[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

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

                                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

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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        Available via the World Wide Web: http://www.govinfo.gov
        
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                   U.S. GOVERNMENT PUBLISHING OFFICE                    
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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

                              ----------                              

                               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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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:
---------------------------------------------------------------------------
    \4\  Section 506J of FD&C Act (21 U.S.C. 356j)

---------------------------------------------------------------------------
          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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
                         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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
                         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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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:
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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. 
---------------------------------------------------------------------------
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 
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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:
---------------------------------------------------------------------------
    \23\  https://medicalcountermeasures.gov/app/barda/coronavirus/
COVID19.aspx

---------------------------------------------------------------------------
          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:
---------------------------------------------------------------------------
    \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

---------------------------------------------------------------------------
          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:
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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, 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
        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.
---------------------------------------------------------------------------
                               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]