[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.
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