[Senate Hearing 118-197]
[From the U.S. Government Publishing Office]
S. Hrg. 118-197
PREPARING FOR THE NEXT
PUBLIC HEALTH EMERGENCY:
REAUTHORIZING THE PANDEMIC
AND ALL-HAZARDS PREPAREDNESS ACT
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HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING THE PREPARING FOR THE NEXT PUBLIC HEALTH EMERGENCY, FOCUSING
ON REAUTHORIZING THE PANDEMIC AND ALL-HAZARDS PREPAREDNESS ACT
__________
MAY 4, 2023
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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
54-475 PDF WASHINGTON : 2024
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
BERNIE SANDERS (I), Vermont, Chairman
PATTY MURRAY, Washington
ROBERT P. CASEY, JR., Pennsylvania BILL CASSIDY, M.D., Louisiana,
TAMMY BALDWIN, Wisconsin Ranking Member
CHRISTOPHER S. MURPHY, Connecticut RAND PAUL, Kentucky
TIM KAINE, Virginia SUSAN M. COLLINS, Maine
MAGGIE HASSAN, New Hampshire LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota MIKE BRAUN, Indiana
BEN RAY LUJAN, New Mexico ROGER MARSHALL, M.D., Kansas
JOHN HICKENLOOPER, Colorado MITT ROMNEY, Utah
ED MARKEY, Massachusetts TOMMY TUBERVILLE, Alabama
MARKWAYNE MULLIN, Oklahoma
TED BUDD, North Carolina
Warren Gunnels, Majority Staff Director
Bill Dauster, Majority Deputy Staff Director
Amanda Lincoln, Minority Staff Director
Danielle Janowski, Minority Deputy Staff Director
C O N T E N T S
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STATEMENTS
THURSDAY, MAY 4, 2023
Page
Committee Members
Sanders, Hon. Bernie, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Cassidy, Hon. Bill, Ranking Member, U.S. Senator from the State
of Louisiana, Opening statement................................ 3
Witnesses--Panel I
O'Connell, Dawn, Assistant Secretary for Preparedness and
Response, Administration for Strategic Preparedness and
Response, United States Department of Health and Human
Services, Washington, DC....................................... 5
Prepared statement........................................... 7
Walensky, Rochelle, M.D., M.P.H., Director, United States Centers
for Disease Control and Prevention, Atlanta, GA................ 9
Prepared statement........................................... 11
Califf, Robert, M.D., Commissioner, United States Food and Drug
Administration, Silver Spring, MD.............................. 16
Prepared statement........................................... 18
Witnesses--Panel II
Ramachandran, Reshma, M.D., M.P.P., M.H.S., Assistant Professor
of Medicine, Yale School of Medicine, New Haven, CT............ 47
Prepared statement........................................... 49
Summary statement............................................ 59
Weissman, Robert, President, Public Citizen, Washington, DC...... 60
Prepared statement........................................... 61
Summary statement............................................ 70
Makary, Martin, M.D., M.P.H., Professor, Johns Hopkins
University, Baltimore, MD...................................... 71
Prepared statement........................................... 73
Summary statement............................................ 90
ADDITIONAL MATERIAL
Sanders, Hon. Bernie:
Letters from Stakeholders groups, Statement for the Record... 97
PREPARING FOR THE NEXT
PUBLIC HEALTH EMERGENCY:
REAUTHORIZING THE PANDEMIC
AND ALL-HAZARDS PREPAREDNESS ACT
----------
Thursday, May 4, 2023
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 1 p.m., in room
430, Dirksen Senate Office Building, Hon. Bernard Sanders,
Chairman of the Committee, presiding.
Present: Senators Sanders [presiding], Murray, Casey,
Baldwin, Murphy, Kaine, Hassan, Hickenlooper, Markey, Cassidy,
Braun, Marshall, Romney, and Budd.
OPENING STATEMENT OF SENATOR SANDERS
The Chair. Okay. Thank you. The Senate Committee on Health,
Education, Labor, and Pensions will come to order.
This afternoon, we are going to hear from two panels. We
are going to hear from on our first panel, Dawn O'Connell, the
Assistant Secretary for Preparedness and Response, Rochelle
Walensky, the Director of the Centers for Disease Control, and
Dr. Robert Califf, the Commissioner of the Food and Drug
Administration.
Our second panel, we are going to be hearing from Dr.
Reshma Ramachandran and we will hear from Robert Weissman, and
Martin Makary. So, we have two very, very important panels. Let
me begin by thanking all of the folks who are on the first
panel. All of us know that the last 3 years have been
unprecedented in our lifetimes. We dealt with the worst public
health crisis in 100 years.
I want to thank all of you under those very difficult
circumstances for the work you have done for the American
people. Today, what our job is, is to take a hard look at where
we are today in terms of preparing, God forbid, for another
pandemic, and the need to reauthorize the Pandemic and All
Hazards Preparedness Act, or PAHPA, later this year.
I want to take this opportunity to acknowledge the previous
leadership on this bill from Senator Murray, who was Chair of
the Committee, and Senator Burr, who was the Ranking Member, as
well as the PAHPA working group that I have helped convene with
Ranking Member Cassidy, which includes Senator Casey and
Senator Romney.
All of those Senators have set aside time for their staff
to meet with mine every week because we all understand how
terribly important the issues are that we are facing in terms
of the possibility of future pandemics.
As everybody here knows, tragically, in the United States,
we lost over 1 million people from COVID. And putting that in
perspective, we lost more people from COVID in the last several
years than we did in World War II.
While cases, deaths, and hospitalizations are all
declining, COVID is still today the leading cause of death in
our Country, with some 250 Americans on average dying every
day. The World Health Organization reports that 7 million
people have died from COVID globally.
But there are experts who think that is--that
underestimates, in fact, the number of people who have died
globally. I think, to be honest, as Americans, we can
understand that every public official tried their best during
COVID.
God knows how hard people worked and what stress they
worked under. But the truth is that we were very, very
unprepared for what hit us 3 years ago. It took a lot longer
for us to effectively respond to that emergency than it should
have.
All of us will remember, all of us will remember that
months after the pandemic erupted, we all saw pictures of
doctors and nurses in overwhelmed hospitals, lacking the
personal protective equipment to keep themselves healthy.
We all remember those images and we remember seeing doctors
and nurses literally using plastic trash bags because they did
not have the personal protective equipment they needed. And we
also know that many, many, many hundreds of medical personnel
died doing their duty, trying to save their fellow Americans.
During that time, we did not have the tests that we needed
to find out who had COVID and who did not. We did not have the
infrastructure we needed to deal with the pandemic. All of us
remember the overwhelmed hospitals and the intensive care units
from one end of this country to the other.
We did not have the vaccines or the treatments that the
American people and people throughout the world desperately
needed. We all recall that we had to shut down our schools, our
businesses, and much of the economy for far too long, causing
millions of Americans not only to lose their jobs, but their
healthcare as well.
In the middle of a pandemic, millions of people actually
lost their healthcare. And here is the scary news, and we have
got to face up to it, really do. And that is maybe the most
important reason for holding this hearing. What scientists are
telling us is that there is a reasonable chance that, God
forbid, that a pandemic as deadly as COVID, COVID-19 could
occur in 10 years.
All of us hope that will not occur, but our job is to make
sure that we are prepared if it does occur. That is what this
hearing is about. That is what this legislation is about. The
scientists have told us that there are now seven viral families
that could cause the next pandemic because they contain viruses
that spread to the respiratory system and can easily spread
from person to person, and our job is to make sure that we are
protecting the American people.
You know, we spend huge amounts of money on the military
because we say, hey, we have got to protect the American
people. You know what? If we want to protect the American
people, we have got to deal with this issue as well.
It means that we must have a capable workforce in place,
not just nurses and doctors, but also public health officials,
our disease detectives, and I think we will hear more about
this in a few minutes, who can tell us where to set up a
vaccination clinic, for example. If there is an outbreak
developing on the West Coast, can we learn about it
immediately, so the rest of the country is alerted, etcetera.
Tragically, during the pandemic, nearly one out of--and
this is incredible, and it impacts not only this hearing but
future hearings. During the pandemic, nearly one out of every
five health care workers quit their jobs and are contemplating
doing so as a result of the enormous stress and burnout that
they have experienced on the job.
Further, we need to have accurate public health data to
know who is getting sick. We need to not only have tests,
vaccines, and treatments available, we have to be able to get
those out to everybody who needs them.
We need to make sure that our medical personnel have the
supplies, the masks, the gowns, the gloves that they need. We
need to have clear communication to the public, something that
has been really very difficult to do. But we need to improve
our communications capability.
We need specially to make sure that we protect the most
vulnerable people in our society, the seniors in nursing homes,
individuals with disabilities, our children, and our infants.
So that is where we are right now. We have experienced a
terrible pandemic. Our hope is that we have learned something
from that and that we will be better prepared as we face an
uncertain future. Senator Cassidy.
OPENING STATEMENT OF SENATOR CASSIDY
Senator Cassidy. Thank you, Chair Sanders. Before
beginning, Director Walensky, I think we all express sympathy
for the family of the CDC employee killed yesterday. It is
always a tragedy, but you represent that family. We feel that
in particular. Today, we are discussing an important
responsibility of the Committee, the reauthorization of the
bipartisan Pandemic and All Hazards Preparedness Act, or PAHPA.
Now, many will focus on the word pandemic, which is
obviously a big part of the discussion, but we need to keep in
mind the wide array of threats that this bill seeks to address,
not just diseases, but natural disasters, attacks, accidents,
other things that could put our Country at risk.
I feel connected to the origins of this bill, although I
was not in Congress at the time. PAHPA was first enacted in
2006, largely to address the failures of the Federal response
following Hurricane Katrina.
Anybody from Louisiana saw firsthand the devastating impact
on a community when governments are ill equipped and ill
prepared to manage a crisis. So PAHPA sought to support states,
local governments, and hospitals so that they would be better
prepared for future emergencies. It established the office of
the Assistant Secretary for Preparedness and Response, or ASPR,
and the Biomedical Advanced Research and Development Authority,
BARDA.
A lot of long things--of course you come up with awkward
sounding acronyms. And it also made improvements to the
Strategic National Stockpile so that vaccines, treatments, and
tests could be easily available during an emergency.
In both 2013 and 2019, Congress acted in a bipartisan way
to reauthorize the bill, and this year, Senators Romney and
Casey are spearheading this work with the Committee. Now, we
don't always agree, but we set politics aside and come together
on reauthorizing PAHPA. We know PAHPA is critical to protecting
the health, safety, and security of us all.
As we saw during the COVID-19 response, the PAHPA framework
is far from perfect. Poor management and maintenance of the
Strategic National Stockpile meant that doctors and nurses were
forced to use expired PPE.
One picture I remember is a huge quantity of masks being
dumped right as the pandemic was starting because they were 2
weeks from being expired. It certainly wasn't a first in, first
out, manage the inventory situation.
I think we can say that in some ways Government hampered
the private sector's ability to quickly launch tests at the
onset of the pandemic, and Government clearly failed
consistently to communicate with the public. Now, that is past.
Let's get better. We made mistakes. We learned some tough
lessons.
Let's work together to make it so that next time it isn't
on the fly that we are figuring it out. Rather there are
systems that we can put into place. Update the playbook and
make sure that whatever we do, is flexible enough to address
the threats beyond just a pandemic. And emphasizing, we need to
look toward a threat to the future, not just prepare for that
one, which is already going by.
Being good stewards of limited taxpayer resources and
better partners with states and the private sector so that we
are all ready and willing to step in when the next public
health threat comes our way.
To accomplish this, the Committee will need to work in a
bipartisan way to enact meaningful policies to make our Country
safer and better prepared, to work toward a consensus. I am
committed to getting this bill done. I thank you for being
here. I look forward to hearing your testimony. And with that,
Mr. Chair, I yield.
The Chair. Thank you, Senator Cassidy. Now we are going to
hear from our witnesses. Our first witness is Ms. Dawn
O'Connell, Assistant Secretary for Preparedness and Response in
the Administration for Strategic Preparedness and Response at
the Department of Health and Human Services. Ms. O'Connell,
thanks very much for being with us.
STATEMENT OF DAWN O'CONNELL, ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, ADMINISTRATION FOR STRATEGIC
PREPAREDNESS AND RESPONSE, UNITED STATES DEPARTMENT OF HEALTH
AND HUMAN SERVICES, WASHINGTON, DC
Ms. O'Connell. Chair Sanders, Ranking Member Cassidy,
distinguished Members of the Committee, it is an honor to
testify before you today about ASPR's ongoing work and the
additional authorities we are seeking in the upcoming PAHPA
Bill.
But first, let me join the Senator in expressing my
condolences for the loss of our CDC colleague. We are very
sorry, Rochelle. Please extend our thoughts and prayers. We are
living in an increasingly interconnected world where diseases
and other threats can travel quickly, unnoticed for days.
We are also experiencing an increase in the frequency and
intensity of natural disasters. As a result, ASPR is working on
more high consequence, no fail missions than ever before. We
are proud to lead so much work on behalf of the country and
want to be sure that we have the authorities we need to
continue to execute that work, with the excellent efficiency
and expertise the American people deserve.
As we move out of the acute phase of the COVID-19 response,
it would be management malpractice for us to look the same and
act the same as we did at the start of the pandemic. I have
taken several important steps in the last few months to
transform our organization and to incorporate lessons learned
from the COVID-19 response. For example, ASPR is now a stand-
alone agency within HHS.
This important change in our departmental status gives me
the independence to build out ASPR's human resources,
acquisitions, and finance infrastructure so it better supports
our unique missions. I also just completed a structural
reorganization that institutionalized important new
capabilities like our stockpile supply chain and domestic
manufacturing work, these capabilities that we built during
COVID and need to keep using moving forward.
Like I also made the Strategic National Stockpile an office
that reports directly to me to increase visibility into and
accountability of this critically important part of the
Nation's preparedness and response apparatus.
With these changes, I have taken the two most
transformational steps available to me to build a better
preparedness and response organization. And now I need your
help to ensure that I have the appropriate authorities to
execute our mission faster and stronger.
With the authorities I am requesting in PAHPA, I am trying
to solve three key problems. The first problem I am trying to
solve is how ASPR can procure more quickly the tools and
supplies the country needs when responding to a bio threat or
disaster. Early in the COVID-19 response, it became clear that
HHS could not procure the products our Country needed at the
speed in which our Country needed them.
As a result, ASPR entered into a memorandum of
understanding with the Department of Defense in which they
agreed to provide acquisition support on our behalf. Using
their unique authorities, DOD executed more than $90 billion in
contracts for us over the 3-years of the acute response.
Our agreement with DOD comes to an end at the end of this
Fiscal Year, which is why I am requesting similar authorities
for ASPR. These include the ability to fund promising
prototypes and then move the successful ones through the
advanced research pipeline without having to re-compete the
contracts, like we do now.
We are also seeking the ability to quickly procure
experimental supplies and important finished products. Each of
these new authorities would allow us to do for ourselves moving
forward what we had to rely on DOD to do for us during COVID.
The second problem I am trying to solve is how ASPR can
continue to invest in the expansion of the domestic industrial
base for key PPE and medical supplies to ensure we are never
again in the position we found ourselves in March 2021, ones
that you both have recognized, when our doctors and nurses did
not have access to the masks, gowns and gloves they needed.
ASPR has used the funds and construction authority given to
us in the COVID supplementals to build new factories nationwide
to produce the PPE and supplies we need in times of emergency.
These investments also provide good paying jobs to many hard
Americans. But once the COVID-19 funds run out, we lose our
construction authority and our ability to continue investing in
similar projects.
That is why I am requesting permanent construction
authority for ASPR. It is important that we have funds and
construction authority to sustain the work we have started and
to expand this work to other parts of the public health supply
chain. The third problem I am trying to solve is how ASPR can
hire staff more quickly to search critical teams during large
response efforts.
In the early days of the COVID-19 response, just as we
relied on DOD for acquisition support, we also relied on FEMA
and the Coast Guard to bolster our response staff. The ability
to hire people quickly and compensate them appropriately for
their long hours and sometimes hazardous work are important
tools missing from ASPR's response toolbox, which is why I am
requesting direct hiring and flexible pay authorities for ASPR.
Direct hiring authority will allow me to quickly scale up
our response efforts so we have enough people when we need them
and pay flexibilities will go a long way toward sustaining our
staff through these dangerous missions and ensuring we do not
lose these seasoned first responders and subject matter experts
to the private sector who pay much more and often require much
less of them.
To solve each of these problems I have just laid out, I
requested important new authorities for ASPR. I look forward to
working with you to solve these important problems and many
others as you draft the new PAHPA Bill. Thank you again for
inviting me to testify today. I look forward to answering your
questions.
[The prepared statement of Ms. O'Connell follows:]
prepared statement of dawn o'connell
Chair Sanders, Ranking Member Cassidy, and distinguished members of
the Committee, it is an honor to testify before you today regarding
areas where additional authorities could strengthen the Administration
for Strategic Preparedness and Response's (ASPR) preparedness and
response capabilities.
ASPR is working on more high-consequence, no-fail missions than
ever before. We are living in an increasingly interconnected world
where diseases and other threats can travel quickly, unnoticed for
days. With infectious disease outbreaks becoming more frequent, we are
also experiencing an increase in the frequency and intensity of public
health threats and natural disasters. To keep up with the evolving
threat landscape, ASPR must remain nimble and ever vigilant while
learning from each response it leads. Following every response, we look
internally at processes and operations and identify where improvements
can be made. These assessments have revealed areas where additional
authorities or modifications to existing authorities would aid our
response and help us play a key role in implementing the National Bio-
defense Strategy, which lays out a coordinated whole-of-government plan
to transform our preparedness for pandemics and deliberate biological
threats.
As we move out of the acute phase of the COVID-19 response, I have
begun looking at our capabilities and evaluating what additional
authorities we need to improve our work going forward. As you may
recall, ASPR had to rely on the Department of Defense (DoD) and DHS/
FEMA for acquisitions authorities and for surge staffing support during
the COVID-19 response--particularly in the early days. With your
support, my goal is to position ASPR (and HHS) to stand on our own
during large-scale response efforts and not need to rely so heavily on
other Departments who have their own missions to run.
Supporting Procurements
Early in the COVID-19 response, it became clear that HHS could not
procure the products our country needed at the speed in which it needed
them. As a result, we entered into a Memorandum of Understanding (MOU)
with DoD in which they agreed to provide assisted acquisitions support
on our behalf. DoD executed more than $90 billion in contracts for us
over the 3-years of the acute response.
DoD's unique authorities allowed it to save critical time when
investing in early stage vaccines, therapies, and tests. DoD could fund
promising prototypes and then move the successful ones through the
advanced research pipeline, without having to recompete the contracts.
This authority was used by DoD to procure five of the six COVID-19
vaccines on behalf of HHS. ASPR's current authorities, on the other
hand, require it to stop and recompete the contracts when they move
into the next phase of development. The authority to award follow-on
production contracts from prototypes without recompeting the
requirements would allow ASPR to move more quickly in the future
without having to stop to negotiate an agreement for DoD's support. In
addition, we know that DoD has its own set of critical national
security responsibilities across this complex threat landscape and may
not always be in a position to assist ASPR in contracting efforts.
Increasing Domestic Manufacturing
Throughout the acute phase of the pandemic response, supply chain
issues emerged as rate-limiting factors again and again. ASPR's
industrial base management and supply chain work was borne out of the
initial supply chain pinches the country experienced in March 2020 when
the whole world needed the exact same supplies at the exact same time
and they were all manufactured elsewhere.
Using emergency supplemental appropriations, ASPR is building a
program to ensure we have personal protective equipment and critical
supplies manufactured in the United States moving forward. COVID-19
supplemental legislation also included language that allowed ASPR to
support the physical construction of domestic manufacturing facilities.
These construction authorities have been used to support the
construction of new factories nationwide for COVID-19 related medical
supplies. Once the COVID-19 funds run out we lose that authority and
the work will stop. Authority for acquisition, construction, or
alteration of non-federally owned facilities would allow ASPR to
sustain the work to onshore and build domestic manufacturing capacity
for critical medicines that will otherwise be produced in China and to
expand this work to other parts of the public health supply chain as
appropriate.
Ensuring the People are in Place to Prepare, Respond, and Recover
Throughout the various responses in 2022--ranging from naturally
occurring events like tornados and hurricanes to infectious diseases,
including Ebola Sudan, COVID-19, and mpox--filling critical workforce
gaps across the organization has been a challenge. Similar to our
reliance on DOD for contracting support, we relied heavily on FEMA and
the Coast Guard to bolster our response staff. Having additional hiring
flexibilities would go a long way toward ensuring that we are able to
quickly scale up our responses when necessary. For example, we are
seeking a permanent extension of the direct hire authority for National
Disaster Medical System (NDMS) personnel. Congress has extended this
authority multiple times as part of appropriations legislation. We are
now seeking to make it a permanent authority. We are also seeking
authorities to allow for some pay flexibilities to ensure we are
recruiting and retraining the right skilled labor force needed for
these high consequence no-fail missions.
Helping States, Localities, Tribes and Territories Augment Their Staff
During an Emergency
In addition to having a strong Federal response workforce at ASPR,
State, local, tribal, and territorial (SLTT) partners have asked us for
additional flexibilities they could use to strengthen their own
responses and better support our efforts.
Our State partners have made it clear that providing liability
coverage to enrolled Medical Reserve Corps (MRC) volunteers would
enhance utilization of the Corps in response and recovery activities.
If liability coverage were extended to MRC volunteers, these
volunteers--most of whom have some medical credentials--could provide
clinical support to local healthcare systems and would serve as
volunteers, reducing the overhead for deployment. In addition to
providing the States' immediate augmentation support on the ground,
this authority would also reduce our need to routinely deploy the more
costly and specialized NDMS teams. ASPR already has an operational
system to verify MRC volunteers' credentials; we are just need the
technical authority to provide the liability coverage to volunteers
under this system. If approved, the MRC volunteers could be deployed as
a Federal asset, similar to NDMS, allowing us to leverage over 300,000
MRC volunteers nationwide for Federal responses such as hurricanes.
Investing in Process Efficiencies
With the designation of ASPR as an Operating Division in July 2022,
ASPR seeks authority to institute a Working Capital Fund (WCF) to
support oversight and management of central costs for the agency. A WCF
is used by many operating divisions to manage enterprise-wide spending
and create transparency across the organization. We began building our
WCF when we were still a staff division using delegated the authorities
attached to the Office of the Secretary. When ASPR became a stand-alone
agency, it was determined that ASPR could no longer use delegated
authority for a WCF but would require direct authorization. Given
ASPR's growth over the last few years, it is important that it have a
WCF fund to provide greater accountability and transparency in its
organization-wide spending.
Hearing From Outside Experts
ASPR is charged with managing the National Advisory Committees
focused on needs and considerations for at-risk individuals during
times of disasters. These include seniors, children, and those with
disabilities. The committees provide valuable insight and perspective
into the needs and challenges of these populations in times of
emergency, and they help inform the work that we do. We value the work
of these committees and are seeking their reauthorization.
Conclusion
At ASPR, we have learned a lot since our last reauthorization, and
it is imperative that we apply those lessons to this current effort. We
know that it is not a matter of whether we will have another public
health emergency or disaster, but a matter of when. With your support,
we can be ready. All of the proposals submitted to Congress in the
Fiscal Year 2024 President's Budget for consideration in the next
iteration of the Pandemic and All-Hazards Preparedness Act will
strengthen ASPR and also enhance national security and bio-defense
efforts. If authorized, these proposals will ensure ASPR can execute
contracts quickly and efficiently to move the needle forward in
preparing for future infectious disease threats. ASPR will be
positioned to increase domestic manufacturing. We will be in a place
where states, locals, tribes, and territories have additional
flexibilities and options to augment public health and medical needs
before, during, and after disaster. and last, we will have greater
process efficiencies and programs to aid in internal management of
resources.
Thank you again for inviting me to testify today to highlight where
additional authorities would aid ASPR in responding to future public
health emergencies. I look forward to answering your questions and
working with you and your staff as we move forward in the 118th
Congress.
______
The Chair. Thank you very much. Our next witness is Dr.
Rochelle Walensky, Director of the Centers for Disease Control
and Prevention. Dr. Walensky.
STATEMENT OF ROCHELLE WALENSKY, M.D., M.P.H., DIRECTOR, UNITED
STATES CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Walensky. Chair Sanders, Ranking Member Cassidy, and
distinguished Members of the Committee, it is an honor to be
here with you today. Before I begin, I would like to take a
moment to acknowledge that our CDC family suffered a tremendous
loss yesterday with the death of Amy Saint-Pierre, who was
killed in the shooting in midtown Atlanta.
Amy was a valued member of our team at the Division of
Reproductive Health, where she worked every day to save lives
of mothers and infants. Our hearts are with her, her family,
friends, and our colleagues as they remember her and grieve
this tragic loss.
In addition to the work that people like Amy do every day
to fight disease and support communities, I am here to talk
about how CDC works 24/7 to protect America, and I want to
thank you for this important opportunity.
CDC has led public health responses since our founding in
1946, providing expertise, resources, and workforce support to
states, tribes, local communities, and territories on the most
pressing public health threats in the United States and across
the globe.
No matter the outbreak, H1N1, Zika, Ebola, COVID-19, Polio,
MPox, or Marburg, CDC has been there offering world class
assistance. Alarmingly, these infectious disease threats have
been emerging at an increased pace and are increasingly
complex.
These diseases don't respect national or state borders, and
the increased frequency of outbreaks means that we should not
be asking if we will face another serious public health threat,
but when.
For many, life has returned to normal after 3 years of
COVID-19. Public health agencies like CDC and your state and
local health departments' mission is to continue to remain
response ready to protect Americans from any resolving or
emerging health threat.
We do this by actively supporting the core capabilities of
public health, including state-of-the-art laboratories, a
diverse public health workforce, culturally competent to
reflect communities, world class data and analytics, rapid
response to outbreaks at their source, and strong domestic and
global preparedness.
We are enhancing these capacities through an all-agency
review, CDC moving forward. We are committed to addressing the
lessons learned from COVID-19, increasing accountability, and
improving how we deliver information to Americans.
The approaching end of the public health emergency once
again reminds us that policy changes and funding are essential
to the readiness of future bio threats. CDC will continue to
closely monitor COVID-19 and provide the information to which
we have access.
After 3 years of the pandemic and 3 months to prepare for
the end of the PHE, we have worked hard to sustain the data to
understand what is happening with the virus in America. But the
end of the PHE means the CDC will no longer be able to collect
data and share information many Americans have come to expect.
As CDC often does, we will adapt to limitations and utilize
tried and true systems to monitor other respiratory diseases to
keep our eye on COVID-19. In some cases, CDC will rely on data
that we have demonstrated are a reasonable surrogate. But there
are data we will no longer have available because they will no
longer be submitted to us.
For example, certain data for a national picture of health
disparities, both for race and ethnicity, and along urban and
rural lines. We will make do. However, this should worry us
all, primarily because what it says about the visibility we
will have into the next outbreak. We will be back to square
one, having to build and negotiate surveillance capacity while
we fight a pathogen.
I know the Members of this Committee are interested in
advancing policy to close the gaps in our public health
response to be better prepared for what comes next. For CDC,
this means supporting the public health workforce by allowing
us to recruit the best of the best through improvements and
student loan reimbursement authority.
We must also be able to surge staff when needed with simple
changes to direct hire legislation and sufficient budget
flexibility, so bureaucracy doesn't stand in the way when an
emerging threat arises.
This also means maintaining the infrastructure our Nation
stood up during COVID-19 to administer vaccines effectively and
quickly. The Vaccines for Adults Program proposal not only
provides Americans access to 14 approved and routinely
recommended lifesaving vaccines, but also supports a response
ready capability that we will lose without continued
investment.
Finally, this means modernizing data policy to support
access to better quality, standardized, and timely data so
individuals and families can make informed decisions about
their health, and policymakers can better target resources to
threats before they become public health emergencies.
The United States should have the most advanced and capable
agency in the world when it comes to disease detection,
tracking, and forecasting. It will take a more modernized,
nimble, and collaborative CDC, and it will also take
partnership with Congress to fully turn CDC into a response
ready agency.
I am committed to working with you to better protect
Americans and our national security. Thank you, and I look
forward to your questions.
[The prepared statement of Dr. Walensky follows:]
prepared statement of rochelle walensky
Chairman Sanders, Ranking Member Cassidy, and distinguished members
of the Committee, it is an honor to appear before you today to discuss
the Pandemic and All-Hazards Preparedness Act reauthorization, and the
Centers for Disease Control and Prevention's (CDC) role in preparedness
and response to public health emergencies.
Americans and people around the world rely on CDC to detect and
respond to emerging public health threats both foreign and domestic.
This requires CDC's world-leading experts to anticipate, prevent,
research, track, and mitigate threats to our Nation's health security.
For decades, CDC has been on the front lines of public health
response, providing assistance to states, tribes, local communities,
and territories on the most pressing infectious disease outbreaks
within the United States and across the globe, including H1N1, Ebola,
Zika, seasonal influenza, COVID-19, polio, mpox, and Marburg.
While the COVID-19 pandemic was the most serious public health
event in over 100 years, the increased frequency of infectious disease
outbreaks should highlight the sobering reality that we should not be
asking if we will face another serious public health threat, but when.
The health security of the United States depends on the strength of
the public health system, and CDC must be ready to play a leading role
in any future public health emergency, whether a global pandemic or a
natural disaster. CDC will innovate and improve on each response, while
building on our existing expertise and successes. This means a CDC that
supports the following activities:
A workforce across the public health system--CDC and
our state, tribal, local, and territorial (STLT) partners--that
is trained and ready to respond to large, sustained, and
concurrent public health emergencies and biosecurity threats.
Strategic partnerships with the private sector to
drive innovation and adoption of data, laboratory systems, and
technology for multiplexed and pathogen agnostic early warning
and real-time monitoring of biological threats.
Timely and quality data and making data and science
quickly available for Federal, state, and local decisionmakers
to translate findings into policy and guidance for communities.
Integrated early warning systems with global public
health partners to expand the perimeter of and advance the
technologies for multiplexed and pathogen agnostic detection of
potential public health threats in an economy that relies on
the movement of people and products across international
borders.
Transparent communication with partners and the
American people so that CDC's mission, methods, and
recommendations are clear and well understood by everyone.
These activities and the vision for a well-prepared public health
system must be built on a foundation of core capabilities in public
health including: state-of-the-art laboratories, a diverse public
health workforce that reflects the communities it serves, world-class
interoperable data & analytics, rapid response to outbreaks at their
source, and strong global capacity & domestic preparedness.
State of the Art Laboratories
CDC's unique laboratory expertise lies in its ability to detect and
track a broad range of microbes and respond to disease threats from
many different pathogens--both well-known infectious diseases and rare
or unknown, but equally dangerous threats--and in its ability to work
with and support state and local public health partners as they respond
to these threats.
For example, the Laboratory Response Network (LRN), a network of
thousands of trained labs across the country was founded in 1999 as a
partnership between CDC, the Federal Bureau of Investigation, and the
Association of Public Health Laboratories to support the U.S. detection
of biological threats and emerging infectious diseases quickly and
accurately anywhere in the United States.
Previous investments in domestic preparedness for smallpox through
the LRN provided immediate testing capacity across the United States
for mpox. In fact, the first case was detected in the Massachusetts
Public Health LRN Laboratory using a PCR test developed by CDC and
authorized by the Food and Drug Administration (FDA) in 2018. The LRN,
in partnership with CDC's high containment laboratory, played a
significant role in slowing the outbreak of mpox in the United States,
from a peak of 600 cases a day in August to fewer than 10 cases a week
since January 21, 2023.
In addition to these efforts in CDC laboratories, CDC's Advanced
Molecular Detection (AMD) program has been working with state and local
health departments over several years to bring genomic sequencing of
pathogens into routine use. The AMD program worked with state and local
partners to rapidly scale up COVID-19 sequencing in U.S. public health
labs, increasing from 23 labs generating around 17,000 COVID-19
sequences during 2020, to 68 labs generating over 690,000 COVID-19
sequences during 2022.
Efforts like these have also provided an opportunity for CDC to
accelerate innovation and partnerships in new ways, harnessing the
collective efforts of public health and academic expertise to advance
the application of genomics in combating outbreaks including through
expanding use of methods such as wastewater surveillance. Two promising
partnerships involve the Pathogen Genomics Centers of Excellence
(PGCoE) network and the Sequencing for Public Health Emergency
Response, Epidemiology, and Surveillance (SPHERES) consortium.
Beginning with COVID-19, the SPHERES consortium engaged academic and
private sector sequencing laboratories to help us monitor changes in
the virus, gain important insights to support contact tracing efforts,
provide crucial information to aid in identifying diagnostic and
therapeutic targets, and advance public health research in the areas
about transmission dynamics, host response, and evolution of the virus.
The Centers of Excellence will extend these partnerships and help CDC
leverage state-of-the-art laboratory technology and public health
innovation to continue to advance genomic surveillance.
Public Health Workforce
State, tribal, local, and territorial health departments are the
foundation of the public health system. The infrastructure needs in
these health departments are substantial: many public health agencies
lack resources for foundational capacities such as operations,
communications, and emergency preparedness, which are the building
blocks of any future response. To be ready for any biothreat, the
public health system in the United States requires a robust and nimble
public health infrastructure and a skilled public health workforce
ready to respond to emergencies. According to a recent report by the
DeBeaumont Foundation \1\, state and local health departments need to
hire a minimum of 80,000 more workers--an increase of nearly 80
percent--to provide minimum public health services.
---------------------------------------------------------------------------
\1\ Staffing-Up-FINAL.pdf (debeaumont.org) Workforce Levels Needed
to Provide Basic Public Health Services for All Americans. Research
Brief--October 2021
CDC has made substantial one-time investments to address these
longstanding needs, including $2 billion for immediate emergency crisis
response and $3 billion in foundational workforce and infrastructure.
These funds not only provide critical support for school-based health
programs, public health professional development, and acquisition of
important technological upgrades, but they allow state and local
jurisdictions to build their workforce to best serve their communities.
---------------------------------------------------------------------------
For example:
The Ohio Department of Health was able to provide
surge staffing during the East Palestine train derailment
response, including epidemiologists and other key personnel
The Vermont Department of Health is retaining staff
hired during the COVID-19 response
The Shelby County, Tennessee Department of Health is
supporting 13 employees pursuing public health degrees at the
University of Memphis
These investments are a good start, but public health needs remain
deep and long-term. As requested in the fiscal year 2024 Budget,
sustained investment in our Nation's public health departments and
infrastructure must remain an ongoing priority.
Internally, CDC is focused on internal transformation so staff can
transition from their daily positions to emergency response rapidly and
effectively when needed. In December 2022, CDC launched the new CDC
Ready Responder Program with a vision to grow and strengthen a diverse
workforce of pre-qualified, trained, and available responders to
establish and sustain public health emergency responses regardless of
frequency, size, or complexity.
World-class Interoperable Data & Analytics
Additionally, public health entities must be able to rapidly share
data within and among jurisdictions, and with CDC, to enable local
leaders to make the best decisions for their communities and save lives
in dynamic situations. We've made incredible progress from the pre-
COVID-19 era. The Response Ready Enterprise Data Integration platform
(RREDI), which is the next generation of HHS Protect, is a secure
decisionmaking and operations platform developed for the whole-of-
government response to the COVID-19 pandemic and is now expanding to
support emerging outbreaks such as mpox and future public health
responses. RREDI uses and integrates data from more than 300 sources
across Federal, state, and local governments and the healthcare
industry; and is accessible to 4,500+ unique users across 30+ Federal
agencies, 56 states and territories, and the private sector. In
addition, CDC's National Healthcare Safety Network (NHSN) has provided
essential data on known and emerging threats from more than 38,000
American healthcare facilities, including the U.S. government's first
comprehensive look at pathogen-agnostic hospital bed occupancy and
capacity data from all U.S. hospitals. CDC continues to leverage
systems like NHSN to meet the goals of the National Biodefense Strategy
and to build on the lessons learned from the COVID-19 pandemic to
maintain and enhance an enduring domestic all-hazards hospital data
collection capability. Even with this progress, we have much more to do
when it comes to building data infrastructure for both routine and
emergency work. Congressional funding and legislative policy changes as
requested in the fiscal year 2024 Budget will be necessary to achieve
these goals.
Rapid Response to Outbreaks at Their Source
To be effective responders, CDC must implement appropriate,
equitable, and immediate early interventions and prevention strategies
to prevent an outbreak from becoming an epidemic or a worldwide threat.
These interventions must be implemented based on the best available
science and informed by the communities where the interventions will
take place. Dedicated CDC preparedness funding over the past two
decades built many of the basic capacities and capabilities that
accelerated the STLT public health response to the COVID-19 pandemic.
CDC-funded infrastructure and CDC guidance enabled jurisdictions to
stand up emergency operations functions, provide medical-grade
warehousing capability and logistics, coordinate mass vaccination and
cold chain management functions, and rapidly distribute millions of
laboratory test kits, personal protective equipment (PPE), and other
critical supplies needed to respond to the COVID-19 pandemic. As just
one example, 93 percent of recipients of funding through the Public
Health Emergency Preparedness (PHEP) program report that PHEP funding
and the capabilities developed through the program built a strong
foundation that positioned them to ramp up COVID-19 response activities
very rapidly. Some successes include Tennessee leveraging a state flu
exercise program into a real-world COVID-19 vaccination campaign, and
Vermont using PHEP funding to enhance its emergency management software
and expand its capacity to manage numerous vaccine administration-sites
during the COVID-19 pandemic.
Strong Global and Domestic Preparedness
In the fight against infectious diseases, no nation can stand
alone. When it takes less than 36 hours for an outbreak to spread from
a remote village to any major city in the world, protecting U.S. health
and national security means making sure other countries have the
knowledge and the resources to stop threats before they can spread
beyond their borders. Together, we must build these first lines of
defense to better prevent, detect, and respond to disease and other
biothreats.
CDC must have strong domestic and global capabilities to respond to
outbreaks, which are becoming ever more complex and frequent, to
protect health, save lives, and protect livelihoods. CDC is
strengthening its existing global efforts and working to build capacity
among international partners to quickly detect and respond to
infectious disease outbreaks. For example, CDC continues to support
responses around the world as demonstrated by the recent Ebola (Sudan
virus) outbreak in Uganda and the current Marburg outbreaks in
Equatorial Guinea and Tanzania.
CDC works 24/7 to protect the health and safety of Americans. CDC
is uniquely suited to use our expertise to support partner governments
in building health programs, address health threats, enhance and
strengthen sustainable and country-owned public health systems, and
improve health outcomes for all.
Moving Forward
The future CDC must be prepared to lead the country in these core
capabilities and to set ourselves up for success, we must first find
ways to address long-standing challenges. Beginning in spring 2022, I
launched an extensive review of the agency's organizational structures,
systems, and processes to strengthen its ability to deliver on its core
mission to equitably protect the health, safety, and security of
Americans. In August 2022, based on this review and other substantial
internal and external input, I launched the CDC Moving Forward
initiative which focuses on the following top improvement areas:
Share scientific findings and data faster
Enhance laboratory science and quality
Translate science into practical, easy to understand
policy
Prioritize public health communications
Develop a workforce prepared for future emergencies--
CDC and nationwide, and
Promote results-based partnerships
On January 24, 2023, I announced a CDC reorganization, one of
several foundational steps to achieve progress in the improvement areas
outlined above. This reorganization aims to eliminate bureaucratic
reporting layers, break down silos in the agency, promote foundational
public health capabilities, and improve accountability at CDC.
Parallel to the reorganization, my leadership team has engaged
staff from across the agency on priority actions that will improve how
we do our work. This work is ongoing, but I'm proud to say that CDC has
already implemented numerous actions, including:
Improved efficiencies in scientific review by
reducing clearance time for CDC publications by 50 percent;
Initiated the CDC Infectious Disease Test Review
Board, an internal group to promote quality assurance prior to
national deployment of laboratory tests;
Established process for institutions to submit
applications for access to investigational drugs; reducing the
time required for institutions to apply from 14 days to 6
hours--utilized with tecovirimat for mpox; and
Implemented executive leader performance plan changes
that outline expectations for CDC leaders in response
participation, data modernization, and scientific quality and
timeliness.
New Authorities
As the CDC community tackles challenges internal to the agency, we
also need support from Congress consistent with the fiscal year 2024
Budget request, to support revised and new authorities so that CDC can
be better prepared and respond to the next emerging disease.
Historically and today, CDC is forced to rely on time-consuming
``work-arounds'' within our existing authorities and policies to meet
operational and programmatic needs when time is of the utmost essence.
The COVID-19 pandemic and other outbreaks have only underscored how
much these challenges have hampered the agency and continue to do so.
If CDC is to play a key role in rapidly detecting pathogens to support
all levels of government response to biological threats as envisioned
in the new National Biodefense Strategy and Implementation Plan, these
gaps must be addressed. In the fiscal year 2024 Budget, we have
requested flexibilities and authorities in the context of the PAHPA
reauthorization that are critical to the agency's ability to be more
effective and responsive during fast moving, large-scale public health
outbreaks. These proposals fall under two broad categories: 1)
operational readiness and 2) strengthening workforce capacity. On their
own, these proposals are not likely to be sufficient to change how CDC
responds to the next emerging threat. However, taken together, they
offer a roadmap to provide the tools and resources CDC needs to better
prepare for, and respond to, the next emerging public health threat,
whether from a local outbreak or a global pandemic. I have highlighted
examples of a few authorities below and welcome continued discussion on
ways to strengthen CDC to protect our national security through public
health.
Data
Data must serve as the foundation for everything we do,
particularly in the context of a public health emergency response where
critical decisions on where and how to target interventions must be
made quickly. Having timely, high-quality data on where disease is
spreading, the severity of illness, and the populations most impacted
is a critical element of operational readiness. It allows state and
local public health and other health care professionals, and
policymakers to target resources to mitigate an outbreak and predict
future spread. We are grateful that Congress has authorized and funded
CDC's newest center, the Center for Forecasting and Outbreak Analytics,
to improve the Nation's ability to prepare for and respond to public
health threats using data, modeling, and analytics. But if CDC must
continue to rely on a decentralized framework for data reporting,
subject to a patchwork of individually negotiated Data Use Agreements,
we will not be able to provide the best forecasts and modeling in the
world.
Where we can, we are making improvements on sharing data. CDC's
Center for Forecasting and Outbreak Analytics delivered four technical
reports on the mpox outbreak. These reports are publicly available,
have been shared widely, and provided timely updates on CDC's response
to the outbreak, including our estimates of the trajectory of the
outbreak. These reports were developed at the speed of the outbreak, to
get the best information we had out to decisionmakers quickly. We
included qualitative risk assessment information in these reports to
deliver the bottom-line up front while also making it clear the level
of confidence we have in our analyses.
However, the way in which public health data are collected and
shared has resulted in delayed, fragmented and inconsistent reporting
to CDC, and to state and local public health partners. To address this
issue and support better data sharing with states, locals, and
providers, CDC will need updated legislation as requested in the fiscal
year 2024 Budget.
Vaccines For Adults
Unlike the public health infrastructure that exists for children to
receive recommended vaccines from their pediatricians, the current
infrastructure for adults is not robust. In response to the COVID-19
pandemic, CDC built infrastructure to rapidly deploy safe and effective
vaccines to the entire U.S. population. As proposed in the fiscal year
2024 Budget, CDC's Vaccines for Adults (VFA) program would begin to
expand access to Advisory Committee on Immunization Practices (ACIP)-
recommended routine and outbreak vaccines at no cost for uninsured
individuals. Establishing a robust infrastructure for adult vaccination
will support response readiness by reducing vaccination coverage
disparities, improving outbreak control of vaccine-preventable
diseases, and enhancing and maintaining the infrastructure needed for
responding to future pandemics.
Strengthening Workforce Capacity
In addition to operational improvements, CDC needs a workforce that
is nimble and response ready. CDC is enhancing its work to better
prepare and coordinate staff across the agency ahead of emergency
events. However, as requested in the fiscal year 2024 Budget, CDC needs
additional operational authority to implement policies to address
issues such as overtime pay caps, danger pay, loan repayments, and
other flexibilities that enable CDC to rapidly respond to urgent public
health needs. These authorities would greatly improve CDC's workforce
capacity and help build a pipeline for future public health leaders.
Conclusion
In conclusion, CDC is working hard to address challenges identified
during the COVID-19 pandemic. We are building on a strong foundation of
core capabilities in public health and leveraging our areas of
expertise and successes to build systems that are more resilient that
can better respond and adapt to emergencies. Yet, to fully enable CDC
to better prepare for, and equitably respond to, the next emerging
public health threat, the agency needs the support, flexibilities, and
authorities as requested in the fiscal year 2024 Budget. We must look
for opportunities to apply lessons learned and advance bipartisan
solutions to be better prepared for future public health challenges.
Congressional action to support these fiscal year 2024 Budget proposals
in the PAHPA reauthorization will improve how CDC responds to future
emerging threats and will support the agency's modern-day mission. I
look forward to working together to implement the solutions that will
make this agency--the work of which is so critical to America's
health--and our partners at the state, local, tribal, and territorial
level, better prepared for what comes next.
Thank you, and I look forward to your questions.
______
The Chair. Thank you very much. Our final witness is Dr.
Robert Califf, Commissioner of the U.S. Food and Drug
Administration. Dr. Califf.
STATEMENT OF ROBERT CALIFF, M.D., COMMISSIONER, UNITED STATES
FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD
Dr. Califf. Good morning, Chair Sanders, Ranking Member
Cassidy, and Members of the Committee. Thanks for the
opportunity to be here today to discuss the importance of
preparedness and how FDA can work with Congress to ensure the
country is ready for the next public health threat.
PAHPA recognizes the key role of FDA in public health,
emergency preparedness, and response. We have effectively used
the authority provided under PAHPA to support our Nation's
preparedness and response capabilities.
However, there have been lessons learned about how these
authorities can be modernized to ensure our actions could be
even more effective. Providing greater transparency in the
supply chains and ensuring operational readiness and storage
capacity within the FDA inspectorate and review staff and
improving laboratory testing regulation are priorities that
will enhance national security and improve public health
preparedness.
First, supply chains. There is a need for greater
transparency into the supply chains of our medical products to
both improve resiliency and ensure continued access for
critical medical products. For example, under the CARES Act,
FDA received new authority to require medical device
manufacturers to submit shortage notifications during a public
health emergency.
FDA used this information to help mitigate approximately
350 shortages. Unfortunately, these notifications will no
longer be required following the end of the current COVID-19
public health emergency. However, we know medical device
shortages occur in many situations that are unrelated to PHEs,
including natural or human made disasters, recalls,
geopolitical conflicts, production shutdowns, and cyber
security incidents.
We also know that these shortages most often impact our
most vulnerable and underserved populations like children,
rural populations, and our veterans in VA hospitals.
Additionally, most drug shortages were historically due to
manufacturing issues that disrupted supply, for which
manufacturers of drugs and active pharmaceutical ingredients,
or APIs, are required to notify the FDA.
The agency has relied on these notifications to help
prevent supply disruptions by working closely with
manufacturers, expediting review, and exercising temporary
regulatory flexibility. However, we have recently seen
unprecedented demand for drugs that would benefit from similar
notification.
The ability to require drug manufacturers and distributors
to report surges in demand to FDA could help the agency to
prevent or mitigate shortages, including for some critical
over-the-counter drugs like we saw in the fall.
Additional improvements should include reporting API
sources and the extent of manufacturer reliance on certain
suppliers in the drug supply chain, and ensuring FDA has an
opportunity to inspect certain over-the-counter drug facilities
before such products are distributed.
Preventing food shortages is also critical to public
health, and we are grateful to Congress for including a
provision in the Fiscal Year 2023 Omnibus to require
manufacturers of infant formulas and medical foods to notify
FDA of potential shortages.
Looking forward, extending this authority to additional
categories of foods during a declared PHE could help prevent
future shortages in the food supply. Second, ensuring
operational readiness and storage capacity is critical in
emergencies.
For example, FDA could achieve more effective and efficient
oversight if it had authority to require internationally
harmonized master powers for drug manufacturing sites and
improved authorities for conducting remote regulatory
assessments. Congress expanded FDA's authority to request
records in advance of or in lieu of an inspection to devices
and via research monitoring sites in the Fiscal Year 2023
Omnibus.
However, the agency could better assure the safety of
products even in times of crisis if this records requests
authority were expressly extended to all FDA regulated
products. Additionally, during COVID-19, we saw the FDA staff
had to be pulled off other work and have been working
relentlessly on pandemic issues, as have our colleagues, for
the past 3 years, leading to a significant backlog in certain
areas and to fatigue.
Through the creation of specialized programs to defend
against emerging pathogens and other threats, the agency would
be well-positioned to respond to emerging and identified
threats of concern.
Third, and finally, the COVID-19 pandemic underscored the
importance of both diagnostic tests access and test accuracy,
and the critical need for a modernized regulatory framework
that applies to all in vitro diagnostics.
This will be integral to ensuring the U.S. is better
prepared for the next threat and to realizing the full
potential of diagnostic innovation. When I look at this list of
improvements, the striking observation is that these
measurements would not only help the FDA serve the public well
in times of crisis, but they would also enable us to help
prevent catastrophic outcomes and conduct our everyday work
more efficiently and effectively.
Thank you and I look forward to your questions.
[The prepared statement of Dr. Califf follows:]
prepared statement of robert califf
Chair Sanders, Ranking Member Cassidy, and distinguished members of
the Committee, thank you for the opportunity to testify before you to
discuss the Food and Drug Administration's (FDA's or the Agency's)
efforts to prepare for the 2023 reauthorization of the Pandemic All
Hazards Preparedness Act.
The last 3 years of the COVID-19 pandemic underscore the need to
continue to optimize our preparedness and response capabilities. The
Agency's continued preparedness for, and capabilities to respond to,
public health emergencies and disease threats such as COVID-19, mpox,
respiratory syncytial virus, and pandemic influenza have been
strengthened by Congress' support of our work. Our efforts are in close
coordination and collaboration with our partners, both within the
Department of Health and Human Services (HHS) and across the Federal
Government, to help facilitate the development, authorization,
licensure, approval, clearance, and availability of critical, safe, and
effective medical products and help ensure the continuity of the food
supply to address current and future public health threats. We look
forward to continuing work with you this Congress to ensure future
readiness.
FDA's Public Health Emergency Preparedness and Response Mission
The Pandemic and All-Hazards Preparedness Act (PAHPA) contains key
legal authorities to sustain and strengthen our Nation's preparedness
for public health emergencies involving chemical, biological,
radiological, and nuclear (CBRN) agents, as well as emerging infectious
disease threats.
The law, including critical policies from both previous
reauthorizations, recognizes the key role FDA plays in public health
emergency preparedness and response. Its provisions further FDA's
mission of fostering the development and availability of drugs,
vaccines, and devices (also referred to as medical countermeasures, or
MCMs) for use in these emergencies.
Together, these authorities for FDA have not only supported and
facilitated government partners' pre-event planning efforts and pre-
positioning of MCMs, but also helped to facilitate MCM development and
the efficient and rapid deployment of these medical products in the
event of a CBRN emergency or emerging disease health threat - including
COVID-19. FDA has effectively used PAHPA provisions to support our
nation's preparedness and response capabilities, and continues to
provide the highest quality and most timely guidance possible to all
stakeholders engaged in MCM product development.
One of the lessons learned from the COVID-19 pandemic was the
importance of a swift and agile response coordinated across all levels
of government and in collaboration with the private sector. Through
effective communication, dexterity, and innovation, we were able to
mitigate the impact of the pandemic and prevent innumerable illnesses
and deaths. From the beginning of the COVID-19 public health emergency
(PHE), FDA has taken a leadership role in the all-of-government
response and continues to focus on facilitating the development and
availability of MCMs to diagnose, treat, and prevent COVID-19;
surveilling the medical product and food supply chains for potential
shortages, disruptions, and contaminated or fraudulent products; and
helping to mitigate or prevent such impacts. Looking ahead, FDA is
committed to continuing to use every tool in our toolbox to prepare for
CBRN response activities, fight future public health emergencies, arm
ourselves with the best available MCMs, and support U.S. response
efforts.
Preparation for future PHEs depends on utilizing the many
strategies that led to a successful response as well as the
establishment and refinement of authorities and flexibilities that
allow the Agency to identify and mitigate risks while promoting
innovation. This includes continuing to proactively leverage existing
relationships with entities outside of FDA in emergency response
situations. For instance, as it relates to the development of COVID-19
testing kits, since January 2020, FDA has engaged with over 1,000 test
developers and worked interactively with them to support emergency use
authorization (EUA) of over 500 tests for COVID-19, including 35 over-
the-counter (OTC) tests. FDA has already been working to strengthen
communication strategies and tools that have proved effective for
ongoing collaboration with our private sector partners as demonstrated
during the COVID-19 PHE, including town halls, webinars, a telephone
hotline and email boxes for stakeholder inquiries, templates, and
interactions with professional and trade organizations. \1\ FDA entered
into a memorandum of understanding (MOU) \2\ with the Centers for
Disease Control and Prevention (CDC) and laboratory stakeholders
(including APHL and ACLA) in May 2022, a formal step in further
building collaborative relationships with the lab community. The Agency
is fully engaged with CDC and developers under this MOU with respect to
mpox. FDA also continues working proactively with the National
Institutes of Health (NIH) Independent Test Assessment Program (ITAP)
\3\ to support developers of at-home COVID-19 tests, including
multiplex tests that can also detect influenza. The program is an
extension of the NIH Rapid Acceleration of Diagnostics (RADx) Tech
program, which supported development of several authorized tests,
including the first OTC COVID-19 test. We have consistently seen
shorter review times for such EUA requests due to our partnership with
ITAP and we are continuing to work with this program to help provide
additional testing options for patients.
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\1\ https://www.fda.gov/medical-devices/coronavirus-covid-19-and-
medical-devices/emergency-use-authorization-covid-19-tests-independent-
assessment-fdas-response
\2\ https://www.fda.gov/about-fda/domestic-mous/mou-225-922-020
\3\ https://www.hhs.gov/about/news/2021/10/25/new-hhs-actions-add-
biden-administration-efforts-increase-access-easy-use-over-counter-
covid-19-tests.html
In addition, FDA leveraged an ongoing partnership with U.S.
veterinary diagnostic laboratories to strengthen COVID-19 testing at
the height of the COVID-19 pandemic. In ordinary times, this
partnership, the Veterinary Laboratory Investigation and Response
Network (Vet-LIRN), helps the U.S. animal health infrastructure rapidly
respond to animal health incidents. During the critical need for COVID-
19 testing, it successfully increased capacity to accurately test both
human and animal samples for COVID-19. FDA's capacity to drive future
PHE responses depends on maintaining and further building
collaborations with regulatory, academic, and industry partners even in
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the absence of a crisis.
The Administration's National Biodefense Strategy and
Implementation Plan on Countering Biological Threats, Enhancing
Pandemic Preparedness, and Achieving Global Health Security describes
in detail a set of transformative capabilities the U.S. Government aims
to build to defend against future pandemics and biological threats.
These include the capability to develop and safely deploy MCMs against
novel pathogens much more rapidly than is possible today. and safely
deploy MCMs against novel pathogens much more rapidly than is possible
today. and safely deploy MCMs against novel pathogens much more rapidly
than is possible today. and safely deploy MCMs against novel pathogens
much more rapidly than is possible today.
Facilitating Access to Safe and Effective Medical Products
As FDA prepares to combat future threats, ensuring access to safe
and effective medical products continues to be of utmost importance.
FDA can provide support to this mission through its work in several
preparedness areas.
Drug Product Supply Chain
There is a need for greater transparency into the supply chains of
our medical products to both improve resiliency and ensure continued
access for critical medical products, including drug products. FDA
works within its limited authorities to find ways to prevent and
mitigate drug shortages, and worked with manufacturers to successfully
prevent 222 shortages in CY 2022. The COVID-19 pandemic served as a
reminder that the drug supply chain is extremely vulnerable to supply
disruptions and surges in demand. Prior to this pandemic, most
shortages were due to manufacturing issues that disrupted supply, for
which manufacturers of drugs and active pharmaceutical ingredients
(API) are required to notify FDA. This notification requirement
provides FDA more time to mitigate or prevent a shortage, and the
Agency has relied on these notifications to help prevent supply
disruptions. However, during the pandemic we also saw unprecedented
demand for drugs and would benefit from similar notifications of supply
disruptions based on demand.
Looking to future preparedness, and in accordance with the National
Strategy for a Resilient Public Health Supply Chain, it is critical for
the U.S. Government to have visibility into the end-to-end supply chain
data access. The authorities provided under section 3112 of the
Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L.
116-136) enhanced FDA's visibility into drug and medical product supply
chains and the tools available to the Agency to help identify, prevent,
and mitigate drug shortages. To increase patient access to critically
needed medications in shortage or to prevent potential shortages, FDA
leveraged available tools medications in shortage or to prevent
potential shortages, FDA leveraged available tools (including the
authorities and requirements added by the CARES Act), including in CY
2022:
Expedited reviews of approximately 200 submissions.
Prioritized certain establishment inspections to
address drug shortages.
Expedited assessments of manufacturing supplements to
facilitate the manufacturing capacity for COVID-19 therapeutic
biologics.
Exercised regulatory flexibility and discretion in 87
instances to increase supplies of critically needed
medications.
However, we believe there are several areas where Congress could
build on our current authorities to improve our visibility into the
supply chain, strengthen our ability to oversee the drug supply chain,
and ensure continued access to critical drug products. The ability to
require drug manufacturers and distributors to report surges in demand
to FDA could help the Agency prevent or mitigate shortages, including
their severity and impact on patients. Additional improvements in drug
supply chain-related authorities could include:
Requiring labeling of bulk drug substances to include
the original manufacturer and requiring labeling of finished
drug products to include additional supply chain information to
help identify sources of APIs, thereby providing greater
insight into the supply chain;
Enhancing information that manufacturers must report
with respect to the amount of listed drugs produced for
distribution, including the suppliers they relied on to
manufacture the listed drug and the extent of such reliance, to
provide more complete supply chain insight. Having this
information would allow the Agency to work more proactively to
diversify the supply chain and reduce the risk of shortages;
Ensuring FDA has an opportunity for a facility
inspection or evaluation before distribution of certain non-
application drug products. Under current law, for drugs that
are not subject to premarket approval requirements, FDA
typically does not have an opportunity to inspect the
manufacturing facilities before such products are shipped to or
distributed in the U.S. Providing an opportunity for facility
inspection would help enable FDA to identify potential safety
issues related to manufacturing before a non-application drug
product is distributed;--Requiring facilities at which drugs
are manufactured to create, submit, and maintain Site Master
Files (SMFs). SMFs are internationally harmonized documents
that typically contain specific information about the firm's
manufacturing and product activities and quality management and
quality control activities at the named site and identify any
closely integrated operations at adjacent and nearby buildings.
SMFs would improve Agency understanding of manufacturing
activities and provide critical information on supply chain
management, thereby providing supply chain transparency to
reduce the risk of shortages.
Finally, as more manufacturers enter the vaccine and
biotherapeutics industries, the ability of ORA's inspectorate to
robustly respond to future pandemics will depend on operational
readiness and surge capacity. For example, FDA could achieve more
effective and efficient oversight if it had improved authorities for
conducting remote regulatory assessments. This could include explicitly
extending FDA's authority to request records or other information, in
advance of or in lieu of inspections, to all FDA-regulated products, as
well as authorizing mandatory remote interactive evaluations. In the
fiscal year (FY) 2023 Omnibus, Congress recognized that such
authorities were key to future preparedness by expanding FDA's
authority to request records and other information, in advance of or in
lieu of an inspection, to devices and to sites or facilities subject to
bioresearch monitoring inspections. However, the Agency could achieve
even greater regulatory compliance if this records request authority
were expressly extended to all FDA-regulated products and the Agency
was provided authority for mandatory remote interactive evaluations.
Critical investments in this space are also needed, such as increasing
the inspectorate's workforce capacity for oversight of medical products
and funding training and continuing education of the inspectorate's
workforce.
Medical Device Supply Chain and Safety
Shortages
U.S. preparedness and our national security depend on a strong
domestic supply chain for medical devices. Under the CARES Act, FDA
received new authority requiring medical device manufacturers to submit
information related to a device shortage during a public health
emergency \4\. As of December 2022, we have received over 455 potential
and actual shortage signals, which translates to hundreds of thousands
of device units that have been in shortage. We used the information we
collected under these new authorities to help mitigate approximately
350 of the 455 shortages. FDA also used information gathered under
these authorities to perform assessments that enabled us to:
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\4\ Section 506J of FD&C Act (21 U.S.C. 356j)
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Expedite premarket reviews and inspections
Issue guidance documents, letters to healthcare
providers, and enforcement discretion;
Publish communication products including conservation
strategies to provide end users with information on device
shortages; and
Work with ASPR on Defense Production Act priority
ratings and other actions by the U.S. Government--as ASPR, the
Department of Defense, the Department of Transportation, and
others all depend on the information from FDA to support
companies who are trying to help support the U.S. response.
Unfortunately, the requirement for manufacturers to provide this
critical information is temporally limited as it is only required to be
provided to FDA during or in advance of a PHE. However, medical device
shortages occur in many situations that fall outside of or are
unrelated to declared PHEs, including certain natural or human-made
disasters, recalls, geopolitical conflicts, production shutdowns, and
cybersecurity incidents. We know that these shortages most often impact
our most vulnerable and underserved populations--like children, rural
populations, and our veterans and VA hospitals. As an example, rural
hospitals often do not have the funding to purchase multiple types of
critical equipment, such as X-ray machines and washers and sterilizers
to clean and sterilize reusable medical devices. When these devices and
equipment cannot be serviced or replaced because of a lack of parts or
materials, patients may have to drive hours, if they can, to other
areas to try to seek the care they need. Moreover, as we saw with the
onset of COVID-19, by the time there is an emergency, it is often too
late to prevent or mitigate shortages.
The fiscal year 2023 Omnibus clarified FDA's ability to receive
voluntary notifications from manufacturers about certain device
discontinuances and interruptions, but this pandemic has demonstrated
that relying on voluntary information-sharing deprives FDA and the
public of critical supply chain information. To protect patients, build
a more resilient domestic supply chain, and help reduce dependence on
foreign sources, it is critical that Congress remove the temporal
limitation that only requires manufacturers to notify FDA about
interruptions or discontinuances in the manufacture of certain devices
during or in advance of a PHE.
Furthermore, COVID-19 also showed us that manufacturers are not
always prepared for situations where their ability to manufacture
product may be disrupted or may be insufficient to meet increases in
demand, especially where they are dependent on one source for a
critical raw material or component that was in shortage. A good example
of this was the recent tracheostomy tube shortage. The manufacturer was
reliant on a single source for a critical raw material component
(silicon)--the vast majority of which comes from China. Having a risk
management plan in place could have helped the manufacturer and FDA to
respond more swiftly to ensure redundancy in suppliers. Risk management
plans are commonplace in all types of industries, and mandatory for
other medical product areas such as drugs, biologics, and critical
foods (the latter of which Congress just enacted in the fiscal year
2023 Omnibus). Providing FDA with statutory authority to require risk
management plans would help ensure manufacturers have plans in place to
improve resiliency and mitigate future supply chain disruptions--and
this includes minimizing reliance on products and components from any
one foreign country. For example, the United States continues to import
45 percent of finished medical devices from China, and we are even more
dependent on China for raw materials and components that are used to
make medical devices.
Our supply chain is too vulnerable and the health care of our
patients--our veterans, seniors, children, and underserved populations
including those in rural areas and others who often suffer the most
when there is a supply chain issue--is too important to rely on
voluntary reporting of this critical information.
In Vitro Diagnostics
The past few years have also highlighted the critical need for a
modernized regulatory framework that applies to all in vitro
diagnostics. The COVID-19 pandemic underscored the importance of both
test access and test accuracy. Beyond COVID-19, tests are used for many
different purposes and are based on many different types of
technologies, and they are becoming increasingly important to our
entire health care system. According to CDC, 70 percent of health care
decisions are based on clinical lab test results. \5\ Some of those
tests are the sole determinant of a patient's treatment. A modern
oversight framework that is specifically tailored to assuring tests
work is critical to position ourselves for the future--whether it is to
prepare for the next pandemic or to realize the full potential of
diagnostic innovation.
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\5\ https://www.cdc.gov/csels/dls/strengthening-clinical-
labs.html-print
Such a system can balance innovation with assurance of accuracy and
reliability for tests. For example, a technology certification approach
could provide assurances for most tests without individual FDA review
of the tests. These assurances are critical. We have seen many examples
of tests that do not work--from COVID-19 tests marketed during the
pandemic, to tests that are the sole determinant of which treatment a
cancer patient receives. In particular, we are concerned that there may
be inaccurate laboratory developed tests, or LDTs, in use today. \6\
This puts patient health at risk, undermines our health care system,
and hinders the country's ability to effectively address PHEs.
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\6\ For example, see: Case studies of 20 LDTs that may have caused
patient harm (http://wayback.archive-it.org/7993/20171114205911/https:/
www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm472773.htm) and
FDA's analysis of 125 EUA requests for COVID-19 tests from labs that
found 66 percent were not designed or validated appropriately (https://
www.nejm.org/doi/full/10.1056/NEJMp2023830).
We look forward to continuing our work with Congress and
stakeholders to create a modern framework for all tests and to
strengthen supply chain authorities. In the meantime, we intend to move
forward using our current regulatory authorities to offer providers and
patients confidence in the diagnostic tests that they use.
Overseeing Products Critical to Public Health and Fostering Medical
Countermeasure Development
We have also seen that a supply disruption for other critical
products can have an immense impact on families, as we saw in the
infant formula shortage. Preventing food shortages is critical to
public health and we are grateful that Congress included a provision in
the fiscal year 2023 Omnibus to require manufacturers of infant
formulas and certain medical foods to notify FDA of potential
shortages. Looking forward, parallel authority to require notifications
of anticipated interruptions in the supply chain of additional
categories of foods designated by FDA during a declared PHE could help
prevent future shortages in the food supply.
Further, enhancing FDA's regulatory capabilities and readiness to
respond to emerging pathogens, help ensure blood safety and
availability, and expeditiously review new vaccines, existing vaccines
and other medical products, is vital to the Agency's continued success
in PHE preparation and response. Our staff have had to be pulled off
other work and have been working relentlessly on pandemic issues for
the past 3 years, leading to a significant backlog in certain areas and
fatigue. During COVID-19 we have seen that FDA staff need to be
prepared to continue to address the current pandemic needs while also
preparing for potential future pandemics and staying on top of our
daily work to help ensure blood safety and availability and regulate
vaccines and other medical products. Through the creation of a
specialized program within CBER to defend against emerging pathogens
and other threats, the Agency would be well positioned to respond to
emerging and identified threats of concern and focus experienced
resources to work quickly on MCM development to address these concerns.
In consultation with HHS partners, the program could: further
accelerate the review of critical MCM product applications, provide
recommendations and guidance to developers of vaccines and other
medical products and to relevant Federal partners; use real-world data
or real-world evidence to study the safety and effectiveness of
products for addressing biological incidents and identify which
products may be best suited for specific pathogens or for use in
different populations; and facilitate product development including
advances in manufacturing. It could also support applied scientific
research within CBER that contributes to development and review of
biological incidents and emerging pathogens.
FDA's ability to monitor the safety of vaccines would also benefit
greatly by a coordinated Federal public health data reporting
authority. Through the Biologics Effectiveness and Safety (BEST)
Initiative, part of the FDA Sentinel Initiative, FDA can analyze
information occurring in millions of health insurance claim submissions
or electronic health records (EHR) recorded in large data systems.
FDA's contractors assist with this program and analyze the data itself
behind their firewall as part of data privacy protections. While the
BEST Initiative has been essential for our work and provided us with a
robust picture of safety data, our ability to analyze claims
information is limited by the fact that some vaccinations are not
recorded in health insurance claims data. Further, when insurance
claims data bases or EHRs detect an adverse event, FDA often needs to
quickly verify information or access additional information to evaluate
the adverse events of interest. When we request records to verify
adverse events detected by the BEST Initiative data bases it has taken
FDA around 8-12 weeks in some cases to receive voluntary access to
these records. Additionally, coordinated Federal public health data
reporting authority would help the Agency to more swiftly identify
adverse event patterns and trends associated with the use of vaccines
or other MCMs, and swiftly be able to communicate with health care
providers and patients about safety signals.
Finally, across all these areas, FDA's partnerships with state,
local, and U.S. territorial governments continue to play an important
role in the protection of public health, particularly as FDA partners
with them in the regulation of products, helping to ensure the safety
and integrity of supply chains, and assisting in enforcement against
products that are being unlawfully sold. New provisions for the
disclosure of non-public information to these agencies with
complementary functions related to FDA-regulated products, and a
federally consistent expectation for disclosure, could achieve faster
and more effective action to protect the public health during national
public health emergencies, other state/local disaster declarations,
outbreaks or other public health events, and for routine regulatory
oversight.
Conclusion
FDA continues to advance its mission to protect and promote public
health by helping to ensure the safety of human and animal food, and
the safety and effectiveness of medical products in the COVID-19
pandemic. The Agency is continuing to monitor its policies, the
marketplace, and national needs, and will continue to adapt as the
circumstances of the pandemic evolve. We take our public health mandate
very seriously and will continue to work each day to help end this
pandemic and prepare for the next one. We look forward to continuing to
work with the Committee on the Agency's public health emergency
preparedness and response mission and strengthening FDA's authorities
to continue building a resilient supply chain for critical medical
products, foods, and medical countermeasures.
Thank you again for the opportunity to testify.
______
The Chair. Thank you very much. Let me start off with a
question for Ms. O'Connell and Dr. Walensky. Nobody can predict
what the next public health emergency will be. And is our job,
and more specifically, your job is to put us in a position
where we can react as effectively as we can, so we don't lose
over a million people next time around.
My question is a pretty simple question, and maybe Dr.
Califf can jump in as well on this one-off. Are we moving
forward right now, can you just tell us confidently that we are
moving forward as fast as we can with creating the kinds of
vaccines we may need in anticipation of the next pandemic?
Do we have the kinds of treatments--are we moving--I know
you may not have them today, but are we moving aggressively
forward to have the treatments that we need if people become
ill? Do we have the workforce infrastructure that we need?
Do we--are you confident in telling us that you can move
rapidly when you learn that a pandemic is--that we are facing a
pandemic and that you can rally all the resources that you
need? Do we have the medical personnel to staff our hospitals
if, God forbid, we find ourselves in the same position again?
Ms. O'Connell, can you start off with that, please.
Ms. O'Connell. Chair Sanders, thank you so much for this
question. This is one of my biggest worries, is that we are
losing time in preparing for the next pandemic.
It is the reason why the Administration requested $88
billion last year to advance the American pandemic preparedness
plan.
We did not receive that funding. We have requested, again,
in our Fiscal Year 2024 budget $20 billion of which $10 billion
would go to ASPR or BARDA to begin that research into the
prototype vaccines, therapeutics, and diagnostics for those
seven viral families most likely to cause the next pandemic.
You know, we were so lucky--I know it doesn't feel like it,
but the one place we were lucky when it came to the Coronavirus
is we had already done a lot of the early work on that because
of SARS and MERS. We need to get the same head start----
The Chair. Are you telling us that we have not done the
kind of work you would like to see us done in preparation for
what may be coming?
Ms. O'Connell. Correct. Not in all the viral families.
The Chair. Okay. Dr. Walensky.
Dr. Walensky. Thank you for that question, Chair Sanders.
So, we started with a very frail public health infrastructure
from years, decades, in fact, of underinvestment. Some have
estimated we have 80,000 public health work jobs in deficit
right now.
In fact, your own state of Vermont hired 120 people during
the COVID-19 pandemic, and through our workforce
infrastructure, you are able to retain--our workforce
infrastructure grant, you are able to retain 12 of those 120.
It just gives you a sense of how frail, and--of the
workforce infrastructure. In addition to vaccines----
The Chair. Let me interrupt you. Are you concerned that so
many doctors and nurses are leaving the profession for a lot of
reasons, but including the burnout and distrust, the experience
during COVID?
Dr. Walensky. Public health workers. Dearly--yes, deeply. I
will also note that----
The Chair. I don't mean to be interrupting you all the
time. What ideas do you have as to how we can rebuild that
critically important workforce?
Dr. Walensky. Much of the workforce authorities that we are
looking for in public health, specifically things like tax
exempt loan repayment, to entice people to come in. We know our
laboratory----
The Chair. We can do a little bit better than tax exempt
loan repayment. We have a massive workforce shortage.
Dr. Walensky. We will have----
The Chair. We need thousands of new workers.
Dr. Walensky. Indeed, we do. And we haven't--many of these
physicians, for example, come out of medical school with
$200,000 worth of debt.
The Chair. So that seems like a very modest, too modest
proposal.
Dr. Walensky. Work--and direct hire authorities, flexible
pay, danger pay, for example. I have with colleagues in
Equatorial Guinea right now on the frontlines of a Marburg
outbreak, and they are not getting danger pay.
These are the workforce things that we need to do to entice
people to come into health and public health. So those are many
of the things that we are asking for as part of this----
The Chair. What I am hearing you say is, despite good
intentions, we--your agency is not as prepared as it should be,
if God forbid----
Dr. Walensky. I would argue that. Yes.
The Chair. Okay. Dr. Califf.
Dr. Califf. What I say, Senator, is that when it comes to
technology, we are unsurpassed and ready to go with regard to
drugs, devices, vaccines, tests. But when there is a profit to
be made, the American industry is premier and goes for it and
is producing amazing things.
For the public health, we have a gap in translation, which
is what my colleagues here are referring to. When there is not
a profit at the end of that pipeline, we need to have the
funding in order to stimulate the industry to produce these
products that we are going to need for the future.
As a former practicing doctor very recently, I am very
concerned about the thing that you all referred to. I want to
stress the public health workforce, not just the docs and
nurses. You lost a very important person yesterday.
This is not--and it is emblematic of how hard this work is.
We are way down in the workforce that we need across the board
to implement. Just talk to any of your friends trying to get on
an appointment in a clinic, particularly in mental health,
these days.
The Chair. Okay. Senator Cassidy.
Senator Cassidy. I will defer to Dr. Marshall.
Senator Marshall. Thank you, Ranking Member and Chairman.
Dr. Walensky, let's--if you don't mind, retrospectively, what
do you feel the impact of lockdowns were on mental health in
this country?
Dr. Walensky. It is--certainly, the impact of lockdowns
resulted in lives saved from COVID-19 and also challenges in
connectivity, and some--there are reports of some children
doing better in school at home, but also some children----
Senator Marshall. My question is mental health.
Dr. Walensky. Right and the lack of connectivity and
challenges in mental health. And we saw increases in mental
health challenges before the pandemic. They were rising before
the pandemic and certainly the pandemic----
Senator Marshall. You are saying the lockdowns had no
impact on mental health----
Dr. Walensky. No, I am sorry, I am not saying that. What I
am saying is that the impact--when you lose 1.1 million people
in this country, there is tragedy, there is loss. There was
loss of lives. There was loss of housing security, food
security. All of these things impact mental health.
Senator Marshall. Thank you, thank you. Ms. O'Connell,
recently we released a 300-page report on the origins of COVID.
Senator Burr helped run that investigation. Want to give credit
to the previous ASPR, Dr. Bob Kadlec and his great efforts as
well.
That report says that there is a preponderance of evidence
that shows that this virus was accidentally released from a lab
in Wuhan, and a significant amount of evidence that would
suggest it was actually made in that laboratory in Wuhan.
As ASPR, what are you doing to research that same issue? Do
you feel it is important that we know the origins of COVID?
Ms. O'Connell. This is not--this has not been in the
purview of the work that I have done at this point. But I would
be happy to take this back to the department and other
colleagues that are taking a look at that.
Senator Marshall. Do you feel like it is important that we
know where this virus came from?
Ms. O'Connell. I think it would be useful to know for sure,
and I know that work is underway. It is not being done in ASPR,
so.
Senator Marshall. How would it be useful?
Ms. O'Connell. Well, as we work to prepare for whatever
comes next, which is my job, it would be important to
understand what I am coming up against. But let me be clear,
whatever it is, I am responsible for responding to it wherever
it came from.
Senator Marshall. If a virus was made in a laboratory, your
response might be different than if it came from nature.
Ms. O'Connell. Well, I think it would help us prevent it
from happening again if we knew the source. Regardless of that,
my responsibility to the country is to help them respond to
whatever comes next.
Senator Marshall. Okay. Dr. Califf, I think my next
question is for you. You can punt it on if you want to. The NIH
did an incredible job in the early days of this COVID pandemic,
sequencing the virus and then releasing--and then sharing that
with any group that they wanted to, any corporation.
At the end of the day, two or three companies end up with a
vaccine that was workable. What--why did the other companies
fail? Was there anything that we could have done to help
promote it to other companies to be more successful? Why did we
end up with just two, maybe three vaccines?
Dr. Califf. That is a really great question. I wish we had
like 6 hours to discuss it because, I mean, as you well know,
90 percent of drugs that enter phase 1 don't make it to market
because mother nature is much more sophisticated and
complicated than our brains are as we devise new therapies.
I think it was wise of the Government to make a bet on nine
or ten vaccines and two or three made it. We often forget about
the ones that didn't. I am not sure that anything we could do
would change that equation, because that is pretty much the
equation that you are seeing--we are seeing.
That is why we have to do human clinical trials. We develop
a therapy. We think it is going to work. All of those 90
percent that don't make it, somebody thought it was going to
work and somebody invested. I think Senator Romney used to--I
guess you didn't invest in these things. But so----
[Laughter.]
Senator Romney. I tried that too.
Dr. Califf. You have to take account of a higher failure
rate in this, which I think the Government is very wise to do
that.
Senator Marshall. There is some value that took what the
Government developed to getting it across the finish line. Not
everyone was able to do that, and I am not sure what the value
is in being able to do that. But you would agree that there was
more than just luck getting that across the finish line for
those two or three successful companies?
Dr. Califf. Oh, the collaboration in the mRNA platform that
had been developed over decades, and the sharing of the viral
sequence. Just the ability to do the viral sequencing and then
to use in silico methods to match vaccine to virus.
That was an amazing feat of science and collaboration that
made a huge difference. We would have had maybe one vaccine out
of ten, I think, if the mRNA technology had not----
Senator Marshall. Some of the companies had already had
significant investment in the mRNA technology before the COVID
was even around, right?
Dr. Califf. That is correct. And that is why we are excited
about new platforms that are coming along with regard to cell
therapy and gene editing and other areas.
Senator Marshall. Thank you. I yield back.
The Chair. Senator Murray.
Senator Murray. Thank you very much, Mr. Chairman, for
holding this hearing. Thank you. It is good to see all of you
again. Dr. Walensky, my condolences to you and all the CDC
family as well for yesterday. Ms. O'Connell, I want to start
with you.
I am working to reintroduce my Public Health Infrastructure
Saves Lives Act, to help provide state and local health
departments with the strong, sustained funding that they really
need, because we know how critical it is to have well-funded,
strong health departments responding to any public health
situation.
I have heard from my constituents in Washington State about
how Federal resources have helped during floods and wildfires
and, of course, COVID. But states and communities still often
lack the funding and the flexibility they need when they face a
public health threat, especially when it comes to reaching and
supporting people with circumstances that put them more at
risk.
We saw this during COVID. What can Congress do to help
ensure that we strategically support those most at risk in a
public health emergency, including people with disabilities,
older people, adult, children, families?
Ms. O'Connell. Senator Murray, thank you so much for that
question. This is top of mind for us, too. We just released an
ASPR strategic plan, a 5-year plan, in which we make very clear
that the country is not prepared until we are all prepared, all
communities.
Those at greatest risk need to be accounted for in all the
planning that we do and the response that we do. As part of the
Fiscal Year 2024 budget, there is an authority to start a human
services response fund, which would quickly move money into
various communities to be sure that we have boots on the ground
able to respond to the various populations that are most at
risk.
I had a wonderful conversation on Tuesday with the head of
our ACL about how important this is. So, we have been in
communications within the department about making sure that the
human services side of our shop is also prepared and ready to
respond to account for these at-risk populations.
Then, Senator, you recall as part of the last PAHPA, we
authorized--you authorized three advisory committees, one for
disasters and seniors, one for disasters and people with
disabilities, and one for disasters and children.
We have been meeting regularly with those experts and have
really valued their input. So, we continue to keep this work
front of mind.
Senator Murray. Okay, good. And as you know, with any
emergency, we need to be able to get supplies where they are
needed most in a quick and effective and equitable manner.
My Prevent Pandemics Act, which was signed into law last
year, includes directives to ASPR to assist state and local
health departments in accessing the Strategic National
Stockpile. Can you just give us a quick update on how ASPR is
implementing that provision?
Ms. O'Connell. Thank you. The Strategic National Stockpile,
making sure that it is squared, that it is fully stocked and
ready to go has been one of the big focuses of my tenure in
this role.
This is an important question for us. We appreciated the
provisions in the PREVENTS bill, and we are working very
carefully against them. We just released our 60-day guidance,
which is guidance for states and localities on how they might
access the Strategic National Stockpile.
We will continue to give technical assistance to those
states that are interested in maintaining their own stockpile.
What do they need to have and how do they need to switch it
out? And then we are looking at all the various innovations for
how we might hold our stockpile with vendor manage inventory
and other ways to switch in and switch out what we have.
This is all front of mind for us. Thank you for those
provisions, and we will continue to keep you and your team
updated as we implement them.
Senator Murray. Very good. I appreciate that. Dr. Walensky,
one of the things we really saw in COVID was that we needed
accurate data. You can't get ahead of an emergency and create a
response to it if you don't have that. I want to ask you today,
can you talk about ways that your agency is working to improve
data collection?
Dr. Walensky. Yes, maybe I will break this into two parts.
One is we are actively working on our data monetization
efforts, and that is that our data highways are interoperable,
that counties and local health departments can give data
swiftly to us on similar highways, and we can offer it straight
back to them so they can see what--not only what is happening
in their county, but in counties around them.
That has yielded huge returns. So, before the pandemic
started, we had 887 health facilities that were doing
electronic case reporting. We are now at 25,000. That is about
20 percent of what we need across the country.
So massive strides happening. Also, in syndromic
surveillance from our emergency departments, and vital
statistics from our death registries, all of this work is
ongoing in our data highways. Where we could really use your
help is the structure of those data is coming into us.
We receive those data voluntarily. If those data don't come
to us, we don't have line of sight and we can't deliver those
data back. So that is among the things that we are asking for
in this PAHPA reauthorization. Thank you.
Senator Murray. Okay. Very good. Thank you. Thank you, Mr.
Chairman.
The Chair. Senator Budd.
Senator Budd. Thank you, Chairman. Again, thank you to the
witnesses for being here today.
Last October, the GAO said the ASPR, the Assistant
Secretary for Preparedness and Response, needs to develop a
clear approach for buying medical countermeasures for the
National Stockpile, and regardless of whether they received
development funding from the--from BARDA, or Biomedical
Advanced Research Development Authority.
Assistant Secretary O'Connell, without a clear process in
place for the stockpile to buy countermeasures, will you commit
to implementing GAO's recommendation to document an approach to
make sure there is equal consideration of medical
countermeasures?
Ms. O'Connell. Senator, thank you so much for that
question. Absolutely. We are working closely with GAO to make
sure that we can take into account the recommendations they
make and implement them.
Of course, making sure the stockpile has what it needs is a
focus of mine. And we have the FMC, which is an interagency
group of experts that come together to give advice to myself
and the Secretary on what should go in there across all of the
various material threats that DHS has issued.
Senator Budd. Thank you for that. You know, Congress
created ARPA-H or Advanced Research Projects Agency for Health.
As it is currently outlined, many of its authorities overlap
with efforts undertaken by the Assistant Secretary for
Preparedness and Response, or ASPR, you. So, what steps can
Congress take to increase interagency coordination and remove
some of the duplicative efforts between ARPA-H and your agency?
Ms. O'Connell. Senator, thanks again for that question. So,
we are really proud of the work that BARDA does. And BARDA's
work is limited to developing countermeasures to make us more
prepared against the threats that we see coming.
ARPA-H has a, as I understand it, a wider remit to develop
innovative products against any disease or threat, not
necessarily the national security threats that we are
responding to. But it is important that we have good
collaboration between our fellow agency, and we work very
closely together, and continue to stay in touch.
But I see a very clear lane for BARDA, and it is important
that BARDA stay in that lane in order to keep this country more
prepared and ready to respond moving forward.
Senator Budd. Thank you. Decentralized clinical trials
where trials take place at locations other than at a research
center like a patient's home, can make groundbreaking cures
more accessible to patients who otherwise wouldn't be able to
participate simply because--maybe because of where they live.
We saw how important these flexibilities were during the
pandemic. So, Commissioner, what steps can Congress take to
reduce the barriers for patients to participate in these trials
to improve accessibility for those with rare diseases, maybe
they are elderly, or they have mobility issues?
Dr. Califf. Thanks, Senator. Being a fellow North
Carolinian, which has got some cities, but is also a very rural
state----
Senator Budd. I didn't have your bio in front of me, but I
appreciate the accent. I was wondering if we were--live nearby.
Dr. Califf. Yes. The big city of Durham is where I have
lived most of my life. And this is really important. We just
put out a guidance on this. Decentralized trials are on the
way. It is dependent on digital technology.
If you ask me, the most important thing you can do is to
make sure the funding for internet expansion to all the rural
areas. I know the bill has passed, the funding is allocated. We
have got to make sure that those digital tech pipes are
deployed out there. I think the methods are coming along great.
You know, I spent time at Alphabet. There is no question
that we have technology that everyone in this country can use.
Almost everyone has a cell phone. So, the methods of doing this
are not requiring the big research center, unless it is a
specialized area that you need special medical exams. That is
the way to go.
Senator Budd. Very good. Thank you all again. Chair, I
yield back.
The Chair. We owe you a minute next time.
Senator Budd. I will take it.
The Chair. Thank you.
Senator Casey.
Senator Casey. Mr. Chairman, thanks very much. I appreciate
the work that you are doing, and the Ranking Member Cassidy, on
the reauthorization of the Pandemic All Hazards Preparedness
Act.
I also want to thank Senator Romney for working with us on
this reauthorization. I wanted to start with Dr. Walensky,
Director Walensky on supply chains and PPE. We learned a
horrible lesson in the pandemic, which--and the way I look at
it, kind of a national failure when we couldn't provide the
kind of PPE that we needed. We don't ever want to have that
transpire again.
We had a buckling of that supply chain in the midst of the
worst pandemic in 100 years. It adversely impacted first
responders and health care workers, essential workers, as you
know. So, I think we all agree, that was totally unacceptable.
One factor that contributed was a heavy reliance upon imported
PPE and the dependence upon those foreign manufacturers and
foreign suppliers is what drove that.
It created a terrible risk that we all know that our
families and our communities paid a price for. How can we
promote innovation when PPE designs are outdated and then
ensure that these innovative new technologies are always
available to essential workers, and whether they are in health
care or otherwise, especially during a pandemic?
Dr. Walensky. Thank you, Senator. I would be happy to have
our team touch base with you about all the research that is
happening at NIOSH now to ensure that we have innovation in
PPE.
One is our National Personal Protective Technology
Laboratory that is working in sites like the one in Pittsburgh
that looks at new technology for PPE that is used in health
care and used in public health emergencies and other
environmental hazards.
That work is ongoing. We are working with academia in that
work, and I am happy to--I would be happy to brief you and your
staff on the work that is happening there. I don't know if the
ASPR had anything to add to that with regard to----
Senator Casey. Sure.
Ms. O'Connell. Thank you, Dr. Walensky. Senator Casey, just
to say, the ASPR organization has invested $16 billion in 87
different contracts for domestic manufacturing of PPE and other
critical supplies.
But when we lose the COVID dollars, we lose our ability to
do this construction authority and to continue to invest in
similar projects. As we are seeing supply chain pinches, as Rob
mentioned, across many different materials and products, it
will be important that we maintain this ability to keep this
work going.
Senator Casey. Well, thank you. It will be a huge issue
among many difficult issues in this reauthorization.
Commissioner Califf, I wanted to ask you a question about
device shortages, which is another challenge.
We know that in the midst of the pandemic, that was another
significant strain. In particular, we saw a terrible shortage
of medical devices. The FDA took advantage of the authorities
it had during the health emergency and required manufacturers
to notify FDA of potential or actual shortages.
How many devices, if you have this number, how many device
shortages has the FDA been able to prevent using this
authority?
Dr. Califf. Approximately 350. So, it is a large number,
and this authority is going to go away. We need it and we need
notification both with drugs and devices, not only when
manufacturing is disrupted, but also when there is a huge surge
in demand so that we can help them make up for it.
Senator Casey. Thanks very much. Mr. Chairman, I am giving
back a minute.
The Chair. Thank you, Senator Casey. Senator Cassidy.
Senator Cassidy. I defer to Senator Romney.
Senator Romney. Thank you, Ranking Member Cassidy. Dr.
Walensky, Dr. Califf, I interact with you a number of times. I
don't know--Ms. O'Connell as well. But I respect you as
individuals and physicians who have demonstrated integrity and
capacity and commitment to the oath that you have taken to the
Nation, but also to your patients. Let me ask each of you, how
many employees do you have that you are responsible for in your
agency? Just go down the row--approximately.
Ms. O'Connell. About 1,000.
Senator Romney. About 1,000.
Ms. O'Connell. About 12,000, and about twice the number of
contractors.
Senator Romney. Okay, thank you.
Dr. Califf. 19,000.
Senator Romney. Yes. I know there are some people who feel
that these individuals must be corrupt or must be bad. They
work for the Government. They must have ulterior motives.
My experience in dealing with those that I have dealt with
is that they are good people. They are brothers, sisters, moms,
dads, and they are trying to do the best job they possibly can.
I sometimes worry that a projection that other people are evil
somehow creates false impressions about how effective our
various agencies are, and hope that you and others recognize
that the great majority of us, certainly in this body, respect
and admire the work you do.
Let me ask if there are any things you think we need to do
to improve the integrity and the credibility that is held by
the public for your respective agencies. So, for instance,
prohibitions on owning stocks in pharmaceutical companies.
I mean, I hear all the time, oh, the FDA approved that
because the people looking at it were investors in that
company. Is this an issue that you are concerned about? Does
this exist in your various agencies? Dr. Califf.
Dr. Califf. Well, since you mentioned FDA specifically, let
me just say that FDA officials, our employees, are prohibited
from owning any stocks in any of the relevant entities that
they regulate.
For us, that is almost it is 20 percent of the economy. So
even like airlines, because they serve food and food is a big
part of our equation. I take great pride and really appreciate
what you said. What could be done to help the most is say a few
nice things about Federal employees.
They work hard, and we can verify they worked extremely
hard, particularly during the pandemic. They were doing all the
regular, more plus of pandemic work at the same time.
Senator Romney. Thank you.
Dr. Walensky.
Dr. Walensky. I would just echo the gratitude for your
comments, and just say that I have an agency that is working
24/7 to take care of health and public health. They are not
getting credit for it.
They--you know, what happens when there is a massive
pandemic that affects 330 million Americans is that they had a
frail infrastructure to start with.
They were working 24/7. Their job is to protect the public
and public health so that you don't have to worry about it. So,
a few nice things I would say would go a really long way.
Senator Romney. Thank you. I was personally concerned, and
I know many others were about, the data that was available to
the public from our Government about what was happening with
COVID, who was getting it, what age groups were getting it.
I was a little dismayed that I went to Johns Hopkins to get
the data as opposed to coming to the CDC or NIH or whatever.
And you indicated that you are making strides to improve our
systems for data collection. You also indicated that for many
institutions, the data that comes is only voluntarily provided.
Are you suggesting that we really need to have some kind of
mandatory reporting, obviously on a basis where people can't
possibly be identified personally? But do we need to do
something to do--have a better system of collecting data and
providing that to the public, as well as to practitioners?
Dr. Walensky. Yes. Let me just note that during the public
health--right after the public health emergency, it took CDC 6
months in order to be able to negotiate data use agreements, in
order to receive hospitalization data, which is why the web
scraping of Johns Hopkins was a very efficient way to do this,
while we were working with our lawyers to do data use
agreements.
Very similar things happen with Mpox. If we are supposed to
and responsible for stopping disease outbreaks before they
start, before they become emergencies, we have to have line of
sight as to those--when those urgent issues, those infectious
threats are sparked, and the only way we do that is by getting
the reporting coming into CDC so that we can, again, give it
back to the communities, and they know that this rare thing
that happened in their county is actually also happening in the
county next to them.
Senator Romney. All right. Thank you. I haven't much time.
I would love to steal the time from the people who gave it up,
but I won't do that. Ms. O'Connell, just to ask a question, it
is one thing to stockpile, for instance, masks and PPE, it is
another to stockpile the machines that make those things.
Do you make a decision--how do you make a decision about
whether to keep productive capacity in place as opposed to just
keeping masks in place? And are we making the right choice in
that regard from your perspective?
Ms. O'Connell. Senator Romney, thank you so much for that
question. That is exactly what we are working to do now, which
is make sure that the stockpile is only one part of the supply
chain continuum.
You know, so what we have on hand in the stockpile is
critical in the early hours or weeks of a response while we
ramp up what we have in the supply chain. But both should work
together.
The hospital employees that had to wear bandanas instead of
real masks should have been able to access those on the
commercial market, were not able to. Stockpile is there to back
that up.
Should have been there to be a backstop for that. But if
both are running well and we are investing in our domestic
manufacturing so that supply chain is stronger and more
resilient, if both are running well, we will not need to
stockpile, and we can rely on the supply chain. But when that
gets pinched, we will have the stockpile.
Senator Romney. Mr. Chairman, thank you.
The Chair. Thank you.
Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman. I want to thank
our witnesses for all your work during a very, very difficult
time. And we are here talking about reauthorization of the
Pandemic and All Hazards Preparedness Act.
But I just want to state not in the form of a question, but
the juxtaposition of an act taken by the House Republicans last
week that would result in drastic cuts to our public health
programs and our research initiatives, and cuts that would
undermine our Nation's competitiveness, as well as our safety,
our public health, and our security, and leave us completely
unprepared for the next public health emergency.
I certainly stand with many of my colleagues who have
voiced concern about that in opposing the measure that the
House Republicans passed last week. Look, in the last Congress,
I worked closely with Ranking Member Cassidy on the Tracking
Pathogens Act.
It enhances our ability to prepare for future pandemics by
strengthening efforts to identify new viral threats through
genomic sequencing. Thanks to genomic sequencing, the U.S. has
been able to identify, survey, and understand emerging variants
of COVID-19 and other diseases, but our work really must
continue.
The Tracking Pathogens Act was signed into law as part of
the Fiscal Year 2023 omnibus. But unfortunately, there is no
sustained funding for this work. Dr. Walensky, can you describe
why sustained funding for CDC's sequencing efforts, including
through the Advanced Molecular Detection Program, is critical
to preparing us for future public health emergencies?
Dr. Walensky. Yes. First of all, thank you, Senator
Baldwin, for all of your efforts on--your bipartisan efforts in
our ability to track pathogens and to track the Coronavirus
through our genomic sequencing.
We were doing at times tens of thousands of sequences a
week so we could see, and we continue to do it now biweekly to
see where and what pathogens and sub-variants are occurring. It
is also the case that we know now that we have this, and we can
do this, that we have massive capacity to be able to do this
for other viral pathogens, for bacterial pathogens,
antimicrobial resistance, and fungal pathogens.
We have a capacity here to make great strides. However,
again, once we have ramped up, if we let it run dry, then we
will not be taking advantage of all of that capacity. I will
also note, I invite all of you to visit your state public
health labs. If you go to your state public health labs, and I
have been to a lot of them, you will see a really frail public
health infrastructure and laboratory infrastructure.
Do you have a genomic epidemiologist that can actually do
this work? Do you have a sequencer onsite that can actually do
this work in your labs? And part of the construction
authorities that I think the ASPR is talking about is to
develop that capacity in your own state labs so that we cannot
only have the resources to do this genomic sequencing, but then
have the places and homegrown people that are. Able to do it.
Thank you.
Senator Baldwin. Thank you. BARDA has recently begun to
explore new types of platform capabilities for emerging
threats.
I believe that as we work to prepare for the future, we
must focus on the development of medical countermeasures for
viral families with the greatest pandemic potential. And
flexible platforms can rapidly pivot to address previously
unknown pandemic threats.
That is why I have led the Disease X Act, which would
dedicate resources to this particular goal. Ms. O'Connell, how
can Congress support BARDA in better prioritizing the
development of medical countermeasures against the viral
families that present the greatest pandemic potential?
Ms. O'Connell. Senator, thank you so much for that
question. You know, BARDA is one of the premier research
organizations within the Federal Government, but it is an
unsung hero in a lot of ways. It doesn't get a lot of credit. I
am grateful for a question and an opportunity to talk about
them.
They have begun to pivot, as you have said, to this
platform technology, and we are seeing some of the advantages
of that in the mRNA vaccine, where you can just clip one little
piece of the virus and switch it out and very quickly ramp back
up production. So, we are exploring that against a pandemic
flu.
What would it mean? We have invested $100 million to see
what it would mean to transition that technology into a
pandemic flu vaccine. So that work is underway, but BARDA is
also asked for in Fiscal Year 2024 $60 million for threat
agnostic countermeasures, which are going against the broad--
you know, we used to be one bug, one drug, and now we are
looking at what we can do for multiple drugs against multiple
bugs.
That work is underway. We have it in our budget, and we are
continuing to look for different applications of the various
countermeasures we are currently developing. Senator Baldwin.
Thank you. The Chairman. Thank you. Senator Cassidy. Senator
Cassidy. I defer to Senator Braun. Senator Braun. Thank you. I
have two questions. One for Dr. Califf and one for Dr.
Walensky. I am going to start first with you, Dr. Califf.
Senator Johnson and I sent you a letter earlier this week.
You have got an upcoming hearing on cellular tissue and
gene therapies through your advisory committee concerning a new
muscular dystrophy drug, treating the Duchenne variety of it.
Unlike most hearings, this one is being done virtually. It is
prohibiting the use of cameras.
It is choosing from the patient segment by lottery who can
speak up.
Diseases like this and many others where it is very
progressive, maybe has a short prognosis window, especially
when there is something happening on the front that may be
promising, why would you go from the normal format to this, de-
emphasizing the patient component of it?
Dr. Califf. Senator, thanks for the question. The
technology obviously is exciting. And this is an advisory
committee, not a hearing, so to speak. And it is really
following all the same rules that we have for all of our
advisory committees.
The goal is to have experts to give advice about the
assessment of the technology as the company presents its data,
and the patients have a chance for their input at the open
hearing, but there is a limited amount of time and so that is
why there is a lottery.
It is not a deviation from our standard procedure. We are
really using our standard procedure.
Senator Braun. How long that standard procedure been in
place then?
Dr. Califf. Years, as best I know. I was an Advisory
Committee Chair 20 years ago----
Senator Braun. You are not reducing the amount of patient
participation?
Dr. Califf. Not that I am aware of, but if----
Senator Braun. I could look into that. And did you get the
letter that we sent to you?
Dr. Califf. I am aware that the letter came in, yes.
Senator Braun. Okay. I think I have been at the forefront
of Promising Pathways Act. To me, on some of these diseases
that have clinical trials that are working, drugs that are
promising, I probably shouldn't have the same kind of dynamic
as something that has less urgency where there are at least
other treatments out there.
Do you view that should be maybe looked at, keeping most of
the gold standard that you always refer to? But since a lot of
these windows don't surpass more than 3 to 5 years, should
there be a little different way of doing it?
Dr. Califf. Well, I completely agree on that. And in fact,
in the user fee agreement that you all approved between us and
the industry, we are hiring about 150 people just in this area,
additional people to focus on it because it is exploding right
now with biological technology that holds great promise.
Senator Braun. Well, that is good to hear because it is now
bipartisan, bicameral, on a Promising Pathways Act with Senator
Gillibrand from New York, which would address this and codify
it. I will send it to your office and hopefully we will get
your endorsement on it. Thank you.
Dr. Walensky, we have had a conversation several times in
the past. Of course, we are lifting the Federal vaccine
mandate, the public health emergency here on May 11th. I will
not forget easily all the angst that was out in the small
business community when we had to put a congressional review
act out to make sure you weren't going to force vaccines on
employees down to employers of 100 employees.
That had more fright when it was in the rearview mirror and
it was coming down, and it took the Supreme Court to come in
and thwart that bad idea. I would like to know if that was your
recommendation, Dr. Fauci's?
It was a Biden administration that did it. Who was going to
push forward that was a good idea before we had to come in and
intervene with the Congressional Review Act and then get the
Supreme Court to weigh in?
Dr. Walensky. Yes, maybe what I will say is, here we are
now in 2023, when we have 96 percent of people who have
protection by one way or another, either infection, prior
infection or by vaccination. At the time, we were seeing our
workforce and police departments, first responders who were----
Senator Braun. This wasn't that long ago. This was just
last year where you had--maybe it wasn't 96 percent, but--when
you and I had a conversation, we knew that it ravaged the
elderly, and it was clear that it wasn't going much more deeply
into the rest of the population.
The trillions of dollars that we spent and the fact that
the economy was shut down for that long, I think, led--you
know, that was much slower to react to the real science and
maybe not the political science.
I am just wondering if you and Dr. Fauci, and who were the
ones that kept pushing forward on that one issue of the vaccine
mandate for employees, private employers, down to 100
employees?
Dr. Walensky. I can tell you that there is a group of us
that advises the President on these Presidential proclamations.
I will also say that to this day, we know that our Bivalent
boosters still have 2.7 times the protection against death if
you have gotten a Bivalent boost than if you haven't. So, we
still know that these vaccines continue to provide protection
for people across all age demographics.
Senator Braun. Thank you. By the way, Dr. Fauci, in a
lasting interview, said that he would probably never recommend
shutting the economy down again for something similar to that,
FYI. Thank you.
The Chair. Senator Kaine.
Senator Kaine. Thank you, Mr. Chair. And thanks to the
witnesses. I am a public health data geek because, like Senator
Hickenlooper, I was a Mayor, Governor, Senator, like the Chair
who was a Mayor. We have the experience of seeing the silos,
local health systems, and state health systems, and in Federal
health systems that don't really share that way with each
other.
Then you have all the providers too, and that created huge
challenges for us early in COVID. I mean, just to kind of run
back to tape, at the beginning of COVID, it was hard even to
get racial information about those who were getting COVID and
dying of it.
It took us a while to realize, and it took a lot of kind of
jerry rigging to realize, okay, this was affecting African
American and Latino more than others. But we didn't know that
right away. And with a better health data system, we would
have.
Often minorities are lower income, and so they have had
less health care access, which has given them more health co-
morbidities, which makes them more susceptible to serious cases
of COVID. Often, racial minorities were working in professions
like home health care aides or grocery store clerks, where they
couldn't just go virtual all of a sudden, so they had more
exposure to COVID.
But it took us a while to figure that out. Then we did
figure it out. And when we started to vaccinate in early 2021,
beginning with populations over age 65, we figured out pretty
quickly that even though it was equally available, over 65
first come first serve, that it wasn't really equitable and it
wasn't effective because the communities that needed it--that
were the most vulnerable, need it the most, were not the ones
who were sitting on their computer to find the nearest CVS
where they could go get a vaccine.
They didn't have computer access. They didn't have the free
time to do it the way some people had. But because we had
figured that out, we were then able to change vaccination
strategies to try to get to not just equality but equity and
effectiveness. But it is just an indication of there is a
million ways where the lack of a functioning public health data
system slows down our response, slows down our ability to have
effective interventions keeping people safe.
I have worked with colleagues on this Committee for a long
time on something we call the Improving Data in Public Health
Act. And some of the pieces of that Act have been included in
earlier appropriations omnibuses, but there are other pieces
that I still think we need to include.
Dr. Walensky, in your opening testimony, I heard just the
back end of it when I came in, talk a little bit--you mentioned
the public health data. Talk a little bit about how better
public health data systems that interoperate can help the CDC
do a better job and help keep us all safe.
Dr. Walensky. Thank you, Senator, and thank you for your
interest in this. And the State of Virginia, actually. The
State of Virginia has been one of those states that has piloted
with CDC and the USDS a combination of case reporting, lab
reporting, and surveillance, too, so that we do have a better
window.
The case that you brought up with COVID is exactly right.
We were unable to see the race and ethnicity data. And oh, by
the way, it happened again with Mpox. We have the same
challenge with Mpox. We had a public health emergency that was
declared 3 days after--that it turns out the peak number of
cases, and we again could not see the race and ethnicity data.
We could not see the places where vaccines were going into
arms, as we were trying to make decisions about a scarce
resource, vaccine deployment with my colleague here to and from
the ASPR, as we were making those decisions. We can't act
swiftly, nimbly, robustly if we can't see what is happening
from a data standpoint.
Those--if we wait for the public health emergencies to be
declared, and then state by state data use authorizations and
data use agreements to happen, it takes months. It took us 6
months to get hospitalization data in COVID-19.
These things--if we are to be nimble, even if we have
remarkably robust interoperable data systems, if there is
nothing driving on those highways, we will not be able to be
nimble and see what is going on.
Truly, we want to have those data at CDC so that we can
give them back to state and local health departments. Thank
you.
Senator Kaine. I hope as we find a way to a big win in this
area, that we could include much more robust data, that
obviously protects people's personal identifying information,
but that just gives our health care professionals the tools
they need.
Dr. Califf, I have heard a lot from my constituents about
drug shortages, and we sent you a letter recently to with about
15 colleagues just asking, hey, what can the FDA do to work
with stakeholders to identify factors that lead to shortages? I
would just like you to, as I close, just tell me that I hope
you are prioritizing this because I am nervous about it.
Dr. Califf. As infant formula has gotten better, I have
gone now to almost full-time drugs shortages because we have
hundreds of short--200, over 200 in the last year we preempted
by working with the manufacturers.
But it is, that number is going up. We are keeping the
actual shortages at the same level, but our employees can only
plug a certain number of holes in a system which has got real
problems, particularly the generic drug pipeline.
We have got a lot of work to do. We have asked, as I said
in my opening statement, perhaps if we had better data so that
we can get out in front of this more. There is a lot more to it
than that, and I look forward to working with you on it.
Senator Kaine. Thank you. Thank you, Mr. Chair.
The Chair. Senator Cassidy.
Senator Cassidy. Hey, thank you, again. Let me echo what
Senator Romney said. I do think all of your employees were
working tirelessly through the pandemic, and I really
appreciate that. Ms. O'Connell, you are a Tulane grad.
Congratulations on a great football season. Top ten--that
is really good. So let me say that. Ms. O'Connell, we have
witnesses on the second panel that are going to suggest drug
pricing policies that they say would increase access to medical
countermeasures.
Now, I raise that because I hear from experts that medical
countermeasure development is uniquely challenging, that many
of these companies are small companies, that many of the
companies that BARDA contracted with went bankrupt and others
got bought by bigger companies, and that bigger companies are
getting out of medical countermeasures. Is that a fairly
accurate depiction of the state of play?
Ms. O'Connell. Senator Casey--Cassidy, thank you for that
question and thank you for the good wishes for the Green wave.
Appreciate that. We are very proud. It doesn't happen a lot.
But to your question, the type of company that we have to
work with are often small biotech companies because there isn't
a commercial market for countermeasures, typically. So, we do
have to work with the smaller companies that have to come in,
are willing to be innovative in a certain way, willing----
Senator Cassidy. Can I stop you for a second? It is my
impression that a lot of those companies are living on venture
capital and actually have not turned a profit before their
first big product. Again, is that a fair characterization?
Ms. O'Connell. We often support the work that they are
doing in order for them to be able to be successful.
Senator Cassidy. If you were to put restrictions on what
medical countermeasure developed could be priced for, perhaps
without knowing all the variables, and if there are--you know,
this is an example, because I think it is a fair example--that
there is really no secondary use, it is for this particular
issue, would that be encouraging of the financing, the private
financing of these firms, or if you will, discouraging?
Ms. O'Connell. Well, let me first say that we remain
committed to making sure that any Government funded----
Senator Cassidy. I have limited time.
Ms. O'Connell. Countermeasures are available to people--to
everyone in America that needs them. So, we are very committed
to that. But there is a risk if we were to add some limitations
in the contracting, that we limit the number of companies that
are willing to come forward and do this work.
Senator Cassidy. You would limit the number of companies
and the number of companies is already limited.
Ms. O'Connell. There is a risk.
Senator Cassidy. Yes. Dr. Califf, good to see you. You are
looking fit, man. Let me just compliment you right off the bat.
Another suggestion, as regards how to develop some of these
products is to incentivize innovation with an x price, a large
sum of money. But that would be in lieu of patent and
regulatory exclusivity.
I don't know if you can comment on the finances of this,
but do you think an x price would be an adequate substitute for
one of these companies in lieu of the patent and regulatory
exclusivity?
Dr. Califf. Well, you know what a complicated question you
just asked. And what I will say is the prices of drugs,
innovative drugs, I believe, are too high. But the solution to
that problem shouldn't, in my view, be to do away with patents.
They serve a vital role in stimulating the kind of thing
you were just discussing. But where are the balances between
those two and the role of prizes? That is a longer discussion.
I don't think it's an either-or situation.
Senator Cassidy. But in general, the intellectual property
protection plays a critical role in incentivizing innovation.
Dr. Califf. Absolutely. And we just got sued today, again,
by a company over that issue. So, it is very important. If
people are going to invest in these companies, there has to be
intellectual property protection.
Senator Cassidy. Ms. O'Connell, I am going to ask you a
question somewhat related to the last. There is a conversation
about having what is called ``reasonable pricing'' clauses that
would dictate the price of something should it enter into the
commercial market. Now in general, is there a commercial market
for most of the things which BARDA is funding?
Ms. O'Connell. In general, there hasn't been. Of the 70
products that we have had licensed, very few of them are
available on the commercial market.
Senator Cassidy. Now, I think I have data showing that the
NIH had reasonable pricing clauses from 1990 to 1995, and after
they removed them, the amount of--you know, here is the kind of
production of drugs, and then they removed it, and it took off.
Now, that may be an association, not a causation. But in
your sense, do you think that a reasonable pricing clause would
make a company more or less willing to work with BARDA on
medical countermeasures?
Ms. O'Connell. We would have to take a look at that. But
like I said, there would be a risk in adding an additional
contracting element to the work that we are doing.
Senator Cassidy. I have more questions, but I have no time.
Thank you.
The Chair. The questions you raised a very interesting and
I look forward to discussing them in the future. Senator
Markey.
Senator Markey. Thank you, Mr. Chairman, very much. So
earlier, I think, Dr. Walensky, you said that--by the way,
congratulations on the great year that the Harvard football
team had up there. So, congratulations.
There is kind of a tale of two pandemics here, with 250
people a day still dying. And so, can you talk about that
cohort, who they are, and what the message is to them, as the
medical emergency in general ends?
Dr. Walensky. Yes. So as the public health emergency is set
to end next week, I do want to just reiterate that we at CDC
are not changing the steam at which we are working through this
resolving public health emergency.
You know, as we look at the kinds of people who continue to
pass from COVID-19, they tend to be elderly, they tend to be
more vulnerable. They tend to be those who are not vaccinated
are not up to date on their vaccines.
As we look at those numbers, they are more fragile people
and people who are not up to date. It is the case of the end of
the public health emergency, we will have less window as to the
data, and that is among the things that we have been talking
about. We will lose our percent positivity.
We won't get laboratory reporting, we won't get case
reporting. So, we will lose some of that. With regard to what
we are doing as we touch as we talked to these vulnerable
communities, we have been doing a lot of work in CDC to address
our disabled communities, our vulnerable communities, our
elderly communities.
Among those things is with every response now we have a
chief health equity officer and a disability officer. We have
been working with our colleagues at ACL. We actually have a
meeting tomorrow to discuss with the disability community the
impact of the end of the public health emergency and what that
means.
We have been putting disability experts within--working
with our partners to put disability experts within states so
that they have resources and references within their local
communities to understand the impact of COVID-19 and other
respiratory threats.
Senator Markey. For those--for that cohort, people over 65
people, with preexisting conditions, immunocompromised, they
still have to act as though the pandemic is still going on, in
terms of protecting themselves.
Because you can be in a culture where everyone else is
saying we are back to normal, but for them, it is not back to
normal in terms of what they need to do to protect themselves.
Is that the message?
Dr. Walensky. Last week, actually, we provided an update to
the Bivalent boosting recommendations so that community could
actually get an access to another dose.
As part of the end of the public health emergency, among
the things that we would like to do is provide data on
hospitalizations, local data on hospitalizations so people can
see the hospitalization rates happening in their communities
and make decisions as to whether or when they want to take
active measures.
Senator Markey. Yes. Thank you. So, they should still act
as though they are still in a pandemic in terms of the
vaccinations, the bivalent protections. Yes, I think that is a
very important signal because it is a tale of two pandemics.
Those people are still out there that--it is 250 a day. That is
1,700 a week times 52 weeks a year.
That is a lot of people who are going to be affected. Dr.
O'Connell, the planet is sick and there are no emergency rooms
for planets, and we see the effects in New Orleans, in other
places, with climate change just having devastating impacts on
communities, which then affects the health care system in those
communities and could be delaying or denying people access, for
example, to opioid treatment methadone treatment, whatever,
when the storm hits, when the system collapses.
Can you talk about what you do in order to make sure that
system is strengthened or needs strengthening across the
country? Because we can really predict, almost guarantee that
we are going to see intensifying storms in our Country.
All experts, all meteorologists, climatologists are saying
that. What do we need to do for our public health system to
make sure that it is more capable of responding?
Ms. O'Connell. Senator Markey, thank you so much. We are
seeing an increase in storms. In fact, FEMA talks about a poly
crisis state where we are seeing the increase in flooding and
in fires, the intensity of storms that are happening.
We are continuing to ramp up our response elements. That is
one of the reasons why the authorities we have asked for in the
new PAHPA bill are so important. They would allow us to hire
more responders, get more people on the ground, search quicker,
be able to procure the tools we need in a faster way.
We are looking across all of those things in the new
landscape that we are living in to make sure that we are
strengthening what we need to have on the ground.
Senator Markey. Thank you. And thank you all for the
historically great work which you did to have our Country
respond the way it did. So, thank you so much, and we will try
to get you the additional resources you need. I think your
recommendations are going to be well received. Thank you.
The Chair. Thank you, Senator Markey. Senator Hickenlooper.
Senator Hickenlooper. Thank you, Mr. Chair. I thank all of
you. It has been a while. Dr. Califf, I am not sure you are
looking that fit, with all due respect.
Look a little tired, obviously, that you are doing one of
the hardest jobs--you all are, and certainly making sure we get
PAHPA put back together the right way with the proper resources
is going to be a big deal for all of us. So, we take that very,
very seriously.
Obviously, it is--how could we do otherwise? Dr. Califf, I
wanted to start. Obviously, an effective regulatory partner is
key to getting these platform technologies to the public in the
context of a pandemic.
The FDA has proposed a specialized program to handle the
emerging pathogen preparedness in your priorities for Fiscal
Year 2024. Can you speak to your vision specifically how the
agency might be able to handle the unique regulatory
considerations for these platform technologies?
Dr. Califf. Sure. We are constantly looking. We have got a
good discussion here today about platforms and how important
they are going to be in the future, where you can mix and
match, and insert a new element and come up with a new therapy
in a very short period of time compared to what it used to be.
That is a reality with messenger-RNA, but there are many
others.
We are asking for a team of people that are dedicated to
this, who can be looking to the future. It is included in some
of the things already in play, but we want to do more of it so
that we have these platforms ready to go.
Then you can depend on the platform, you don't have to redo
all the regulatory work that you would do if you were
developing a drug from scratch. Let me also quickly mention
relative to some of the questions, I am 71. I got my Bivalent
vaccine a few days ago, which is why I look a little tired.
[Laughter.]
Senator Hickenlooper. I was just kidding----
Dr. Califf. Trying to saw off a T-shirt as a demonstration
project, I still have the band aid, but my staff told me that
was not allowed in a Senate hearing.
Senator Hickenlooper. Let me suggest you go and have a 4-
month-old child at home. Then you will be really tired. Dr.
O'Connell, or Assistant Secretary O'Connell, sorry, COVID had
obviously these immense costs.
We have gone over again this morning the economic costs,
human costs. I do think important work will be done as we look
back over the entire arc of this pandemic. And again, I can
remember vividly I was just a couple of years out of being the
Governor.
I watched the decisions that were being made by Governors
all across the country and by all of us in Washington in real
time with an unbelievably limited information. The data just
wasn't there, the facts wasn't there.
But I think it will be useful to go back and look, given at
each time what information we had, did we make the right
decisions? I think we should be upfront saying that is--there
is no harm in that. Mistakes in a time of crisis--it. Is
impossible to get everything right.
One thing we did see was that regional co-ordination and
resilience were our key to weathering future pandemics.
Colorado, we have got the big city hospital, Denver Health, has
been a successful demonstration site for both the Regional
Disaster Health Response System and the National Special
Pathogens Program.
But neither of these have gotten permanent authorization.
They are just test cases. So, can you speak, as Assistant
Secretary, as to the success of this process, but also what the
likelihood is in terms of getting more continuity there?
Ms. O'Connell. Senator, thank you for that. I think you are
absolutely right. You know, we built the system where we looked
at coalitions locally and then expanded out regionally, and
then across nationally.
Frankly, COVID was one of the first major responses we have
dealt with, that we have needed a national response
immediately. So, to be able to have these strong places within
the country to lean on have been really, really important.
You mentioned our regional disaster response health
systems. At this point we have only funded four of those. So
only four regions have the benefit of what Colorado has. One of
the goals I have is to be able to expand that. So, it actually
is national, and we have one of those in each region that can
make sure we are coordinating across.
You know, you see how important that is in something like
COVID when the ICU was were overwhelmed and one hospital to
know where to go within the region. And the next one that could
take a bed was critically important.
The RESPTCs, the national special pathogens that you
mentioned, those came out of the COVID--of the Ebola response
in 2014 when we realized not every hospital could handle an
Ebola patient.
We set up this system across the country of regional
locations that were able to take those patients. And we have
trained them and continue to work them. I am really proud of
the success that they have had.
In fact, unfortunately, we have had to exercise them
recently with the Ebola Sudan outbreak in Uganda and the
Marburg outbreak we are seeing in Tanzania and Equatorial
Guinea, in case anyone came back, we needed to be sure we were
ready to handle and treat. So, very important capabilities.
Senator Hickenlooper. Well, I think we saw a lot of that.
Also, the regional response and resilience came from community
health centers of all the hospitals, as well as the research
places.
I mean, that did show the strength of our public health
care system. I will leave you with, each of you, I am out of
time, so you just have to think on it. But as we try to build
the various platforms and build a pandemic preparedness that is
worthy of the words, I think we have also got to be vigilant on
the creep of red tape and bureaucracy.
Already I am beginning to hear people saying, oh, my gosh,
I have to apply for this or talk about that, that. You know,
there is so much paperwork, there is so much process that we
have created because people are so worried about making a
mistake.
That is why I think it's important as the Senate reviews
the strength, the successes, the failures, the misses, the
hits, that we realize we are never going to get perfectly, but
there is real value to constantly be trying to find ways we can
limit the red tape and the bureaucracy. Especially in the FDA,
I think there is--there is less work to be done. Anyway, thank
you all for your public service.
The Chair. Thank you, Senator Hickenlooper. And that is, I
think, our last questioner. And we thank the panelists very
much for being with us today. And now we will hear from our
next panel. Convene our second panel, and we thank our
panelists for being here and for sitting through the first
panel.
Before I introduce our panelists, let me just say a few
words. I think sometimes it is important to take a 30,000-foot
look at the systems under which we live, and we don't do that
often enough. We deal with a crisis by crisis. In my view, we
are living with a health care system which is broken, and which
is dysfunctional.
We spend twice as much per capita on health care as any
other country on earth. $13,000 every year, which is
unsustainable. And yet, despite that, 85 million Americans are
uninsured and underinsured. We are seeing in many parts of this
country unbelievably, above and beyond COVID, a decline in our
life expectancy.
We have a half a million Americans who every year
experience bankruptcy, which is related to the medical debt
that they have. And we saw during the pandemic how unprepared
we were for the major health care crisis that hit us. There are
a lot of reasons for the dysfunctionality of our health care
system, but one of them, to me, is the outrageously high cost
of prescription drugs in this country.
What that means is that one out of four patients who
receive a prescription from their doctor are unable to afford
to fill that prescription. How absurd and counterproductive is
that? Because in too many cases, these folks are only going to
get sicker. Maybe they end up in the emergency room at a higher
cost to the system.
We see Medicare costs are extraordinarily high because they
pay very high prices for the prescription drugs that they
dispense, meaning that our deficit and national debt goes
higher. And all that together, we are losing about 60,000
people a year unnecessarily because they can't afford the
medicine they need or get to a doctor on time.
The questions that we have got to ask ourselves, well, is
our current prescription drug model working? Well, I guess it
is working for the pharmaceutical industry and the PBMs,
because they make tens and tens of billions of dollars a year.
Their CEOs make compensation packages of millions of dollars a
year.
Yet millions of people cannot afford the outrageously high
prices that we pay. So, the question that we have to ask is how
does it happen that we pay by far the highest prices of any
major country for prescription drugs? I have been with
Americans going to Canada where they got the medicine they
needed at one-tenth the price they are paying in the United
States, all right.
What I hope we will discuss is the dysfunctionality, in my
view, of the current model, and how we advance to another model
which does what we all want to do. Do we all believe that it is
terribly important that we have cutting edge prescription drugs
to save lives, to ease pain? Yes, we do.
Do we all understand that the best drug in the world is
meaningless if somebody can't afford it? Do we all understand
that we have a huge deficit, which is in some ways attributable
to the high cost of health care and prescription drugs in this
country?
What are the tools that we need? What should we be doing
that other countries do, where they provide prescription drugs
to their people at a fraction of the cost that we pay? So those
are some of the issues that I hope we will be discussing.
Senator Cassidy.
Senator Cassidy. Thank you, Chair. I have been so
efficient, I put away my opening remarks. Let's wing it. Thank
you, all. You all each bring a unique perspective to this
issue. We emerged from the pandemic with an understanding that
however robust PAHPA was in the past, it was not adequately
robust for the pandemic through which we just went.
They always say the generals fight the last war. I think
our generals actually plan for the next. In a sense, you are
the generals who are helping to plan for the next war. Now,
some things that we will be considering here are traditionally
a little far afield from PAHPA, but that is just the way the
Committee has been convened.
But nonetheless, I look forward to your input, and you all,
by the way, have very impressive resume, so let me just thank
you all for giving of your time to be here. Thank you.
The Chair. Okay. Thank you, Senator Cassidy. Our first
witness will be Dr. Reshma Ramachandran, who is an Assistant
Professor of Medicine at the Yale School of Medicine, an expert
in ensuring equitable patient access to safe and effective
health technologies. Dr. Ramachandran, thanks very much for
being with us.
STATEMENT OF RESHMA RAMACHANDRAN, M.D., M.P.P., M.H.S.,
ASSISTANT PROFESSOR OF MEDICINE, YALE SCHOOL OF MEDICINE, NEW
HAVEN, CT
Dr. Ramachandran. Chairman Sanders, Ranking Member Cassidy,
and distinguished Members of the Committee, thank you for the
invitation to testify today. My name is Reshma Ramachandran.
I am an Assistant Professor of Medicine at Yale School of
Medicine, where I co-direct an interdisciplinary research and
policy program called the Yale Collaboration for Regulatory
Rigor, Integrity, and Transparency.
I am also a primary care physician at a federally qualified
health center in New Haven, Connecticut. I am honored to
testify before you today. My remarks reflect my own views and
not that of my employers, nor the organizations I work with.
In 1 week, the declaration of COVID-19 as a public health
emergency will come to an end with this year's reauthorization
of paper becomes an opportunity to reflect on this period and
utilize the lessons learned from dispersing significant public
investment that led to the rapid and successful development of
vaccines and therapeutics.
To inform this legislation, Congress should answer the
following fundamental question, how can we ensure that the
American public has equitable access to medical countermeasures
developed in response to public health emergencies in the
future?
Looking back at the COVID-19 pandemic, the Federal
Government effectively removed manufacturers' risk and
developing and producing urgently needed vaccines and
treatments by granting direct public investment, as well as
access to scientific expertise, and resources across agencies.
In return, however, the American public, who underwrote
these investments, have received little guarantee that they
will have equitable, sustainable access when the public health
emergency period ends. Instead, manufacturers have announced
plans to raise prices exorbitantly, ignoring that even lower
pandemic prices, they have been able to reap billions in
profit.
Without intervention from the Federal Government, my most
vulnerable patients, including those without health insurance,
as well as those at higher risk of severe illness, will
disproportionately bear the burden of such untethered price
hikes. While current policies offer some measure of protection
for insured Americans in removing cost sharing for vaccines,
they too will likely confront these prices indirectly in the
form of higher premiums.
The Federal Government, in procuring vaccines and
therapeutics, will also bear these expected increased costs.
Further increasing taxpayer spending on these publicly funded
medical countermeasures will mean that there will be less money
and resources available for other critical public health
interventions to prevent future resurgence or address other
threats.
Moreover, based on trends that we studied in public and
private procurement of another publicly funded vaccine, that of
influenza, these initial COVID-19 vaccine prices following the
public health emergency period will likely be the floor for
continued price hikes in the future.
What must Congress conclude as a part of PAHPA to protect
the American public and their investment? First, Congress
should empower the Federal Government to exercise necessary
leverage when allocating funds for the development of medical
countermeasures and negotiating procurement contracts.
Through bulk purchasing agreements, the Government could
mitigate the impact of substantial price increases through
negotiated lower price, as they did during the COVID-19
pandemic.
To further prevent these prices from continually rising
year after year, as they have with other vaccines, the
Government should call for a ceiling price to be upheld.
Additionally, similarly to what has--what they have been able
to negotiate in a few contracts, the Government could also
ensure that manufacturers give them the best price compared to
that of other high-income countries.
Besides securing reasonable pricing provisions, the Federal
Government must not sacrifice access and compliance safeguards
within these contracts under the guise of flexibility and
speed.
Use of contracting mechanisms such as other transactions
authority hinder the ability of the Federal Government to
remove unnecessary access barriers to taxpayer funded medical
countermeasures such as unaffordable pricing. Instead,
allocation of any such funds should be tied to provisions that
confirm that the supported medical countermeasure is indeed
safe and meaningfully effective.
During an ongoing public health emergency, it may be
acceptable for residual uncertainty of these products to remain
at the time of market authorization. However, the Federal
Government must condition taxpayer funding on the completion of
additional studies that verify that they do indeed work as
intended, and that answer other important public health
questions beyond FDA authorization and approval.
Understanding how different treatments and vaccines compare
to one another or across different populations would better
inform the Government in determining how many doses to procure
of each individual product and at what price. Without a doubt,
COVID-19 demonstrated how effective the Government can be in
spurring the rapid innovation of medical countermeasures.
However, the success of these efforts should not only be
measured by whether these medical products reach the market.
Rather, Congress must ensure that success under PAHPA is
redefined as a Government acting as an effectual steward of
taxpayer funds and ensuring equitable access of truly effective
and safe health technologies in return. Thank you.
[The prepared statement of Dr. Ramachandran follows:]
prepared statement of reshma ramachandran
Chairman Sanders, Ranking Member Cassidy, and distinguished members
of the committee, thank you for the invitation to testify today. My
name is Reshma Ramachandran. I am an Assistant Professor at Yale School
of Medicine where I co-direct an interdisciplinary research and policy
program called the Yale Collaboration for Regulatory Rigor, Integrity,
and Transparency (CRRIT). Through CRRIT, we study medical product
evaluation, regulation, and coverage and translate these findings with
the aim of improving patient health outcomes.
I am also a primary care physician at a federally qualified health
center where I see and take care of patients, many of whom are
uninsured or underinsured and face significant, but unnecessary
barriers to accessing the treatments I prescribe. Additionally, I lead
the Doctors for America Food and Drug Administration (FDA) Task Force,
which is an independent group of physicians across specialties who
provide unbiased expertise in evaluating and responding to the FDA
regulatory process in a way that maximizes meaningful clinical outcomes
for our patients. My written remarks reflect my own views and not that
of my employers nor the organizations I work with.
The past 3 years of the COVID-19 public health emergency have
demonstrated the incredible capability of the Federal Government in
fostering and supporting targeted innovation to rapidly develop and
make available novel health technologies amid a devastating pandemic.
Not only did American taxpayers contribute billions in direct funding
for the discovery, development, production, and distribution of COVID-
19 diagnostics, vaccines, and drugs, \1\, \2\ they also indirectly
contributed resources, personnel, and expertise through Federal
agencies that enabled the successful innovation of these technologies.
\3\, \4\ Now, in just 1 week, the declaration of COVID-19 as a public
health emergency will come to an end. With this year's reauthorization
of the Pandemic All-Hazards Preparedness Act (PAHPA) comes an
opportunity to reflect on this period and utilize the lessons learned
from disbursing this significant public investment. To inform this
impending legislation, Congress can answer the following fundamental
question:
---------------------------------------------------------------------------
\1\ ``COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic
Development, but More Transparency Needed on Emergency Use
Authorizations'' (Washington, DC.: Government Accountability Office,
November 2020), https://www.gao.gov/assets/720/710691.pdf.
\2\ Biomedical Advanced Research and Development Authority,
``BARDA'S Rapidly Expanding COVID-19 Medical Countermeasure
Portfolio,'' accessed May 2, 2023, https://
www.medicalcountermeasures.gov/app/barda/coronavirus/COVID19.aspx.
\3\ ``NIH Launches Clinical Trials Network to Test COVID-19
Vaccines and Other Prevention Tools,'' NIH.gov, July 8, 2020, https://
www.nih.gov/news-events/news-releases/nih-launches-clinical-trials-
network-test-covid-19-vaccines-other-prevention-tools.
\4\ U.S. Food and Drug Administration, ``Coronavirus Treatment
Acceleration Program (CTAP),'' FDA.gov (FDA, January 24, 2023), https:/
/www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-
acceleration-program-ctap.
---------------------------------------------------------------------------
How can we ensure that the American public has equitable access to
medical countermeasures developed in response to public health
emergencies in the future?
In my written testimony, I will outline a few select principles and
policies for lawmakers to consider as part of PAHPA toward enabling a
fair return for the Federal Government as well as the American public
for the significant public investment made to address public health
emergencies.
The Federal Government must require rigorous evidence to be generated
of medical countermeasures demonstrating safety and efficacy.
During a public health emergency (PHE) when the American public is
at grave risk of disease, FDA can employ flexibilities such as
emergency use authorization (EUA) to quickly evaluate and authorize
unapproved medical products. Over the course of the COVID-19 PHE, FDA
awarded numerous EUAs to vaccines, diagnostics, and drugs while
continuing to assess additional safety and efficacy data to determine
if the product should remain on or be withdrawn from the market. \5\
Amid an ongoing PHE, it may be necessary for the FDA to allow market
access to medical countermeasures despite having residual uncertainty
of their safety and efficacy at the time of authorization or approval.
However, this must be coupled with requirements for pharmaceutical
companies to conduct studies to confirm that their medical products are
indeed safe and meaningfully effective.
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\5\ Office of the Commissioner, ``Emergency Use Authorization,''
FDA.gov (FDA, May 2, 2023), https://www.fda.gov/emergency-preparedness-
and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-
authorization.
For COVID-19 vaccines, FDA established rigorous regulatory
standards for EUA of potential candidates, requiring large and diverse
participant enrollment into randomized-controlled trials with clinical
endpoints. \6\ The agency also set parameters for the clinical trial
design, calling for them to be placebo-controlled and double-blinded
with adequate follow-up of participants. These standards were also
discussed publicly with independent experts through the Vaccines and
Related Biologic Products Advisory Committee (VRBPAC) and others. \7\
FDA also issued draft guidance on these regulatory standards allowing
for feedback through a public comment period. \8\
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\6\ U.S. Food and Drug Administration, ``Development and Licensure
of Vaccines to Prevent COVID-19: Guidance for Industry,'' June 2020,
https://www.fda.gov/media/139638/download.
\7\ Ravi Gupta et al., ``During COVID-19, FDA's Vaccine Advisory
Committee Has Worked To Boost Public Trust--It Can Still Do More,''
Health Affairs Forefront, accessed May 1, 2023, https://doi.org/
10.1377/forefront.20210225.712221.
\8\ U.S. Food and Drug Administration, ``Guidance Documents
Related to Coronavirus Disease 2019; Availability,'' August 3, 2020,
https://www.govinfo.gov/content/pkg/FR-2020-08-03/html/2020-16852.htm.
The National Institutes of Health (NIH) also played a pivotal role
in ensuring rigorous clinical trial design, particularly through their
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
program. \9\ Within ACTIV, NIH worked closely alongside other agencies
and the biopharmaceutical industry to develop and implement a
coordinated research strategy to move promising technologies more
expeditiously from the preclinical to clinical trial stage. Under
ACTIV, NIH also established several working groups where they convened
public agencies and manufacturers to develop clinical trial protocols
and harmonize efficacy trial designs for therapeutics and vaccines.
Additionally, NIH funded and led several clinical trials in
coordination with pharmaceutical company sponsors, providing critical
scientific expertise and access to NIH's own clinical trial networks
and others. \10\, \11\
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\9\ ``Accelerating COVID-19 Therapeutic Interventions and Vaccines
(ACTIV),'' National Institutes of Health (NIH), accessed January 19,
2022, https://www.nih.gov/research-training/medical-research-
initiatives/activ.
\10\ ``NIH Launches Clinical Trials Network to Test COVID-19
Vaccines and Other Prevention Tools.''
\11\ Francis Collins et al., ``The NIH-Led Research Response to
COVID-19,'' Science 379, no. 6631 (February 3, 2023): 441--44, https://
doi.org/10.1126/science.adf5167.
However, such regulatory rigor across medical countermeasures has
not been consistent. For instance, remdesivir was initially granted an
EUA in May 2020 based on evidence that it may be effective for the
treatment of severe COVID-19. \12\ Just months later in October 2020,
FDA granted its first full approval \13\ for remdesivir despite
conflicting evidence of its effect on time to recovery for patients who
are hospitalized and diagnosed with COVID-19. At the time of
traditional approval, infectious disease experts could only conclude
that remdesivir might work. \14\ Although FDA attempted offset this
uncertainty through 29 additional required and voluntarily committed
studies (more than three to four times the number typically required or
requested) \15\, \16\, none of the required studies addressed the key
question of whether in light contradictory results across clinical
studies, remdesivir did indeed decrease time to recovery for
hospitalized COVID-19 patients with less severe disease or reduce
mortality. \17\
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\12\ ``Coronavirus (COVID-19) Update: FDA Issues Emergency Use
Authorization for Potential COVID-19 Treatment,'' FDA.gov (FDA, May 4,
2020), https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-issues-emergency-use-authorization-potential-covid-
19-treatment.
\13\ ``FDA Approves First Treatment for COVID-19,'' FDA.gov (FDA,
October 22, 2020), https://www.fda.gov/news-events/press-announcements/
fda-approves-first-treatment-covid-19.
\14\ Paul Sax, ``Does Remdesivir Actually Work?,'' NEJM Journal
Watch, October 18, 2020, https://blogs.jwatch.org/hiv-id-observations/
index.php/does-remdesivir-actually work/2020/10/18/.
\15\ Joshua D. Wallach et al., ``Postmarketing Commitments for
Novel Drugs and Biologics Approved by the US Food and Drug
Administration: A Cross-Sectional Analysis,'' BMC Medicine 17, no. 1
(June 17, 2019): 117, https://doi.org/10.1186/s12916-019-1344-3.
\16\ Joshua D. Wallach et al., ``Postmarket Studies Required by
the US Food and Drug Administration for New Drugs and Biologics
Approved between 2009 and 2012: Cross Sectional Analysis,'' BMJ 361
(May 24, 2018): k2031, https://doi.org/10.1136/bmj.k2031.
\17\ John Farley, ``NDA Approval Letter for Veklury,'' October 22,
2020, https://www.accessdata.fda.gov/drugsatfda--docs/appletter/2020/
214787Orig1s000ltr.pdf.
Less than a year later, researchers from the Veterans Health
Administration published a study finding that remdesivir was not
associated with improved 30-day survival and that instead, it was
associated with an increase in time to hospital discharge. \18\ Had the
FDA required further evidence of the drug's efficacy ahead of
traditional approval or had imposed postmarketing requirements to
confirm its efficacy with adequate oversight to ensure timely
completion, the Federal Government could have possibly saved a
substantial amount rather than spending on excessive procurement and
reimbursement. \19\, \20\
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\18\ Michael E. Ohl et al., ``Association of Remdesivir Treatment
With Survival and Length of Hospital Stay Among US Veterans
Hospitalized With COVID-19,'' JAMA Network Open 4, no. 7 (July 15,
2021): e2114741, https://doi.org/10.1001/jamanetworkopen.2021.14741.
\19\ Eric M Tichy et al., ``National Trends in Prescription Drug
Expenditures and Projections for 2022,'' American Journal of Health-
System Pharmacy 79, no. 14 (July 15, 2022): 1158--72, https://doi.org/
10.1093/ajhp/zxac102.
\20\ Karyn Schwartz and 2020, ``How Could the Price of Remdesivir
Impact Medicare Spending for COVID-19 Patients?,'' KFF (blog), July 14,
2020, https://www.kff.org/coronavirus-covid-19/issue-brief/how-could-
the-price-of-remdesivir-impact-Medicare-spending-for-covid-19-
patients/.
Besides maintaining rigorous standards for FDA regulatory review
and approval, the Federal Government could also ensure that further
studies are conducted that are scientifically meaningful for public
health. For instance, although the Federal Government made several
investments across various vaccine candidates and provided scientific
guidance, personnel, and additional resources including access to
clinical trial networks, manufacturers were not required to conduct
head-to-head vaccine trials to compare efficacy and safety were
conducted. Such studies would allow the Federal Government to better
understand if vaccine products have differential effects across
populations. Moreover, this would also allow the Federal Government to
be a better steward of public funding when negotiating procurement
contracts with manufacturers for bulk purchase agreements to ensure
that the American public has access to the most appropriate medical
countermeasures.
Case Study: Low FDA regulatory standards for FDA approval of
antibiotics have yielded drugs of unclear clinical benefit
Updated estimates paint a sobering picture of the human and
economic toll of antimicrobial resistance. In 2019, 1.27 million deaths
globally were estimated to be attributable to bacterial antimicrobial
resistance \21\ and the CDC estimates that 35,000 in the U.S. die
because of resistant bacterial infections. \22\ Additionally, the CDC
in collaboration with academic researchers has estimated that treatment
of the six most alarming antibiotic resistant pathogens contribute to
more than $4.6 billion in health care costs each year. \23\
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\21\ Christopher JL Murray et al., ``Global Burden of Bacterial
Antimicrobial Resistance in 2019: A Systematic Analysis,'' The Lancet
0, no. 0 (January 19, 2022), https://doi.org/10.1016/S0140-
6736(21)02724-0.
\22\ ``COVID-19: U.S. Impact on Antimicrobial Resistance, Special
Report 2022'' (National Center for Emerging and Zoonotic Infectious
Diseases, June 14, 2022), https://doi.org/10.15620/cdc:117915.
\23\ Richard E Nelson et al., ``National Estimates of Healthcare
Costs Associated With Multidrug-Resistant Bacterial Infections Among
Hospitalized Patients in the United States,'' Clinical Infectious
Diseases 72, no. Supplement--1 (January 15, 2021): S17--26, https://
doi.org/10.1093/cid/ciaa1581.
While exigency is certainly warranted for addressing antimicrobial
resistance, this global public health threat differs from COVID-19 in
terms of urgency of action and disbursement of federally funded
incentives. COVID-19 with its rapid spread and resulting substantial
mortality and morbidity required immediate action with the acceptance
of some level of uncertainty in evaluating and authorizing new
diagnostics, vaccines, and drugs. In contrast, for antimicrobial
resistance, the Federal Government can take strategic steps in
allocating public funding and resources to ensure equitable access for
the American public to truly effective and safe treatments and other
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health technologies.
Instead, stakeholders including the pharmaceutical industry have
urgently called for the adoption of costly pull incentives for drug
manufacturers without clear assurance or safeguards that the
antimicrobials yielded are clinically beneficial or effective against
future resistant pathogens. \24\, \25\ Under the Pioneering
Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act,
manufacturers of newly approved antimicrobials would be eligible to
receive as much as $3 billion in regular installments over a five to 10
year contract period for an individual drug. \26\ An additional $1
billion could also be allocated as an extension of the initially
contracted period or given ahead of FDA approval for a promising
antimicrobial drug candidate. However, absent from this lucrative award
for drug manufacturers is a requirement that eligible drugs improve
patient health outcomes. Instead, it is one of several ``favored
characteristics''; among these is that a drug would be eligible for
valuable subscription contract if it has received a prior
``transitional subscription contract.'' Eligibility for such a
transitional includes that the drug has received the FDA ``qualified
infectious disease product'' (QIDP) designation and has been developed
to treat resistant infections listed within CDC's most recent
``Antibiotic Resistant Threats in the United States'' report.
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\24\ Andrew Jack, ``Drugmakers Eye Government Money to Combat
Antibiotic Resistance,'' Financial Times, October 27, 2022.
\25\ Reshma Ramachandran and John H. Powers, ``Why the PASTEUR Act
Is No Cure for Antimicrobial Resistance--The Hill,'' The Hill, December
13, 2022, https://thehill.com/opinion/healthcare/3773180-why-the-
pasteur-act-is-no-cure-for-antimicrobial-resistance/.
\26\ Michael F. Bennet, ``PASTEUR Act of 2021,'' Pub. L. No. S.
2076 (2021), https://www.Congress.gov/bill/117th-congress/senate-bill/
2076/text.
Examination of recently approved antimicrobials including those
granted the QIDP designation by the FDA has shown that the agency
approves treatments of unclear benefit and at worst, antimicrobials
that are less effective than what is currently available. Prior
characterization of pivotal clinical trials for FDA-approved
antibiotics (including a small number awarded the qualified infectious
disease product or QIDP designation) between 2010 and 2015 have shown
that most of these trials were noninferiority studies with none
evaluating direct patient outcomes as a primary endpoint. \27\ A more
recent study of antibiotics approved by the FDA between 2016 and 2019
found that all drugs, many of which were designated as QIDPs, were
approved based on surrogate endpoints. More than half of the pivotal
trials supporting their approval also used a non-inferiority design,
which means that the drugs can be either marginally better or worse by
some amount than older, effective alternatives. \28\ The study authors
also found these new antibiotics despite uncertainty of their clinical
benefit at the time of approval were frequently more expensive than
other effective alternatives.
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\27\ Dalia Deak et al., ``Progress in the Fight Against Multidrug-
Resistant Bacteria? A Review of U.S. Food and Drug Administration--
Approved Antibiotics, 2010--2015,'' Annals of Internal Medicine 165,
no. 5 (September 6, 2016): 363, https://doi.org/10.7326/M16-0291.
\28\ Mayookha Mitra-Majumdar et al., ``Evidence at Time of
Regulatory Approval and Cost of New Antibiotics in 2016-19: Cohort
Study of FDA Approved Drugs,'' BMJ Medicine 1, no. 1 (December 1,
2022), https://doi.org/10.1136/bmjmed-2022-000227.
In an ongoing research study examining the evidentiary basis for
approval of QIDP indications, we found that over 20 percent were
approved based on in vitro studies and a majority were tested in non-
inferiority pivotal trials, which as noted earlier, allow for
intervention drugs to be less effective compared with older, effective
antimicrobials by a prespecified margin. \29\ Moreover, nearly half of
the QIDP indication pivotal trials failed to enroll patients with
potential or confirmed resistance. In fact, the FDA only confirmed
efficacy against any resistant pathogens for less than a third of these
indications based on their pivotal clinical trials. Moreover, FDA has
not required manufacturers to conduct further studies after approval to
confirm clinical benefit, superiority compared to other effective
alternatives, or clinical efficacy against resistant bacterial
infections. This suggests that these financial incentives in the form
of assured high revenues may be misaligned, rewarding manufacturers of
QIDPs for unclear effectiveness against resistant pathogens, despite
receiving this special designation intended for this purpose.
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\29\ Food and Drug Administration, ``Non-Inferiority Clinical
Trials to Establish Effectiveness: Guidance for Industry,'' November
2016, https://www.fda.gov/media/78504/download.
Proponents of the PASTEUR Act claim that the legislation would
delink the price of newly approved antimicrobial as well as the volume
of doses administered from the drug's development costs. However, the
legislation has several fundamental flaws in its design including that
it would fail to guarantee the American public access to truly
effective and safe antimicrobials. Instead, PASTEUR would guarantee
that pharmaceutical companies would be awarded a multi-billion-dollar
contract funded by taxpayers. Alternatively, as with COVID-19, the
Federal Government should set higher standards for regulatory approval
that would lead to novel and effective innovation and focus taxpayer
investments earlier in the pipeline including for late-stage clinical
trials to yield treatments with proven public health and clinical
impact.
Summary of Key Points:
During COVID-19, the Federal Government through its
agencies including FDA, CDC, and NIH demonstrated that even
during a public health emergency period, parameters for robust
clinical trial design could be set to ensure greater certainty
of efficacy and safety of novel medical countermeasures.
While during the public health emergency period
Federal agencies may allow for regulatory flexibility of novel
medical countermeasures, they must also put in place
requirements for sponsors to provide further data even after
initial authorization or approval to confirm the product's
efficacy and safety.
In return for significant public investment and
resources directed toward the development of novel medical
countermeasures, the Federal Government should require sponsors
to conduct additional studies of medical countermeasures to
answer important public health questions and more efficiently
allocate public funding and resources.
When developing medical countermeasures outside of a
public health emergency, the Federal Government should take
strategic steps to ensure that any such public investment
yields products that are proven to be safe and effective
throughout rigorous and well-designed clinical studies.
Y Erosion of FDA regulatory standards has led to the
approval of new antimicrobials of unclear clinical
benefit and efficacy against resistant threats with no
safeguards in place to confirm whether these drugs are
truly effective after approval.
Y Pull incentives such as the recently re-introduced
PASTEUR Act fail to guarantee the American public
access to truly novel, effective, and safe
antimicrobials, but guarantee pharmaceutical
manufacturers revenues under multi-billion-dollar
subscription contracts.
The Federal Government must ensure that the American public has
affordable access to medical countermeasures.
The Federal Government has played an outsized role in financing and
supporting the development of medical countermeasures. Yet it has
exercised very little leverage in ensuring affordable access and fair
pricing of these medical products. As discussed at the recent hearing
held by the Senate HELP Committee on March 22, 2023, COVID-19 vaccine
manufacturers received significant public funding support for
discovery, development, production, and manufacturing activities
through Operation Warp Speed and other initiatives. \30\ Even predating
the pandemic, the U.S. Government invested an estimated $337 million
toward early and late stages of development as well as manufacturing
capacity of mRNA vaccines. \31\ Ahead of confirmation of efficacy and
safety, several manufacturers were granted advanced purchase agreements
for hundreds of millions of doses without necessitating FDA
authorization or approval. \32\ Essentially, the Federal Government de-
risked several stages of vaccine development and production for
manufacturers.
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\30\ ``Taxpayers Paid Billions For It: So Why Would Moderna
Consider Quadrupling the Price of the COVID Vaccine?--The U.S. Senate
Committee on Health, Education, Labor & Pensions,'' March 22, 2023,
https://www.help.senate.gov/hearings/taxpayers-paid-billions-for-it-so-
why-would-moderna-consider-quadrupling-the-price-of-the-covid-vaccine.
\31\ Hussain S. Lalani et al., ``US Public Investment in
Development of MRNA Covid-19 Vaccines: Retrospective Cohort Study,''
BMJ 380 (March 1, 2023): e073747, https://doi.org/10.1136/bmj-2022-
073747.
\32\ Leila Abboud and Hannah Kuchler, ``Why the Three Biggest
Vaccine Makers Failed on Covid-19,'' Financial Times, February 16,
2021, https://www.ft.com/content/657b123a-78ba-4fba-b18e-23c07e313331.
Despite this, COVID-19 vaccine manufacturers have been able to
negotiate prices with the Federal Government well above the cost of
production, \33\ reaping multiple billions in profits. Now, as the PHE
period comes to an end, these companies have also announced significant
price increases to their products. \34\ Coupled with the likelihood
that COVID-19 will be considered an endemic disease possibly requiring
regular booster doses, \35\ similar to that of influenza, these
anticipated price hikes will translate to significant costs for
patients and the Federal Government. Without intervention, uninsured
populations will directly face these anticipated vaccine price hikes
and deterring many from receiving a potentially necessary prevention
measure.
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\33\ Zoltan Kis and Zain Rizvi, ``How to Make Enough Vaccine for
the World in One Year'' (Washington, DC.: Public Citizen, May 26,
2021), https://www.citizen.org/article/how-to-make-enough-vaccine-for-
the-world-in-one-year/.
\34\ Pfizer, ``Pfizer Reports Second-Quarter 2021 Results,'' July
28, 2021, https://investors.pfizer.com/investor-news/press-release-
details/2021/PFIZER-REPORTS-SECOND-QUARTER-2021-RESULTS/default.aspx.
\35\ U.S. Food and Drug Administration, ``FDA Briefing Document:
Future Vaccination Regimens Addressing COVID-19,'' January 26, 2023,
https://www.fda.gov/media/164699/download.
For these populations, manufacturers have promised to establish
patient assistance programs. \36\ However, to ensure access, these
programs as they have been traditionally established and implemented
will not be adequate. Not only do such programs often lack a
standardized application process, but their applications are onerous
and complex often requiring assistance from health professional
personnel. \37\ Additionally, supply is typically allocated through
patients' providers, necessitating an extra step and potentially, an
additional payment for a clinic visit to obtain the needed treatment.
To realize the intention of these programs of providing equitable and
free access to COVID-19 vaccines for uninsured patients, the Federal
Government must set minimum requirements for manufacturers to make
these products easily accessible without any cost.
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\36\ ``Moderna's Commitment to Patient Access in the United
States,'' modernatx.com, February 15, 2023, https://
investors.modernatx.com/Statements--Perspectives/Statements--
Perspectives-Details/2023/Modernas-Commitment-to-Patient-Access-in-the-
United-States/default.aspx.
\37\ Niteesh K. Choudhry et al., ``Drug Company--Sponsored Patient
Assistance Programs: A Viable Safety Net?,'' Health Affairs 28, no. 3
(May 1, 2009): 827--34, https://doi.org/10.1377/hlthaff.28.3.827.
Manufacturers have also argued that insured populations will not
see these costs in the form of out-of-pocket payments. While this is
certainly true under the Affordable Care Act and the Inflation
Reduction Act, the Federal Government and private insurers will likely
bear the burden of higher post-pandemic prices, which could lead to
higher premiums for the insured American public. \38\ The Federal
Government could continue to purchase vaccine doses in bulk at a lower
price as anticipated in the near-term; \39\ however, as evidenced by
the case of the influenza vaccine which similarly was developed and
manufactured with public funding support, \40\ even the initial public
procurement price will become a floor for continued price increases.
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\38\ 2023, ``How Much Could COVID-19 Vaccines Cost the U.S. After
Commercialization?,'' KFF (blog), March 10, 2023, https://www.kff.org/
coronavirus-covid-19/issue-brief/how-much-could-covid-19-vaccines-cost-
the-u-s-after-commercialization/.
\39\ ``Fact Sheet: HHS Announces `HHS Bridge Access Program For
COVID-19 Vaccines and Treatments' to Maintain Access to COVID-19 Care
for the Uninsured,'' Text, HHS.gov, April 18, 2023, https://
www.hhs.gov/about/news/2023/04/18/fact-sheet-hhs-announces-hhs-bridge-
access-program-covid-19-vaccines-treatments-maintain-access-covid-19-
care-uninsured.html.
\40\ Reshma Ramachandran et al., ``Future of Covid-19 Vaccine
Pricing: Lessons from Influenza,'' BMJ 373 (June 22, 2021): n1467,
https://doi.org/10.1136/bmj.n1467.
For COVID-19 treatments, pricing following the PHE is less certain.
Public procurement prices for antivirals such as molnupiravir
(Lagevrio), nirmatrelavir-ritonavir (Paxlovid), and remdesivir
(Veklury) have far exceeded their production costs \41\, \42\, \43\ and
despite their manufacturers also having received Federal funding
support and resources for their development. \44\, \45\, \46\ The CEO
of Pfizer, which markets nirmatrelavir-ritonavir referred to the $530
per course price point the Federal Government was able to receive
through its initial bulk purchasing agreement as ``really very
attractive'' and indicated the drug will cost significantly more on the
commercial market. \47\ For these and other COVID-19 treatments, the
burden of potentially unaffordable access will fall onto
disproportionately on the most vulnerable populations who are at higher
risk of developing severe illness.
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\41\ Prepared Melissa J Barber and Dzintars Gotham, ``Estimated
Cost-Based Generic Prices for Molnupiravir for the Treatment of COVID-
19 Infection,'' Working Paper, October 1, 2021.
\42\ Prepared Melissa J Barber and Dzintars Gotham, ``Estimated
Cost-Based Generic Prices for Nirmatrelvir/Ritonavir (Paxlovid),''
Working Paper, January 12, 2023.
\43\ Andrew Hill et al., ``Minimum Costs to Manufacture New
Treatments for COVID-19,'' Journal of Virus Eradication 6, no. 2
(n.d.): 61--69.
\44\ ChangWon C. Lee et al., ``Origins and Ownership of
Remdesivir: Implications for Pricing,'' The Journal of Law, Medicine &
Ethics 48, no. 3 (September 1, 2020): 613--18, https://doi.org/10.1177/
1073110520958890.
\45\ Travis Whitfill, ``A Likely New Treatment for Covid-19 Was
Made Possible by Government-Funded Innovation,'' STAT (blog), October
5, 2021, https://www.statnews.com/2021/10/05/government-funding-backed-
molnupiravir-possible-new-covid-19-treatment/.
\46\ Ryan P. Joyce, Vivian W. Hu, and Jun Wang, ``The History,
Mechanism, and Perspectives of Nirmatrelvir (PF-07321332): An Orally
Bioavailable Main Protease Inhibitor Used in Combination with Ritonavir
to Reduce COVID-19-Related Hospitalizations,'' Medicinal Chemistry
Research 31, no. 10 (2022): 1637--46, https://doi.org/10.1007/s00044-
022-02951-6.
\47\ Hannah Recht, ``COVID-19 Treatment Paxlovid Has Been Free so
Far. Next Year, Sticker Shock Awaits,'' PBS NewsHour, December 18,
2022, https://www.pbs.org/newshour/health/covid-19-treatment-paxlovid-
has-been-free-so-far-next-year-sticker-shock-awaits.
Other medical countermeasures developed to address public health
emergencies have also benefited from significant public funding and
resource support for their discovery, basic and preclinical studies,
and clinical trials supporting regulatory authorization or approval.
\48\ The Federal Government has also often secured bulk purchasing
agreements ahead of market authorization from the FDA. Such agreements
have given the Federal Government leverage to negotiate a likely more
reasonable price point with manufacturers. However, few contracts have
included provisions guaranteeing such reasonable pricing, particularly
in comparison to procurement prices paid by other countries. As part of
their agreement with Novavax, the Department of Defense stated that it
should receive the lowest, best price for a period of 5 years for
purchase of doses administered in the U.S. \49\ In exchange for $1.8
billion, Sanofi had been prohibited in its agreement to sell its
vaccine to any member of the G7 or Switzerland at a price lower than
that of the Federal Government. \50\ In their contract with Paxlovid,
the Federal Government including a ``most-favored nation'' pricing
clause that would allow them to receive a lower price if one of six
other high-income countries were to negotiate a better deal. \51\ Such
conditions that better safeguard affordable access both during the PHE
period as well as afterward should be applied across medical
countermeasures by the Federal Government.
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\48\ Michael S. Sinha et al., ``Expansion of the Priority Review
Voucher Program Under the 21st Century Cures Act: Implications for
Innovation and Public Health,'' American Journal of Law & Medicine 44,
no. 2--3 (May 2018): 329--41, https://doi.org/10.1177/0098858818789430.
\49\ Kathryn Ardizzone, ``Novavax and Inovio COVID-19 Vaccine
Contracts Limit Prices Companies Can Charge for Their Products,''
Knowledge Ecology International (blog), January 28, 2021, https://
www.keionline.org/35185.
\50\ Kathryn Ardizzone, ``$1.8 Billion Sanofi Vaccine Contract
Contains International Reference Pricing Clause, Preserves Standard IP
and Data Rights,'' Knowledge Ecology International (blog), December 2,
2020, https://www.keionline.org/34776.
\51\ Sydney Lupkin, ``Feds' Contract with Pfizer for Paxlovid Has
Some Surprises,'' NPR, February 1, 2022, sec. Treatments, https://
www.npr.org/sections/health-shots/2022/02/01/1075876794/feds-contract-
with-pfizer-for-paxlovid-has-some-surprises.
Besides conditions directly focused on pricing, the Federal
Government should also ensure that public funding and resources granted
to pharmaceutical companies and others do not include flexibilities
that could preclude access. During COVID-19, the Biomedical Advanced
Research and Development Authority (BARDA) along with the Department of
Defense routinely utilized the mechanism of Other Transaction
Agreements (OTAs) to attract private partners to enter into government
contracts granting Federal funding support for the development and
production of various medical products. \52\ While such flexibilities
are employed to hasten contracting with private sector partners, they
also remove potentially important safeguards that would enable
affordable access. For instance, OTAs are not subject to conditions
under the Bayh-Dole Act, which means that when pricing of publicly
funded medical countermeasures hinders reasonable access of these
products, Federal agencies are unable to exercise march-in rights that
would compel the patent owner to license the pertinent patents to
another company such as a generic drug manufacturer. \53\ BARDA has
proposed as part of their 2022-2026 Strategic Plan to leverage OTAs
further as part of their contracting process \54\ putting at risk the
ability of the Federal Government to intervene to ensure affordable
access.
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\52\ Eric Steinberg, ``Use of Other Transactions at ASPR,''
accessed May 3, 2023, https://doi.org/10.1037/e658332011-001.
\53\ Stuart W. Turner, ``Other Transactions Authority (OTA):
Protests and Disputes,'' Arnold & Porter, June 28, 2018, https://
www.arnoldporter.com/en/perspectives/advisories/2018/06/other-
transactions-authority-ota-protests.
\54\ Assistant Secretary for Preparedness and Response and
Biomedical Advanced Research and Development Authority, ``BARDA
Strategic Plan 2022--2026'' (Department of Health and Human Services,
May 2022), https://www.medicalcountermeasures.gov/media/38717/barda-
strategic-plan-2022-2026.pdf.
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Summary of Key Points:
Although the Federal Government has played an
outsized role in financing and supporting the development of
medical countermeasures, it has exercised very little leverage
in ensuring affordable access and fair pricing of these medical
products even during public health emergency periods.
Untethered price hikes of COVID-19 vaccines and
therapeutics following the public emergency period will a
disproportionate and undue impact on those populations who are
uninsured and at higher risk of severe illness unless the
Federal Government intervenes.
Although manufacturers argue that insured patients
will not face barriers in accessing COVID-19 vaccines due to
anticipated price hikes due to policies that prevent cost-
sharing of CDC-recommended vaccines for those who are insured,
they may face these costs in the form of higher premiums.
Additionally, the Federal Government and private insurers in
procuring doses from the manufacturers may also face these
significant price hikes, precluding allocation of such funds
for other necessary public health interventions.
Although the Federal Government could mitigate the
impact of such price hikes through bulk purchasing agreements
at a negotiated lower price, the initial public procurement
price following the public health emergency period will likely
be the floor as evidenced by trends in public and private
influenza vaccine pricing over time.
In a few contracts, the Federal Government has been
able to include provisions guaranteeing reasonable pricing in
comparison to other wealthy countries, which should also be
included in all future purchasing agreements.
The Federal Government should also ensure that such
agreements do not include provisions that remove access
safeguards at the expense of flexibility and speed.
The Federal Government must continuously evaluate the success of
publicly awarded incentives and sunset those that fail to generate
truly innovative, effective, and safe medical countermeasures.
Along the drug and vaccine development pipeline, agencies have
awarded various incentives to pharmaceutical companies and other
stakeholders ranging from push incentives that lower the cost of
development to pull incentives that ensure or increase revenue. While
the purpose of such incentives is to enable greater participation from
stakeholders including private partners in the development of novel
medical countermeasures, there has been little effort to evaluate these
incentives once implemented and sunset those that have not been proven
to be effective.
One such incentive is the medical countermeasure priority review
voucher, created under the 21st Century Cures Act in 2016. \55\ Awarded
at the time of FDA approval, manufacturers can redeem priority review
vouchers allowing for another product in their portfolio. Under the
traditional review process, these products would be reviewed by the FDA
within 10 months; with a voucher, the product would instead receive
priority review without having to meet specific eligibility criteria,
shortening regulatory review time to a maximum of 6 months and allowing
for earlier market entry. The Government Accountability Office (GAO)
analysis of three existing priority review voucher programs including
for medical countermeasures generally did not find any effect of these
vouchers on innovation. \56\ The GAO report also noted another
analysis, which found that 25 of the 26 medical countermeasures in
clinical trials received public funding for their development, raising
questions on the necessity of such vouchers to incentivize innovation.
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\55\ ``Material Threat Medical Countermeasure Priority Review
Vouchers: Draft Guidance'' (Rockville, MD: Food and Drug
Administration, January 17, 2018), https://www.fda.gov/media/110193/
download.
\56\ Government Accountability Office, ``DRUG DEVELOPMENT: FDA's
Priority Review Voucher Programs,'' January 2020, https://www.gao.gov/
assets/710/704207.pdf.
In a study we published in 2021, \57\ we found that all five
medical countermeasures initially awarded a priority review voucher
were initially developed through public funding--the discovery of four
of the five products was underwritten by the Federal Government and the
remaining one by the German government. The U.S. Government also
sponsored late-stage clinical trials supporting FDA approval of all
five products; for three, Federal agencies designed and conducted these
trials. FDA also granted all five medical countermeasures additional
regulatory incentives including designations allowing these drugs and
vaccines to receive expedited review. Additionally, FDA awarded further
intellectual property protections in the form of exclusivity periods,
barring generic entry for variable periods of time. Finally, the
Federal Government also ensured a market for these products through
bulk advance purchase agreements, often secured before regulatory
approval. Considering that the Federal Government has granted several
financial, regulatory, and intellectual property incentives along the
medical countermeasure development pipeline, issuance of an additional
priority review voucher is likely unnecessary.
---------------------------------------------------------------------------
\57\ Reshma Ramachandran, Ravi Gupta, and Jing Luo, ``An
Unnecessary Gift for COVID-19 Vaccines and Therapeutics: The Medical
Countermeasure Priority Review Voucher,'' American Journal of Public
Health, October 14, 2021, e1--4, https://doi.org/10.2105/
AJPH.2021.306495.
Moreover, there may be undue impacts from the awarding of such
priority review vouchers, creating an undue burden for patients and
clinicians. Redeeming the priority review voucher forces the FDA to
more rapidly access the safety and efficacy of a medical product that
would otherwise be ineligible for this expedited review designation.
Such designations have been associated with increased risk of FDA
safety actions after approval \58\ as well as lower standards of
evidence including fewer pivotal trials, fewer enrolled pivotal trial
participants, and more frequent use of surrogate endpoints instead of
more clinically relevant ones. \59\ As examination of this incentive
has failed to effectively promote the development of medical
countermeasures and may instead lead to the hasty approval of
potentially unsafe medical products of uncertain benefit, legislators
should reconsider and even sunset this program altogether.
---------------------------------------------------------------------------
\58\ Nicholas S. Downing et al., ``Postmarket Safety Events Among
Novel Therapeutics Approved by the US Food and Drug Administration
Between 2001 and 2010,'' JAMA 317, no. 18 (May 9, 2017): 1854--63,
https://doi.org/10.1001/jama.2017.5150.
\59\ Audrey D. Zhang et al., ``Assessment of Clinical Trials
Supporting US Food and Drug Administration Approval of Novel
Therapeutic Agents, 1995-2017,'' JAMA Network Open 3, no. 4 (April 21,
2020): e203284, https://doi.org/10.1001/jamanetworkopen.2020.3284.
For antimicrobials, other incentives have been introduced to
encourage the development of novel drugs with limited evaluation of
their value. Entering into a ``subscription'' contract under the
PASTEUR Act would not disqualify manufacturers from receiving other
financial incentives. One such other financial incentive is that of new
technology add-on payments from the Centers for Medicare and Medicaid
Services (CMS), which in 2019 modified these to be higher and removed
the eligibility criteria of ``substantial clinical improvement'', thus
lowering the bar for receiving this additional reimbursement. This
payment received by manufacturers when the antimicrobial is dispensed
to a patient is effectively a volume-based incentive that is
antithetical to the need to conserve these drugs to prevent against
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further resistance.
Therefore, should the PASTEUR Act be included as part of PAHPA,
manufacturers of new antimicrobials would not only be eligible to
receive billions in federally awarded subscription contracts, but also
additional revenue through new technology add-on payments. This may
create a perverse situation in which health systems and hospitals would
be incentivized to prescribe more of a new antimicrobial that should be
conserved as a last line treatment. Moreover, as the PASTEUR Act only
addresses public remuneration of new antimicrobials in the form of
regular lump sum payments, manufacturers of these drug products would
also potentially be able to receive private payer reimbursement
separately as additional revenue, which may incentivize the overuse or
misuse of these new treatments.
Such financial incentives that may prompt health systems and
hospitals to inappropriately prescribe novel antimicrobials encompassed
by the PASTEUR Act would not be offset by the stewardship provisions in
the bill. \60\ As written, the legislation does not tie specific
stewardship efforts to antimicrobials for which a ``subscription''
contract has been issued, making it unclear how these treatments will
be conserved to prevent further antimicrobial resistance. Any such
incentive awarded to antimicrobial manufacturers must fully delink the
development costs from both the price as well as volume to ensure
equitable, affordable access and not excess. \61\
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\60\ Bennet, PASTEUR Act of 2021.
\61\ Anthony D. So and Tejen A. Shah, ``New Business Models for
Antibiotic Innovation,'' Upsala Journal of Medical Sciences 119, no. 2
(March 19, 2014): 176--80, https://doi.org/10.3109/
03009734.2014.898717.
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Summary of Key Points:
The Federal Government has supported the development
of several medical countermeasures through push incentives that
lower the cost of development as well as pull incentives the
ensure or increase revenues. Following the implementation of
these incentives, there has been limited evaluation of their
success as well as efforts to sunset those that have not been
found to be effective.
There is little evidence that the medical
countermeasure priority review voucher is effective in
promoting the development of novel products as the Federal
Government has granted several other financial, regulatory, and
intellectual property incentives to these same health
technologies. Granting priority review vouchers may instead
lead to the hasty approval of potentially unsafe medical
products of uncertain benefit. Therefore, legislators should
reconsider and even sunset this program altogether.
For antimicrobials, pull incentives such as the
recent increase in new technology add-on payments awarded by
CMS and removal of the ``substantial clinical improvement''
criteria may incentivize hospitals and health systems to
overuse these drugs, which need to be conserved to prevent
exacerbating antimicrobial resistance.
Any incentive awarded to antimicrobial manufacturers
must fully delink the development costs from both the price as
well as volume to ensure equitable, affordable access and not
excess.
Considering Opportunity Costs and Conclusion
Resulting from any allocation of funding and resources by the
Federal Government to promote the development of novel medical products
will be opportunity costs. For public health emergencies, the wager of
awarding financial and other resource incentives can be risky as
targeting these toward particular health technologies would preclude
their use for other purposes including public health interventions not
involving individual products. For instance, much of the focus of
Federal funding support to address COVID-19 has been largely for
promoting the development of individual diagnostic, vaccine, and
therapeutic products with comparatively less Federal investment
allotted for other public health prevention strategies.
For antimicrobial resistance, significantly more has also been
spent and proposed for innovation of individual drugs compared to other
strategies that would prevent the emergence and spread of bacterial
resistance and in turn, the need for continuous development of novel
antimicrobials effective against the next future resistant pathogen. In
fact, the OECD has estimated that three out of four deaths due to
antibiotic resistance could be prevented by spending $2 per individual
annually on non-pharmacologic interventions such as handwashing,
stewardship of antibiotics, and rapid testing. \62\
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\62\ ``Stemming the Superbug Tide: Just A Few Dollars More,'' OECD
Health Policy Series (OECD, November 7, 2018), https://www.oecd.org/
health/stemming-the-superbug-tide-9789264307599-en.htm.
In view of the Federal Government and taxpayers as critical
investors in addressing future public health emergencies, variation
within their investment portfolio with balanced allotments for both
prevention as well as treatment independent of non-pharmacologic
measures will be necessary to ensure a truly effective response.
Nevertheless, the Federal Government should continue to support through
direct funding and resources across agencies the development of novel
medical countermeasures in the form of therapeutics and vaccines.
However, the success of these efforts should not be hinged on the
authorization or approval of these products, but rather on whether the
Federal Government can be an effective steward of taxpayer funds and
ensure equitable access to truly effective and safe health
technologies.
______
[summary statement of reshma ramachandran]
The Federal Government must require rigorous evidence to be
generated of medical countermeasures demonstrating safety and efficacy.
While during the public health emergency period
Federal agencies may allow for regulatory flexibility of novel
medical countermeasures, they must also put in place
requirements for sponsors to provide further data even after
initial authorization or approval to confirm the product's
efficacy and safety.
In return for significant public investment and
resources directed toward the development of novel medical
countermeasures, the Federal Government should require sponsors
to conduct additional studies of medical countermeasures to
answer important public health questions and more efficiently
allocate public funding and resources.
When developing medical countermeasures outside of a
public health emergency, the Federal Government should take
strategic steps to ensure that any such public investment
yields products that are proven to be safe and effective
throughout rigorous and well-designed clinical studies.
The Federal Government must ensure that the American public has
affordable access to medical countermeasures.
Untethered price hikes of COVID-19 vaccines and
therapeutics following the public emergency period will a
disproportionate and undue impact on those populations who are
uninsured and at higher risk of severe illness unless the
Federal Government intervenes.
Although the Federal Government could mitigate the
impact of such price hikes through bulk purchasing agreements
at a negotiated lower price, the initial public procurement
price following the public health emergency period will likely
be the floor as evidenced by trends in public and private
influenza vaccine pricing over time.
In a few contracts, the Federal Government has been
able to include provisions guaranteeing reasonable pricing in
comparison to other wealthy countries, which should also be
included in all future purchasing agreements.
The Federal Government should also ensure that such
agreements do not include provisions that remove access
safeguards at the expense of flexibility and speed.
The Federal Government must continuously evaluate the success of
publicly awarded incentives and sunset those that fail to generate
truly innovative, effective, and safe medical countermeasures.
The Federal Government has supported the development
of several medical countermeasures through push incentives that
lower the cost of development as well as pull incentives the
ensure or increase revenues. Following the implementation of
these incentives, there has been limited evaluation of their
success as well as efforts to sunset those that have not been
found to be effective.
There is little evidence that the medical
countermeasure priority review voucher is effective in
promoting the development of novel products as the Federal
Government has granted several other financial, regulatory, and
intellectual property incentives to these same health
technologies. Granting priority review vouchers may instead
lead to the hasty approval of potentially unsafe medical
products of uncertain benefit. Therefore, legislators should
reconsider and even sunset this program altogether.
Any incentive awarded to antimicrobial manufacturers
must fully delink the development costs from both the price as
well as volume to ensure equitable, affordable access and not
excess.
______
The Chair. Thank you very much. Our next witness is Mr.
Robert Weissman, who is President of Public Citizen. Mr.
Weissman is an expert on drug pricing and specifically ensuring
equitable access to drugs. Mr. Weissman, thanks a lot for being
with us.
STATEMENT OF ROBERT WEISSMAN, PRESIDENT, PUBLIC CITIZEN,
WASHINGTON, DC
Mr. Weissman. Thank you very much. Chair Sanders and
Ranking Member Cassidy, for the opportunity to be here today. I
think it is fair to say that Operation Warp Speed was a great
success in speeding the development of COVID vaccines and a
validation of the BARDA investment model, to an extent.
But it was also a great failure, and we need to learn that
lesson as well. It was a failure in that although the U.S.
Government was responsible for funding of the COVID vaccine
from before COVID even emerged, through the isolation of the
key spike protein, through the clinical trials, and up through
the development and production of the vaccine, BARDA imposed
effectively no restraint on how Moderna and other partners, but
especially Moderna, would operate.
The result was while Moderna executives became
billionaires, taxpayers were price gouged. Hundreds of
thousands or maybe millions of people lost their lives because
we had a global shortage of a vaccine that could have been
avoided if we had shared the technology. And now Moderna has
announced it plans to quadruple prices, further limiting
access, further gouging consumers, further gouging the
taxpayer.
As everyone here has agreed, we need to learn the lessons
from what happened during the pandemic period and do better
going forward. We absolutely need PAHPA, we need BARDA, but we
need to do better. What are some key lessons going forward?
First, we need more transparency in the contracting process.
Taxpayers should know who they are providing grants to, who
are they making acquisitions from, and on what terms. When drug
companies and vaccine makers are making co-investments in a
product, they should know, taxpayers should know how much is
being done on the private sector side along with the public
side.
Second, we need to have reasonable pricing for the products
that we, the taxpayers, pay for. That should just be common
sense. If we pay for it, we ought not to pay for it again with
unreasonable prices.
The starting point for reasonable pricing should be that
the United States does not pay more than other high-income
countries do for a product. But that is just a starting point.
We can do much better than that.
In general, the way we should think about reasonable
pricing is tailoring a reasonable price to the amount of
private sector investment and risk taken. Where the Government
pays for the development of a drug all the way through, the
reasonable price should be a lot lower than where a private
sector partner took on a lot of the risk and made a lot of
early stage investments.
Third, we have to guarantee international access. We know
that pandemics definitionally mean that everyone around the
world needs the products we are talking about. Drug
manufacturers, vaccine makers may not have capacity and often
don't have interest in serving the global markets.
As such, we should have a proactive requirement for
licensing to the World Health Organization of crucial
technologies and licensing and sharing of technology and know-
how as well, to make sure that other manufacturers can produce
products that everyone needs. Last, we should consider as well
as the traditional model for supporting research and
development, prize models, such as those that you have
supported in the past are legislation, Chair Sanders.
We know in the case of BARDA that the patent monopoly model
of support innovation by definition doesn't work. That is why
BARDA is making the investments, because the private sector
model in these cases, as Commissioner Califf said earlier,
doesn't work.
It is at least insufficient. Given that, we ought to think
creatively about what might work better. Prizes can be
calibrated to provide appropriate incentives sufficient to
enable manufacturers and researchers to enter the space, while
also ensuring affordability and access on the back end.
You can also do other things to promote innovation, like
giving people rewards when they don't actually get the final
product, but they make contributions along the way. So, these
are the some of the lessons I think, that come out of the
pandemic and that we must incorporate into PAHPA going forward.
Thank you very much.
[The prepared statement of Mr. Weissman follows:]
prepared statement of robert weissman
Mr. Chairman and Members of the Committee,
Thank you for the opportunity to testify today on the
reauthorization of the Pandemic and All-Hazards Preparedness Act
(PAHPA). I am Robert Weissman, president of Public Citizen. Public
Citizen is a national public interest organization with more than
500,000 members and supporters. For more than 50 years, we have
advocated with some considerable success for stronger health, safety
and consumer protections; for corporate and government accountability;
and for affordable access to essential medicines and biomedical
technologies.
Public Citizen strongly supports public investment in public health
research and development (R&D), including especially for pandemics and
emergency situations. But taxpayers must get a fair return on their
investment. That should mean that the products that are the fruit of
that investment are widely available and affordable for those who need
them, on a global basis.
This testimony has two parts. In the first section, I review the
experience with government funding for Covid vaccines. That investment
helped get products to market in remarkable time. But the government
failed to include conditions in its grant and acquisition agreements,
or to make use of other available tools, to ensure that 1) taxpayers
were not ripped off; 2) there was sufficient production of mRNA
vaccines to meet global need; and 3) taxpayers and patients would be
protected from price gouging as the pandemic wound down.
The second section aims to learn from the lessons of the Covid
vaccine experience. It recommends building into grant agreement
provisions to ensure transparency, affordability and global access. It
also encourages the adoption of alternative funding models, such as
prize funds, to support innovation. In many cases, especially in the
market segments covered by PAHPA, alternative funding models will
deliver superior benefits to the patent monopoly approach.
I. Lessons from COVID Vaccine Development
Operation Warp Speed was a great success in speeding the
development of lifesaving vaccines and getting them to market. It was
proof that the Biomedical Advanced Research and Development Authority
(BARDA) model can work.
But it also was proof that the BARDA model needs important
refinements, because taxpayers were gouged; hundreds of thousands or
perhaps millions of people likely died needlessly because of avoidable
vaccine shortages; and now patients and the public are poised to be
ripped off further, with vaccines needlessly rationed due to high
prices.
Government support underlay the entire Covid vaccine R&D project,
beginning decades before Covid appeared and continuing through clinical
trials and scaled up production. Covid-19 was not the first infectious
disease caused by a coronavirus. NIH invested $700 million in
coronavirus research in the two decades after SARS, during which period
there was very little private sector investment in the field. In 2019,
before Covid, there were only six active coronavirus clinical trials
involving pharmaceutical companies. All of them depended crucially on
public funding. \1\
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\1\ Zain Rizvi, ``Blind Spot: How the COVID-19 Outbreak Shows the
Limits of Pharma's Monopoly Model,'' Public Citizen, February 19, 2020,
https://www.citizen.org/article/blind-spot.
The Federal Government's early investment in coronavirus research
laid the foundation for the rapid response to Covid, helping accelerate
the development of many leading vaccine candidates. \2\
---------------------------------------------------------------------------
\2\ Zain Rizvi, ``Leading COVID-19 Vaccine Candidates Depend on
NIH Technology,'' Public Citizen, November 10, 2020, https://
www.citizen.org/article/leading-covid-19-vaccines-depend-on-nih-
technology.
Most of the leading first-generation Covid vaccine candidates--
including those by Pfizer/BioNTech, Johnson & Johnson and Moderna--
relied on the NIH's approach of ``freezing'' coronavirus spike proteins
in their pre-fusion shape. One vaccine scientist noted that we were
``very lucky, actually'' that scientists had earlier developed the
method for freezing coronavirus spike proteins. \3\
---------------------------------------------------------------------------
\3\ Ryan Cross, ``The tiny tweak behind COVID-19 vaccines,''
Chemical & Engineering News, September 29, 2020, https://tinyurl.com/
yxoj472x.
Among the vaccine makers, Moderna uniquely benefited from Federal
support, \4\ though the company consistently maneuvered to downplay
Federal support:
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\4\ ``'We did the front end. They did the middle. And we did the
back end,' said Dr. Barney Graham, a former top NIH official, referring
to the process for designing the spike-protein sequence, manufacturing
vaccines and running clinical trials.'' Selam Gebrekidan and Matt
Apuzzo, ``Rich Countries Signed Away a Chance to Vaccinate the World,''
New York Times, March 21, 2021, https://www.nytimes.com/2021/03/21/
world/vaccine-patents-us-eu.html.
Moderna tried to file patents on certain vaccine
technologies that had been co-invented with NIH. After Public
Citizen drew attention to the maneuver, \5\ Moderna backed
down. \6\
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\5\ Peter Maybarduk to Francis Collins, November 2, 2021, https://
www.citizen.org/article/letter-urging-nih-to-reclaim-foundational-role-
in-nih-moderna-vaccine.
\6\ Rebecca Robbins and Sheryl Gay Stolberg, ``Moderna backs down
in its vaccine patent fight with the N.I.H.,'' New York Times, December
17, 2021, https://www.nytimes.com/2021/12/17/us/moderna-patent-
nih.html.
BARDA gave large-scale grants to Moderna to complete
clinical trials and scale up manufacturing. \7\
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\7\ Zain Rizvi, ``Sharing the NIH-Moderna Vaccine Recipe,'' Public
Citizen, August 10, 2021, https://www.citizen.org/article/sharing-the-
nih-moderna-vaccine-recipe.
Altogether, the U.S. Government spent roughly $2.5
billion on the vaccine that would be called--misleadingly--the
Moderna vaccine. It should rightly have been called the NIH-
Moderna vaccine (or perhaps simply the NIH vaccine). The U.S.
Government paid the entire cost of its development, save for a
relatively tiny donation ($1 million) from the singer Dolly
Parton. \8\
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\8\ Allie Clouse, ``Fact check: Moderna vaccine funded by
government spending, with notable private donation,'' USA Today,
November 24, 2020, https://www.usatoday.com/story/news/factcheck/2020/
11/24/fact-check-donations-research-grants-helped-fund-moderna-vaccine/
6398486002.
While the vaccine was developed through a 4-year
partnership with the National Institutes of Health (NIH),
Moderna fought against naming Federal scientists co--inventors
\9\ of the vaccine sequence, as Public Citizen revealed in
2021. \10\ Rather than credit the Federal Government for its
role, Moderna quietly abandoned these patents in March 2023.
\11\
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\9\ Sheryl Gay Stolberg and Rebecca Robbins, ``Moderna and U.S. at
Odds Over Vaccine Patent Rights,'' New York Times, November 9, 2021,
https://www.nytimes.com/2021/11/09/us/moderna-vaccine-patent.html.
\10\ Public Citizen letter to NIH Director Francis Collins,
November 2, 2021, https://www.nytimes.com/interactive/2021/11/09/us/
public-citizen-nih-moderna-vaccine.html.
\11\ Katherine Ellen Foley and David Lim, ``Moderna Quietly
Abandons Some MRNA Patents,'' Politico, March 7, 2023, https://
www.politico.com/newsletters/prescription-pulse/2023/03/07/eli-lilly
insulin-cost-cuts-00085724
In 2020, Public Citizen revealed that Moderna and
others also relied on a separate technique discovered by
Federal scientists and academic researchers to stabilize spike
proteins and elicit an immune response. \12\ Columbia Law
School clinical professor Christopher Morten demonstrated that
Moderna likely infringed the NIH-owned patent. \13\ Moderna
eventually agreed to pay NIH $400 million plus future royalties
for its use of the technique. \14\
---------------------------------------------------------------------------
\12\ Zain Rizvi, ``Leading Covid-19 Vaccine Candidates Depend on
NIH Technology,'' Public Citizen, November 10, 2020, https://
www.citizen.org/article/leading-covid-19-vaccines-depend-on-nih-
technology/'eType=EmailBlastContent&eId=3dbde9f7-8f59-48e0-99d8-
78b49ea5e77e.
\13\ Christopher Morten, et al.., ``U.S. 10,960,070: The U.S.
Government's Important New Coronavirus Vaccine Patent,'' Technology Law
and Policy Clinic, New York University School of Law, April 14, 2021,
https://www.dropbox.com/s/1om1v1kagg7j9dn/NYU percent20TLP
percent20Clinic percent20Report percent20on percent20NIH percent27s
percent20070 percent20Patent percent2020210414 percent20 percent28FINAL
percent29.pdf'dl=0.
\14\ Benjamin Mueller, ``After Long Delay, Moderna Pays NIH for
Covid Vaccine Technique,'' New York Times, February 23, 2023, https://
www.nytimes.com/2023/02/23/science/moderna-covid-vaccine-patent-
nih.html.
All this spending and co-invention status gave the U.S. Government
powerful authority to condition how Moderna behaved and to share the
---------------------------------------------------------------------------
technology. It did not do so.
Moderna generated tens of billions in Covid vaccine sales--
including roughly $10 billion in advance purchase commitments and
purchases by the U.S. government \15\--and several of its executives
became billionaires. \16\
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\15\ Jennifer Kates, Cynthia Cox and Josh Michaud, ``How Much
Could Covid-19 Vaccines Cost After Commercialization?'' KFF, March 10,
2023, https://www.kff.org/coronavirus-covid-19/issue-brief/how-much-
could-covid-19-vaccines-cost-the-u-s-after-commercialization.
\16\ Giacomo Tognini, ``Surging Moderna Stock Mints The Vaccine
Maker's Fifth Billionaire,'' Forbes, June 15, 2021, https://
www.forbes.com/sites/giacomotognini/2021/06/15/surging-moderna-stock-
mints-the-vaccine-makers-fifth-billionaire.
Meanwhile, the world went for more than a year with an insufficient
vaccine supply. Developing countries were unable to obtain enough
vaccines for their people. When they could get access, it was often to
lower-quality vaccines, not the high-quality mRNA vaccines of Moderna
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or Pfizer.
That delay in vaccination likely cost hundreds of thousands and
possibly millions of lives. \17\ It also made it more likely that new
variants would emerge and that COVID would evolve into an endemic
disease. \18\
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\17\ Chad Wells and Alison Galvani, ``The global impact of
disproportionate vaccination coverage on COVID-19 mortality,'' The
Lancet, June 23, 2022, https://www.thelancet.com/journals/laninf/
article/PIIS1473-3099(22)00417-0/fulltext.
\18\ ``One Million and Counting: Estimates of Deaths in the United
States from Ancestral SARS-CoV-2 and Variants,'' Public Citizen, June
1, 2022, https://www.citizen.org/article/one-million-and-counting-
estimates-of-deaths-in-the-united-states-from-ancestral-sars-cov-2-and-
variants.
This scenario could have been avoided, or at least mitigated. It
was entirely possible to share the mRNA technology controlled by
Moderna and scale up vaccine manufacturing in order to have vaccinated
the world more quickly. \19\
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\19\ Zoltan Kis and Zain Rizvi, ``How to Make Enough Vaccine for
the World in One Year,'' Public Citizen, May 26, 2021, https://
www.citizen.org/article/how-to-make-enough-vaccine-for-the-world-in-
one-year.
Even though the development of vaccine technology depended so
heavily on U.S. Government support--and entirely, in the case of the
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NIH-Moderna vaccine--that was the road not taken.
Now, Moderna is jacking up prices further, quadrupling the price
for Covid vaccines, which are expected to be needed annually. Public
Citizen has estimated it costs $3 or less per dose to manufacture the
vaccine. At the height of the pandemic Moderna charged the United
States from $15 to $26 per dose, accumulating billions in profits.
Moderna's price going forward of $110-$130 per dose is completely
unjustified and has no plausible explanation beyond profiteering.
The unavoidable result of Moderna's price spike will be rationing.
Uninsured and under-insured people will face a significant cost barrier
to accessing vaccines, and--notwithstanding Moderna's pledge to make
vaccines available for free to uninsured and underinsured persons
\20\--many simply won't take the vaccine. People will needlessly get
sick and die as a result.
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\20\ Alexander Tin, ``Moderna to Offer Free Covid Vaccines to
Uninsured After Emergency Ends,'' CBS News, February 18, 2023, https://
www.cbsnews.com/news/free-covid-vaccine-moderna-uninsured-after-public-
health-emergency-ends.
Moreover, because many opting for future booster shots will be over
65, Medicare stands to bear a disproportionate burden of payments.
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Taxpayers will once again bear the expense.
Even for people with private health insurance, price spikes that
are picked up by insurance companies could lead to higher premiums.
\21\
---------------------------------------------------------------------------
\21\ Jennifer Kates, Cynthia Cox and Josh Michaud, ``How Much
Could Covid-19 Vaccines Cost After Commercialization?'' KFF, March 10,
2023, https://www.kff.org/coronavirus-covid-19/issue-brief/how-much-
could-covid-19-vaccines-cost-the-u-s-after-commercialization.
All of this, too, could and should have been avoided--if safeguards
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had been written into BARDA and NIH's contracts with Moderna.
We must at least learn from this Covid experience and prevent a
repeat with future technologies funded and developed by BARDA and PAHPA
investments.
II. Learning from COVID: Measures to Advance Transparency,
Affordability and Universal Access
Transparency
The starting point for policy around PAHPA investment in drug,
vaccine, therapeutics and diagnostics research, development and
acquisition should be proactive transparency. The public should know
what it is financing, on what terms and the degree to which private
sector partners are contributing to research and development costs.
In general, and building on existing practice, \22\ BARDA and other
government agencies should continue to aim toward standard-form
provisions for R&D investments, licensing terms and acquisition
contracts, to avoid wasted time with negotiation, prevent gamesmanship
and ensure taxpayer interests are protected robustly. Some variation
will be unavoidable, as agencies tailor terms and provisions for
different needs and product markets, but the more reliance on standard
provisions, the better.
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\22\ https://www.phe.gov/about/amcg/BARDA-BAA/Documents/otar-
consortium.pdf
Building on but going beyond what it already has in place, \23\
BARDA should maintain a publicly available, downloadable, searchable
and sortable data base of all grants it has made and acquisition
contracts into which it has entered, with easy public access to the
contracts. Proprietary redactions should be minimized. Specific
contract terms that should presumptively and proactively be made public
include:
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\23\ https://medicalcountermeasures.gov/app/barda/coronavirus/
COVID19.aspx
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The amount of government grants;
The ownership and licensing terms for inventions
funded directly or indirectly by government grants, not limited
to instances in which the government may claim Bayh-Dole
rights;
Provisions on reasonable pricing;
Reach-through terms to ensure reasonable pricing or
other conditions for products incorporating government-funded
inventions;
International access terms; and
The price paid and volume amount of acquisitions.
Building on existing practice, BARDA contracts should also require
affirmative disclosures from contracting parties. These disclosures
should include:
The documented dollar amount of co-funding that
contractors and third parties provide for research projects;
The terms, if any, by which the contractor licenses
inventions arising from a government-funded project to third
parties; and
The price that contractors charge third parties for
products developed with substantial government support.
The issue of contractor co-funding requires special attention.
Rather than accepting just a single claim of total contractor
investment, the government should require disaggregated information.
Drawing on expert reviews \24\ and prior legislative proposals, \25\ we
recommend that contractors' total expenditures on R&D be itemized by
direct and indirect costs, including for:
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\24\ NYU Law, Clinical Trial Cost Transparency at the NIH: Law and
Policy Recommendations (2020), https://www.law.nyu.edu/centers/
engelberg/pubs/2020-08-17-Clinical-Trial-Cost-Transparency-at-the-NIH
\25\ S. 909--Prescription Drug Price Relief Act of 2021, https://
www.Congress.gov/bill/117th-congress/senate-bill/909/text
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Basic and preclinical research; and
Clinical research, reported separately for each
clinical trial, per patient, per year, comprising:
Y Personnel costs (including salary and benefits)
` Administrative staff
` Clinical staff
Y Materials and supplies
Y Clinical procedures
Y Site management
` Site monitoring costs
` Site retention
` Other
Y Central laboratory
Y Equipment
Y Other direct costs
` Publication Costs
` Subawards/Consortium/Contractual Costs
` Other;
Y Development of alternative delivery systems, dosage
forms, strengths or combinations; and
Y Other development activities, such as post-approval
testing and record and report maintenance.
Affordability and Reasonable Pricing
In funding new drugs, vaccines, therapeutics and diagnostic tools
to address emergency or potential emergency solutions, taxpayers aim to
bring to market products that otherwise would not be developed or to
speed their development. Getting the product to market is essential,
but so is ensuring reasonable pricing. If products are going to be
purchased by taxpayers, not only is there a taxpayer interest in
prudently conserving public funds, but high prices may drain public
funds at the expense of other public health benefits or may limit the
size of government acquisition and distribution plans. If products are
going to be purchased by private insurers and/or directly by
individuals, then high prices will unavoidably limit access.
This latter point cannot be emphasized enough: access to essential
medical technologies necessarily must take into account affordability,
not mere provision in the market. A high-priced medical product is as
inaccessible to those who cannot afford it as one that does not exist.
Moreover, in public health crises, it will often be the case that
price-based rationing has broader, multiplier impacts beyond the direct
impact on those who cannot obtain a product. Rationing due to price or
for other reasons may permit pandemics to spread or allow viruses to
mutate, for example.
In short, reasonable pricing provisions are vital for PAHPA-related
investments.
The first starting point for reasonable pricing is that the United
States should not pay more for drugs and products it helped develop
than other high-income countries pay. This should be non-controversial.
If the U.S. Government helped pay for the invention and development of
a drug or biomedical product, then surely it should not be charged
prices higher than other rich countries which did not support
development of the product.
The government has, episodically, included ``Most Favored Nation''
(MFN) clauses in procurement contracts, including in its contract with
Pfizer for purchases of the antiviral Paxlovid. \26\ The operative MFN
provision in that contract reads:
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\26\ See discussion of the MFN provision at: Claire Cassidy,
``Pfizer Agrees to International Reference Pricing in Government
Contract for Covid-19 Therapeutic,'' Knowledge Ecology International,
February 2, 2022, https://www.keionline.org/37294.
If, at any time prior to, or during, the base term and any
exercised options of this contract, Contractor enters into any
agreement with a Covered Nation under which the Covered Nation
commits to purchase (i) the same or a lesser volume of Product
than the U.S. Government commits to purchase (ii) at a price
lower than the price the U.S. Government is obligated to pay
for Product under this contract, Contractor shall provide
notice of such lower price to the U.S. Government within 30
days of the execution of the Contractor-Covered Nation
agreement and the U.S. Government may elect, at its discretion,
to receive the benefit of this provision and purchase the
Product at that lower price. \27\
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\27\ The MFN provision is H.7 in the full contract, which is
available here: https://www.keionline.org/misc-docs/COVID19/Pfizer-
Contract-Paxlovid-W58P0522C0001-17Nov2021.pdf.
But MFN provisions are just a bare minimum starting point for
thinking about affordability and reasonable pricing. The overarching
point to understand about reasonable pricing for biomedical products is
that manufacturing costs are generally very low relative to overall
development costs. The main costs that drug, vaccine and other
biomedical corporations must recover are research and development,
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including cost of failure in pursuing many different ideas.
From this overarching point follows two key principles that should
define reasonable pricing. First, a reasonable price should correlate
to a manufacturers' development expense and acceptance of risk. If a
drug maker can show that it incurred large R&D costs, or that it
invested heavily in the riskier, earlier stages of development, then,
all other things equal, the reasonable price of a resultant drug should
be higher. On the other hand, if the government incurred most of the
expense and the manufacturers' actual outlay was small, or if the
government primarily funded the early stage work, then a reasonable
price should be lower.
Second, at a certain point, a manufacturer has obtained a
reasonable return on its original investment and should no longer be
entitled to supra-competitive profits. Although we support reasonable
pricing conditions and revenue caps for products that are completely
developed in the private sector, the situation is qualitatively
different with government funding. In the pure private case, the patent
monopoly and the possibility of a bonanza payout is, at least in
theory, the incentive for undertaking the up-front risky investment.
However, where the government has assumed a substantial portion of the
risk--including by directly funding the manufacturer to undertake R&D--
and where the government guarantees purchases, the manufacturers' risk
is greatly lessened. In these circumstances, after a manufacturer
secures a certain return on its investment, it should no longer be
entitled to supra-competitive profits and an automatic license to
manufacture the patented invention (and gain access to needed materials
and make use of testing data) should be available to all qualified
manufacturers.
Price terms are obviously a central subject of any purchase
agreement, but reasonable pricing terms should be included in R&D
contracts, covering both later government purchases and provision of
products in the private market. As regards government purchases,
including reasonable pricing terms will establish market norms and
expectations. Not only does this leverage the government's unique power
at the point it is making grants and investments in new products, it
orients drug maker and market understandings and forecasts. No
manufacturer should be blindsided by a government demand for reasonable
prices; and no manufacturer should feel empowered to challenge the rule
that it is entitled to a reasonable reward, but no more.
It is even more important that reasonable pricing provisions apply
to the private market. In the absence of price restraints, Big Pharma
pricing models regularly deny people access to necessary treatments,
therapies and preventative services. When Big Pharma corporations price
drugs to maximize profits, they are necessarily setting prices out of
reach for many people, especially those with no insurance, limited
insurance or insurance with high co-pays. The median launch price of a
new drug in the United States jumped from $2,115 in 2008 to $180,007 in
2021, a 20 percent annual inflation rate, according to researchers at
Brigham and Women's Hospital in Boston. \28\
---------------------------------------------------------------------------
\28\ Robert Langreth, ``New Drug Prices Soar to $180,000 a Year on
20 percent Annual Inflation,'' Bloomberg, June 7, 2022, https://
www.bloomberg.com/news/articles/2022-06-07/new-drug-prices-soar-to-180-
000-a-year-on-20-annual-inflation.
As a result of these soaring prices, non-adherence to drug regimens
due to price--the cost of drugs, co-pays and deductibles--is at
epidemic levels. Thirty percent of Americans report that they have
skipped drug treatments or otherwise haven't taken medicines as
prescribed because of cost. \29\
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\29\ Liz Hamel, Lunna Lopes, Ashley Kirzinger, et al., ``Public
Opinion on Prescription Drugs and Their Prices,'' Kaiser Family
Foundation, April 5, 2022, https://www.kff.org/health-costs/poll-
finding/public-opinion-on-prescription-drugs-and-their-prices
Forced rationing based on excessive pricing is morally appalling
and antithetical to good public health policy in any circumstance. The
idea that high prices would deny access to care for vital medicines,
vaccines or treatments in a time of public health emergency--for
products invented and/or developed with support from U.S. taxpayers--
should be unthinkable. It certainly shouldn't be tolerated. And it is
completely avoidable if BARDA and other relevant agencies operate
---------------------------------------------------------------------------
proactively to ensure reasonable pricing.
Nor should reasonable pricing obligations end with the wind-down of
a public health emergency. In cases where the public has made
substantial contributions to the development of a product, then the
public has every reason to demand that the resultant products remain
affordable. The case of the Moderna vaccine is illustrative. Moderna
has generated enormous profits during the pandemic and is quadrupling
Covid vaccine prices now that the acute phase of the pandemic is over.
People will continue to need updated Covid vaccines; Moderna has
already generated more than fair returns on its modest investment; and
yet the company aims to price gouge consumers. BARDA and other agencies
should ensure this scenario never repeats.
International Access
PAHPA support for R&D should be contingent on ensuring that U.S.-
supported inventions are available globally on reasonable terms. To be
clear, this access need not come at the expense of Americans. The
objective should be to expand affordable supply to meet the needs of
people around the world.
Guarantees of global accessibility will advance a diverse range of
U.S. interests:
First, the United States has a humanitarian interest in ensuring
everyone has access to needed drugs, vaccines, therapies and
diagnostics. The market alone will not ensure universal access; in
fact, relying on the market alone ensures massive disparities in global
access. Monopolistic manufacturers of new products may not have
capacity on their own to scale up production to meet global needs.
Beyond production capacity, Big Pharma routinely overlooks low-income
and lower-middle-income countries, which do not have the ability to pay
high-income prices for products. Especially for U.S. taxpayer-funded
products, the United States has a humanitarian duty to ensure global
access.
Second, the United States has a public health interest in ensuring
global access. As the waves of Covid variants reminded us, failing to
control a highly transmissible virus in one part of the world invites
mutations that will inevitably impact the United States. Ensuring
people around the world have access to vaccines, drugs, treatments and
diagnostics directly assists public health in the United States.
Third, sharing biomedical technology can afford enormous global
economic benefits. The Covid pandemic massively disrupted the global
economy. Major government intervention in the United States offset the
impacts, but the pandemic led to massive reductions in global trade and
long-lasting supply chain shocks. \30\ To whatever extent sharing of
biomedical technology could reduce comparable impacts in the future,
the economic benefits would be extraordinary--just shaving months off
the period of a pandemic could save hundreds of billions of dollars for
the U.S. economy.
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\30\ ``Study Shows Vaccine Nationalism Could Cost Rich Countries
US$4.5 Trillion,'' International Chamber of Commerce, January 25, 2021,
https://iccwbo.org/news-publications/news/study-shows-vaccine-
nationalism-could-cost-rich-countries-us4-5-trillion/; Eleanor Bell, et
al.., ``Estimates of the Global Burden of Covid-10 and the Value of
Access to Covid-19 Vaccines,'' Vaccines, August 15, 2022, https://
www.mdpi.com/2076-393X/10/8/1320.
Last, sharing technology and ensuring global availability of
important biomedical advances would secure tremendous diplomatic gains
for the United States. It would evidence not only our technological
---------------------------------------------------------------------------
prowess but our beneficence.
Ensuring affordable global access to new biomedical inventions
requires establishing sufficient global manufacturing capacity and
taking measures to promote affordability, including especially in
lower-income countries. Both these components are crucial. In the case
of the pandemic, once the mRNA vaccines were developed, there was very
little supply available for poor countries. To a very considerable
degree, the shortage was artificial, a result of Moderna and Pfizer
refusing to share their technology with other manufacturers. But
adequate supply by itself is not enough. Products must be affordable
for low-and middle-income countries, otherwise they will remain as
inaccessible as if they did not exist.
To this end, PAHPA-related R&D contracts should include the
following provisions:
An automatic license to the World Health Organization
(WHO) and efforts such as the WHO's mRNA Technology Transfer
Program. \31\ Along with a license for relevant intellectual
property and testing data, U.S. research and development
contracts should require grantees to engage affirmatively in
technology transfer, including the sharing of biomaterials,
product recipes and manufacturing methods. The affirmative
objective should be to buildup manufacturing and development
capacity in developing countries.
---------------------------------------------------------------------------
\31\ ``mRNA Technology Transfer Programme Moves to the Next Phase
of its Development,'' World Health Organization, April 20, 2023,
https://www.who.int/news/item/20-04-2023-mrna-technology-transfer-
programme-moves-to-the-next-phase-of-its-development
A duty for manufacturers to make best efforts to
scale up production to meet global need and to license with low
and fixed royalties to qualified third parties to manufacture
for developing country markets. Licensing for developing
countries can be easily arranged through the Medicines Patent
Pool, an international institution established for exactly this
purpose. \32\
---------------------------------------------------------------------------
\32\ https://medicinespatentpool.org/
An obligation for affordable pricing for developing
countries. Generally, this should be marginal pricing for low-
and middle-income countries and substantially discounted
pricing for upper-middle-income nations. Companies should be
able to satisfy the pricing obligation by providing non-
exclusive licenses, if they prefer. It is important that
affordability and licensing arrangements cover middle-income
countries to ensure rapid, worldwide availability of critical
new products. By way of example, Public Citizen has estimated
that the need for the Covid treatment Paxlovid (Nirmatrelvir/
ritonavir) in non-high income countries is at least 10 times
what has been purchased. \33\
---------------------------------------------------------------------------
\33\ Letter to Katherine Hiner, Acting Secretary to the U.S.
International Trade Commission, Public Citizen, April 12, 2023, https:/
/www.citizen.org/article/post-hearing-brief-for-investigation-no-332-
596-covid-19-diagnostics-and-therapeutics-and-flexibilities-under-the-
trips-agreement/
---------------------------------------------------------------------------
Other Pro-access, Pro-innovation Contract Terms
PAHPA contract terms should include other pro-access, pro-
innovation measures, including:
``Reach-through'' provisions, ensuring that any party
using a licensed technology must apply the same access and
affordability provisions as included in the original contract
terms. Reach-through provisions prevent gaming of the
affordability and accessibility obligations, for example,
through modest alterations of the original product. They also
extend the affordability and accessibility benefits to follow-
on and combination products, re-paying the taxpayers for their
initial investments.
Duties to license to other qualified drug researchers
and manufacturers to facilitate more innovation. The licensing
obligation should include intellectual property and data rights
for the end product, but also materials needed for conducting
research. Additionally, BARDA procurement contracts should
include boilerplate language safeguarding the ability to
conduct necessary research on existing and next generation
products. There is evidence to suggest that companies are
restricting access to Covid vaccine that would be used for
research purposes, for example, imposing potentially severe
impediments to important research. \34\
---------------------------------------------------------------------------
\34\ ``Science Held Hostage: How Pharma is Using mRNA Vaccine
Contracts with Government to Delay Future Innovation,'' PrEP4All, April
2023, https://static1.squarespace.com/static/5e937afbfd7a75746167b39c/
t/643ee03ce3538e2bb5d925bf/1681842236736/
PrEP4All+Prevention+Equity+Alert4-2023.pdf
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Prizes and Other Models to Support Biomedical Innovation
The work of BARDA and related agencies is so important because they
address market failures. These failures trace to familiar sources and
have nothing to do with the behavior or ethics of any individual
corporation or researcher. The core problem is that Americans need to
support innovation in products that we hope will never be used, or for
which market demand is very uncertain. We need biomedical products for
pandemics that we hope never occur, and we need to be prepared to scale
up for pandemics with a profile different than what we have planned
for. We need new antibiotics that we may hold in reserve to prevent
resistance. We need countermeasures for biological and chemical weapons
that we hope will never be deployed. In such circumstances, the
traditional model of incentivizing R&D by the grant of limited term
patent monopolies breaks down. PAHPA and BARDA are direct responses to
that market failure.
In addition to the contractual measures sketched above, a
reauthorized PAHPA should also authorize different approaches to
supporting R&D--that is, to move beyond research grants grafted on to
the patent monopoly model. PAHPA in fact contemplates such alternative
approaches, \35\ but these should be more affirmatively supported and
required.
---------------------------------------------------------------------------
\35\ (42 U.S.C. 247d-7e(c)(4)(D)). Perversely, BARDA has used this
authority to circumvent the modest existing rules in existing law to
promote affordability. A reauthorized PAHPA should explicitly prevent
this misuse of ``other transition'' authority. See Christopher Rowland,
``Trump Administration Makes it Easier for Drugmakers to Profit from
Publicly Funded Coronavirus Drugs, Advocates Say,'' Washington Post,
July 1, 2020, https://www.washingtonpost.com/business/2020/07/01/
vaccine-coronavirus-barda-trump.
One model is to offer prizes in place of patents. \36\ Instead of
offering a patent monopoly as an incentive for innovation, BARDA and
other agencies may offer prizes. Developers may be awarded dollar
awards from a prize fund, with all intellectual property and related
rights vested in the Federal Government. There are numerous potential
benefits to a prize fund. First, it can offer sufficient incentive for
research and development work for products for which there may be no
apparent market, as described in the cases above. Thus prizes can be
used to induce more innovation than patents might. Second, the prize
fund can be reasonably calibrated to the public health value of the
product or products being developed. This is very different than
patents, which are calibrated not to public health value, but market
demand. Third, prizes can eliminate price gouging. Innovators are
rewarded by prizes, not monopolies, so the resultant products can be
licensed broadly to manufacturers and sold as generics. Fourth, prizes
can be adjusted to avoid the winner-takes-all problem of patents.
Portions of a prize fund may be shared with innovators whose research
assisted the development process but did not ultimately lead to a
patented invention, an approach proposed in Senator Sanders' Medical
Innovation Prize Fund Act as an ``open-source dividend.'' Fifth, prizes
can incentivize collaboration, with diverse research centers pooling
efforts and sharing the prize, rather than trying to lay claim to a
singular patent. Similarly, prizes can overcome the problem of patent
thickets.
---------------------------------------------------------------------------
\36\ Senator Sanders has previously introduced legislation to
create a prize fund for biomedical research. See the Medical Innovation
Prize Fund Act, introduced as S495 in the 115th Congress. https://
www.Congress.gov/bill/115th-congress/senate-bill/495/text's=2&r=1&q=
percent7B percent22search percent22 percent3A percent5B
percent22Medical+Innovation+Prize+Fund+Act percent22 percent5D
percent7D. For a detailed discussion of innovation prizes, see the work
of Knowledge Ecology International, here: https://www.keionline.org/
book/prizes-to-stimulate-innovation.
Prizes are an important alternative to the monopoly incentive model
in all circumstances, but they are particularly important--and
especially deserving of much more widespread usage--in the PAHPA
---------------------------------------------------------------------------
context, where the temporary monopoly model definitionally fails.
A second model is to lean in more heavily to the research
contracting model. This would involve contracting with research centers
at universities and corporations to undertake research in service of
the U.S. Government, rather than making grants but allowing the
grantees to control the fruits of the research. The government would
maintain ownership and control of all intellectual property and
associated rights; coordinate product development; and license final
products on a non-exclusive basis to all qualified manufacturers. In
the case of the NIH-Moderna vaccine, where essentially the entire
enterprise was funded by the U.S. Government, this is practically what
occurred--with the crucial caveat that Moderna was permitted to control
the fruits of the research.
A third model is patent and/or know-how buyouts: In a case of a
chemical weapon countermeasure, for example, the government would
negotiate with the patent holder a fair agreement to purchase all
intellectual property and related rights--a one-time payment--and then
license multiple manufacturers to produce the countermeasure on a
contractual basis. If the U.S. Government is the only purchaser, this
is what will effectively happen in any case, but it converts the price
negotiation into a more rational process to determine fair compensation
to the innovator for the value of their innovation.
These varied approaches may be combined. For example, a prize
system can be supplemented with direct grants, with the size of the
prize awards effectively adjusted. In a case of patent or know-how
buyouts, the payment to the grantee should be adjusted to reflect the
grant contributions from the government and the amount of capital
risked by the patent holder.
These models, especially combining prize funds and direct grants,
are especially appealing to prepare for future threats. The public
health imperative is to investigate and prepare for a wide range of
threats and to position the country (and the world) to have products
already identified and in far-along or completed development stage if
any of those threats emerge. Researchers at NIH have identified 20
virus families for which they propose a series of steps that would lead
to prototype vaccines. \37\ This is not work that will receive drug and
vaccine maker investment with a temporary monopoly incentive, because
the problems are too speculative and the likelihood of payout too
uncertain. But it is exactly the kind of work that PAHPA should be
supporting though prize funds and direct research contracting.
---------------------------------------------------------------------------
\37\ Gina Kolata, ``Fauci Wants to Make Vaccines for the Next
Pandemic Before it Hits,'' New York Times, July 25, 2021, https://
www.nytimes.com/2021/07/25/health/fauci-prototype-vaccines.html; Barney
S. Graham and Nancy J. Sullivan, ``Emerging Viral Diseases from a
Vaccinology Perspective: Preparing for the Next Pandemic,'' Nature
Immunology, 19, 20-28 (2018), https://www.nature.com/articles/s41590-
017-0007-9.
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Conclusion
The underlying theory of PAHPA was validated by the Covid pandemic,
which showed the crucial importance of a real public health
infrastructure to prepare for pandemics and emergencies and to make
significant investments in biomedical innovation. But so too did the
pandemic illustrate the very real costs--in dollars and lives--of
failing to act proactively to ensure an adequate supply and
affordability of key biomedical products. The reauthorization of PAHPA
must be the moment to make our pandemic and emergency preparedness more
robust. First, a reauthorized PAHPA should require BARDA and other
agencies to build transparency, affordability, production and licensing
terms into R&D and acquisition contracts. Second, it should require
BARDA and other agencies to adopt prize funds and other creative
measures to more efficiently fund biomedical R&D and advance public
health objectives.
______
[summary statement of robert weissman]
Lessons from Covid Vaccine Development: Operation Warp Speed was a
great success in speeding the development of lifesaving vaccines and
getting them to market. It was proof that the Biomedical Advanced
Research and Development Authority (BARDA) model can work.
But it also was proof that the BARDA model needs important
refinements. Government support underlay the entire Covid vaccine R&D
project, beginning decades before Covid appeared and continuing through
clinical trials and scaled up production. Among the vaccine makers,
Moderna uniquely benefited from Federal support. The government's
extensive investments and co-invention status for the vaccine made by
Moderna gave the U.S. Government powerful authority to condition how
Moderna behaved and to share the technology. It did not do so.
As a result, while Moderna executives became billionaires,
taxpayers were gouged; hundreds of thousands or perhaps millions of
people around the world likely died needlessly because of avoidable
vaccine shortages; and now patients and the public are poised to be
ripped off further, with vaccines needlessly rationed due to high
prices.
Measures to Advance Transparency, Affordability and Universal
Access: We must at least learn from this Covid experience and prevent a
repeat with future technologies funded and developed by BARDA and PAHPA
investments.
Transparency: The starting point for policy around PAHPA investment
in biomedical R&D and acquisition should be proactive transparency. The
public should know what it is financing, on what terms and the degree
to which private sector partners are contributing to research and
development costs.
Reasonable Pricing: Getting products to market is essential, but so
is ensuring reasonable pricing. A high-priced medical product is as
inaccessible to those who cannot afford it as one that does not exist.
The first starting point for reasonable pricing is that the United
States should not pay more for drugs and products it helped develop
than other high-income countries pay. Beyond ``Most Favored Nation''
provisions, BARDA should require reasonable pricing for the products it
supports, with reasonable pricing scaled to private partner investments
and assumption of risk.
International Access: PAHPA support for R&D should be contingent on
ensuring that U.S.-supported inventions are available globally on
reasonable terms. This access need not come at the expense of
Americans. The objective should be to expand affordable supply to meet
the needs of people around the world, by requiring licensing of
technologies to, and sharing of know-how with, the World Health
Organization (WHO) and other international partners.
Prizes and Other Models to Support Biomedical Innovation: Instead
of offering a patent monopoly as an incentive for innovation, BARDA and
other agencies should, at least in some cases, offer prizes. Developers
would be awarded dollar awards from a prize fund, with all intellectual
property and related rights vested in the Federal Government. This
approach could induce more innovation, while advancing access and
affordability objectives.
______
The Chair. Thank you very much. Senator Cassidy, did you
want to introduce your panelist?
Senator Cassidy. Yes. We are joined today by Dr. Martin
Makary, a Surgeon, Researcher, and Professor at the Johns
Hopkins School of Medicine, a Professor for the Johns Hopkins
Carey Business School.
Dr. Makary focuses his research on public health and health
care delivery issues ranging from health care costs to COVID-
19. He previously worked for the World Health Organization,
where he helped develop the surgeon's checklist, which has
helped reduce surgery related deaths around the world.
He holds degrees from Bucknell, Thomas Jefferson, and
Harvard Universities, completed his medical training at
Georgetown and Johns Hopkins, and is the author and coauthor of
over 250 peer reviewed papers.
Did I get that right, man? Pretty impressive. I look
forward to hearing from you today. Thank you for joining us,
doctor.
STATEMENT OF MARTIN MAKARY, M.D., M.P.H., PROFESSOR, JOHNS
HOPKINS UNIVERSITY, BALTIMORE, MD
Dr. Makary. Thank you. Thank you, Senator Sanders. Thank
you, Ranking Member Cassidy. Thank you, Senator Markey. It is a
privilege to present. I speak on behalf of myself, not Johns
Hopkins University or the National Academy of Medicine, for
which I am a member.
Congress should avoid the false narrative that insufficient
Federal findings were to blame for our pathetic COVID response.
Take, for example, one Johns Hopkins student created a COVID
tracker that the world used, and it was not created by the
21,000 employees at the CDC.
As a matter of fact, when HHS met with the CDC, they said
it would take months to create such a tracker. Did the CDC need
25,000 employees or 50,000 employees? We just had the head of
ASPR, the Assistant Secretary of Preparedness and Response say
she needs more hiring power.
How about firing power for incompetence, or both? I mean,
21,000 employees cannot come up with a COVID tracker. More
tragically, the NIH has $42 billion. BARDA, which is a part of
the PAHPA Act, has another billion dollars and they couldn't do
the most basic clinical research we needed done quickly to
answer the basic questions, to end the controversies and the
conspiracy theories, to finally get out the questions Americans
were asking us, how does it spread? Is it from touching
surfaces? Do I need to pour 20 gallons of alcohol on my
groceries?
Fauci was telling teachers in July to wear gloves and
goggles. Or was it spread airborne? That could have been
answered in 24 hours in one of our BSL 4 labs, or in 1 week of
clinical research to answer the question, when are you most
contagious? What is the peak day of viral shedding? How long do
you have to quarantine for? Do masks work?
We could have answered this with definitive basic clinical
research early. They didn't. And so, I think it's fair to ask
how did they do in preparing us for the pandemic? We have spent
over $20 billion on PAHPA over the last 20 years. What has that
done for us? How many lives were saved during the COVID
pandemic because of investments by PAHPA or BARDA?
Now, they have done some good work. I have seen it. But
regardless of one's political affiliation, they have got to
acknowledge that we, doctors, and the public were flying blind.
We had opinion ruling the day on what we should do or not do,
when we could have been governed by evidence, policy driven by
good basic clinical research.
We didn't have that, and so we had a void of clinical
research, and guess what filled that void. Over half a year, a
year, 2 years, what filled that void where political opinions.
Those controversies could have been ended early. We had the
money. And as a result, the COVID pandemic became the most
politicized pandemic in U.S. history. It was avoidable. Much of
it was avoidable.
My research team at Johns Hopkins did a study of where the
NIH spent their money in 2020. They spent 2.2 times more money
on aging research than they did on COVID research the year of
the pandemic. Now, I am all for aging research, especially as I
get older, but not during a global pandemic when 3,000
Americans are dying a day.
Much of this research was misguided, and our study
published in the BMJ that I included in the packet showed that
it took the NIH after they decided to fund a research study, it
took them 5 months to give that money to the researchers. That
does not work during a health emergency.
Now, while the NIH is outside of the scope of the
reauthorization, BARDA is, and I think the public has a right
to ask what has BARDA and what has PAHPA done for them in
preparing for COVID? How many lives were saved because of the
investment? What is the single best investment BARDA made with
that roughly $20 billion before the pandemic, that saved lives
during the pandemic?
I think it is fair to ask those questions. How many beds
are available today? Do we track the number of beds available?
We are going to have more catastrophes, not just viral
pandemics. We are going to have mass shootings and floods and
other natural disasters.
We have spent a lot of money at BARDA making hospitals, a
lot of money, giving them a lot of money, private startup
companies making money, contractors making a lot of money. But
the question is, where was the basic clinical research?
We have been funding virus hunting internationally, sending
teams to get exotic viruses and bringing them back into
populated areas. How about funding basic clinical research?
Thank you, Senator Sanders and Ranking Member. I look forward
to your questions.
[The prepared statement of Dr. Makary follows:]
prepared statement of martin makary
Chairman Sanders, Ranking Member Cassidy, Members of the Committee,
thank you for the invitation to present.
Congress should avoid the false narrative that insufficient Federal
funding was to blame for the country's pandemic response. In fact, it
was a case study in bureaucratic failure.
One Johns Hopkins student developed a Covid tracker that the CDC,
with its 21,000 employees, was unable to create. Was the CDC
understaffed? Did the it need 25,000 employees to make a website for
the world to track the pandemic? No, the CDC was mired in bureaucracy.
More tragic, the NIH, with a $42 billion budget, failed to conduct
basic clinical research in a timely fashion. Critical scientific
questions went unanswered--questions that could have been answered with
1 week of clinical study, like:
Does Covid primarily spread from touching or is it
airborne?
When is the peak day of viral shedding and contagion?
How long should you quarantine?
Do masks work?
Leaving many basic scientific questions unanswered for half a year
or more, public health officials ruled by opinion in lieu of conducting
or funding clinical research quickly.
In July, 2020, Dr. Fauci told the American Federation of Teachers
president at a public event that teachers should wear goggles and
gloves. He has since said that we didn't know back then because we
didn't have the science. But he controlled a $6 billion research budget
at NIAID. Did NIAID need $7 billion to find out that Covid was
airborne? Did he need an additional $7 billion to tell us if cloth
masks on toddlers and 50 million children for 2 years is effective?
Regardless of one's political affiliation, in the absence of good
scientific evidence, doctors and the public were flying blind. What
filled the void were opinions. That's how Covid became the most
political pandemic in U.S. history.
My Johns Hopkins research team went back and found that in 2020,
the year the pandemic hit the U.S., the NIH spent 2.2-times more money
on aging research than it did on Covid research. I'm all for aging
research, especially as I get older, but not when 3,000 Americans are
dying everyday. Our study, published in BMJ, also found that when the
NIH made a decision to fund a Covid research study, it took them 5
months to actually send the money to the researchers to start the
research. In short, the government failed to pivot, not because they
didn't have enough resources, but because of a rusty and bloated
bureaucracy.
Ironically, while the U.S. failed to fund basic clinical research
on the big Covid questions, we were funding labs overseas to engage in
the dangerous business of virus hunting, sending people to remote
uninhabited rainforests and caves to obtain exotic viruses and bring
them to labs in highly populated cities of 8-10 million people--the
population of Wuhan. There are at least a million different viruses in
the world and a small fraction, roughly fewer than 1 percent, infect
humans. Why is the U.S. funding this dangerous work? The promise of
virus hunters that they could use this information to predict future
pandemic was a fallacy. It's never happened and never will. We don't
need A.I. to prepare for future pandemics, we just need I.
The U.S. needs a rapid response team to conduct or fund clinical
research to guide pandemic responses, so we're not simply following
opinions.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
______
[summary statement of martin makary]
Chairman Sanders, Ranking member Cassidy, members of the committee,
thank you for the invitation to present.
Congress should avoid the false narrative that insufficient Federal
funding was to blame for the country's pandemic response. In fact, it
was a case study in bureaucratic failure.
One Johns Hopkins student developed a Covid tracker that the CDC,
with its 21,000 employees, was unable to create. Was the CDC
understaffed? Did the it need 25,000 employees to make a website for
the world to track the pandemic? No, the CDC was mired in bureaucracy.
More tragic, the NIH, with a $42 billion budget, failed to conduct
basic clinical research in a timely fashion. Critical scientific
questions went unanswered--questions that could have been answered with
1 week of clinical study, like:
Does Covid primarily spread from touching or is it
airborne?
When is the peak day of viral shedding and contagion?
How long should you quarantine?
Do masks work?
Leaving many basic scientific questions unanswered for half a year
or more, public health officials ruled by opinion in lieu of conducting
or funding clinical research quickly.
In July, 2020, Dr. Fauci told the American Federation of Teachers
president at a public event that teachers should wear goggles and
gloves. He has since said that we didn't know back then because we
didn't have the science. But he controlled a $6 billion research budget
at NIAID. Did NIAID need $7 billion to find out that Covid was
airborne? Did he need an additional $7 billion to tell us if cloth
masks on toddlers and 50 million children for 2 years is effective?
Regardless of one's political affiliation, in the absence of good
scientific evidence, doctors and the public were flying blind. What
filled the void were opinions. That's how Covid became the most
political pandemic in U.S. history.
My Johns Hopkins research team went back and found that in 2020,
the year the pandemic hit the U.S., the NIH spent 2.2-times more money
on aging research than it did on Covid research. I'm all for aging
research, especially as I get older, but not when 3,000 Americans are
dying everyday. Our study, published in BMJ, also found that when the
NIH made a decision to fund a Covid research study, it took them 5
months to actually send the money to the researchers to start the
research. In short, the government failed to pivot, not because they
didn't have enough resources, but because of a rusty and bloated
bureaucracy.
Ironically, while the U.S. failed to fund basic clinical research
on the big Covid questions, we were funding labs overseas to engage in
the dangerous business of virus hunting, sending people to remote
uninhabited rainforests and caves to obtain exotic viruses and bring
them to labs in highly populated cities of 8-10 million people--the
population of Wuhan. There are at least a million different viruses in
the world and a small fraction, roughly fewer than 1 percent, infect
humans. Why is the U.S. funding this dangerous work? The promise of
virus hunters that they could use this information to predict future
pandemic was a fallacy. It's never happened and never will. We don't
need A.I. to prepare for future pandemics, we just need `I'.
The U.S. needs a rapid response team to conduct or fund clinical
research to guide pandemic responses, so we're not simply following
opinions.
______
The Chair. Thanks very much. Let me start off with an issue
that has bothered me for a long time. It is kind of a
philosophical issue, maybe a moral issue. If I have a product,
a prescription drug or a vaccine that can save his life, and I
say, Bill, you can have it, but it is going to cost you
$100,000.
You say, hey, Bernie, I don't have $100,000. I say, well, I
am sorry, Bill. My business model is that is the price it. So,
are you going to die? Nice guy. That is the way it is. Now, Mr.
Weissman, you were talking about maybe millions of people
around the world, poor people dying because they don't have the
vaccine. We have it.
I think the vaccine as I understand it, somebody correct me
if I am wrong, now costs a couple of dollars to produce. Not a
whole lot of money. What is the morality, and I want all three
of you to respond to it, of us having a product that cost a few
dollars to produce but not making it available to people around
the world who are dying, and in our own country as well, but
poor people around the world. Doctor.
Dr. Ramachandran. Senator Sanders, what you are describing,
the situation--you know, the hypothetical is the lived reality.
I see it pretty much every single time I have a clinic where
patients come to me and say that they can't afford whatever I
am prescribing them.
The fact that this could happen with a publicly funded
vaccine is frightening, frankly, to me, after the public health
emergency period ends. So, absolutely I think it should be
unconscionable. It should not be allowed for that to happen.
You know, no one should be poor because they are sick, and
no one should be sick because they are poor. So, you know----
The Chair. If I have a product that can save your lives
that costs me a few bucks to manufacture, should I deny it to
you?
Dr. Ramachandran. No, definitely not.
The Chair. Okay. Mr. Weissman.
Mr. Weissman. Well, thank you for the question. It really
is a core one. It is obviously an unconscionable scenario that
you are describing, I think, when we look at it globally, what
is worth underscoring is that there effectively is no market in
low middle income countries for big pharma.
They are not holding out to see if someone can pay more.
They are just not going to sell there at all. So, leaving aside
what we think about to happen in high or in our market, or in
high income country markets, in those markets, we just have to
figure out ways to get the technology disseminated there.
When it comes to lifesaving technologies like a vaccine,
especially a U.S. Government supported vaccine, if they don't
want to make it to sell there, fine, but require them to share
the technology with other manufacturers, give them the know how
so they can make it on their own. That is the least we should
obligate.
The Chair. Mr. Makary, should people die because they can't
afford a product that costs a couple of bucks to manufacture?
Dr. Makary. Cost should never be an access--a barrier.
However, I must note that there are sacred cows nobody will
talk about with drugs in the United States, like----
The Chair. Test me.
Dr. Makary. Pharmacy benefit managers and group purchasing
organizations.
The Chair. We will talk about it.
Dr. Makary. Thank you for your work on----
The Chair. We are going to have them next week. They are
going to be sitting exactly where you are sitting along with
the three major insulin manufacturers in the world. How is
that?
Dr. Makary. Great. Sole supplier contracting is also tied
into shortages. The FDA Commissioner was just asked about
shortages and what he is doing, and he said, we need better
data. How about these mass monopoly powers?
We have got three suppliers that supply 85 percent of U.S.
hospitals. They enter into these cozy sole supplier contracts.
The manufacturer gets a flimsy supply chain. For something like
insulin, we have maybe one manufacturer.
The Chair. All of the points you are raising are good
points. I am going to get it back to you. Tell me about the
moral issue. I have a product, costs me two bucks to
manufacturer. Will save his life. He can't afford it. Is that a
good--is that a moral business model that we should sustain, in
your judgment?
Dr. Makary. It is an unacceptable barrier. But I think the
best way to lower drug prices in America are to stop taking
drugs we don't need and to cut the waste in the system.
The Chair. Okay. Senator Cassidy.
Senator Cassidy. Thank you all for being here. Dr. Makary,
what do you really think, man?
[Laughter.]
Senator Cassidy. Well, of course, the theoretical that was
just given is an absurd theoretical. I say that because Moderna
has already pledged that they will make this vaccine available.
I come from treating a group of patients who are uninsured in
Louisiana. I speak with some authority.
Between a Medicaid expansion state and 340(b) and other
mechanisms, drugs should be available for those who otherwise
would not have. Now, as regards to the vaccine, I could also
give you a theoretical. What if we so disincentivize the
production of cutting-edge therapies that somebody would not
develop it? Well, we have seen that before, haven't we? Now
what happens is we end up not having cures.
I think that we have to have a note of reality as we give
theoretical. Dr. Makary, in full disclosure, I had a very
productive conversation before the last hearing with Dr.
Walensky. One concern I had, there seemed to be--and by the
way, I think in fairness, we have to say the Federal agencies
to which we refer generally conceded didn't do well, did, some
of them at least, before the pandemic, but they are making
major efforts to reform.
Let's just acknowledge that. And one of the productive
conversations I thought we had is how you could have
information sharing. That it wouldn't be siloed or if you will,
quarantined from others seeing it by a Federal agency, but with
sufficient protection of privacy, that there would be access by
other researchers who might have a different idea than CDC.
You are a person, I think all three of you are people who
have different ideas about how these things should be handled.
And so, again, with sufficient protection for privacy, having
access to that data base, CDC may maintain it or someone else,
but some good researcher at Johns Hopkins who wants to test
that thesis could similarly do so, one more time, with
appropriate safeguards. What are your thoughts about that?
Dr. Makary. Public health officials really downplayed and
silenced dissent on many different levels. Why has the Oxford-
AstraZeneca vaccine never been approved in the United States,
being given to over a billion people? Covaxin, why has it never
been approved? What is it with the cozy relationship between
regulators----
Senator Cassidy. Yes, but go back to the information
sharing because that is the point of my question. So, is there
a way that we can have more--I kind of group outsourcing or
group sourcing the analysis of the data that would allow us to
make better public health decisions.
Dr. Makary. Yes, we have not had good access to data. We
have asked for hospitalization rates in people under 50 by
booster versus non booster, just the primary vaccine series. We
didn't get it. Why? Probably doesn't support the narrative.
Science should not be censored or corrupted.
Senator Cassidy. I accept that. But I am just--I got
limited time, so I don't mean to cut you off. Mr. Weissman, you
heard Dr. Califf's concern that if you went to an x prize
model, if you did not sufficiently protect intellectual
property, that would be a disincentive for companies to make
large scale investments, etcetera, etcetera, etcetera. Your
thoughts on that?
Mr. Weissman. Yes, I think Dr. Califf is mistaken. You
know, in the scenario that you laid out for him, there was no
private sector market at all. You are talking about--you were
talking about countermeasures where the Government was the sole
purchaser.
The intellectual property, the monopoly, that is not what
is going on. It is not about how we can charge the most for
private individuals. All that does is give the company that the
U.S. Government funded more bargaining power with the United
States when we purchase from them. That doesn't seem to me like
a sensible thing----
Senator Cassidy. I am not quite sure I am following your
logic. I think the original premise was that if you are trying
to get the company to commit significant resources to
developing something, is it better to give them intellectual
property--whether or not the U.S. will be the sole purchaser--
but when there is this setting, and of course, we are talking
about the initial, we got to jumpstart it.
The premise of the discussion was, is it better to give
them an x prize in which you just take it all--you just bet the
farm on winning that prize. If not, you lose. Or is it better
to give them intellectual property protection and better to
give them some sort of kind of traditional intellectual
property.
Mr. Weissman. Well, I understood the scenario you laid out
to Dr. Califf actually was where the U.S. Government was the
purchaser, but I think it is an interesting question also where
the U.S. Government is not.
I would actually reverse what you said. To me, the patent
monopoly model is the winner take all and it is an uncertain
winner take all. So, the one who gets the patent, that is who
is the winner. They don't really know the value because you
don't know what the market is going to be. You have more
certainty with the price because you know the value of it.
But you can calibrate the prize and share actually,
incentivize people to get into space, even if they are not the
winner. So, you may give an award to someone who drove the
research forward but didn't get the final thing that would have
become----
Senator Cassidy. This has a kind of nice group theory kind
of approach to it, the idea that everybody would kind of
outsource that, I am not sure that--I can already envision the
lawsuits over it is my share, not your share, at least with
the----
Mr. Weissman. As you know, the patent field is quite full
of lawsuits already.
Senator Cassidy. Oh, sure. But that is a minefield that has
already been well tread and people understand. Dr.
Ramachandran, again, thank you for your good work. Let me just
finish by saying this--and maybe any of you could take this. I
have a graph showing that there is a reasonable pricing clause
in the Cooperative Research and Development Agreement, which
stopped in 1995.
Prior to that point, you had this kind of level of
commercialization of research. And then after that removal,
there really took off. So, it suggests that, in fact, the
conclusion of this is, the primary stimulus for the increase in
the cooperative research and development agreements after 95
was the removal of reasonable pricing clauses, etcetera,
etcetera.
That is the punch line. Would you disagree with that or
lack of familiarity? That is okay, if not.
Dr. Ramachandran. No, I think any of what you said,
mentioned before of this being so possibly an association, but
not causation comes into play. Also, during COVID-19, we
actually did see the use of reasonable pricing clauses, which
companies, including major manufacturers, not just small
biotech companies that only have one product in their
portfolio, accepted. Pfizer was one of them with Paxlovid that
negotiated with U.S. Government.
Actually, within that contract, there was a most favored
nation clause, a pricing provision that Pfizer accepted.
Similarly, Sanofi and Novavax also had reasonable pricing
clauses.
We are also seeing this even outside of the medical
countermeasure space. Just recently, University of California,
Berkeley, announced reasonable pricing provisions for U.S.
populations for their products, and that includes gene
therapies that they are developing.
You can see even for products where there is a large
commercial market, these sorts of protections could be
included. And especially for an agency like NIH that has so
much leverage and access to technology that companies do want
to have.
Senator Cassidy. Excellent answer. I yield.
The Chair. Thank you. Let me just as a follow-up on Senator
Cassidy's point. If I am not mistaken, I think you called my
question an absurd hypothetical. All right. It doesn't happen.
You say, I suggested that people die or get sick because they
can't afford medicine. Do you think that is an absurd
hypothesis? I don't know----
Senator Cassidy. It's not $100 million--charging $100
million for life saving.
The Chair. Not 100 million. $100,000. Look, cancer drugs
are $100,000 right now, all right. I would like to--doctors, I
think we have two doctors and an expert on it, is it an absurd
hypothesis to suggest that people are dying or suffering or
going bankrupt or having their lives disrupted because they
cannot afford the outrageous price of prescription drugs?
Doctor.
Dr. Ramachandran. No, it is not a hypothetical at all. It
is the lived reality for so many Americans, especially people
around the world.
The Chair. You see it in your practice.
Dr. Ramachandran. All the time.
The Chair. Mr. Weissman.
Mr. Weissman. A few points, if I may, Senator. First of
all, in the global context, we were talking about, it is
commonplace. It is the norm.
The Chair. How many people do we think died because they
didn't have access to the vaccine in the world? Do we have a
guess?
Mr. Weissman. There are very good estimates of between
hundreds of thousands and millions. It has hard to sort of pin
it down. And most of those who did get vaccinated didn't get
the higher quality, mRNA vaccines.
In the U.S., second point is, in the U.S., as you said, 25
to 30 percent of Americans actually ration their prescription
drugs because of price. Now, not all of them are dying as a
result, but some are. The launch price of new drugs right now
is $182,000. So, $100,000 is not a far-out drug--it is actually
an underestimate----
The Chair. Somebody if I am wrong here, but I think many of
the cancer drugs that are out there are over $100,000 a year.
Is that correct?
Mr. Weissman. That is correct. And some are now going up to
$1 million. I just wanted to say one other thing on the
question you had asked to Senator Cassidy about the CRADA
agreement and reasonable pricing.
Actually, what happened there is that in 1995, at the point
that NIH stopped using the reasonable pricing provisions and
CRADAs, they added a new category of CRADA. So, the original
category of CRADA were standard CRADAs, these are cooperative
research and development agreements. Those stayed roughly
consistent after the removal of the reasonable pricing clause.
They added a new category of material CRADAs. So, the
numbers that you are looking at that show, this seeming
juxtaposition pre 1995 and post 1995 reflect a change in
categorization, not to removal of the reasonable pricing
clause.
The Chair. Dr. Makary, in my--did I pose an absurd
hypothesis to Senator Cassidy that people are dying or
suffering because they can't afford medicine?
Dr. Makary. It happens. The American Cancer Society did a
study that 48 percent of cancer patients say they have avoided
or delayed future care for fear of the bill. So that is a real
problem.
With the promise of the Affordable Care Act lowering costs
not panning out, we now have higher deductibles, creating a new
problem called the functionally uninsured. They have insurance,
but they can't afford the----
The Chair. Exactly right. I don't think, Senator Cassidy,
that my hypothesis was absurd.
Senator Cassidy. Well, cancer drugs, of course, have
nothing to do with PAHPA. Dr. Ramachandran, of course, refers
to the global environment, that is different. We can talk about
vaccines, lack of availability worldwide. That is a different
issue than PAHPA. And by the way, most of the patients do have
coverage. Yes, there is an occasional who doesn't. But
theoretically, Medicare Part D provides coverage for most of
those cancer drugs.
The Chair. Occasionally, a few who have no coverage. Is
that what you said?
Senator Cassidy. Well, if the Affordable Care Act was
successful----
The Chair. I am not here to defend the Affordable Care Act.
Senator Cassidy. Well--obviously, we are way off field from
PAHPA.
The Chair. All right, that is fine. We are, but that is all
right, we have three witnesses here. Late afternoon. We are
having an intellectual exercise here. All right, but with that,
I think we both have to catch planes.
I want to thank you all for the work you are doing and
thank you very much for being with us. And here is my
bureaucratic thing here. For any Senators who wish to ask
additional questions, questions for the record will be doing 10
business days on May 18th at 5.00 p.m..
Finally, I ask unanimous consent to enter into the record
six statements from stakeholder groups outlining their
priorities for the Pandemic and all Hazards Preparedness Act.
[The following information can be found on pages 97-121 in
Additional Material:]
The Chair. Committee stands adjourned. Thank you very, very
much.
ADDITIONAL MATERIAL
American Ambulance Association,
Washington, DC 20090,
March 28, 2023.
Senator Bernie Sanders, Chairman,
Senator Bill Cassidy, Ranking Member,
Senator Bob Casey,
Senator Mitt Romney,
U.S. Senate Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Dear Chair Sanders, Ranking Member Cassidy, Senator Casey, and
Senator Romney:
I am writing on behalf of the American Ambulance Association (AAA)
to provide comments on policies the Committee should consider during
the reauthorization of the Pandemic and All-Hazards Preparedness Act
(PAHPA).
The members of the AAA provide mobile health care services to more
than 75 percent of Americans. These essential mobile health care
services include the local operation of the 9-1-1 emergency medical
services (EMS) system, as well as both emergent and non-emergency
interfacility care transition ambulance services and transportation.
Often ground ambulance service organizations are the first medical
professionals to interact with individuals in need of a health care
encounter. These organizations also serve as the health care safety net
for many small communities, especially those located in rural areas
where other providers and suppliers have reduced their hours of
operation or left the community altogether. As such, these
organizations play a critical and unique role in the country's health
care infrastructure.
Ground ambulance services are essential to our nation's emergency
medical response system, whether they are needed for a pandemic,
natural disaster, or terrorist attack. The country's EMS system
requires Federal support to ensure the availability of a well-trained
workforce to provide these ground ambulance services. Ground ambulance
services are also essential to protecting patient access to the right
level of facility-based treatment options.
I. Support for Jurisdictional Preparedness and Response Capacity:
Hospital Preparedness Program / ASPR activities financed through the
general HHP budget
The AAA supports continued funding for the Hospital Preparedness
Program (HPP). Our members have been working closely with the Assistant
Secretary for Planning and Evaluation (ASPR) to find ways to direct
some of the currently allocated HPP dollars to support ground ambulance
services, particularly to address the workforce crisis and support
expanded recruitment and training for emergency medical technicians
(EMTs) and paramedics. During these discussions, it has become clear
that more direct language authorizing the use of a specified portion of
the HPP funds to support non-governmental and governmental ground
ambulance services would allow ASPR to tackle this issue in a timelier
manner.
Ground ambulance service organizations are facing crippling
staffing challenges that threaten the provision of crucial emergency
healthcare services at a time of maximum need. As we face a pandemic
that waxes and wanes but does not end, our 9-1-1 infrastructure remains
at risk due to these severe workforce shortages. The 2022 Ambulance
Employee Workforce Turnover Study by the American Ambulance Association
(AAA) and Newton 360--the most sweeping survey of its kind involving
nearly 20,000 employees working at 258 EMS organizations--found that
overall turnover among paramedics and EMTs ranges from 20 to 30 percent
annually with organizations on average having 30 percent of their
paramedic positions open and 29 percent of their EMT positions.
The Congress and the President recognized the crisis and the fiscal
year 2023 Consolidated Appropriations called on ASRP to address this
shortage by implementing a grant program to support non-governmental
and governmental ground ambulance suppliers and providers through the
HPP to address emergency medical services preparedness and response in
light of the workforce shortage. While this language is helpful, the
AAA recognizes that authorizing authority would provide a more
sustainable approach to support an EMS workforce grant program.
Such a program would be consistent with the goals of ASRP. The
fiscal year 2024 HHS Budget in Brief highlights to goal of making
``transformative investments in pandemic preparedness and biodefense
across HHS public health agencies to enable an agile, coordinated, and
comprehensive public health response to future threats and protect
American lives, families, and the economy.'' (HHS Budget in Brief 142).
Ground ambulance medical services are an essential part of this
preparedness and response goal.
Our nation's ground ambulance service organizations, EMTs, and
paramedics need Congress to address the EMS workforce challenges facing
these front-line health care workers by including direct authority to
use $50 million of the HPP funding to establish an EMS workforce grant
program to address the crippling EMS workforce shortage, including in
underserved, rural, and tribal areas and/or address health disparities
related to accessing prehospital ground ambulance healthcare services,
including critical care transport. The grants would be available to
governmental and non-governmental EMS organizations to support the
recruitment and training of emergency medical technicians and
paramedics. The program would emphasize ensuring a well-trained and
adequate ground ambulance services workforce in underserved, rural, and
tribal areas and/or addressing health disparities related to accessing
prehospital ground ambulance health care services.
This program is critically important to supporting the non-
governmental and governmental ground ambulance service organizations
that are the backbone of the country's first emergency medical response
system. The dollars would be used to provide grants directly to non-
governmental and governmental ground ambulance service organizations to
support training and retention programs, such as paying for initial
training; providing tuition for community colleges EMT/ paramedic
training courses; paying for required continuing education courses;
supporting costs related to licensure and certification; and supporting
individuals in underserved areas with transportation, child care, or
similar services to promote accessing training.
II. Gaps in Current Activities and Capabilities: Gaps in HHS'
capabilities and what activities or authorities needed to fulfill
intent of PAHPA and related laws
The most significant gap in PAHPA and HHS on preparedness and
readiness activities is the exclusion of non-governmental entities from
many of the Federal programs targeted to first responders and EMS. This
oversight results in more than one-third of local communities and their
citizens not being able to access or benefit from the programs and
funding that Congress intended be provided to support them. The AAA
requests that the Committee recognize the decisionmaking authority to
rely on non-governmental ground ambulance service organizations and
provide access to programs that are currently available to governmental
organizations.
During the pandemic, non-governmental local community ground
ambulance organizations were not permitted to apply for or participant
in many of the Federal grant programs in place during the pandemic. As
a result, these programs fell short of the goal of supporting
preparedness and response activities at the local level.
The distinction between governmental and non-governmental appears
to be based on outdated assumptions that first responders are only
governmental or not-for-profit entities. This assumption ignores the
decisions of State and local governments to contract with private
ground ambulance service providers and suppliers to provide 911 or
equivalent services. The Federal Government should respect these local
decisions and support all ground ambulance services as first-responders
and EMS.
One example of this problem is the FEMA public assistance grant
program that reimbursed ``first responders'' for PPE and other expenses
related to the response to COVID-19. When non-governmental (including
not-for-profit) emergency ambulance service organizations sought direct
reimbursement under the program, they were turned away. This
differential treatment impacts communities across the United States,
including those in Arkansas, California, Colorado, Florida, Georgia,
Indiana, Louisiana, Massachusetts, Mississippi, Nevada, New York,
Oregon, Texas, and Wisconsin, among others.
Appendix A includes list of some of the program the AAA has
identified that should reviewed and updated to include non-governmental
entities.
The solution to this problem is to use the more inclusive language
that the Congress adopted in the Homeland Security Act of 2002 (6
U.S.C. Sec. 101) on non-governmental and governmental entities within
the definition of ``emergency response providers.'' This language
provides access to all ground ambulance services and the communities
they serve to funding when available to support preparedness and
response activities.
III. Conclusion
On behalf of ground ambulance service organizations of the AAA, I
want to thank you for the opportunity to provide comments on the PAHPA.
We look forward to working with your team as you continue develop these
policies.
Sincerely,
Randy Strozyk,
President.
Appendix A: Grant Program for Review
Assistance to Firefighters Grant (AFG): http://
www.firegrantsupport.com/afg/faq/08/faq--emer.aspx
The grant program prohibits ``for-profit'' organizations from
applying for grant funding.
Staffing for Adequate Fire and Emergency Response (SAFER):
Retrieved from http://www.firegrantsupport.com/safer/faq/08/faq--
elig.aspx
Only fire departments and volunteer firefighter interest
organizations are eligible for SAFER grants.
Federal Disaster Relief Funds
$45B to reimburse activities such as medical response, procurement
of PPE National Guard deployment, coordination of logistics,
implementation of safety measures, and provision of community services.
According to FEMA, these funds will cover overtime and backfill costs;
the costs of supplies, such as disinfectants, medical supplies and PPE;
and apparatus usage. (The Federal Government will cover 75 percent of
these costs.) NAEMT recommends FEMA's new sheet on FEMA's Simplified
Public Assistance Application. In addition, you should consult with
their State emergency managers to begin the process of being
reimbursed. Eligible to apply: Public and some non-profit services.
Emergency Management Baseline Assessment Grant Program
The Emergency Management Baseline Assessment Grant (EMBAG) program
provides non-disaster funding to support developing, maintaining, and
revising voluntary national-level standards and peer-review assessment
processes for emergency management and using these standards and
processes to assess state, local, tribal, and territorial emergency
management programs and professionals.
Nonprofit Security Grant Program
The Nonprofit Security Grant Program (NSGP) provides funding
support for target hardening and other physical security enhancements
and activities to nonprofit organizations that are at high risk of
terrorist attack.
Siren Act
The Siren Act supports public and non-profit rural EMS agencies
through grants to train and recruit staff, fund continuing education,
and purchase equipment and supplies from naloxone and first aid kits to
power stretchers or new ambulances.
ASPR_National Bioterrorism Hospital Preparedness Program
Eligibility requirements exclude for-profit private EMS.
Public Safety Officers Death Benefit
Public Safety Officers' Benefits Improvements Act of 2011 (S.
1696). Added non-profits (but still excluded for profits) in the Public
Safety Officers' Benefit (PSOB) program. This legislation extended the
Federal death benefit coverage to paramedics and emergency medical
technicians (EMTs) who work for a private non-profit emergency medical
services (EMS) agency and die in the line of duty and thank you for
including the language of the Dale Long Emergency Medical Service
Providers Protection Act (S. 385) in this new bill. Congress
established the Public Safety Officer Benefit program to provide
assistance to the survivors of police officers, firefighters and
paramedics and emergency medical technicians in the event of their
death in the line of duty. The benefit, however, currently only applies
to those public safety officers employed by a Federal, state, or local
government entity and non-profits.
Urban Area Security Initiative (UASI) & Metropolitan Medical Response
System (MMRS)
Retrieved from: http://www.iowahomelandsecurity.org/Portals/0/
CountyCoordinators/Grants/FFY09HSGPguida nce.pdf
Inclusion of Emergency Medical Services (EMS) Providers
DHS requires State and local governments to include emergency
medical services (EMS) providers in their State and Urban Area homeland
security plans. In accordance with this requirement, and as States,
territories, localities, and tribes complete their application
materials for the fiscal year 2009 HSGP, DHS reminds our homeland
security partners of the importance for proactive inclusion of various
State, regional, and local response disciplines who have important
roles and responsibilities in prevention, deterrence, protection, and
response activities. Inclusion should take place with respect to
planning, organization, equipment, training, and exercise efforts.
Response disciplines include, but are not limited to: governmental and
nongovernmental emergency medical, firefighting, and law enforcement
services; public health; hospitals; emergency management; hazardous
materials; public safety communications; public works; and governmental
leadership and administration personnel.
Interoperable Communications Grants
Retrieved from: http://www.fema.gov/government/grant/iecgp/
index.shtm
Eligibility and Funding: The Governor of each State and territory
has designated a State Administrative Agency (SAA), which can apply for
and administer the funds under IECGP. The SAA is the only agency
eligible to apply for IECGP funds.
Technology Transfer Program (CEDAP)
Retrieved from: http://ojp.usdoj.gov/odp/docs/cedap--factsheet--
2008.pdf
Eligibility: Eligible applicants include law enforcement agencies,
fire, and other emergency responders who demonstrate that the equipment
will be used to improve their ability and capacity to respond to a
major critical incident or work with other first responders. Awardees
must not have received technology funding under the Urban Areas
Security Initiative, or the Assistance to Firefighters Grants program
since Oct. 1, 2006. Organizations must submit applications through the
Responder Knowledge Base (RKB) website at www.rkb.us.
______
American Pharmacists Association,
Washington, DC 20037,
May 4, 2023.
Senator Bernie Sanders, Chairman,
Senator Bill Cassidy, Ranking Member,
U.S. Senate Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Dear Chair Sanders and Ranking Member Cassidy:
APhA appreciates the opportunity to comment on the Senate Health,
Education, Labor, and Pensions hearing on ``Preparing for the Next
Public Health Emergency: Reauthorizing the Pandemic and All Hazards
Preparedness Act (PAHPA).''
APhA is the largest association of pharmacists in the United States
advancing the entire pharmacy profession. APhA represents pharmacists
and pharmacy personnel in all practice settings, including community
pharmacies, hospitals, long-term care facilities, specialty pharmacies,
community health centers, physician offices, ambulatory clinics,
managed care organizations, hospice settings, and government
facilities. Our members strive to improve medication use, advance
patient care, and enhance public health.
During the COVID-19 public health emergency (PHE), pharmacists have
demonstrated the ability to significantly expand access and equity to
health care and will continue to do so if regulatory and statutory
barriers are removed. The pandemic has demonstrated how essential and
accessible pharmacists are in the United States. While many communities
across the country do not have access to a primary care provider, more
than 90 percent of Americans live within 5 miles of a pharmacist. A
strong body of evidence has shown that including pharmacists on
interprofessional patient care teams with physicians, nurses, and other
health care providers produces better health outcomes and cost savings.
As a result, lifting barriers to access is essential as we continue to
look toward ways to improve patient access to critical health care
services.
During the most recent pandemic, pharmacists and pharmacies were
able to test, treat, and immunize patients for conditions ranging from
COVID-19 to the flu. The flexibilities offered by the Federal
Government made access to health care easier for pharmacists to provide
care to patients during the COVID-19 PHE. The problem is many of these
flexibilities and authorities are not considered permanent and further
action is needed to expand access to pharmacist-provided services. As
you look to reauthorize programs such as PAHPA, we ask that you take
into consideration these flexibilities and continue to remove barriers
that would prevent pharmacists from providing these essential services
as part of the health care team.
To illustrate this urgency, U.S. Department of Health and Human
Services (HHS) Secretary Xavier Becerra recently lengthened the PREP
Act authority for pharmacists and pharmacy technicians to administer
COVID-19 vaccines and tests, along with flu vaccines until December
2024. Without this extension that authority would have expired on May
11, 2023 when the COVID-19 health emergency officially ends.
The extension of authority and the Secretary's recognition of
pharmacist services is a critical first step in expanding access to
patient care, but the Federal Government should do more to ensure this
authority will remain as pharmacists are clearly relied upon by the
Federal Government as a vital part of our nation's public health
infrastructure.
One manner in which we can make this authority permanent is by
enacting legislation such as H.R. 1770 the Equitable Community Access
to Pharmacists Services Act (ECAPS), led by Representatives Adrian
Smith (R-NE), Brad Schneider (D-IL), Larry Bucshon (R-IN), and Doris
Matsui (D-CA). This legislation would provide for reimbursement through
Medicare Part B for pharmacist's services including the testing of
COVID-19, flu, RSV, and strep; treatment of COVID-19, flu, and strep;
and the vaccination of COVID-19 and flu.
Despite the fact that many states and Medicaid programs are turning
to pharmacists to increase access to health care, Medicare Part B does
not cover many of the impactful and valuable patient care services
pharmacists can provide. As proven during the COVID-19 pandemic,
pharmacists are an underutilized and accessible health care resource
who can positively affect beneficiaries' care and the entire Medicare
program.
By recognizing pharmacists as providers under Medicare Part B, H.R.
1770 would enable Medicare patients to better access health care
through state-licensed pharmacists practicing according to their own
state's scope of practice. Helping patients receive the care they need,
when they need it, is a common sense and bipartisan solution that will
improve outcomes and reduce overall costs.
Public health interventions by pharmacists and teammates averted 1
million deaths, 8 million hospitalizations, and $450 billion in health
care costs. Patients have come to expect that they can access these
vital health care services at their local pharmacy, particularly in
underserved communities, where the neighborhood pharmacy may be the
only health care provider for miles.
Congress could ensure increased patient access to health care by
enacting legislation such as ECAPS and by making permanent some of the
temporary authorities mentioned in the PREP Act.
Congress needs to act immediately to make these temporary
authorizations, whether authorized by the PREP Act or Federal PHE,
permanent to ensure patients will be able to receive the health care
services they need at pharmacies across the country during the current
and future PHEs.
Accordingly, APhA urges Congress and the Committee to use its
authority to pass legislation in PAHPA to make permanent:
Pharmacists' ability to order, authorize, test,
treat, and administer immunizations and therapeutics against
infectious diseases;
Removal of operational barriers that address
workforce and workflow issues that previously prevented
pharmacists from engaging in patient care; and
Allowing license portability across State lines, so
pharmacists can continue to provide care wherever there are
needs across the country.
APhA appreciates the opportunity to offer these comments and are
grateful for the Committee's leadership on this issue. Should you have
any questions, please contact Doug Huynh, JD, APhA Director of
congressional Affairs (dhuynh@aphanet,org).
Sincerely,
Michael Baxter,
Acting Head of Government Affairs.
______
American Pharmacists Association,
Washington, DC 20037,
May 4, 2023.
Senator Bernie Sanders, Chairman,
Senator Bill Cassidy, Ranking Member,
U.S. Senate Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Dear Chair Sanders and Ranking Member Cassidy:
APhA appreciates the opportunity to comment on the Senate Health,
Education, Labor, and Pensions hearing on ``Preparing for the Next
Public Health Emergency: Reauthorizing the Pandemic and All Hazards
Preparedness Act (PAHPA).''
APhA is the largest association of pharmacists in the United States
advancing the entire pharmacy profession. APhA represents pharmacists
and pharmacy personnel in all practice settings, including community
pharmacies, hospitals, long-term care facilities, specialty pharmacies,
community health centers, physician offices, ambulatory clinics,
managed care organizations, hospice settings, and government
facilities. Our members strive to improve medication use, advance
patient care, and enhance public health.
During the COVID-19 public health emergency (PHE), pharmacists have
demonstrated the ability to significantly expand access and equity to
health care and will continue to do so if regulatory and statutory
barriers are removed. The pandemic has demonstrated how essential and
accessible pharmacists are in the United States. While many communities
across the country do not have access to a primary care provider, more
than 90 percent of Americans live within 5 miles of a pharmacist. A
strong body of evidence has shown that including pharmacists on
interprofessional patient care teams with physicians, nurses, and other
health care providers produces better health outcomes and cost savings.
As a result, lifting barriers to access is essential as we continue to
look toward ways to improve patient access to critical health care
services.
During the most recent pandemic, pharmacists and pharmacies were
able to test, treat, and immunize patients for conditions ranging from
COVID-19 to the flu. The flexibilities offered by the Federal
Government made access to health care easier for pharmacists to provide
care to patients during the COVID-19 PHE. The problem is many of these
flexibilities and authorities are not considered permanent and further
action is needed to expand access to pharmacist-provided services. As
you look to reauthorize programs such as PAHPA, we ask that you take
into consideration these flexibilities and continue to remove barriers
that would prevent pharmacists from providing these essential services
as part of the health care team.
To illustrate this urgency, U.S. Department of Health and Human
Services (HHS) Secretary Xavier Becerra recently lengthened the PREP
Act authority for pharmacists and pharmacy technicians to administer
COVID-19 vaccines and tests, along with flu vaccines until December
2024. Without this extension that authority would have expired on May
11, 2023 when the COVID-19 health emergency officially ends.
The extension of authority and the Secretary's recognition of
pharmacist services is a critical first step in expanding access to
patient care, but the Federal Government should do more to ensure this
authority will remain as pharmacists are clearly relied upon by the
Federal Government as a vital part of our nation's public health
infrastructure.
One manner in which we can make this authority permanent is by
enacting legislation such as H.R. 1770 the Equitable Community Access
to Pharmacists Services Act (ECAPS), led by Representatives Adrian
Smith (R-NE), Brad Schneider (D-IL), Larry Bucshon (R-IN), and Doris
Matsui (D-CA). This legislation would provide for reimbursement through
Medicare Part B for pharmacist's services including the testing of
COVID-19, flu, RSV, and strep; treatment of COVID-19, flu, and strep;
and the vaccination of COVID-19 and flu.
Despite the fact that many states and Medicaid programs are turning
to pharmacists to increase access to health care, Medicare Part B does
not cover many of the impactful and valuable patient care services
pharmacists can provide. As proven during the COVID-19 pandemic,
pharmacists are an underutilized and accessible health care resource
who can positively affect beneficiaries' care and the entire Medicare
program.
By recognizing pharmacists as providers under Medicare Part B, H.R.
1770 would enable Medicare patients to better access health care
through state-licensed pharmacists practicing according to their own
state's scope of practice. Helping patients receive the care they need,
when they need it, is a common sense and bipartisan solution that will
improve outcomes and reduce overall costs.
Public health interventions by pharmacists and teammates averted 1
million deaths, 8 million hospitalizations, and $450 billion in health
care costs. Patients have come to expect that they can access these
vital health care services at their local pharmacy, particularly in
underserved communities, where the neighborhood pharmacy may be the
only health care provider for miles.
Congress could ensure increased patient access to health care by
enacting legislation such as ECAPS and by making permanent some of the
temporary authorities mentioned in the PREP Act.
Congress needs to act immediately to make these temporary
authorizations, whether authorized by the PREP Act or Federal PHE,
permanent to ensure patients will be able to receive the health care
services they need at pharmacies across the country during the current
and future PHEs.
Accordingly, APhA urges Congress and the Committee to use its
authority to pass legislation in PAHPA to make permanent:
Pharmacists' ability to order, authorize, test,
treat, and administer immunizations and therapeutics against
infectious diseases;
Removal of operational barriers that address
workforce and workflow issues that previously prevented
pharmacists from engaging in patient care; and
Allowing license portability across State lines, so
pharmacists can continue to provide care wherever there are
needs across the country.
APhA appreciates the opportunity to offer these comments and are
grateful for the Committee's leadership on this issue. Should you have
any questions, please contact Doug Huynh, JD, APhA Director of
congressional Affairs (dhuynh@aphanet,org).
Sincerely,
Michael Baxter,
Acting Head of Government Affairs.
______
Children's Hospital Association Statement for the
Record
Washington, DC 20005
May 4, 2023
Senator Bernie Sanders, Chairman,
Senator Bill Cassidy, Ranking Member,
U.S. Senate Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
On behalf of the nation's children's hospitals and the children and
families we serve, thank you for holding this hearing, ``Preparing for
the Next Public Health Emergency: Reauthorizing the Pandemic and All-
Hazards Preparedness Act (PAHPA).'' We applaud your efforts to ensure
the U.S. is better prepared to respond to a future pandemic or other
public health emergency (PHE) and encourage you to prioritize the
distinct needs of children, who represent some 25 percent of the total
U.S. population. Ensuring that the unique physical and mental health
needs of children are met during a pandemic or other PHE must be a
major part of Congress' work in the upcoming PAHPA reauthorization. We
welcome the opportunity to provide our input on how best to meet the
unique physical, mental, developmental and social needs of children in
a pandemic and disaster response framework as you work on this
important legislation.
Over the last few years, children's hospitals have experienced
unprecedented pediatric volumes driven by a series of PHEs, including a
substantial increase in childhood respiratory illnesses like
respiratory syncytial virus (RSV) and the ongoing surge in mental
health visits. The challenges that confronted children's hospitals and
their nimbleness to respond demonstrate how critical it is that the
nation's pandemic preparedness system can appropriately account for
differences between the way physical and mental health care delivery
and support systems are structured for children compared with adults.
Pediatric-specific Needs in an Emergency Preparedness and Response
System
Children are not little adults, and their physical and mental
health care needs, the delivery system to meet those needs and their
support systems (e.g., schools, childcare settings, etc.) are different
from those of adults. Children are constantly growing and developing,
and child-appropriate care will support that healthy development.
Disruptions in their care, trauma, social isolation, financial
insecurity, food and housing insecurity, and grief associated with a
natural disaster or pandemic can have a significant negative impact on
children's mental and physical health and their long-term well-being.
This is especially true for children and families in underserved,
under-resourced, and racial and ethnic minority communities. Children
are also dependent on their caregivers, and the needs of their parent
or guardian must be considered in a pediatric care framework.
Furthermore, pediatric care typically requires extra time,
monitoring, specialized medications and equipment, and specially
trained health care providers who are compassionate and understand kids
of all ages and from all backgrounds. Children's hospitals, unlike
adult-focused medical facilities, are increasingly the only places in
their State and region with the breadth of pediatric specialists and
subspecialists, the pediatric-appropriate medical equipment, and other
resources required to treat children, particularly those with rare and
complex clinical conditions. Given the regionalization of pediatric
specialty care, children's hospitals' critical care and ``surge''
capacity for children is limited during a widespread PHE, such as a
pandemic or natural disaster, adding a significant level of complexity
to the nation's capacity to meet children's needs.
Targeted pediatric resources and a national pediatric framework
that are not dependent on national emergency declarations are needed to
meet current and future preparedness and response system challenges.
During the recent surges, Federal emergency declarations gave
children's hospitals certain flexibilities that provided financial and
legal protections to adapt service delivery models to meet immediate
needs. However, once those protections expire it is not clear how
children's hospitals will maintain that vital flexibility that allows
rapid response to a public health threat. Preparedness and response
efforts must strengthen pediatric capacity, address pediatric workforce
shortages and allow for the triage/consolidation of pediatric patients
to centers best designed for their care.
Congressional Action Needed
A key component of the future of pediatric care will be the
development of a national disaster response infrastructure that adapts
to the changing landscape of health emergencies while remaining focused
on the goal of providing comprehensive and high-quality services to
deliver optimal child health. Solutions must be pediatric-specific.
Several key opportunities within PAHPA to address pediatric pandemic
and disaster preparedness and relief strategies are highlighted below.
Strengthen pediatric initiatives within the National Health
Security Strategy (NHSS). We urge Congress to ensure that the NHSS
builds on, and strengthens, existing pediatric-focused initiatives at
the Assistant Secretary for Preparedness and Response (ASPR) and the
Health Resources and Services Administration (HRSA), as well as the
National Advisory Committee on Children and Disasters (NACCD). In
particular, pandemic and disaster relief preparedness strategies must
include coordinated pediatric care structures and plans that address
the operational capacity of the nation's medical facilities to meet
children's unique physical and mental health needs. Pediatric experts
should be included in all short-and long-range coordinated care
planning efforts.
Bolster the National Advisory Committee on Children and Disasters
(NACCD) and the Children's Preparedness Unit (CPU) The NACCD is
instrumental to ensuring that the national pandemic and emergency
response infrastructure meets the unique needs of children, in a
developmentally and socially appropriate manner, across their entire
spectrum of their physical, mental, emotional and behavioral well-
being. We urge Congress to support bolstering the NACCD and the
committee's ability to expand its membership and scope of
recommendations of high-impact issues for subsequent reports, such as
addressing pediatric workforce issues, supply shortages, and products
for the Strategic National Stockpile (SNS). We recommend that ASPR be
designated the appropriate funding and authority to fully implement
NACCD recommendations and provide adequate resources in a timely
manner. These efforts and others throughout government must be aligned,
coordinated, strengthened and adequately funded to support a shared
pediatric mission and framework.
The CPU is another important component of the emergency response
framework. It is critical that Congress empower the CPU to fulfill its
mission and be allowed to develop and implement a nimble and
appropriate public health response to the ongoing, and any future,
pandemics while also having a focus on pediatric preparedness. It is
particularly important that CPU be required to work with its partners
to help disseminate and amplify key preparedness messages and ensure
that children with special health care needs are provided special
support services, including medicine, medical equipment and mental
health support.
Target Hospital Preparedness Program (HPP) resources to meet
pediatric needs. The HPP must target resources for children's hospitals
and children's health care systems to plan for and respond to pediatric
needs in large-scale emergencies and disasters. The regionalization of
pediatric specialty care adds a significant level of complexity to the
nation's capacity to meet children's needs. It is imperative that the
nation's children's hospitals' critical care capacity is ensured and
that communities without a children's hospital have operational
capacity to meet children's basic needs.
Immediate targeted HPP support is needed to strengthen pediatric
capacity, address pediatric workforce shortages and allow for the
triage/consolidation of pediatric patients to centers best designed for
their care. The recent surge in RSV, influenza, and COVID-19 cases, the
so-called ``Tripledemic,'' stretched pediatric critical care resources
to the breaking point. During the RSV surge, children's hospitals
experienced the need for trained pediatric professionals, as well as
challenges accessing critically necessary supplies and medications,
such as child-sized ventilators, smaller sized, cuffed endotracheal
tubes used for advanced airway management and emergent mechanical
ventilatory support, as well as smaller doses of albuterol. Systems and
plans must be in place to facilitate a streamlined and rapid response
that is tailored to children's unique health care needs so specialized
pediatric supplies and medications are available in a timely manner.
Therefore, Congress should direct ASPR to develop and disseminate
``pediatric toolkits'' to non-pediatric hospitals that include
equipment, training modules, as well as dosages and usages of
therapeutics, to successfully handle surge capacity and any transferred
child-patient. All medical facilities should be required to have
policies and procedures for the provision of nutrition (e.g., formula),
cribs and other appropriate sleeping accommodations, diapers, etc. for
infants and toddlers. They also should be equipped to provide
accommodations for the families of child patients during pandemic and
disaster situations. Furthermore, non-pediatric hospitals should have
pediatric interfacility transfer agreements and interoperability
capabilities to allow for electronic access to specialized pediatric
clinical and mental health care providers for remote consultations.
The HPP must also include mechanisms to allow for the continuation
of key pediatric services in the community. These include immunization
programs, services for children with special health care needs, child
nutrition programs, newborn screening, children's mental health
services and other services for at-risk children.
Equip the SNS with pediatric supplies and allocate them to all
medical facilities. We urge Congress to require the SNS to include
emergency medications in age-appropriate delivery formulations,
equipment and related supplies that meet children's needs. The
stockpile's distribution system must include a communication structure
capable of relaying information about the availability of specific
supplies to ensure the appropriate allocation of necessary pediatric
supplies to all medical facilities. At a minimum, the SNS should be
directed to equip all emergency departments with a basic kit that can
be adapted for use with children, and includes infant formula, diapers,
safe sleeping facilities and other necessities for the care of infants
and toddlers.
Strengthen pediatric-specific readiness within Public Health
Emergency Medical Countermeasures Enterprises. For medical
countermeasures (MCMs) to meet the needs of children, there must be a
strong focus on research, development, procurement, strategy and
guidance that can ensure timely access to sufficient pediatric-
appropriate equipment, medications and supplies and a quick response to
shortages. Pediatric care requires specialized medications,
therapeutics, and equipment. For example, many pediatric drugs come in
specific formulations that support safer dosing and with practical
methods for appropriate delivery for growing children, such as altered
concentrations or formats. Pediatric-specific supplies are created with
children's sensitive skin, growing bodies, and smaller size in mind.
Drug and supply shortages are particularly challenging in pediatric
health care. Given the specific requirements and considerations for
children, pediatric and drug products can go into shortage more quickly
than adult products. Once in shortage, it can take longer for
manufacturers to respond and bring adequate product back to market.
Congress can help ensure that children have access to needed
medications and other medical supplies during a PHE in several ways.
First, Congress should require resources to be directed to research
pediatric dosing and formulations for MCMs that are already approved
for adults. Congress should also require properly dosed pediatric
medications and delivery mechanisms to be available and ready for rapid
deployment. Furthermore, relevant Federal agencies, such as the CDC,
ASPR and FDA, should be authorized to develop a process that allows for
the advance approval--through the emergency use authorization process--
of off-label use of medical countermeasures for children before the
declaration of a PHE. Advanced approval or protocols should also be
developed that allow for the importation of product in the event of a
catastrophic supply event, such as occurred during the recent shortage
of infant formula.
It is also critical that Congress extend the requirement for device
manufacturers to notify the FDA of significant interruptions and
discontinuances of critical devices outside of a PHE. We support FDA
authorities to require manufacturers to develop and share risk
management plans, particularly for sole-source suppliers, and identify
alternate suppliers and manufacturing sites.
Invest in child-focused mental health systems. We urge Congress to
develop a strategic plan to specifically address the mental health
needs of children and youth, including a strategy to support continued
access to, and availability of, mental health and substance use
disorder services during PHEs. The effects of the COVID-19 pandemic on
children's and teens' mental health painfully illustrate the importance
of strengthening investments in child-focused mental health systems of
care now to ensure that kids' needs will be adequately addressed when
we face another pandemic or PHE. Further, we know that children who
live through an emergency, such as COVID-19, have a greater risk of
having traumatic experiences, and when families struggle to find mental
health care, kids are at greater risk for experiencing long-term
impacts on their health and well-being.
Pandemic and disaster preparedness efforts throughout government
must be aligned, coordinated, strengthened and adequately funded to
support a shared pediatric mission and framework. That framework must
ensure the broader capacity of the nation's medical facilities to meet
children's physical and mental health needs--as well as those of their
entire caregiving/support system--through the delineation of
appropriate staffing, specialized equipment, training and other child-
centric resources. Thank you again for your commitment to ensuring the
needs of children are met during a future pandemic or disaster.
Children's hospitals stand ready to partner with you to advance
policies that will make measurable improvements in the lives of our
nation's children. Children need your help now.
______
Premier Inc.,
Washington, DC,
May 4, 2023.
Senator Bernie Sanders, Chairman,
Senator Bill Cassidy, Ranking Member,
U.S. Senate Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Premier Inc. appreciates the opportunity to submit a statement for
the record on the Senate Health, Education, Labor, and Pension
Committee (HELP) hearing titled ``Preparing for the Next Public Health
Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act
(PAHPA)'' on May 4, 2023. Premier applauds Chair Sanders and Ranking
Member Cassidy for holding this hearing. It is vital that we as a
nation consider lessons learned during the COVID-19 response and
improve the nation's public health infrastructure and preparedness to
respond to the next public health threat. Premier further appreciates
the thoughtful approach outlined under the HELP Committee leadership to
seek stakeholder input as part of the process of developing consensus
policy proposals and the acknowledgement that collaboration across the
public and private sectors is essential to ensuring the nation's
readiness and ability to proactively address future public health
threats. Premier previously submitted detailed comments to the
Committee's request for information on PAHPA reauthorization.
The existence of PAHPA during the COVID-19 pandemic was
instrumental in supporting the nation's rapid response. As a nation we
would have been in a much worse situation had PAHPA's infrastructure
not been in place. However, lessons learned during the COVID-19
pandemic, and subsequently the Mpox public health emergency,
demonstrate that there are opportunities to strengthen PAHPA to be
better responsive to public health needs during unprecedented times.
Specifically, Premier recommends revisions to PAHPA to mitigate
national security challenges by:
Modernizing the country's data infrastructure;
Strengthening the Strategic National Stockpile;
Incentivizing domestic manufacturing;
Mitigating drug and device shortages;
Maintaining supply chain integrity;
Leveraging technology to prevent infections in
nursing homes;
Finding sustainable solutions to environmental issues
impacting patient care;
Identifying and bundling waivers and flexibilities
for expeditious implementation during a future public health
emergency;
Broadening and better organizing lab networks;
Ensuring emergency efforts account for the needs of
disabled individuals and their families; and
Holding manufacturers accountable for the
cybersecurity of their devices.
I. Background on Premier Inc.
Premier Inc. is a leading healthcare improvement company and
national supply chain leader, uniting an alliance of more than 4,400
U.S. hospitals and health systems and approximately 250,000 continuum
of care providers to transform healthcare. Premier's sophisticated
technology systems contain robust data from nearly half of U.S.
hospitals and 200,000 ambulatory clinicians. Premier is a data-driven
organization with a 360-degree view of the supply chain, working with
more than 1,460 manufacturers to source the highest quality and most
cost-effective products and services.
Premier is also a leader in identifying, fulfilling and closing
gaps in diverse sources for critical product categories--working
directly with manufacturers to incentivize new manufacturers to enter
the marketplace--a strategy that proved to be critical as the country
looked to increase domestic manufacturing and identify new sources of
critical supplies. Premier also identified and solved a major gap for
continuum of care providers to obtain PPE and created an e-commerce
platform to ensure continuum of care providers could access critical
medical supplies.
A Malcolm Baldrige National Quality Award recipient, Premier plays
a critical role in the rapidly evolving healthcare industry,
collaborating with healthcare providers, manufacturers, distributors,
government and other entities to co-develop long-term innovations that
reinvent and improve the way care is delivered to patients nationwide.
Headquartered in Charlotte, North Carolina, Premier is passionate about
transforming American healthcare.
I. Assistant Secretary for Preparedness and Response (ASPR)
Since the onset of the COVID-19 pandemic, the Assistant Secretary
for Preparedness and Response was elevated to an operating division
within HHS in 2022 and is now known as the Administration for Strategic
Preparedness and Response (ASPR). With the elevation to an operating
division, it was noted that ASPR ``leads the nation's medical and
public health preparedness for, response to, and recovery from
disasters and other public health emergencies.'' Seemingly, this
indicated the ASPR would take point on future pandemic response and
alleviate much of the confusion that existed during the early days of
the COVID-19 pandemic regarding which Federal agency was leading
response efforts.
However, shortly after ASPR's elevation a public health emergency
for Mpox was declared. While many anticipated that ASPR would be named
to lead response efforts given its newly elevated role and mission, it
surprised many when officials from FEMA and CDC were named as the
primary and secondary leads for the Mpox response.
Furthermore, the CAA of 2023 establishes within the Executive
Office of the President an Office of Pandemic Preparedness and Response
Policy creating further confusion regarding the role of this new office
versus ASPR.
Therefore, Premier recommends that PAHPA reauthorization help
clarify the roles and responsibilities of the various Federal agencies
during a pandemic response and articulate which agency, or agencies,
should lead response efforts during a pandemic.
II. National Health Security Strategy (NHSS)
One of the three primary objectives of the NHSS is to leverage the
capabilities of the private sector by:
Developing and sustaining robust public-private
partnerships for MCM development and production;
Fostering the creation of a resilient medical product
supply chain; and
Incentivizing and sustaining private sector
healthcare surge capacity for large-scale incidents.
Premier's comments in this section focus on creating a sustainable
medical product supply chain.
Developing a Real-Time Inventory Data Management System
A major failure during the pandemic was the lack of downstream
visibility into the exact quantities of critical medical supplies and
drugs on US soil at any given time. As a result, there was a surplus of
products in many parts of the Nation, for example, while communities in
the New York City area were operating in crisis mode and leveraging
household products such as garbage bags to protect frontline workers.
Moreover, because of the lack of understanding of what product
availability risks existed, there was excessive purchasing of products,
the emergence of unscrupulous and fraudulent vendors, and hoarding,
which created shortages for others.
In response to the urgent need to understand product availability
and risks, the Federal Government stood up a health information
collection process to determine these factors across the supply chain.
However, this system was antiquated and created substantial additional
work for healthcare providers, with hospitals being asked to report
inventory on hand via the equivalent of Excel files. Furthermore, the
system proved to be of little use as inconsistent data nomenclature
meant hospitals were reporting ``boxes'' and ``units'' differently from
one another, and in many cases, many hospitals opted to cease reporting
inventory levels due to the administrative burden and fear that
available products would be confiscated by the government.
An August 2021 GAO report reviewed this system, pointing to the
inadequate and duplicative hospital reporting and data collection
system used during the pandemic. \1\ The siloed system burdened many
public health authorities, practicing physicians and hospitals with
time-consuming manual work all the while failing to provide early
warnings of supply shortages, putting communities and patients at risk.
Compounding these challenges and further splintering the nation's
approach was the multitude of data reporting requests from numerous
state, local, and private entities, which placed a significant burden
on health systems and rendered data that was not real-time,
standardized, reliable, actionable or usable for robust analytics.
---------------------------------------------------------------------------
\1\ GAO Report: COVID-19 HHS's Collection of Hospital Capacity
Data. August 2021. Available at: https://www.gao.gov/assets/gao-21-
600.pdf
The GAO report highlighted the limitations and inefficiencies of
the system put in place during the pandemic and the need for a better
approach to understand the health systems' capacity to provide care and
---------------------------------------------------------------------------
to inform the allocation of resources. Specifically:
The GAO examined the new data ecosystem HHS launched
during the pandemic--HHS Protect--designed to collect and share
national and state-level COVID-19 data on hospital capacity and
supply of ventilators, PPE and the availability of COVID-19
therapies.
The GAO found that hospitals' existing workflows
often did not align with HHS Protect, requiring them to either
create new data workflows or enter and report data manually,
which was done via Excel worksheets. Similarly, the way HHS
asked hospitals to report on PPE supplies was not consistent
with how these data are collected and maintained by hospital
systems.
The GAO observed that ``accurate, complete,
consistent and timely data are essential for monitoring trends
at the State and regional level, and for making informed
comparisons between these areas and assessing the effect of
public health response measures.'' This is a need that will
persist beyond the pandemic, GAO noted.
Instead, the nation's incomplete, inconsistent and
opaque line of sight on the quantity, location, and production
of critical PPE, drugs and other medical supplies left
healthcare providers and government officials largely in the
dark as they sought to locate needed products in the supply
chain.
In addition, a February 2021 report from the Business Executives
for National Security (BENS), a group chaired by Senators Hassan and
Cassidy, concluded the following:
``Shared awareness of fast-developing crisis metrics is
indispensable to an informed, effective national response. Yet,
stakeholders described struggling to gain a common operating
picture during the COVID-19 response. Reported obstacles
included minimal data sharing and the lack of an established
method to submit requests for resources and track responses in
real-time.
Compounding this problem, the national emergency response
enterprise is characterized by a patchwork of antiquated, non-
standard, and non-interoperable IT systems, further inhibiting
coordination. Of note, the after-action report on the Crimson
Contagion joint exercise expressly noted that HHS' and DHS/
FEMA's use of disparate information management systems
``hampered their ability to establish and maintain a national
common operating picture.'' Developing interoperable systems,
technologies, and capabilities to facilitate robust, resilient
communication and data sharing between all Federal, state, and
local emergency operations centers will be critical to
achieving this goal.'' \2\
---------------------------------------------------------------------------
\2\ Findings and Recommendations of the BENS Commission on the
National Response Enterprise: A CALL TO ACTION. February 2021.
Available at: https://www.bens.org/file/national-response-enterprise/
CNRE-Report-February-2021.pdf
Furthermore, in recent conversations with ASPR, it was noted that
only about 50 percent of State stockpiles are currently reporting into
the Supply Chain Control Tower under HHS Protect. It was also noted
---------------------------------------------------------------------------
that a major blind spot continues to be hospital inventory.
A key component to an end-to-end supply chain solution is an on-
call, nimble automated data collection infrastructure that the Nation
can call upon in any future crises similar in magnitude to COVID-19.
Rather than standing up an inadequate and duplicative system as we
experienced during the pandemic, the Nation needs a system that can
track critical product availability--from the manufacturer, to
distribution, to State and national stockpiles, to hospital inventory.
This system would exist behind the scenes and be ready to be ``turned
on'' in a moment's notice. It would provide visibility of supplies in
hospital inventories with detailed information that would enable
accurate and intelligent decisions about supply allocation and needs at
the local, state, regional and national levels. This information would
inform dynamic and appropriate product allocation and distribution
strategies, minimize hoarding, and allow for powerful and accurate
prediction, enabling the Nation to manage supplies during a crisis.
This data infrastructure would also strengthen the Strategic
National Stockpile (SNS) by:
Creating visibility into inventory via a standardized
data nomenclature and automated acquisition of data across the
SNS, manufacturers, distributors, and within healthcare systems
that is tied to real-time resource demand data.
Providing inventory monitoring and advanced alerts of
critical supply inventory levels warranting movement of product
from the SNS to points of care, ramping up production of
certain supplies, etc.
To accomplish these goals, policy changes are needed to provide
data rights to create predictive algorithms and to acquire and utilize
data for surveillance. In addition, incentives must be established to
encourage reporting such as providing two-way visibility into the
medical supply chain to reporting entities.
Consistent with the findings of the GAO report and Premier's
recommendations, the bipartisan Medical and Health Stockpile
Accountability Act of 2022 (H.R. 6520, 117th Congress) would require
the HHS Secretary to establish an automated supply chain tracking
application that provides near real-time insight into critical supplies
available in the SNS and medical and health supply inventories in
communities across the country. Development of The Medical and Health
Stockpile Accountability Act considered stakeholder feedback from the
hospital, distributor, and supplier communities as well as several
Federal agencies.
Specifically, the legislation would:
Establish a system for internal tracking of supplies
within the SNS during a public health emergency, natural
disaster, or other unforeseen circumstance that impacts the
healthcare supply chain. Tracked supplies would include only
those considered critical to addressing the emergency.
Allow for data access during an emergency by the HHS
Secretary to the medical and health stockpiles of State, local,
and private partners including suppliers, distributors, and
hospitals that choose to participate.
To incentivize participation, authorize $250 million
across fiscal year 2022-27 for the HHS Secretary to assist
State, local, and private partners in setting up automated
reporting systems--creating efficiencies and easing burden
associated with manual reporting during a future emergency.
Ensure transparent and efficient mechanisms for
health care entities, including hospitals, to voluntarily
report data in an emergency, including detailed data regarding
all relevant supplies secured and available.
Ensure that (1) HHS protects any data from hospitals,
manufacturers and distributors shared through the application;
and (2) that Federal data collection is leveraged for
monitoring and dynamic allocation and will not be used to
remove or re-allocate inventory from organizations.
Premier supports reintroduction of this legislation in the 118th
Congress to help ensure that hospitals, doctors, nurses and others
responding to health emergencies have the supplies they need when they
need them to provide safe, effective care for patients and not be put
in harm's way themselves. Armed with information from this inventory
monitoring infrastructure, decisionmakers will be better able to plan
and allocate PPE, syringes, and rapid testing kits, among other
critical items. This will prevent shortfalls and hoarding, move
products from the SNS and other stockpiles to points of care, or ramp
up production.
Incentivizing Domestic Manufacturing
Regarding domestic manufacturing and reducing the dependence on
overseas manufacturing, there are five major barriers that policy
proposals must address. These barriers include: 1) capacity; 2)
environmental regulations; 3) labor costs; 4) availability of raw
materials; and 5) historical policy decisions that advantaged
offshoring.
While Premier recognizes a need to incentivize domestic
manufacturing, we also recognize a need to ensure global diversity in
manufacturing. For example, moving all manufacturing onshore would
create a similar overreliance on a single geographical region.
Therefore, Premier recommends that there be at least three global
suppliers of the final form, ancillary products and raw materials for
critical medical supplies and drugs. Global suppliers should be from
geographically diverse regions, including at least one domestic
supplier.
To stimulate domestic manufacturing, Premier has thought critically
about how to incentivize manufacturers to invest in domestic production
while also ensuring that domestically manufactured goods are price
competitive with globally sourced products. To that end, Premier
recommends a two-part approach that leverages tax credits as a
mechanism for achieving these goals.
Part I:
A 30 percent tax incentive for investments to support
the domestic manufacturing of critical medical supplies and
drugs, including their raw materials. Examples of how the tax
incentive could be applied include, but are not limited to:
Y Investments in advanced manufacturing equipment or
machinery
Y Investments to repurpose existing abandoned
facilities
Y Investments to build new facilities
Y Investments to expand existing facilities
Y Investments to relocate foreign facilities back to
the U.S.
Y Investments to upgrade facilities to meet EPA
requirements
Y Regulatory filing fees for new domestic entrants to
the market (e.g. FDA, NIOSH, etc.)
The tax incentive should be reevaluated in 5 years to
determine its ongoing necessity and whether the incentive level
can be lowered or eliminated.
Part II:
A 10 percent tax credit on the income generated from
the sale of domestically manufactured goods to reward
manufacturers who have already invested in domestic
manufacturing. This would also help lower the cost of goods
manufactured domestically and make them price competitive with
globally sourced products.
To be prudent, companies found to be price gouging or
selling counterfeit products by the Department of Justice,
Federal Trade Commission, or other agency should not be
eligible for the tax credit. Guardrails would help ensure
companies aren't artificially increasing their prices to take
advantage of the tax credit from higher sales prices and
support the integrity of the supply chain.
To truly create a long-term domestic manufacturing infrastructure
that is sustainable, incentives for onshoring manufacturing must be
coupled with committed purchasing volumes so new entrants to the market
have a guaranteed sales channel. To accomplish this goal while
cultivating global diversity, Premier recommends that government
purchasers be required to contract for critical medical supplies and
pharmaceuticals from a mixture of onshore, near-shore (such as Central
and South American countries) and off-shore countries. Purchase
thresholds based on a geographical region can help prioritize domestic
manufacturers while ensuring global diversity and sustainability of the
supply chain. In addition, longer-term contracts (at least 3 years in
length) will help provide ongoing volume commitments and assurance for
suppliers entering the marketplace.
Finally, Premier recommends that Congress consider incentives for
healthcare providers to purchase domestically manufactured critical
medical supplies and drugs through programs such as tax incentives, CMS
bonus payments, etc. to create committed purchasing volume for domestic
suppliers and offset higher acquisition costs. For example, CMS
recently finalized a Premier-supported payment adjustment to compensate
hospitals for the increased cost of domestically produced N95 masks,
however, absent congressional action--the payment policy was
implemented in a budget-neutral manner, impacting its ability to be
applied broadly to additional domestically manufactured critical
medical supplies. Therefore, Premier recommends that Congress provide
CMS with statutory authority to implement payment adjustments for
domestically manufactured critical medical supplies and pharmaceuticals
in a non-budget neutral manner.
Finally, to truly support domestic manufacturing, the FDA
regulatory framework for approval must be adapted to expedite review of
applications and inspections of manufacturing facilities for new
domestic entrants. As manufacturers seek to invest in onshoring the
manufacturing of critical medical supplies and pharmaceuticals, it is
essential that our nation's regulatory framework support, and not
inhibit or deter, repatriation. As such, Congress should consider
policies that expedite FDA review for domestically manufactured
critical medical supplies and pharmaceuticals.
Mitigating Drug Shortages
Premier applauds congressional action to pass sections 3101, 3111
and 3112 of the Coronavirus Aid, Relief, and Economic Security (CARES)
Act to mitigate drug shortages necessary for patient care during the
pandemic. Specifically, these provisions:
Created a priority pathway for the review of drug
shortage applications;
Required a report examining national security risks
as a result of drug shortages;
Strengthened FDASIA Title X reporting requirements to
include full disclosure of the problems resulting in a
shortage, information concerning the extent of a shortage, its
expected durations, and other information the Secretary may
require;
Extended FDASIA Title X reporting requirements to
Active Pharmaceutical Ingredient (API) manufacturers; and
Required manufacturers to maintain redundancy and
contingency plans to ensure ongoing supply.
While the provisions included in the CARES Act are monumental to
continuing the fight against drug shortages, the pandemic highlighted
additional vulnerabilities in the pharmaceutical supply chain
warranting a revisit of drug shortages legislation to strengthen the
FDA's ability to proactively address and respond to potential
shortages. These include:
Requiring manufacturers, including API manufacturers,
to report the volume of product that is manufactured in each
FDA-registered facility.
Y The FDA currently collects information regarding the
number of registered manufacturers in each country, but
a blind spot is the actual volume of product that is
produced by each facility. For example, FDA data shows
that 18 percent of registered API manufacturers are
located in India whereas Premier data shows that
upwards of 30 percent of the world's API is
manufactured in India. On the contrary, FDA data shows
that 28 percent of registered API manufacturers are
located in the United States whereas Premier data shows
that approximately 15-20 percent of the world's API is
manufactured domestically. Furthermore, it is estimated
that upwards of 80 percent of the world's raw
materials, also known as key starting materials, for
pharmaceuticals are manufactured in China. The
inability of the FDA to pinpoint the volume of product
that is derived in each country results in a lack of
transparency in the pharmaceutical supply chain
regarding source of raw materials, API and finished
dose forms (FDF)--making it difficult to assess the
downstream risk to supply disruptions. This lack of
transparency creates challenges to assess the true risk
to the pharmaceutical supply chain due to manufacturing
delays, export bans, global pandemics, etc.
Expanding the FDA drug shortage list to include
regional shortages as well as shortages based on strength and
dosage form.
Y The FDA drug shortage list currently does not
account for regional shortages or shortages based on
excipient, strength or dosage form. These limitations
created difficulties during the COVID-19 pandemic as
drug shortages were rampant in hot spots while the
majority of the Nation did not experience the same.
This resulted in an inability of providers and
manufacturers to move product to areas of greatest need
and leverage other statutory and regulatory
flexibilities that would have otherwise been applicable
in a shortage situation, such as 503B compounding as an
interim solution.
Modernizing the FDA's data infrastructure to collect
shortage signals from the private sector.
Y Oftentimes, the warning signals of an impending
shortage can be seen weeks to months in advance due to
discrepancies in demand vs supply data. For example,
during the COVID-19 pandemic, Premier shared weekly
demand signals with the FDA for approximately 250
critical medications to help the FDA understand what
medications were at risk for shortage due to increased
demand. Premier's 360-degree view into the demand vs
supply signals from a broad swath of our membership
across multiple suppliers provided an accurate and
predictive model for determining which drug products
were at risk of disruption. While individual suppliers
could report increases in demand to FDA, as requested
in the President's fiscal year 2024 budget, in practice
individual demand signals are not telling of a
potential disruption and create unnecessary and undue
reporting burden on the supplier. Instead, it is
critical to work with larger data sets and predictive
modeling with artificial intelligence to truly
understand medications at risk for disruption.
Therefore, to better help the FDA predict shortages
before they occur, Premier recommends that Congress
provide FDA with funding to modernize its data
infrastructure and work with existing private sector
data sets to collect and analyze market demand signals.
Leveling the playing field for all FDA inspections.
Y Currently, the FDA assesses whether a facility is in
a State of control through periodic inspections that
provide an evaluation of manufacturing operations,
including their system for quality management. However,
not all facilities are treated the same as domestic
manufacturers are inspected regularly via unannounced
inspections whereas many foreign facilities are
inspected less regularly via announced inspections.
This dichotomy in inspection authority creates an undue
burden for domestic manufacturers and can create an
incentive for manufacturers to build their facilities
overseas. It is welcome news that the Fiscal Year (FY)
2023 Omnibus Appropriations Bill contains a provision
requiring the FDA to establish a pilot program for
unannounced foreign inspections, but the quality
standard should focus on FDA approval and inspection,
with all FDA-registered global manufacturers inspected
equitably and consistently via unannounced inspections
at the same time intervals. Both domestic and overseas
manufacturers of FDFs and APIs should be held to the
same standard. To level the playing field, the FDA will
require the appropriate resources in highly trained and
experienced inspectors and may also need additional
statutory authority. Once a level playing field is
adopted as policy, the FDA should provide Congress with
a 5-year plan, with metrics and annual targets to
achieve the desired parity.
Expanding drug shortage authorities to vaccines.
Y While the FDA has statutory authority to mitigate
drug shortages, vaccines are currently excluded from
those authorities. Therefore, if shortages of COVID,
Mpox or other vaccines needed to address and treat a
public health emergency were to go into shortage in the
future, FDA would have limited authority to mitigate
the shortage. Therefore, Premier recommends that
Congress expand FDA's statutory authority to address
shortages to include vaccines.
Premier urges Congress to provide FDA greater authority to further
mitigate drug shortages.
Mitigating Device Shortages
Premier applauds congressional action to pass section 3121 in the
CARES Act to mitigate device shortages necessary for patient care
during the pandemic. Specifically, these provisions:
Required device manufacturers to notify the FDA of a
permanent discontinuance in the manufacture of the device or an
interruption of the manufacture of the device that is likely to
lead to a meaningful disruption in the supply of that device in
the U.S., and the reasons for such discontinuance or
interruption;
Required FDA to publish a device shortage list with
information on the discontinuance or interruption of the
manufacture of devices reported; and
Prioritized and expedited review of applications and
inspections for a device that could help mitigate or prevent
such shortage.
While these were positive steps in the right direction and created
the first-ever device shortage reporting requirements, these provisions
are temporary and tied to reporting only during a public health
emergency. More can be done to make the device shortage program robust
and akin to the drug shortage program at the FDA. This includes:
Making permanent the device shortage requirements.
Y Currently, device manufacturers are only required to
report supply disruptions to the FDA for the duration
of the public health emergency. COVID-19 exposed
weaknesses in the U.S. supply chain and the country's
overdependence on medical supplies, devices and
components imported from overseas. Shortages persist
today and span a variety of categories, including
supplies essential for patient care such as blood
collection tubes, contrast media, tourniquets, and
more. Thanks to the authority granted to FDA in the
CARES act, the FDA has been able to better understand
and monitor the complex web of supply chains that feed
the medical device industry and to solve problems more
proactively before they occur. As a result, the FDA has
recommended actions that have helped industry,
providers and the Nation mitigate potential damage and
further disruption. But while the FDA's new authority
has been important, it does not cover all situations
that can lead to shortages. These can and will arise
outside of public health emergencies, such as during
natural disasters, device recalls, geopolitical issues,
and other unforeseen circumstances impacting the supply
chain. Therefore, it is critical that this authority be
made permanent so that the FDA can continue this
important work and proactively mitigate device
shortages before they occur.
Requiring device manufacturers to implement risk
management plans.
Y A key component of a resilient supply chain is
having a backup plan to ensure redundancy in
manufacturing and minimize supply disruptions.
Therefore, Premier supports Congress extending FDA's
authority to requiring risk management plans on device
manufacturers. Congress provided similar statutory
authority to the FDA to require risk management plans
for drug manufacturers in the CARES Act.
Premier urges Congress to provide FDA greater authority to further
mitigate device shortages.
Maintaining Supply Chain Integrity
During the pandemic, unfortunately a lack of clear visibility of
distributor fulfillment led to uncertainty on where products where
delivered. This continued uncertainty left providers with dwindling
confidence in the normal supply chain and proliferated more maverick
and forward buying, as well as hoarding. This also led to a rampant
gray market and many entities purchasing counterfeit products thereby
challenging the integrity of the medical supply chain.
In the CAA 2023, Congress included the INFORM Consumers Act which
establishes a national standard, enforced by the Federal Trade
Commission (FTC) and State Attorneys General, that requires online
platforms that allow for third party sellers of consumer products
(including PPE and other medical goods) to verify the identity of high-
volume third-party sellers. The CAA 2023 also strengthened FDA
enforcement authority against, and increased the penalties for, selling
counterfeit medical devices, including PPE, in the United States.
While the CAA 2023 made great strides, to further combat the gray
market and ensure supply chain integrity, Premier offers the following
recommendations:
Establish a national, centralized clearinghouse to
vet all gray market offers for critical medical supplies,
pharmaceuticals and vaccines. A clearinghouse approach would
remove the risk and guess work from efforts by healthcare
providers, states and other entities to secure a reliable
supply of critical medical supplies and drugs. The
clearinghouse should:
1. Hold all payments in escrow until testing is
validated;
2. Test lot samples through a certification process;
3. Permit the sale of products that are validated;
and
4. Confiscate and take appropriate action against the
gray market actor if the product is not validated.
Require entities associated with the distribution of
critical medical supplies and drugs to implement checks and
balances systems, similar to suspicious order monitoring
requirements for controlled substances, to identify potential
diversion of products to the gray market.
Promote the reporting of gray market offers to the
FDA Office of Criminal Investigations and share reported
incidents with the Federal Trade Commission (FTC).
Establish best practices for security to minimize
diversion from sites.
Broaden FDA's authority to destroy counterfeit
devices that are imported into the United States.
Premier encourages Congress to consider policies that combat the
gray market and ensure supply chain integrity.
III. National Advisory Committee (NAC) on Individuals With Disabilities
and Disasters
Recently during recovery efforts for Hurricane Ian, Premier became
aware of a lack of emergency services and shelters that can accommodate
the specialized needs for individuals with disabilities. For example,
many disabled individuals and their families that were in the path of
the hurricane were unable to evacuate their homes as shelters did not
have the necessary infrastructure and support services needed to care
for disabled individuals. This unfortunately resulted in these
individuals having to shelter in place and hope for the best. Premier
encourages Congress to work with Federal agencies such as FEMA, and
relief organizations such as the American Red Cross, to provide
appropriate funding to ensure that emergency efforts during a public
health emergency, natural disaster, or other unforeseen circumstance
account for the needs of disabled individuals and their families.
IV. Strategic National Stockpile
Regarding the Strategic National Stockpile (SNS), Premier strongly
supports the need to augment the SNS to better respond to global
pandemics by enabling public-private partnerships. However, to develop
a truly cohesive and holistic national strategy for addressing future
global pandemics and stabilizing the U.S. supply chain to respond to
surge demand for essential medical supplies and drugs, Premier believes
that it is critical to take a broader approach than the SNS was
originally designed for by creating a true end-to-end supply chain
solution that is transparent, diverse, and reliable. In addition, it is
critical to not only focus on the quantity on hand for critical
supplies, but also focus on the time to inventory and ensuring the U.S.
has contractual relationships established, including contingency and
redundancy plans, to ramp up production expeditiously and efficiently
upon identification of need.
The SNS is the supply chain of last resort for health systems,
continuum of care providers, and first responders. Therefore, the SNS
must be built by providers for providers. The SNS must also leverage
analytics and insights to assist providers in the delivery of care
during global pandemics that is in the best interest of patients and
ensure access to the right supplies at the right time.
Premier's vision for the next generation SNS includes the following
elements that can be accomplished via a public-private partnership:
Establish a Public-Private Advisory Council: As
outlined in section VI below, Premier urges Congress to amend
PHEMCE to create a public-private advisory council.
Identify A List of Critical Medical Supplies, Drugs
and Other Supplies Necessary to Manage a Surge: The public-
private advisory council should be tasked with:
Y Identifying the list of critical medical supplies,
drugs, medical foods and other supplies needed to treat
a global pandemic and associated comorbidities that
should be included in the SNS, including determining
the most cost-effective product where multiple options
may exist within a single product category or
therapeutic category. This includes broadening the
scope of products maintained in the SNS beyond
countermeasures to include lifesaving and protective
equipment and medications, such as ventilators, PAPRs
and medical gas cylinders, and the corresponding
consumables, such as breathing circuits, filters and
hoses that sustain life or protect front line staff.
The list should be inclusive of all products necessary
to treat a potential global pandemic, including
potential comorbidities, and take into account special
patient populations such as pediatrics and geriatrics.
Y Annually, at minimum, assessing, refining and
revising the list of critical medical supplies, drugs,
medical foods and other supplies contained in the SNS
to account for product discontinuations, emerging
technologies, changes in clinical guidelines and
identification of best practices. The list should be
dynamic and regularly updated.
Create Transparent and Diverse Sourcing for Critical
Medical Supplies and Drugs: Establishing a transparent, diverse
and reliable supply chain is essential for ensuring the U.S. is
prepared to respond to future global pandemics. This is
critical information to understand vulnerabilities, overseas
reliance on manufacturing, and the impact of geopolitical
issues such as export bans and manufacturing shutdowns. A
robust sourcing strategy for the SNS should:
Y Create transparency by obtaining upstream visibility
into the supply chain to determine source of raw
materials, ancillary products and finished goods. All
manufacturers contracted with the SNS should commit to
providing upstream visibility into the sourcing for
their products to provide a holistic view.
Y Assure diversity by ensuring there are several
suppliers of raw materials, ancillary products and
finished goods from geographically diverse regions.
Y Leverage multiple sourcing options including
contracting directly with manufacturers, contracting
with group purchasing organizations to help aggregate
purchasing volume and keep prices competitive, and
recruiting and incentivizing the entry of new
manufacturers for product categories that lack
diversification. Policy changes may be needed to 1)
permit the SNS to pursue innovative contracting
methodologies to meet the vision of the next generation
SNS; and 2) amend the Federal Supply Schedule to
incentivize domestic manufacturing and ensure a stable
supply at a sustainable price.
Y Identify and contract with at least a primary and
secondary manufacturer for each critical medical supply
and drug. The contract should stipulate the ability of
the manufacturer to meet certain supply requirements
within a specified period during surge demand,
redundancy and contingency plans for manufacturing,
requirements for safety stock and warehousing of the
product, and quality standards that must be ensured.
The Public-Private Advisory Council should be tasked
with:
` Developing criteria for awarding SNS contracts to
manufacturers including product specifications;
` Vetting and approving all SNS contracts to
manufacturers to provide an agnostic and unbiased
voting process;
` Providing recommendations for warehousing at the
product level; and
` Prioritizing product categories for domestic
manufacturing.
Develop a Network of Stockpiles Throughout the
Country: Stockpiles should be designed to create coordination,
rather than competition. Stockpiles should also be curated to
meet specific needs such as acute, continuum of care, first
responders, etc. as each segment of healthcare will have
varying needs. Therefore, the SNS should develop a network of
stockpiles that creates a ``hub-and-spoke'' model with the SNS
as an anchor offering a full array of services that is
complemented by State and local stockpiles to optimize supply
and ensure coordination. To further optimize the availability
of supplies as close to the point of care as possible, the SNS
should explore opportunities to leverage health system and
alternate site provider warehouses in major metropolitan areas
or in rural areas. Finally, to ensure the network of stockpiles
are interoperable and complementary to one another, the public-
private advisory council should be tasked with developing
national standards that all stockpiles must meet at a minimum.
Better coordination amongst stockpiles would also permit a national
infrastructure to absorb excess inventory that exists in State or
health system stockpiles versus purchasing net new products.
Rotate Inventory: The SNS should rotate soon-to-
expire product out of the SNS. This can be accomplished either
by 1) contracting with a third party vendor to rotate
inventory; or 2) selling short-dated products to health systems
and alternate site providers at a discounted rate, a newly
created authority under the CAA 2023; or 3) maintaining a
virtual inventory by working with manufacturers or private
sector partners to maintain and rotate inventory on behalf of
the SNS, akin the Vaccine for Children program that leverages
vaccine manufacturers to maintain and rotate inventory.
Critical to establishing, maintaining and rotating inventory is
to avoid huge bulk purchases as they can create noise and
distortion in market demand signaling. In addition, bulk
purchases can result in downstream shortages as manufacturers
prioritize government fulfillment over standard distribution
thereby impacting the availability of products for frontline
patient care. Finally, rotation of product should also occur as
products are discontinued or removed from the SNS as the list
of critical medical supplies and pharmaceuticals is updated
annually.
Create an Efficient and Dynamic Fulfillment Process:
The current process for accessing the SNS is cumbersome and
State specific. Therefore, the SNS should create a single,
streamlined and efficient electronic process for submitting
requests to the SNS along with a standardized process for
responding to requests. It is also critical for the SNS to
develop a dynamic distribution methodology that leverages a
data-driven approach to ensure products are available in the
right place at the right time, versus relying on a historical
allocation process as was leveraged during the pandemic.
Finally, a nimble and flexible distribution method is also
needed to move supplies amongst health systems from areas with
excess product or declining need to hot spots or areas with
increasing needs.
Test the Functionality, Readiness and Reliability of
the SNS: To ensure the next generation SNS can deliver during
future global pandemics, it is critical to periodically
pressure test the system. Annually, without prior notice, the
SNS should require all contracted manufacturers to provide the
SNS with a specified quantity of product. An annual test allows
the SNS to ensure all contracted manufacturers can
expeditiously and efficiently ramp up production to meet surge
demand, as well as ensure production lines remain operational
and are maintained.
Analyze and Report: Transparency regarding the
efficiency and utilization of the SNS is critical to
understanding its purpose and continued need. The SNS should be
transparent regarding distribution of supplies and drugs from
the SNS and therefore should provide, at minimum, a detailed
monthly report of what supplies were requested versus
distributed to where and in what quantities. During a public
health emergency, reporting should occur weekly.
Premier urges Congress to take additional steps to modernize the
nation's stockpile.
V. Biomedical Advanced Research and Development Authority (BARDA)
Throughout the pandemic, the Industrial Base Management and Supply
Chain (IBMSC) Program Office within BARDA invested billions of taxpayer
dollars in over 50 manufacturers to ``expand, secure, and build
resiliency across the entire public health and medical industrial
base.'' In many cases, it appears that these investments were made
without a formal request for proposals (RFP) process and bypassed
traditional government contracting requirements, potentially cherry-
picking award recipients and not providing a fair opportunity for
eligible entities to compete. Furthermore, little to no information has
been made available publicly regarding the ability of these
manufacturers to meet their manufacturing goals and the impact to the
supply chain. Therefore, Premier urges Congress to request an OIG
report regarding the distribution of IBMSC funds, the progress to date
of award recipients in meeting their contractual obligations and the
impact to supply chain resiliency. Furthermore, Premier urges Congress
to leverage the OIG findings to develop a process for awarding future
IBMSC funds in a transparent manner and for regular public reporting of
progress by award recipients.
VI. Public Health Emergency Medical Countermeasures Enterprises
(PHEMCE)
The SNS should establish a public-private advisory council that
includes representatives from the private sector such as manufacturers,
group purchasing organizations, distributors, physicians, pharmacists,
nurses, laboratorians, non-acute providers, patients, professional
associations, and others as well as representatives from the public
sector such as Federal agencies (HHS, FEMA, ASPR, CDC, CMS, FDA,
SAMHSA, the Veterans Health Administration, Indian Health Services,
etc.), prisons, first responders, State and local representatives, and
others. The advisory council should leverage a multi-committee
structure to ensure the appropriate expertise is represented for
specific product categories such as pharmacy, lab, nursing homes,
pediatrics, etc. The advisory council will be critical to ensuring the
SNS is soliciting feedback from a broad range of entities to augment
its operations through a data-driven approach, remain unbiased and
vendor agnostic, support a collaborative decisionmaking process,
identify innovative products, and continuously refine the vision of the
SNS. Essentially, the advisory council structure helps ensure the SNS
is built by providers for providers.
To accomplish this, statutory changes are required to amend the
composition of the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE), the group responsible for dictating the contents
of the SNS. The PHEMCE is currently led by ASPR and includes three
primary HHS internal agency partners: the Centers for Disease Control
and Prevention (CDC), the Food and Drug Administration (FDA) and the
National Institutes of Health (NIH), as well as several interagency
partners: the Department of Defense (DoD), the U.S. Department of
Veterans Affairs (VA), the Department of Homeland Security (DHS) and
the U.S. Department of Agriculture (USDA). The PHEMCE currently does
not include private sector feedback. This was also highlighted in a
recent National Academies of Medicine report, Ensuring an Effective
Public Health Emergency Medical Countermeasures Enterprise, that
provides recommendations from an expert committee for a re-envisioned
PHEMCE. Therefore, Premier recommends that Congress amend the
composition of PHEMCE to include private sector representation and
create a true public-private advisory council.
VII. Medical Reserve Corps (MRC)
During the pandemic, to help alleviate staffing challenges
throughout the country, several Federal resources from HHS, DOD, FEMA,
the Public Health Service and other agencies were deployed to provide
on-the-ground support to hospitals and health systems. In some
situations, this help was welcome and beneficial. However, in certain
cases, hospitals have reported that the help may have been duplicative
or not geared toward the specific areas where assistance was needed the
most. Premier recommends that Congress direct the GAO to study the
effectiveness of federally deployed resources to hospitals and health
systems. The study should look at lessons learned, efficiencies
created, opportunities for improvement and recommendations for how to
optimize Federal resources during future public health emergencies.
VIII. Playbook of Regulatory Flexibilities for Future National Public
Emergencies
Throughout the COVID-19 pandemic, Federal agencies provided a host
of regulatory waivers and flexibilities that were critical to hospital
operations and permitted providers to focus on patient care. While the
various waivers and flexibilities were extremely helpful, they were
also released in a piecemeal fashion and it was often difficult for
providers to keep track of what requirements were being waived. In
addition, while some waivers came expeditiously, others took time to
establish such as the hospital-at-home waiver that was not established
until November 2020. For future pandemics, a recent Premier survey
found that the expeditious establishment of waivers and flexibilities
would be essential to ensuring a prompt response from hospitals.
Specifically, respondents noted that it would be beneficial if a
bundle of waivers or flexibilities could be pre-identified as essential
to operations during a future pandemic such that they could be
immediately implemented, and hospitals would know exactly what to
expect. Therefore, Premier recommends that Congress direct Federal
agencies to identify and bundle waivers and flexibilities that would be
automatically invoked and could be expeditiously implemented during a
future public health emergency to improve patient care and reduce
burden on hospitals and other healthcare providers.
IX. Epidemiology and Laboratory Capacity Grant Program
Early COVID-19 testing was plagued by a lack of testing locations,
a shortage of specimen collection swabs, inadequate lab capacity to
process tests and sporadic genomic sequencing to monitor for variants.
With Mpox, efforts to speed access to testing were swifter as the CDC
effectively onboarded commercial labs to expand testing for Mpox within
1 month. While an improvement, that 1 month delay did have consequences
creating testing bottlenecks.
As we learned during COVID-19, delays of even a day can have dire
effects on limiting transmission. Instead, the government should
broaden and better organize the lab network to include hospitals,
academic medical centers, and regional testing laboratories that have
the ability and capacity to perform these tests in their communities.
Broadening the lab network will help ensure that regionally based
testing can produce more timely results, empowering immediate and
effective public health action. It is also critical for the Nation to
develop a genomic sequencing strategy for Monkeypox to stay ahead of
potential variants.
X. Public Health Situational Awareness and Biosurveillance Network
Programs
Syndromic Surveillance to Predict Community Outbreaks
In the early days of the pandemic, Premier leveraged clinical
decision support, powered by machine-learning, artificial intelligence
and natural language processing, to effectively predict COVID-19 surges
and regional flare ups well before patients started showing up at the
hospital for treatment. Armed with positive results, Premier advocated
for Federal agencies to adopt a national system for syndromic
surveillance to better track and predict outbreaks--and quicken
response times.
Symptoms are the earliest and most reliable indicator of the
emergence of infectious diseases that threaten our nation's public
health. Identifying suspected cases early is the best signal of the
need to take action. However, a recent Government Accountability Office
(GAO) report notes how a lack of Federal action to modernize the public
health data infrastructure seriously undercut efforts to combat the
COVID-19 virus. This is a situation that was unfortunately replayed
with the Mpox public health emergency.
America needs an automated, near real-time means to collect
symptoms and confirmed case information consistently and
comprehensively so that it can be shared between and among multiple
public and private stakeholders, including Federal, state, local,
Territorial and tribal public health authorities as well as on-the-
ground providers:. Such a system can pull in information on symptoms,
comorbidities and other vital information, allowing for targeted
tracing and interventions to proactively prevent outbreaks. Earlier
recognition of new hot spots speeds quarantining of potentially
infected persons, reduces the spread of the virus and saves the Nation
money on contact tracing and testing. This reality is possible today
and Congress should push Federal agencies to explain how a system that
was required under PAHPA in 2006 in still not operational today.
Automated Tracking and Reporting the Spread of Disease
During the COVID-19 pandemic, virtually all reporting was done
using paper-based forms that were then faxed back to the State and
local public health departments for recording and follow up. Reporting
was limited to hospitals providing treatment for the most severe cases
and labs that encountered a positive COVID-19 test. This meant public
health agencies received no information from milder cases diagnosed in
a physician office, or from patients self-diagnosed via at-home tests.
Fast forward to Mpox and some improvements in reporting were made.
Any labs performing a Mpox test were required to report all results
directly to public health departments and are strongly encouraged to
submit this data electronically, as opposed to via paper forms.
However, electronic reporting is still not a requirement and public
health case investigation forms used to track the source of
transmission are still paper based and very lengthy (e.g. more than six
pages long for Mpox). The Federal Government should require and
prioritize efforts for automated, streamlined nationwide public health
data collection, exchange and sharing using data and interoperability
standards.
XI. Additional Areas for Consideration
Presidential Advisory Council on Combating Antibiotic-resistance
Bacteria (PACCARB)
COVID-19 has brought to the forefront the specific challenges
nursing homes face in containing the spread of infectious disease. The
virus accelerated at nursing homes because residents are generally
vulnerable to its complications and more susceptible in the contained
space of facilities. While data about infections in nursing homes is
limited, the CDC notes that, even prior to the pandemic, a staggering 1
to 3 million serious infections occur annually in these facilities and
as many as 380,000 people die of infections in nursing homes every
year.
Infection prevention oversight and training at nursing homes is a
challenge in and of itself with limited staffing and several layers or
reporting requirements. This challenge is compounded by limited
Electronic Health Record (EHR) functionality at the sites. Without a
comprehensive infection prevention surveillance workflow, the
surveillance, tracking, documenting and reporting of epidemiologically
significant organisms and infection is difficult for everyday risks,
such as multi-drug resistant organisms, but also when an outbreak like
COVID-19 occurs.
Clinical analytics technologies are currently widely leveraged in
hospitals and acute setting to detect patient care issues through
surveillance, interventions and reporting capabilities that are needed
to support antimicrobial stewardship programs. These systems utilize
data from EHRs and have significantly helped clinicians and pharmacists
in acute settings identify overuse of antibiotics and drug-bug
mismatches, reduce time-to-appropriate therapy and enhance therapy for
difficult-to-treat pathogens. Those health systems already utilizing
clinical surveillance technology were well positioned to respond to
COVID-19 before the pandemic hit.
Unfortunately, clinical analytics technologies are currently not
widely used in nursing homes and other long-term and post-acute (LTPAC)
settings. These settings should have the same access to tools that will
help them combat infection spread during any future disease outbreaks
and during their day-to-day operations, but unfortunately funding
remains a significant barrier as programs authorized and funded under
the Health Information Technology for Economic Clinical Health (HITECH)
Act excluded LTPAC providers. These entities are already challenged
with meeting their more visible needs, such as testing and securing
adequate PPE levels at their sites, but a more comprehensive approach
is needed to ensure data collection is efficient, non-duplicative and
being analyzed in ways that are helpful for facilities. Furthermore, it
is critical that lessons learned from meaningful use are applied
forward as we develop cohesive solutions to address the lack of EHRs
and clinical surveillance technology in nursing homes and create
appropriate incentives for adoption.
Premier encourages Congress to consider policies that incentivize
nursing homes and other LTPAC providers to implement EHRs and
electronic clinical surveillance technology to provide meaningful
assistance with infection control.
Strategy for Public Health Preparedness Response to Address
Cybersecurity Threats
Alongside technology innovations and the frequent electronic
exchange of health information, cybersecurity for medical devices and
equipment has become a top priority for healthcare providers. These
cyberattacks not only threaten patient privacy and clinical safety and
outcomes, but also a hospital's financial resources. Alongside direct
costs related to a breach, providers may see added costs in hardware,
software, firmware and labor.
In the CAA of 2023, Congress required manufacturers of cyber
devices to develop processes to ensure their devices are secure, have
plans to identify and address cybersecurity vulnerabilities, provide a
software bill of materials in their labeling, and submit this
information to FDA in any premarket submissions. However, these
provisions are only applicable to devices going through a traditional
510(k) pathway and it is unclear how devices and other products granted
an emergency use authorization during a public health emergency would
be required to comply with these provisions. Given heightened
cybersecurity concerns during pandemics, Premier urges Congress to
clarify the roles and responsibilities of manufacturers granted an
emergency use authorization as it relates to cybersecurity of their
devices. In addition, Premier urgers Congress to decrease fines and
other civil monetary penalties for healthcare providers if they
experience a cybersecurity breach due to a device granted an emergency
use authorization that did not comply with FDA cybersecurity
requirements.
Port Congestion and Transportation Delays
During the pandemic, port congestion and delays in global logistics
nearly doubled and tripled product lead times. This resulted in supply
shortages due to an inability to prioritize cargo ships carrying
healthcare supplies. These delays and shortages were further
exacerbated due to shortages of drivers and impending discussions of a
rail strike.
To help combat this, the private sector piloted a ``fast pass''
system led by the Health Industry Distributors Association. The pilot
was successful in testing the ability of ports to prioritize and
expedite the offloading of healthcare supplies. Premier urges Congress
to prioritize and expedite the delivery of healthcare supplies during
public health emergencies.
Contracting and Hiring Authority
Throughout the pandemic, a rate limiting step in Federal agency
response was contracting and hiring authority. While some agencies had
more flexibility to increase resources to meet the task at hand, other
agencies did not have the same authority or flexibility to increase
their staff. To better respond to future pandemics, Premier urges
Congress to ensure all Federal agencies with a potential role in
response to a future pandemic have similar contracting and hiring
authority to expeditiously obtain the resources necessary to adequately
carry out their duties.
______
[Whereupon, at 3:15 p.m., the hearing was adjourned.]
[all]