical preparedness and response.


1. Tests, Treatments, and Vaccines--Accelerate Research and Development

       Among those responses focused on accelerating research and 
     development of tests, treatments, and vaccines, respondents 
     recommended leveraging public-private partnerships and 
     tapping into strategic computing reserves, expanding the 
     capacities of the Biomedical Advanced Research and 
     Development Authority (BARDA), and sustaining on-shore 
     manufacturing for high-priority countermeasures, like 
     vaccines and treatments, and other aspects of pharmaceutical 
     manufacturing, such as active pharmaceutical ingredients and 
     fill-finish capacity for bulk drug substances. While the 
     federal government currently has robust programs in these 
     areas, commenters recommended that these programs be 
     bolstered further, better integrated with one another, and 
     improve coordination of priorities across programs, 
     particularly between BARDA and the National Institutes of 
     Health.


2. Disease Surveillance--Expand Ability to Detect, Identify, Model and 
                   Track Emerging Infectious Diseases

       The need for improved emerging infectious disease 
     surveillance was addressed by several commenters. Many 
     stakeholders suggested improving the public health 
     information systems by modernizing current public health data 
     reporting systems and better integrating such systems. 
     Commenters specifically mentioned the public health data 
     systems modernization provisions included in the Lower Health 
     Care Costs Act as a solution to this problem. In addition, 
     many responses included suggestions for how to improve 
     contact tracing capabilities within states. Some experts 
     mentioned investing in improved disease surveillance and 
     leveraging technology or private-public partnerships in order 
     to better detect, identify, and model emerging infectious 
     diseases.


3. Stockpiles Distribution and Surges--Rebuild and Maintain Federal and 
    State Stockpiles and Improve Medical Supply Surge Capacity and 
                              Distribution

       Many commenters discussed the need for improved stockpiling 
     and distribution of medical supplies. General themes covered 
     by commenters on this subject include improved situational 
     awareness and streamlined distribution of medical supplies 
     and countermeasures, such as testing supplies, personal 
     protective equipment, and an eventual COVID-19 vaccine; 
     better oversight of the contents of stockpiles; and improved 
     coordination between federal, state, and local governments. 
     Some commenters discussed their preference for an enhanced 
     federal role in stockpiling and distributing supplies. 
     However, other commenters agreed that increasing stockpiles 
     at the state and local level and in health care facilities 
     would provide more efficient access to supplies during a 
     public health emergency. Commenters who agreed with the 
     concept of state stockpiles highlighted the need for strong 
     coordination between the federal government and the states on 
     stockpile inventories and deployments so that supplies are 
     used as efficiently as possible. Additionally, some 
     commenters pointed out that certain products, like 
     specialized countermeasures for threats like anthrax and 
     smallpox, would not be appropriate to stockpile at the state 
     level. Rather, they said that state stockpiles should focus 
     on products like personal protective equipment and broad-
     spectrum antibiotics, which are typically available through 
     commercial distributors and are useful across responses.


  4. Public Health Capabilities--Improve State and Local Capacity to 
                                Respond

       Many experts and stakeholders addressed the importance of 
     improving public health infrastructure, and recommended 
     additional funding to enhance state and local response 
     capabilities. Specifically, some experts suggested bolstering 
     testing infrastructure, and investing in greater state 
     laboratory and biosafety laboratory capacity. They also 
     highlighted the need for an improved public health workforce 
     by implementing additional preparedness training for health 
     care providers and public health workers. Lastly, commenters 
     suggested making permanent several temporary flexibilities 
     provided during the COVID-19 public health emergency that 
     have expanded access to telehealth services, as well as 
     improving interoperability for electronic health records.

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5. Who is on Flagpole?--Improve Coordination of Federal Agencies During 
                       a Public Health Emergency

       Many commenters also addressed the lack of consistent 
     coordination between the federal government, states, and the 
     private sector and uncertainty over federal leadership during 
     a pandemic. Generally, commenters agreed that the Office of 
     the Assistant Secretary for Preparedness and Response (ASPR) 
     at the U.S. Department of Health and Human Services is the 
     right entity to coordinate the day-to-day operational 
     response to a public health emergency. However, multiple 
     commenters noted that ASPR does not have sufficient authority 
     to direct the activities of other departments and agencies, 
     which is necessary during a whole-of-government response. 
     Additionally, these commenters noted that White House 
     involvement, both during a response and when there is no 
     public health emergency in effect, is necessary to ensuring 
     coordination among departments and agencies and that public 
     health preparedness remains a top priority, even after COVID-
     19. Some commenters recommended reestablishing an office 
     within the National Security Council focused on biodefense to 
     institutionalize this responsibility.


                         6. Additional Comments

       A theme across all responses was a specific need for 
     increased and sustained funding for public health 
     preparedness programs. Over the past several decades, funding 
     for these programs at the federal, state, and local levels 
     has experienced inconsistencies. In areas where funding has 
     occasionally increased, such as for research, development, 
     and procurement of medical countermeasures, these increases 
     have been relatively modest and often not consistent year to 
     year. This variability in funding has led to uncertainty from 
     the private sector and other levels of government that these 
     capabilities will be there when the country needs to respond 
     to a public health threat. Without sustained and reliable 
     funding for these programs, commenters stated that we will 
     not be prepared for the next pandemic.

                          ____________________