[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]


  ANTIMICROBIAL RESISTANCE: EXAMINING AN EMERGING PUBLIC HEALTH THREAT

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

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             FIRST SESSION
                               __________

                             APRIL 28, 2023
                               __________

                           Serial No. 118-31
                           
                           
                  [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


     Published for the use of the Committee on Energy and Commerce

                   govinfo.gov/committee/house-energy
                        energycommerce.house.gov
                        
                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE
                    
55-668 PDF                WASHINGTON : 2024   


                    COMMITTEE ON ENERGY AND COMMERCE

                   CATHY McMORRIS RODGERS, Washington
                                  Chair
MICHAEL C. BURGESS, Texas            FRANK PALLONE, Jr., New Jersey
ROBERT E. LATTA, Ohio                  Ranking Member
BRETT GUTHRIE, Kentucky              ANNA G. ESHOO, California
H. MORGAN GRIFFITH, Virginia         DIANA DeGETTE, Colorado
GUS M. BILIRAKIS, Florida            JAN SCHAKOWSKY, Illinois
BILL JOHNSON, Ohio                   DORIS O. MATSUI, California
LARRY BUCSHON, Indiana               KATHY CASTOR, Florida
RICHARD HUDSON, North Carolina       JOHN P. SARBANES, Maryland
TIM WALBERG, Michigan                PAUL TONKO, New York
EARL L. ``BUDDY'' CARTER, Georgia    YVETTE D. CLARKE, New York
JEFF DUNCAN, South Carolina          TONY CARDENAS, California
GARY J. PALMER, Alabama              RAUL RUIZ, California
NEAL P. DUNN, Florida                SCOTT H. PETERS, California
JOHN R. CURTIS, Utah                 DEBBIE DINGELL, Michigan
DEBBBIE LESKO, Arizona               MARC A. VEASEY, Texas
GREG PENCE, Indiana                  ANN M. KUSTER, New Hampshire
DAN CRENSHAW, Texas                  ROBIN L. KELLY, Illinois
JOHN JOYCE, Pennsylvania             NANETTE DIAZ BARRAGAN, California
KELLY ARMSTRONG, North Dakota, Vice  LISA BLUNT ROCHESTER, Delaware
    Chair                            DARREN SOTO, Florida
RANDY K. WEBER, Sr., Texas           ANGIE CRAIG, Minnesota
RICK W. ALLEN, Georgia               KIM SCHRIER, Washington
TROY BALDERSON, Ohio                 LORI TRAHAN, Massachusetts
RUSS FULCHER, Idaho                  LIZZIE FLETCHER, Texas
AUGUST PFLUGER, Texas
DIANA HARSHBARGER, Tennessee
MARIANNETTE MILLER-MEEKS, Iowa
KAT CAMMACK, Florida
JAY OBERNOLTE, California
                                 ------                                

                           Professional Staff

                      NATE HODSON, Staff Director
                   SARAH BURKE, Deputy Staff Director
               TIFFANY GUARASCIO, Minority Staff Director
              Subcommittee on Oversight and Investigations

                      H. MORGAN GRIFFITH, Virginia
                                 Chairman
MICHAEL C. BURGESS, Texas            KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky                Ranking Member
JEFF DUNCAN, South Carolina          DIANA DeGETTE, Colorado
GARY J. PALMER, Alabama              JAN SCHAKOWSKY, Illinois
DEBBIE LESKO, Arizona, Vice Chair    PAUL TONKO, New York
DAN CRENSHAW, Texas                  RAUL RUIZ, California
KELLY ARMSTRONG, North Dakota        SCOTT H. PETERS, California
KAT CAMMACK, Florida                 FRANK PALLONE, Jr., New Jersey (ex 
CATHY McMORRIS RODGERS, Washington       officio)
    (ex officio)
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. H. Morgan Griffith, a Representative in Congress from the 
  Commonwealth of Virginia, opening statement....................     2
    Prepared statement...........................................     4
Hon. Kathy Castor, a Representative in Congress from the State of 
  Florida, opening statement.....................................     7
    Prepared statement...........................................     9
Hon. Cathy McMorris Rodgers, a Representative in Congress from 
  the State of Washington, opening statement.....................    11
    Prepared statement...........................................    13
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................    16
    Prepared statement...........................................    18

                               Witnesses

Mary Denigan-Macauley, Ph.D., Director, Health Care, Government 
  Accountability Office..........................................    20
    Prepared statement...........................................    23
Kevin Outterson, Austin B. Fletcher Professor, Boston University 
  School of Law, and Executive Director, CARB-X..................    39
    Prepared statement...........................................    41
Amanda Jezek, Senior Vice President, Public Policy and Government 
  Relations, Infectious Diseases Society of America..............    59
    Prepared statement...........................................    62
Amy J. Mathers, M.D., Associate Director of Clinical Microbiology 
  and Associate Professor of Medicine and Pathology, University 
  of Virginia School of Medicine.................................    79
    Prepared statement...........................................    81

 
  ANTIMICROBIAL RESISTANCE: EXAMINING AN EMERGING PUBLIC HEALTH THREAT

                              ----------                              


                         FRIDAY, APRIL 28, 2023

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:00 a.m. in the 
John D. Dingell Room 2123, Rayburn House Office Building, Hon. 
H. Morgan Griffith (chairman of the subcommittee) presiding.
    Members present: Representatives Griffith, Burgess, 
Guthrie, Palmer, Lesko, Armstrong, Cammack, Rodgers (ex 
officio), Castor (subcommittee ranking member), Schakowsky, 
Tonko, Ruiz, and Pallone (ex officio).
    Also present: Representative Carter.
    Staff present: Kate Arey, Digital Director; Sean Brebbia, 
Chief Counsel, Oversight and Investigations; Lauren Eriksen, 
Clerk, Oversight and Investigations; Tara Hupman, Chief 
Counsel; Peter Kielty, General Counsel; Emily King, Member 
Services Director; Chris Krepich, Press Secretary; Karli 
Plucker, Director of Operations (shared staff); Gavin Proffitt, 
Professional Staff Member, Oversight and Investigations; John 
Strom, Counsel, Oversight and Investigations; Joanne Thomas, 
Counsel, Oversight and Investigations; Dray Thorne, Director of 
Information Technology; Austin Flack, Minority Junior 
Professional Staff Member; Waverly Gordon, Minority Deputy 
Staff Director and General Counsel; Tiffany Guarascio, Minority 
Staff Director; Liz Johns, Minority GAO Detailee; Will 
McAuliffe, Minority Chief Counsel, Oversight and 
Investigations; Christina Parisi, Minority Professional Staff 
Member; Harry Samuels, Minority Oversight Counsel; and Caroline 
Wood, Minority Research Analyst.
    Mr. Griffith. The Subcommittee on Oversight and 
Investigations will now come to order.
    Housekeeping detail first. We expect votes to be called at 
10:00. In an attempt to accommodate everybody's schedule, what 
we are going to do is we are going to have rolling votes. It is 
a single vote, so people can leave and then come back. But we 
will continue the questioning so that we can move this process 
along without folks having to have a half-an-hour or 45-minute 
break in the process.
    All right. That being said, I now recognize myself for a 5-
minute opening statement.

OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE 
         IN CONGRESS FROM THE COMMONWEALTH OF VIRGINIA

    Welcome to what I hope will be a productive fact-finding 
hearing on a subject I have long been interested in: 
antimicrobial resistance, or AMR.
    We heard in yesterday's hearing that the risk of a pathogen 
escaping from a lab and causing a pandemic is very real. Just 
as real is the threat posed by an antimicrobial-resistant 
pathogens.
    Prior to the discovery of penicillin, significant research 
was being done on bacteriophage, or phage therapy. Phage 
therapy is where we search for a virus to attack harmful 
bacteria. Ever since the discovery of penicillin, antibiotics 
have been developed to treat previously untreatable infections. 
And they truly are lifesavers. But unfortunately, as the 
development of antibiotics took off, attention to phage therapy 
fell to the wayside.
    Recently, the CDC and NIH are studying and doing more 
research into phage therapy, but more is needed. The problem 
is, over time, pathogens become resistant to the commonly used 
classes of antibiotics. Accordingly, if a new way to kill the 
pathogen is not found, the patient is defenseless to the 
disease caused by the pathogens. As it stands right now, 
antibiotic-resistant infections can be extremely difficult to 
treat. AMR is often referred to as the silent pandemic and has 
become one of the biggest medical concerns today.
    The pipeline for AMR drugs has slowly been drying up due to 
various reasons that deserve our attention and which we hope to 
highlight today. Despite the increased demand, there has been a 
significant reduction in investment and development of new 
antimicrobials. According to data, since 1990, 78 percent of 
major drug companies have cut or scaled back antibiotic 
research due to developmental challenges.
    According to the Centers for Disease Control and 
Prevention, at least 2.8 million people--that is right, 2.8 
million people--are infected with antibiotic-resistant bacteria 
in the United States each year, and more than 35,000 people 
will die as a result of such infection.
    The rise of drug-resistant infections places a heavy burden 
on our Nation's healthcare system. The CDC suggests that 
approximately 30 percent of all antibiotics prescribed in the 
U.S. are for infections that do not necessarily require 
antibiotics, which amounts to about 47 million antibiotic 
courses prescribed in these settings each year. That said, 
often what happens is individual doctors, faced with perplexing 
symptoms while trying to save their patients, will 
understandably turn to antibiotics.
    AMR is not just an issue that arises in a hospital or a 
healthcare setting. Antibiotic usage in humans and animals all 
have the possibility of developing antimicrobials with 
expanding resistance. And it is a problem that sometimes we 
don't understand everything that nature is doing.
    I have recently met with a veterinarian and a professor 
from Virginia Tech, which is in my district, about her work in 
southern Africa. While there she came across abandoned mongoose 
who had an antimicrobial resistant to antibiotics that she had 
never seen before. This shows that the antibiotic antimicrobial 
resistance can appear anywhere and everywhere.
    I look forward to hearing from our witnesses about 
potential innovative solutions like phage therapy. I expect we 
will also hear today from the GAO about deficiencies at the 
Department of Health and Human Services, the agency with the 
most responsibility for tackling the AMR problem.
    One issue that I hope we can shine a light on and bring 
more oversight into is the number of Federal programs and 
initiatives the Government currently has to address 
antimicrobial resistance. While I am pleased to see we are 
addressing this silent pandemic, it is Congress' duty to 
provide oversight into how dollars are being spent. Have the 
various programs found any success yet? And which of these 
programs are duplicative?
    As we consider potential solutions to confront these 
antimicrobials, we must consider the work that is already being 
done and the dollars already being spent to combat this crisis 
and look for ways that will yield more successful outcomes 
fighting these superbugs. While there is no easy solution to 
the problem of AMR, we are committed to exploring potential 
solutions to address this public health crisis.
    I want to emphasize and be clear that this hearing is not 
about taking a position on any legislation introduced. But 
rather, as this committee usually does, it is to gather 
information and to find out the facts. Our goal today is to 
examine the AMR problem, assess the role of the Federal 
Government, and explore potential solutions. I look forward to 
hearing and learning from our great witnesses who are here with 
us today.
    [The prepared statement of Mr. Griffith follows:]

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    Mr. Griffith. With that, I yield back and now recognize Ms. 
Castor, the ranking member of the subcommittee, for her 5 
minutes for an opening statement.

  OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF FLORIDA

    Ms. Castor. Well, good morning, and thank you, Mr. 
Chairman, for holding this important hearing on the urgent 
public health issue of antimicrobial resistance.
    If we have learned anything from the COVID-19 pandemic, it 
is that we must dedicate sufficient resources to prepare for 
the public health threats that we know of, while also working 
to prepare for the new and emerging threats. CDC's 2019 Threat 
Assessment Report identified 18 bacteria and fungi that are 
showing evidence of resistance to currently available 
treatments, and that trend is expected to rise.
    The U.S. Government has been aware of this threat for some 
time and has taken steps to address it. In 2015, for example, 
President Obama, the Federal Government--in accordance with an 
Executive order issued by President Obama, the Federal 
Government released a National Action Plan for combating 
antibiotic-resistant bacteria that outlined the framework for 
the Federal response to this growing health threat.
    While we have made some strides in preventing and treating 
antibiotic resistance, there is ground to regain as we emerge 
from 3 years of a pandemic that put unprecedented strains on 
the entire healthcare system and rolled back some of that 
progress. The effort to combat antibiotic resistance requires a 
strong, coordinated response involving both private- and 
public-sector stakeholders to advance new technologies, 
effectively collect data on incidents of antibiotic-resistant 
infections, and make resources available for hospitals and 
providers to practice sound antibiotic stewardship. We have got 
to foster scientific research on new treatments and therapies 
and implement prevention measures.
    At yesterday's hearing, some Republicans on the 
subcommittee expressed real skepticism about the value of 
pandemic research. Today we are hearing all about the 
importance of addressing antimicrobial resistance, which will 
require a strong, supported medical and scientific workforce. 
While the tones of these back-to-back hearings are certainly 
intentioned, I hope we can come out of them with a better 
appreciation for the work of our scientific community.
    Let me make an obvious but important point here. While 
there are many fronts on which to have--we--on which we have to 
fight these serious threats, we make no progress without 
consistent investment in scientific research. If the 
Republicans proceed with appropriations in accordance with the 
Default on America Act that they passed this week, scientific 
research will suffer greatly.
    We need scientists to study these threats to help us 
prepare against them, and they should be able to do so free of 
political interference designed to malign or ban certain types 
of public health research. Our important oversight 
responsibilities include pressing for improvements across the 
scientific and research enterprise, and in doing so to build 
trust and confidence in the agencies that are at the forefront 
of a national response, like the CDC and the NIH.
    I am pleased that the GAO is testifying today on its 
thorough report that was coincidentally completed right at the 
start of the COVID-19 pandemic. It is an excellent resource to 
build from as we enter pandemic recovery and turn our attention 
to the broader array of public health threats--hopefully, with 
a new appreciation for the importance of preparedness.
    I would also like to thank our other witnesses for being 
here to share your expertise on the several different angles of 
this complex issue. Antimicrobial resistance is a problem for 
patients, for healthcare professionals, and researchers across 
the healthcare system. And it is also important to emphasize 
that there are environmental and agricultural aspects 
contributing to the rise in resistance that we have to address, 
as well.
    A multipronged issue requires a multiprong solution, so I 
look forward to the discussion today and coming out of this 
hearing with a deeper understanding of the nature and scope of 
the threat of antimicrobial resistance so we can make more 
informed policy decisions to help combat it.
    [The prepared statement of Ms. Castor follows:]

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    Ms. Castor. Thank you again, Mr. Chairman, for holding this 
important hearing, and I yield back.
    Mr. Griffith. I thank the gentlelady for yielding back. I 
now recognize the Chair of the full committee, Mrs. McMorris 
Rodgers, for her 5-minute opening statement.

      OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A 
    REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON

    Mrs. Rodgers. Thank you, Chair Griffith, for convening this 
hearing about the growing threat of antimicrobial resistance, 
or AMR, facing our Nation and, indeed, the world. And thank you 
to our panel of witnesses here today.
    More than 2.8 million antibiotic-resistant infections occur 
in the United States each year, resulting in more than 35,000 
deaths. In 2019 an estimated 1.3 million deaths globally were a 
direct result of drug resistance. AMR is a very real threat.
    In recent days we have had eyedrop recalls due to 
contamination by an extensively drug-resistant strain of 
bacteria that has led to multiple deaths and loss of vision 
among patients in 16 States. This outbreak strain has never 
been reported in the United States prior to this outbreak. And 
just this week, a hospital in downtown Seattle announced an 
outbreak of antibiotic-resistant bacteria often found in 
healthcare settings which infected 31 people, 4 of whom have 
died.
    This morning we seek to gain a better understanding of AMR, 
examine current efforts to address this ongoing public health 
threat, and explore innovative paths forward. Antibiotics are 
powerful, lifesaving drugs. Their discovery truly 
revolutionized modern medicine. In addition to their use to 
protect human lives, they are used in veterinarian care to 
treat animals and keep our food supply safe from harmful 
pathogens.
    Globally and in the U.S., antimicrobials, particularly 
antifungals, are a relatively inexpensive way to control plant 
diseases and protect agricultural crops. Over time, however, 
through natural adaptation and use, microbes can develop into 
superbugs, making drugs ineffective against them. AMR is a 
complex web that can develop and spread through a variety of 
settings, including healthcare facilities, food production, the 
community, and the environment.
    There is a need to learn more about AMR, its underlying 
causes, and innovative solutions to address this threat. We 
also must examine and understand the already existing efforts 
and initiatives underway, and assess how these programs are 
operating, including any successes and shortcomings.
    In 2016, Congress appropriated an unprecedented 160 million 
of new investments for CDC to fight AMR. By fiscal year 2022, 
this appropriation had increased to more than 182 million. We 
are working to understand how this funding has been used, what 
initiatives CDC is undertaking, and how effective they have 
been.
    In addition to CDC funding, there are a countless number of 
HHS interagency efforts focused on AMR, including the creation 
of numerous Federal task force and committees such as the 
Presidential Advisory Council on Combating Antibiotic Resistant 
Bacteria and the Combating Antibiotic Resistance Bacteria Task 
Force, as well as an array of national plans, strategies, 
directives, data bases, and monitoring systems, guidance 
documents, toolkits, and guides.
    And these efforts are not restricted to HHS. According to 
the Congressional Research Service, the USDA, DoD, State 
Department, EPA, USAID, VA, and Interior each have their own 
individual existing initiatives and programs. Several 
subagencies within these agencies also have separate programs. 
HHS has at least eight subagencies with individual initiatives.
    The fact that AMR continues to be a growing threat and a 
health burden despite this heavy investment of resources is 
alarming. And I am hopeful our witnesses here today will be 
able to provide greater insight into why this is the case and 
how we can improve our ongoing efforts to address this problem.
    Thank you to the Ranking Member Pallone, my colleagues 
across the aisle. Thank you to the chairman and the ranking 
member for working together on this. I look forward to today's 
hearing as we continue to explore the increasing burden and 
threat of AMR facing our Nation and world.
    [The prepared statement of Mrs. Rodgers follows:]

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    Mrs. Rodgers. Thank you. I yield back.
    Mr. Griffith. I thank the gentlelady for yielding back. I 
now recognize Mr. Pallone, the ranking member of the full 
committee, for his 5-minute opening statement.

OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Mr. Chairman, and thank you to our 
witnesses for helping us better understand the serious threat 
that antimicrobial resistance poses to public health.
    Antimicrobial resistance is not a new phenomenon. It has 
been vexing scientists and Congress for years. However, it has 
been increasing across the board and poses major health risks 
to the public. According to the Centers for Disease Control and 
Prevention, more than 2.8 Americans had an antimicrobial-
resistant infection in 2019 and more than 35,000 Americans died 
from the infection, and these numbers are expected to grow as 
more and more dangerous organisms develop a resistance to the 
treatments available today. And that is a deeply concerning 
risk to our public health.
    There does not seem to be one obvious solution to this 
issue. It cuts across the board from how we identify new drug-
resistant threats to how we administer available drugs while 
also fostering the development of new treatments. Physicians 
face a challenging balance between withholding certain 
antibiotics from patients in order to avoid unintentionally 
promoting more resistant strains of bacteria and providing 
their patients with the best treatment available.
    In terms of developing new treatments, normal market forces 
do not always encourage the development of new drugs in this 
space. We want antibiotics to be developed that are more 
powerful for those that really need them, but we want to use 
them as little as possible. And this is a challenge that is 
repeatedly addressed in our witnesses' testimony, and I look 
forward to all of your perspectives on how we might navigate 
this dilemma.
    To address these challenges, we must continue to support 
our health agencies and public health infrastructure. Our 
health agencies in particular will play a central role in 
identifying and addressing antimicrobial resistance. The CDC 
will increasingly be responsible for identifying and monitoring 
new threats resulting from antimicrobial resistance.
    The Food and Drug Administration plays a role in reviewing 
and approving new diagnostic and pharmaceutical tools to stay 
ahead of the threat.
    And the National Institutes of Health will need to continue 
to support good research into the risks that are posed and how 
we combat those risks.
    We also need to ensure that our health and research 
workforce are strong enough to address these challenges. From 
physicians and nurses to microbiologists, the whole spectrum of 
the health workforce has a role to play here, and we need to 
make sure that our health centers and research labs are 
equipped.
    While the threat of antimicrobial resistance is 
increasingly on the radar for the general public, it presents a 
constant threat for some individuals with certain health 
conditions, such as cystic fibrosis, who--they rely on 
antibiotics to prevent and treat ongoing risks of infection. 
And the patients know all too well the serious threat that 
antibiotic resistance bacteria can pose to your health if you 
have cystic fibrosis.
    So the public health challenges posed by antimicrobial 
resistance are serious, and they are growing. I thank the 
chairman for holding this hearing and look forward to the 
discussion with our witnesses this morning.
    [The prepared statement of Mr. Pallone follows:]

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    Mr. Pallone. Thank you again, and I yield back, Mr. 
Chairman.
    Mr. Griffith. I thank you for yielding back. And that 
concludes Members' opening statements.
    I would remind all Members that, pursuant to the committee 
rules, the Members' opening statements will be made a part of 
the record.
    I want to thank our witnesses for being here today and 
taking the time to testify before our subcommittee.
    Each witness will have the opportunity to give an opening 
statement, followed by a round of questions from Members.
    Our witnesses today are Mary Denigan-Macauley, Director of 
Health Care, U.S. Government Accountability Office; Kevin 
Outterson, professor of law and executive director of CARB-X, 
Boston University; Amanda Jezek--I hope I said that right--
senior vice president, Infectious Disease Society of America; 
Amy Mathers, associate professor of medicine and pathology, 
University of Virginia School of Medicine.
    We appreciate all of you being here today, and I look 
forward to hearing from you on this important issue.
    You all are aware that the committee is holding this 
oversight hearing, and when we hold oversight hearings we have 
the practice of taking testimony under oath. Do any of you have 
an objection to testifying under oath?
    Seeing no objections, we will proceed.
    You are also advised that you have the right to have 
counsel present, should you wish to do so pursuant to House 
rules. Do any of you desire to be advised by counsel during 
your testimony today?
    Seeing that none require, would you all please rise and 
raise your right hand?
    [Witnesses sworn.]
    Mr. Griffith. Seeing all witnesses answered in the 
affirmative, you are now sworn in and under oath, subject to 
penalties set forth in title 18, section 1001 of the United 
States Code.
    You may be seated. With that we will now recognize Mary 
Denigan-Macauley for her 5-minute opening statement.

 STATEMENTS OF MARY DENIGAN-MACAULEY, Ph.D., DIRECTOR, HEALTH 
CARE, GOVERNMENT ACCOUNTABILITY OFFICE; KEVIN OUTTERSON, AUSTIN 
  B. FLETCHER PROFESSOR, BOSTON UNIVERSITY SCHOOL OF LAW, AND 
     EXECUTIVE DIRECTOR, CARB-X; AMANDA JEZEK, SENIOR VICE 
 PRESIDENT, PUBLIC POLICY AND GOVERNMENT RELATIONS, INFECTIOUS 
    DISEASES SOCIETY OF AMERICA; AND AMY J. MATHERS, M.D., 
   ASSOCIATE DIRECTOR OF CLINICAL MICROBIOLOGY AND ASSOCIATE 
  PROFESSOR OF MEDICINE AND PATHOLOGY, UNIVERSITY OF VIRGINIA 
                       SCHOOL OF MEDICINE

           STATEMENT OF MARY DENIGAN-MACAULEY, Ph.D.

    Dr. Denigan-Macauley. Thank you very much. Chairs Griffith, 
Rodgers, and Ranking Members Castor and Pallone, and members of 
the subcommittee, thank you for the opportunity to discuss 
GAO's work on antibiotic resistance.
    As we address the COVID-19 pandemic, another pandemic has 
been quietly brewing. Not one from a single disease, but rather 
one of resistance. Since the discovery of penicillin less than 
100 years ago, many lifesaving antibiotics have been developed 
and become essential to the practice of modern medicine. 
However, the rising prevalence of antibiotic resistance 
threatens these gains.
    Today, many of infections have become more difficult, if 
not impossible, to treat because of an increasing number of 
microbes that have developed resistance to most or, in some 
cases, all currently available antibiotics. According to the 
WHO, if nothing changes by 2050, 10 million people are expected 
to die from drug-resistant diseases--infections every year. 
Resistance can also complicate the response to a public health 
emergency, with secondary infections exasperating a crisis. The 
CDC and WHO consider antibiotic resistance to be one of the 
greatest public health threats of our time.
    The solution to resistance is not simple. It is a complex 
issue involving the movement of not only bacteria, but fungi, 
viruses, and other microbes between humans, animals, and our 
environment. Today I will focus my statement on GAO's most 
recent work related to Federal efforts, human health, and 
antibiotics. While many Federal efforts are underway, I would 
like to focus on four key areas where we believe more can be 
done.
    First, the precise magnitude of this problem is not known. 
While we have estimates that antimicrobial resistance has 
killed more than a million people worldwide and infected many 
more, the true extent of the problem is not known because data 
here in the U.S. and overseas is not complete or timely.
    Second, there are limitations with tests for diagnosing 
antibiotic-resistant infection. Rapid and accurate diagnostic 
tests help doctors identify cases of resistant infections and 
help them to know which antibiotic to prescribe. However, more 
studies are needed to develop tests and demonstrate their 
benefits to encourage their use.
    Further, because bacteria are always changing, their 
resistance to antibiotics also changes. Therefore, it is 
important to monitor tests and update them to ensure that they 
can accurately detect these resistant infections.
    Third, according to experts, the pipeline of antibiotics in 
development is insufficient to tackle this growing threat, 
notably because of the inadequate return on investment for drug 
companies. This is concerning because we reported in 2020 that 
no new classes of antibiotics approved for human use had been 
approved since the mid-1980s, despite Government incentives. 
Experts believe there may be potential for other incentives, 
particularly those that would help newly developed drugs remain 
on the market to reduce costs and potentially save lives. Some 
experts also believe that nontraditional therapies such as 
phage are promising.
    Finally, more is needed to monitor and promote the 
appropriate use of antibiotics. The WHO has warned that the 
world urgently needs to change the way antibiotics are 
prescribed and how they are used in order to preserve their 
effectiveness and help slow the development of resistance. 
However, Federal efforts to promote appropriate use are 
limited. For example, reporting on antibiotic use has, to date, 
only been required for VA and DoD healthcare facilities. 
Greater reporting and monitoring are critical, because behavior 
can be challenging to change. For example, a doctor may feel 
pressured to prescribe antibiotics to satisfy a patient's 
demand, even when it is not warranted, such as for a viral 
respiratory infection which we know the antibiotic will not 
work.
    As we emerge from COVID-19, while it is fresh on our minds 
and before a new crisis emerges, I wanted to share some 
parallels with antimicrobial resistance that may help us 
understand the importance of preparedness for a public health 
threat. For example, both are complex global issues exacerbated 
by supply disruptions and poor hygiene and a lack of medical 
countermeasures.
    Better data and diagnostic tools are needed to understand 
the magnitude and monitor progress. Public-private 
partnerships, investments, and innovation drive solutions. 
Clear communication and education are key. And finally, action 
saves lives now and for our future generations.
    Chairmans and ranking members, this concludes my prepared 
statement. I look forward to our discussion today on this 
important issue.
    [The prepared statement of Dr. Denigan-Macauley follows:]

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    Mr. Griffith. Thank you so much.
    Mr. Outterson, you are now recognized for your 5 minutes.

                  STATEMENT OF KEVIN OUTTERSON

    Mr. Outterson. To the Chairs Griffith and Rodgers, and to 
the Ranking Members Castor and Pallone, and the other members 
of this committee--subcommittee, good morning. I am Kevin 
Outterson, professor of law at Boston University. I am also the 
executive director of CARB-X, which is the global nonprofit 
accelerator for antibacterial innovation created under the U.S. 
National Action Plan by BARDA. I have spent most of my academic 
career in the topics we are discussing today, and thank you for 
the opportunity to speak with you at the hearing.
    Americans rely on effective antibiotics and antifungals. 
Every hospital in your district, every cancer patient, every 
new mom that gets a C-section, and even people my age who are 
thinking about hip or knee replacement, all of us depend on 
antibacterials and antifungals in order to enable modern 
medicine. But resistance is eating away at this miracle just 
like rust eats away at a bridge.
    Antibiotics are valuable, but this market is really broken. 
FDA approval should be a celebration, but for new antibiotics, 
the payday and the celebration never comes. Because of 
resistance, doctors are doing the right thing by being careful 
with the newest antibiotics. They put them on the shelf behind 
glass like a fire extinguisher.
    And let me tell you, the fire extinguisher company gets 
paid at the moment that that fire extinguisher hangs on the 
wall. You get paid at the moment the preparedness starts, not 
when the fire starts. But for antibiotics, we are paying for 
them only after the fire starts. A new drug that isn't used 
much in the early years cannot make money. In the last decade, 
seven antibiotics have come to the market sponsored by small 
companies. Seven. All of those companies, 100 percent of them, 
have gone either bankrupt, or the economic equivalent of their 
R&D investors losing their shirts, even after approval from the 
FDA.
    No wonder that every expert report agrees that the clinical 
pipeline of antibiotics is in terrible shape. There's a couple 
dozen antibiotics in the clinical pipeline being tested in 
humans, more than a thousand for cancer. Cancer drugs make 
money, so future cures are always moving towards the patient. 
Antibiotics lose money, with a predictable result in 
innovation.
    Now is a great time to respond to this national security 
crisis. We must change the way we pay for antibiotics. After 
more than a decade of studying this problem, G7 governments, 
the wealthy governments of the world, are creating antibiotic 
pull incentives to reward innovation while allowing the 
antibiotic to be used carefully. If Congress creates a 
subscription program, Americans will get the new antibiotics we 
need. They will be sitting on the shelf, ready to go like that 
fire extinguisher, but the companies will also get what they 
need, which is not bankruptcy.
    Antibiotic subscriptions should be carefully crafted to 
ensure that taxpayers get a good deal. They must focus only on 
the most promising new drugs. The required size of these 
antibiotic subscriptions is well understood, as well as the 
fair share that other wealthy countries should pay. 
Subscription payments can start at an appropriate point and 
increase over time if stronger evidence is presented on the 
importance of the new drug.
    Subscriptions will be remarkably good value for the U.S. 
taxpayer. The Centers for Global Development forecast a 
financial return on investment for Americans of six to one over 
a decade. From recent data that I published in the Nature 
journal, we know that a U.S. subscription would cost less than 
what we spend on patent antibiotics just a few years ago. This 
is affordable to do what we need to do, because we did it 
ourselves 5 to 10 years ago. It is time to invest in the future 
of antibiotics again.
    By restoring some common sense to the market for 
antibiotics, subscriptions will bend the curve towards 
innovation. Globally, the health impact of a subscription 
program is remarkable: 9.9 million lives will be saved over the 
next 10--next 2 decades, an amazing legacy.
    Now, I know all of this not just because of academic work 
or the work of other experts. I know it because, in a sense, I 
have seen the future. At CARB-X we see the most promising 
antibiotic candidates 10 to 15 years before potential FDA 
approval. Let me tell you, that future is bright so long as you 
continue to support push incentives like CARB-X and BARDA and 
complement them with a new pull incentive like the antibiotic 
subscription. And I know it is not a legislative hearing, but 
the example would be the PASTEUR Act.
    At CARB-X, we mainly work with very small startup companies 
with highly innovative new products, including three phages, 
minidiagnostics, microbiome, vaccines, and many first-in-class 
products. A dozen of these CARB-X companies have initiated 
first-in-human testing, which is really the measure of our 
success. Push incentives like CARB-X are working, but these 
companies need a future other than bankruptcy. A program--a 
subscription program will finish the job.
    Threats to bacteria and fungi are bad today and will be 
worse tomorrow. If you want a steady stream of lifesaving 
innovation, let's do something about it. And I think the path 
is clear.
    Thank you for your time. I look forward to your questions.
    [The prepared statement of Mr. Outterson follows:]

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    Mr. Griffith. I thank the gentleman. I now recognize Ms. 
Jezek for her 5-minute opening statement.
    Ms. Jezek. Chairs Griffith and McMorris Rodgers, Ranking 
Member [audio malfunction] inviting me to testify on behalf of 
the Infectious Diseases Society of America. IDSA represents 
over 12,000 infectious diseases physicians and other health 
professionals specializing in ID.
    Our members are seeing more patients with resistance, 
sometimes impossible-to-treat infections----
    Mr. Griffith. Yes, is your mike functioning? Is the light 
on?
    Ms. Jezek. Yes, it's on.
    Mr. Griffith. Can you pull it up, get a little closer to 
it?
    Ms. Jezek. Sorry.
    Mr. Griffith. That is all right.
    Ms. Jezek. Our members are seeing more patients with----
    Mr. Griffith. Yes, I don't think it is working. Hang on.
    Ms. Jezek. It is lit up.
    Mr. Griffith. There you go, that worked.
    Ms. Jezek. Do you want me to start it again?
    Mr. Griffith. Yes, I think it is probably good if you start 
again, so we get it all recorded so that, when they replay it, 
people can hear at home.
    Ms. Jezek. That is a good idea.
    [Pause.]
    Ms. Castor. I think you need to switch.
    Mr. Griffith. Yes. Let's see if we can switch mikes for 
you. We will get you our highly skilled technical team down 
there.
    [Laughter.]
    Mr. Griffith. Or just slide the other mike over. All right, 
go ahead.
    Ms. Jezek. OK, take three.

                   STATEMENT OF AMANDA JEZEK

    Ms. Jezek. Chairs Griffith and McMorris Rodgers, Ranking 
Members Castor and Pallone, distinguished subcommittee members, 
thank you for holding this hearing on antimicrobial resistance 
and for inviting me to testify on behalf of the Infectious 
Diseases Society of America.
    IDSA represents over 12,000 infectious diseases physicians 
and other health professionals specializing in ID.
    Our members are seeing more and more patients with 
resistant, sometimes impossible-to-treat infections, such as 
the report earlier this week of an ongoing outbreak of 
Klebsiella bacteria at a Washington State hospital that has 
impacted dozens and resulted in four deaths. Today I will 
describe AMR challenges and one health policy opportunity to 
ensure we have the tools to combat AMR, including novel 
antimicrobials, stewardship programs, and an expert workforce.
    Antimicrobial resistance is pathogens' ability to resist 
to--to evolve to resist antimicrobial drugs. When resistant--
while resistance does occur in nature, antimicrobial misuse 
speeds up resistance. Antimicrobials are unlike any other 
therapeutics, in that use in one individual can impact efficacy 
in the rest of the population. In 2019 an estimated 1.27 
million deaths worldwide were directly caused by AMR, and AMR 
played a part in nearly 5 million deaths.
    Antimicrobials enable modern medicine, because so many of 
our medical advances--cancer chemotherapy, organ 
transplantation, hip and knee replacement, C-sections, wound 
and burn treatments--all carry a risk of infection.
    The opioid epidemic is also fueling the spread of resistant 
infections. CDC estimates that individuals who inject drugs are 
16 times more likely to develop a MRSA infection.
    AMR is even impacting healthy individuals in the community. 
For example, an ongoing outbreak of drug-resistant eye 
infections due to contaminated eyedrops has caused blindness 
and even death in several patients.
    AMR disproportionately impacts historically marginalized 
populations, exacerbating health inequities.
    National healthcare costs linked to infections of just 6 of 
the biggest AMR threats are estimated to be more than $4.6 
billion annually, with $1.9 billion of those costs estimated to 
be borne by Medicare.
    AMR was further exacerbated by COVID-19. In 2020 U.S. 
hospitals experienced a 15 percent increase in AMR infections 
and deaths. Emergencies like outbreaks, pandemics, and even 
hurricanes and bioterror attacks all create ripe opportunities 
for the spread of secondary drug-resistant infections.
    The current antimicrobial pipeline is insufficient. 
Antimicrobials must be used judiciously to limit the 
development of resistance, which thus limits the ability to 
earn a return on investment for antimicrobial R&D. This broken 
market has resulted in large companies leaving the market, has 
forced small companies who have developed new antimicrobials 
into bankruptcy, and has prevented promising drugs from getting 
to patients.
    In addition, we must ensure the optimal use of 
antimicrobials. In 2020 about 80 percent of patients 
hospitalized with COVID received antibiotics, despite that 
COVID is caused by a virus. Even before the pandemic, about 
half of all hospitalized patients were prescribed antibiotics, 
with up to 50 percent of those prescriptions being estimated as 
inappropriate or unnecessary.
    Antimicrobial stewardship programs aim to ensure that 
patients receive the right drug for the right bug. They improve 
patient outcomes, while also reducing inappropriate antibiotic 
use and lowering healthcare costs. While many hospitals can 
meet CMS stewardship requirements on paper, they often lack the 
resources and staff necessary to extend the benefits of 
stewardship to all patients.
    The infectious diseases workforce that is needed to care 
for patients with resistant infections is in crisis. Nearly 80 
percent of U.S. counties lack an ID physician. Only 56 percent 
of ID physician training programs filled in 2023. Financial 
barriers pose huge challenges to ID recruitment. ID physicians 
are among the lowest-paid medical specialists, and high levels 
of medical student debt often drive physicians to higher-paying 
specialties.
    Congress must take steps to ensure the availability of an 
expert ID workforce to combat AMR by addressing medical student 
debt, improving ID physician reimbursement, and providing 
sufficient resources for training and early development.
    Congress can also revitalize antimicrobial innovation by 
paying for the value of antimicrobial drugs instead of volume 
under a subscription model approach, like the bipartisan 
PASTEUR Act, which would also support antimicrobial stewardship 
programs.
    Nontraditional therapies such as phages may also have a 
very useful role in treating resistant infections, and 
additional research should be pursued to inform optimal 
clinical use of phage therapy.
    IDSA is deeply grateful for this committee's history of 
leadership on AMR, and we look forward to working with you to 
address persistent needs. Thank you.
    [The prepared statement of Ms. Jezek follows:]

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    Mr. Griffith. I thank you very much. We are going to take a 
brief timeout to change mikes for you, so that maybe yours will 
work next time. Apparently, we had an infected cable.
    [Laughter.]
    Ms. Jezek. It is OK. ID people are used to dealing with the 
unexpected.
    [Pause.]
    Mr. Griffith. All right, stand by, guys. Make sure that Dr. 
Mathers' mike works. Oh, yes, sounds good.
    [Pause.]
    Mr. Griffith. All right, let's go ahead and finish our 
opening statements. If you all need more time to work on that, 
then we can do that after.
    All right, thank you.
    Dr. Mathers, you are now recognized for your 5-minute 
opening statement.

               STATEMENT OF AMY J. MATHERS, M.D.

    Dr. Mathers. Chairman Griffith, Ranking Member Castor, and 
distinguished members of the subcommittee, thank you for 
holding a hearing on AMR and inviting me to testify. I am the 
clinical director of antimicrobial stewardship and associate 
director of clinical microbiology at the University of 
Virginia.
    I am here today representing the American Society of 
Microbiology, ASM. With 30,000 members, it is one of the 
largest life science societies. Addressing antimicrobial 
resistance through science, clinical practice, global health 
programs, and policy is a top priority for ASM as well as 
myself.
    As an infectious disease physician who sees hospitalized 
patients with serious infections, I am motivated by the harm 
AMR has had on many of the patients I care for. This hearing is 
very timely, as I am seeing firsthand several types of AMR 
bacteria and fungi that are emerging and reemerging in the wake 
of the public health emergency. In my clinical practice, 
through antimicrobial stewardship, I work with other 
physicians, pharmacists, and hospital leadership to minimize 
the selection pressure from antimicrobial overuse.
    I am also a scientist. My expertise is in detecting and 
tracking AMR, and my research works to understand where AMR 
pathogens originate and how they spread in even the most 
sterile places like hospitals. My colleagues and I do this 
through collaborating on the following areas: developing novel 
interventions for the hospital environment to prevent 
transmission; developing genomic technologies to better detect 
and understand AMR emergence; utilizing diagnostic tools to 
treat infections and curtail antimicrobial overuse.
    Given AMR is one of the most daunting public health 
challenges facing the U.S. and the world, I believe there are 
four elements that are crucial to addressing AMR.
    First, investments in basic and translational research is 
foundational to addressing AMR, as there are large knowledge 
gaps in our understanding of the emergence and transmission. 
Unlike SARS-CoV-2 sequencing, where variants emerge from a 
single species, AMR genes can move between bacteria and species 
strains, which adds a great deal of complexity.
    AMR develops across a variety of pathogens, as already 
pointed out, and resistance may be exchanged between pathogenic 
and nonpathogenic bacteria. Resistant fungal infections have 
also emerged more recently and pose a serious threat. Perhaps 
the most prominent example of this is the rapid spread of 
Candida auris in healthcare facilities, which is now considered 
an urgent threat, according to CDC.
    Second, improved antimicrobial resistance monitoring and 
reporting, especially with a focus on pathogens in hospitalized 
patients, both in the U.S. and globally, will be critical in 
addressing some of these gaps. Recent congressional funding of 
the Public Health Academic Partnership to adopt novel genomic 
technologies and improved data use through the CDC Pathogen 
Genomics Centers of Excellence Network will be hugely helpful 
if this funding is sustained.
    As an academic partner in the network for Virginia, many of 
our projects focus on developing cutting-edge genomic tools for 
monitoring emerging AMR pathogens in hospitals, as well as 
exploring wastewater potential as a surveillance tool for AMR.
    Third, improved diagnostics is critical in both preventing 
the continued use of antimicrobials--overuse of antimicrobials 
as well as maximizing the treatment of patients with AMR 
infections. For example, I recently had two unique patients 
come to UVA, both with severe bacterial infections requiring 
ICU care. Both were initially prescribed powerful 
antimicrobials while we had to guess at the type of infections 
that each one of them had while waiting for test results. One 
patient was exposed to broad-spectrum antibiotics for almost 
three days before testing showed a more targeted antibiotic 
would have worked. The other patient had a bacteria which was 
highly resistant and did not get effective antimicrobials for 
almost two days. We need investment in research and rapid 
diagnostics and approaches to more quickly reduce antimicrobial 
overuse and target AMR pathogens when needed to treat 
infections.
    Last, another ongoing issue with diagnostics is personnel 
shortages in clinical microbiology laboratories. We need to 
recognize and incentivize people to pursue medical microbiology 
as a career. Adequate personnel will allow for the increased 
adoption of current improved laboratory practices, including 
the use of current susceptibility breakpoints to optimize 
prescribing and detect AMR, testing of newly developed 
antimicrobials, as well as the adoption of newer technologies 
which can streamline prescribing. We need more people 
postpandemic in the clinical micro lab.
    In closing, ASM, I want to thank--in closing, ASM and I 
want to thank you for inviting me to testify at this really 
important hearing on a topic that affects every one of us. ASM 
and its members look forward to working with you and your 
colleagues to advance policies that will enable us to address 
the daunting challenge of AMR head on for the benefit of all 
humankind. Thank you very much.
    [The prepared statement of Dr. Mathers follows:]

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    Mr. Griffith. Thank you. Let me apologize on behalf of the 
committee that, you know, we had our team down there working in 
front of you while you were giving your statement, and at one 
point they actually popped up in front of you. The fact that 
you kept your composure is remarkable, so we appreciate your 
patience.
    That being said, I do appreciate all of your testimony, and 
thank you for being here today and for that testimony. We will 
now move into the question-and-answer section of our hearing, 
and I will begin the questioning by recognizing myself for 5 
minutes.
    Now, you all are the experts. You are probably wondering 
why we finally paid attention to this. And it is not just me, 
but there were others who were interested in this. But I got 
hooked a few years ago when I read ``The Perfect Predator.''
    For those at home that may not understand this, this is a 
great romance story with a medical mystery wrapped all around 
it. It is good stuff.
    [Laughter.]
    Mr. Griffith. Ms. Jezek, in--for those who don't have time 
to read the book or figure it out on their own, could you 
please share with the committee and with those at home what 
phage therapy is and how it could be an effective tool to 
combat AMR, or be an alternative to antibiotics in those cases 
where needed?
    Ms. Jezek. Absolutely. So we think phage therapy actually 
has a great deal of progress--or a great deal of promise, but 
there is not enough known about it.
    So most of the information that we have now about phage 
comes from reports collected through compassionate-use cases. 
And in many of those cases, phage was actually used in addition 
to and in concert with antibiotics for infections that were not 
responding to antibiotics on its own, suggesting that phage 
therapy has sort of an additive effect.
    But what clinicians really want are more robust studies to 
help them understand all the different kinds of indications 
where we could use phage to help us better understand how phage 
resistance can develop, because that happens, as well, and to 
help us understand the optimal dosing and duration of phage 
therapy, so that we can really make sure patients get the 
greatest benefit. It is really an area where more research 
could yield tremendous benefits.
    Mr. Griffith. Well, and in the book that I just referenced, 
Thomas Patterson's life was saved. His wife was a virologist 
who had all kinds of medical folks, and they did use a cocktail 
of antibiotics. In the end, what did it was they found--I think 
it was a Maryland sewage treatment plant--they found a virus 
that attacked the shell of the bacteria that was causing all of 
his health problems--and he was in a coma--and they found a 
bacteria that cracked the shell, but they still needed the 
antibiotic to kill the bacteria off. So you are exactly right.
    So that being said, let me ask you this, because this is 
one of the problems that we have, and I am glad the FDA granted 
them compassionate use in that case. But we are so used to 
having the clinical trials, but so many of these AMRs are one-
offs or very rare. Some of them aren't. We have heard about the 
case in Washington. But clinical trials aren't going to work, 
are they, for a lot of these fixes?
    Ms. Jezek. Well, I think we can get more creative with our 
approaches to clinical trials.
    Mr. Griffith. All right.
    Ms. Jezek. I think for phage, in addition to clinical 
trials, simply having one central database, where anyone who is 
using phage in a compassionate-use setting or any other setting 
can report that data, and making sure that we are reporting not 
only the cases where phage worked, but also the cases----
    Mr. Griffith. Where it didn't work.
    Ms. Jezek [continuing]. Where phage didn't work, because 
sometimes we learn as much from our failures as we do from our 
successes.
    There--I believe there actually is a clinical trial for 
phage therapy that is starting to get up and running. So we are 
hopeful that we will have more information soon.
    On the antibiotic side, yes, clinical trials are difficult, 
there are a lot of enrollment challenges, but they are 
absolutely possible. And in fact, the 21st Century Cures 
legislation included some provisions to streamline and improve 
clinical trial processes. It is really the economic challenges 
that several of us talked about that are the biggest barrier 
right now for antimicrobial R&D.
    Mr. Griffith. And this committee as a whole is very proud 
of the work we did on 21st Century Cures.
    Professor Outterson, you have been wanting to jump in on 
these issues. Jump on in.
    Mr. Outterson. I also wanted to be polite to Amanda Jezek.
    CARB-X supports three phage companies. I think it is the 
most concentrated support anywhere in the world for phage.
    I would say that they are moving into clinical trials, and 
it will be interesting how they interact with the FDA and the 
agencies to make sure that they are well supported in that 
endeavor.
    I would say I know Tom and Stephanie, the authors of this 
book, well. I would encourage you to--maybe to have a hearing 
in which you just hear from patients, because the stories that 
they tell--and people like them--are remarkable.
    Mr. Griffith. We are certainly working to maybe have that 
happen, but this is step one. And obviously, there is more than 
just phage. That is what I am interested in, because of the 
book, but there's a whole lot of things that each of you all 
have touched on.
    Dr. Mathers, did you want to jump in on this? And I 
apologize----
    Dr. Mathers. Sure.
    Mr. Griffith [continuing]. I am not probably going to have 
time to get to you, but somebody will.
    Dr. Mathers. Very, very quickly, I just--I think with your 
question about clinical trials, they are really important. But 
I think the days of, you know, penicillin, finding another 
penicillin or finding another fluoroquinolone, or, you know, a 
kind of magic bullet, if you will, that antibiotics were coming 
from the 1950s through--into the early 1980s, and coming to 
market, those days may not exist. And so we may have to cobble 
together in a different way than our historic clinical trials 
to treat antibiotic resistance and to actually get drugs to 
market.
    Mr. Griffith. And it is important, and I will just make 
this note before I yield back. It is important that we get 
these things to market quickly, particularly when we don't have 
anything else that might work.
    I note that George Orwell died of tuberculosis with 
probably about 6 to 8 months before antibiotics were available 
for him to use.
    But anyway, I yield back and now recognize Ms. Castor for 
her 5 minutes for questioning.
    Ms. Castor. Well, thank you, Mr. Chairman, and thank you 
for providing me a copy of the book. I am going to dig into it 
really soon, and thanks to our witnesses.
    I want to focus on two important factors identified by 
our--the experts here today as being essential parts of the 
approach to AMR diagnostics and surveillance. Arming doctors 
with better diagnostic tools can allow them to provide more 
targeted care to their patients.
    Dr. Mathers, in your testimony you say that diagnostics 
have, quote, ``a central role in preventing, detecting, and 
combating AMR and in practicing antimicrobial stewardship.'' 
What improvements in diagnostic tests are most needed, and how 
would those advancements help doctors provide better care to 
patients with infections?
    Dr. Mathers. Thank you so much for the question. I--you 
know, diagnostics are so critical to preserving antimicrobials. 
And as more antibiotic resistance emerges, we are going to need 
diagnostics to make sure that we target. With these sort of 
niche antibiotics, you don't know what somebody is infected 
with. Current state, when somebody comes in with a serious 
bacterial infection, you do not know what they are infected 
with. We do not have immediate antibiotics. Things that would 
tell us whether or not somebody has a bacterial versus a viral 
infection would be very helpful for doctors in prescribing.
    And then once, you know, you take the blood, let's say they 
have got blood--or a bacteria in their blood, we take their 
blood. Right now sometimes it takes 3 to 4 days before we know 
which bacteria, and what that bacteria is susceptible to so 
that we can really target antibiotics. In that timeframe 
sometimes we have to use multiple antibiotics that the patient 
really doesn't need, when we could be using more targeted 
antibiotics. So the collateral damage of resistance selection 
and overuse is occurring during that time.
    So if we had--if we could move the clock back and have more 
rapid diagnostics, that would be helpful.
    Ms. Castor. So what is your recommendation to Congress to 
move ahead on that?
    Dr. Mathers. So I think there's a couple of different 
things. I think investments--and CARB-X, I know does--also 
looks at diagnostics, but investing in diagnostic technologies, 
and research and development in how we could move the clock 
backwards for diagnostics. Some of this will probably be 
molecular and genomic, and some of it may be taking advantage 
of the fact that the bugs grow so well and cheaply, because we 
want them to be affordable and not break the bank, as well.
    Ms. Castor. Great. And, you know, one of the lessons we 
learned from the fight against COVID-19 was the importance of 
data gathering and surveillance, high-quality data, to 
understand and respond to a public health threat.
    Dr. Denigan-Macauley, GAO found in its 2020 report that CDC 
faces challenges in conducting disease surveillance for 
antibiotic resistance. And they made--you made recommendations 
to improve the collection of public health data from various 
stakeholders. You noted, though, that CDC has made some 
progress on addressing these recommendations, but you are--they 
remain open. How can improving the quality of reporting 
critical information to the CDC improve the U.S. response to 
AMR?
    Dr. Denigan-Macauley. Yes, we reported that the data is 
neither comprehensive or complete, and this is particularly the 
case if you have data that is voluntary. So a lot of the data 
that is coming in is required only for certain organizations--
for example, the VA or DoD--because of the tie, obviously, with 
the Federal Government. So if you have something that is 
optional and you have hospitals that already are taxed and 
short on resources, being able to get that data, even if they 
could do it, to the Federal Government is very challenging.
    And there is some promise out there. It is our 
understanding that there is some legislation that is going to 
come into effect in 2024 with some strings for hospitals to 
improve their data collection, which will definitely help with 
our surveillance activities.
    Ms. Castor. Because I understand across the data-reporting 
enterprise from local communities, States, hospitals, it is 
just so outdated. And we--the Congress provided significant 
funds to help modernize reporting. Not having to do it by fax 
machine would--that is so costly.
    So what is your recommendation for us to continue focusing 
on this, and providing public health interest the ability to 
report in a modern fashion, efficient fashion?
    Dr. Denigan-Macauley. Well, as I mentioned in my oral 
statement, I mean, there are a lot of parallels with what we 
see with antibiotic resistance as we saw with COVID. And so not 
losing the gains that we have--we already lost some of the 
developments that we had with antimicrobial resistance with the 
pandemic, seeing the number of resistant infections going up 
any time you have more people in a hospital, and the strains 
have an opportunity to be able to spread and infections rise--
so making sure that we don't lose the gains that we already 
have.
    Many of our recommendations also went to HHS. They have to 
get a better understanding on how much information is enough to 
know what the magnitude of the problem is and to be able to 
track the progress. And for example, if COVID were to come 
back, it would be disheartening if we weren't able to know when 
are we done, when are we out of this problem. And so we have 
recommendations to HHS, and we urge Congress to not lose the 
gains that we made during COVID.
    Ms. Castor. Thank you.
    Mr. Griffith. The gentlelady yields back. I now recognize 
the chairwoman of the full committee, Mrs. McMorris Rodgers, 
for 5 minutes of questioning.
    Mrs. Rodgers. Thank you, Mr. Chairman. According to the 
Congressional Research Service, there are over 10 task force 
committees and programs across the U.S. Government, including 5 
separate interagency programs that are specific to or include 
antimicrobial resistance and--oh, OK, so that is that. And then 
eight different offices and agencies within Health and Human 
Services: AHRQ, ASPE, ASPR, CDC, CMS, FDA, NIH, and the Office 
of Global Affairs. So each one of these have individual, 
ongoing work on AMR, and this is in addition to the numerous 
multilateral efforts the U.S. is a part of, and 
internationally.
    So I wanted to start with Ms. Denigan-Macauley. Has GAO 
examined to the extent there is coordination and collaboration 
among all these efforts, or at least the sharing of lessons 
learned?
    Dr. Denigan-Macauley. We have. And we are happy to report 
that, because there is a presidential task force and there is a 
coordinating body, there is the task force among the Federal 
Government--and within HHS they are currently leading that--
there is a task force right now that has a rotational 
leadership capacity between USDA, DoD, and HHS, and HHS has the 
lead. Within that they have ASPE, that is helping to 
coordinate.
    So from GAO's standpoint, we always look at leadership. 
Leadership is absolutely paramount, and those coordination--
understanding roles and responsibilities is key, as well. So we 
have looked at that. We did make a recommendation about how to 
better coordinate. In one particular aspect we were talking 
about diagnostic tools and resistant infections and making sure 
that there is not a lot of finger-pointing of who is going to 
take the lead to ensure that we have the studies that are 
needed to show that using diagnostic tests have outcomes--have 
positive health outcomes so that we have judicious use of 
antibiotics.
    Mrs. Rodgers. Thank you. And you referenced this, because I 
was focusing on Health and Human Services and the programs 
there, and then there's seven different USDA offices that have 
AMR programs, and other departments such as DoD, State 
Department, EPA, USAID, VA, and Department of the Interior each 
have their AMR efforts. Would you speak to how well the Federal 
Government is doing with a problem like this, when it is 
assigned to so many departments and agencies?
    Who is responsible for the strategy--which I think you were 
talking to a little bit--who can be held accountable, and how 
can any progress, lessons learned, or successes be shared 
appropriately?
    Dr. Denigan-Macauley. Yes. So as I mentioned before, we do 
have a task force. We do have leadership, which is extremely 
important.
    This is a very complex issue, and we are pleased to see 
also that we are taking a One Health approach. This is not just 
a human problem. This is a problem of agriculture. We give 
drugs to our food animals in a preventative measure. We also 
give drugs to our pets. It happens in the environment, and 
resistance occurs naturally. So that coordination across the 
Government is absolutely key, and the fact that we have task 
forces that are able to do that coordination across the 
Government is very good.
    You had mentioned lessons learned. One of the 
recommendations that we did make was you not only need to 
report on their progress--which, I want to say, they do report 
yearly on the progress to the President that they are making--
but you need to, I think as Dr. Mathers had said, you need to 
also talk about your failures. What can't you do?
    That is where we are having the problems. That is why we 
don't make the progress that we need. We need to own up to that 
and to say, ``Here is what we need.'' And we do see in the 
budgets this year at least there is mention of antimicrobial 
resistance and some need for direction there.
    Mrs. Rodgers. OK. Well, as a followup to that, you--in your 
testimony you discuss how HHS and CDC haven't taken significant 
steps to address information on uncertainties around estimates 
of resistant infections and creating timely, comprehensive 
reports on antibiotic resistance. Would you tell us any--you 
want to elaborate any more on the efforts to achieve those 
recommendations and the consequences of not achieving them?
    Dr. Denigan-Macauley. Yes. So the agencies did agree with 
the recommendations. They are working on them. They understand 
the importance of this. As I mentioned, it is a complex issue. 
It is not only one that impacts the United States, but we are 
global, right? We travel. The COVID showed us that, the COVID-
19 pandemic.
    More is needed, though. As I mentioned, the CMS rule is 
promising. Having hospitals require reporting is quite 
important, but we also don't have a good understanding of what 
is happening in our community. And we had mentioned the fact 
that we had problems--COVID complicated the number of resistant 
infections. But if you recall, a lot of people weren't even 
going to the doctor.
    Mrs. Rodgers. OK.
    Dr. Denigan-Macauley. We don't know that----
    Mrs. Rodgers. I am out--I appreciate that. There is more.
    I just want to highlight that there's always fiscal 
concerns, and programs always request more funding. The 2020 
report outlines certain funding provided. BARDA has awarded 959 
million in grants, agreements, contracts to developers of 
antibiotic drugs since 2010. CARB-X funded 47 programs, costing 
up to 133 million. I recently sent a letter to NIH regarding 
the $1 billion they have spent on public relations and 
communications--$1 billion. Perhaps NIH could do a better job 
of allotting funding that is already--should be put towards 
fighting this AMR program--or problem.
    Yes, I yield back.
    Mrs. Lesko [presiding]. Thank you. And now I recognize the 
ranking member of the full committee, Mr. Pallone.
    Mr. Pallone. Thank you. Democrats on this committee have 
long prioritized a holistic approach to public health 
preparedness and response. And over the past 2 years in 
particular, we have taken steps to foster a resilient public 
health workforce, protect disproportionately impacted 
communities, and empower researchers to understand how 
infectious diseases begin and spread. And public health 
preparedness requires that Congress and the American people 
encourage rather than stifle beneficial research, and build 
trust in our public health institutions rather than tearing 
them down.
    So let me start with Dr. Mathers. As we emerge from the 
COVID-19 public health emergency, what are some of the lessons 
that we can take away from the pandemic to better tackle 
challenges like antimicrobial resistance?
    Dr. Mathers. Thank you so much for the question. I think 
there's a couple of things that I take away from it.
    First off, we are seeing emerging antibiotic resistance 
postpandemic. The CDC has incomplete data, as already was 
highlighted. But from the data that we do have, there is 
emerging resistance in some of the most significant pathogens, 
especially those affecting hospitalized patients, which to me 
says what we were doing and how we were able to dedicate the 
same resources that then had to be somewhat diverted to manage 
the public health emergency in hospitals and clinical micro 
labs and in infectious disease writ large, it was working to 
prevent the emergence of antibiotic resistance.
    There were several areas where we were making progress and 
seeing decreased. And now that we sort of took the eye off the 
ball, we are seeing in our hospitals--like, in my hospital I am 
seeing antibiotic resistance I haven't seen in years, and in a 
way that it is affecting patients--now sort of postpandemic, 
but maybe postpublic health emergency.
    And so what we were doing was probably working. I think 
that--yes, I guess the main answer to my question.
    I think that, you know, the other things that we need is we 
need to--you know, it has kind of come across here--we need to 
both preserve the antibiotics we have with efforts in 
antimicrobial stewardship and diagnostics that we talked about, 
but also to come up with new antibiotics so I have agents to 
give patients. I have--I mean, it was within the last month 
that I just had a patient that expired from an untreatable 
antibiotic infection.
    I mean, this is happening in hospitals right now. And I 
need new antibiotics, or maybe, like I am alluding to, it may 
not be that we have another super antibiotic or magic bullet 
because the bacteria have really developed armor for the 
antibiotics we have. And so we probably need multipronged 
approaches between all the different technologies to treat 
antibiotic resistance.
    And lastly, I will say that surveillance would be hugely 
helpful. Patients transferred from other hospitals, I don't 
know what their resistance looks like at that hospital because 
we don't have a central repository to really communicate about 
antibiotic resistance emergence, even at a State level, let 
alone Federal Government level. I mean, it is all voluntary 
right now. So there's just huge gaps in where are the problems. 
And as a researcher trying to understand where should we put 
our efforts, I don't really know or have resolution on what the 
biggest issues are.
    Mr. Pallone. Let me just ask you one more question, because 
we are out--almost out of time. But one of my concerns coming 
out of the pandemic is that the public has lost trust in some 
of our public health institutions and in doctors, generally. So 
do you have--can you talk about the importance of patients' 
trust in their doctors and medical institutions when dealing 
with these--you know, this issue?
    Dr. Mathers. Yes, I am not an expert in this, but I can 
tell you personally I feel it. I feel mistrust from patients, 
and it feels like somebody else is at the bedside. I don't know 
if it is social media or who is--but it--there is just a lot of 
misinformation that has been out there that has impacted trust 
that is making it harder to take good care of patients, and 
rightfully so.
    You know, I think there were a lot of--you know, we had a 
novel virus that a lot of people didn't know what to do with, 
including myself or--and so we had to change course many times, 
and I think that caused mistrust because maybe we overpromised 
and underdelivered in some areas, as a medical community, not 
as a society. So I think it is a big issue.
    And I think antimicrobial resistance is such a complicated 
issue, it doesn't fit in a sound byte. And so it is going to be 
really hard to communicate why this is so important and how it 
is affecting individuals--maybe until it is too late.
    Mr. Pallone. Yes, I mean, I worry because, as we said 
earlier, you know, you have these challenges as to, you know, 
basically telling people when they should take things, when 
they should not. And if they don't trust the doctors or the 
health institutions, they are not going to listen. So thank you 
so much, really.
    Dr. Mathers. Thank you.
    Mr. Pallone. Thank you, Madam Chair.
    Mrs. Lesko. Thank you. And now I recognize Representative 
Guthrie for his 5 minutes of questioning.
    Mr. Guthrie. Thanks, Madam Chair. I appreciate the 
recognition.
    And Ms. Denigan-Macauley, we are currently 2\1/2\ years 
into our national plan for combating antibiotic resistance 
bacteria. Could you give us an update on this plan, and focus 
on--you know, the first national plan released in 2015 
indicated there were 6 milestones in progress, and 5 not 
achieved. And would you address where we are in the plan and 
how we are going to ensure we effectively address the 
milestones that weren't achieved?
    Dr. Denigan-Macauley. Yes. The new plan came out after we 
last reported. So we have not done a deep analysis on that 
plan. However, it is our understanding that they are behind in 
doing their progress reports. And so we will be reviewing those 
as part of our recommendation followup when they do come out.
    Mr. Guthrie. We want to make sure we meet the new 
milestones, or--that weren't achieved. So just--would you 
commit to working with us, the committee----
    Dr. Denigan-Macauley. Absolutely.
    Mr. Guthrie [continuing]. To ensure that we get to those--
thank you very much.
    And Mr. Outterson, how does CARB-X decide which products to 
invest in, and why?
    And since 2016, how many of these products that have been 
funded have reached the market, and what are some of the 
specific products on the market?
    Mr. Outterson. Thank you, Mr. Guthrie, for the question.
    CARB-X makes its decisions based on using an external 
scientific review committee. We always pick based on what we 
think is the best science. We then evaluate across our 
portfolio using a portfolio risk and value tool to try to--
because we want to take many shots, we are quite early, we do 
translational work that is just barely out of the university 
into a small start-up company. And our deliverable is to result 
in products that are--have completed their first in-human 
clinical trials.
    At that point, the follow-on funders are groups like BARDA 
as well as the AMR Action Fund and other private investors. To 
date we have had 12 products, therapeutic products, that have 
gone into clinical--human clinical trials, first in-human 
trials. And of those, the--none of the therapeutics are 
anywhere near FDA approval. That is probably another 5 to 8 
years away, just--it takes time. But two of our diagnostic 
products that we have supported are actually on the market. 
They have CE marks in Europe that are not yet approved here in 
the United States.
    Mr. Guthrie. Yes, you mentioned BARDA. So CARB-X has also 
been supported by NIH--infectious diseases at NIH, as well as 
BARDA. Can you outline specifically how this money has been 
used and what successes there are to show for it?
    And I know you had always--and areas that--anything. I was 
a quality engineer, you always look at needs for improvement 
and room for improvement. And what are those, and what are your 
plans for improvement?
    Mr. Outterson. Certainly. The money that we receive from 
BARDA right now is 40 million USD per year. We have leveraged 
that by attracting other governments and other charitable 
foundations to support CARB-X. Our total spend is--BARDA is a 
little bit less than half of our total expenditures. The NIH 
provides preclinical services to CARB-X-supported companies but 
doesn't fund us directly. But they collaborate with us in the 
governance, together with BARDA.
    The program--you know, the goal here is to radically 
enhance the pipeline, the quality of the pipeline. And as we 
have heard from many witnesses, the clinical pipeline today, 
the things that we have seen recently, are not very innovative, 
and not new classes, as the witnesses have said.
    In the therapeutics and CARB-X, almost everything that we 
have supported is an entirely novel class--would be the first 
in my lifetime, really, to make it--or an entirely new 
mechanism of action, or something that is so new that there is 
not even an established FDA path. We call these 
nontraditionals, things like phage. Many of the products that 
we support are two out of those three, and more than a dozen or 
three out of those three.
    And so we are taking high-risk, high-reward shots. And our 
goal is to deliver, again, you know, through first in-human 
testing so that others like BARDA behind us, downstream from 
us, can take those forward.
    Mr. Guthrie. Thanks. And also, getting back to BARDA, in 
the Consolidated Appropriations Act of 2023 there was $950 
million provided to BARDA, and 820 million for the Project 
BioShield Reserve Fund. And how does CARB-X interact or benefit 
from the--particularly, the BioShield Reserve Fund? You had--
you mentioned BARDA already, but the BioShield Reserve Fund.
    Mr. Outterson. Yes, I don't think the--CARB-X doesn't 
receive any money from the Project BioShield Reserve Fund. We 
receive $40 million per year. And so all of that other money 
goes to other antimicrobial programs at BARDA, including their 
phase two, phase three, broad-spectrum antimicrobial program.
    The BioShield program, they have funded two antibiotics 
companies with that program, and that has been publicized, but 
that is completely separate from CARB-X, and much further 
downstream, these are companies that are either on the market 
or almost on the market, typically.
    Mr. Guthrie. OK, thank--perfect timing. My time is expired, 
and I will yield back. Thank you.
    Mr. Griffith [presiding]. I thank the gentleman for 
yielding back. I now recognize the gentleman from New York, Mr. 
Tonko, for his 5 minutes of questioning.
    Mr. Tonko. Thank you, Mr. Chair, and thank you and the 
ranking member for bringing attention to what is a very 
important topic.
    I would be remiss if I didn't mention that this was a topic 
close to the heart of my good friend, the late Congresswoman 
Louise Slaughter. As the only microbiologist in Congress, 
Louise raised the alarm on antibiotic resistance. And in her 
honor, I hope that as a Congress we can continue to work on 
this issue and build on her legacy.
    Each of you here today has talked about how the situation 
is only getting more dire, and that is why federally funded 
research is so important as we move forward. I recently heard 
from a family in my district who knows how urgent the situation 
is. They have a 6-year-old named Kellen, who was diagnosed with 
cystic fibrosis when he was a newborn, just 9 days old.
    Kellen is a funny, athletic, and vibrant kindergartner. 
Kellen plays baseball, hockey, and football. He adores his 
older brother and is the heart and, as they say, funny bone of 
their family. Kellen's family feels fortunate for the 
breakthroughs in the CF medical world. Kellen has, 
unfortunately, had two bouts with Pseudomonas, along with other 
respiratory and lung infections that required Kellen to take 
antibiotics to fight off the infections.
    Antimicrobial resistance is a fear for Kellen's family, 
along with others who live with CF, because they know that this 
is a likely issue they may face somewhere down the road if he 
becomes resistant to the few antibiotics that can indeed fight 
these infections.
    Recognizing the magnitude of the threat, President Biden's 
budget for fiscal year '24 includes increased funding for CDC's 
antimicrobial resistance and public health data modernization 
efforts, increased funding for Project BioShield, and steady 
funding for NIH's National Institute of Allergy and Infectious 
Diseases, which funds research into diagnostics and novel 
treatments for antimicrobial resistant infections.
    So, Mr. Outterson, what do we need to do to more 
efficiently translate this research into new treatments for 
those who need it most, like my constituent Kellen?
    Mr. Outterson. Thank you for the question, and thank you 
also for remembering Louise Slaughter.
    The CF community is remarkable. I have spent a lot of time 
talking to these individuals, and it is shocking that the new 
drugs are--they are not dying from cystic fibrosis anymore. 
They are dying from resistant lung infections. And this is a 
tragedy. And I have met and talked with many of these people 
that are struggling with that.
    What we have to have, then, are entirely new classes, 
entirely new approaches to restock the pipeline. I mean, 
penicillin was a wonderful drug. We would love to have a drug 
that good again. And it is just hard to do it without taking 
radically difficult scientific approaches.
    For the companies, given how little money is to be made, 
they have typically stayed within known classes and focused on 
things that are small, incremental improvements. And so at 
CARB-X we take the 40 million a year from BARDA and match it 
with other governments, and we invest in things that are 
completely, radically novel so that 5 or 10 years from now we 
will actually have options for patients like this young man.
    Mr. Tonko. Thank you, sir.
    And Dr. Mathers, what benefits have Federal investments, 
including partnerships between the Federal Government and 
academic institutions like the University of Virginia, brought 
about in addressing antimicrobial resistance?
    Dr. Mathers. Thank you for the question. Just in my own 
experience, CDC has funded us to understand transmission of 
highly resistant bacteria within the hospital environment and 
funded research and successfully developed interventions 
through that funding to prevent the spread of antimicrobial 
resistant organisms from the hospital environment to patients. 
And so that has been one successful funding effort.
    I would say also there has been some really important 
developments in the way that we do susceptibility testing, and 
partnership between the--you know, the way that we test 
bacteria for susceptibilities through standard development 
organizations like CLSI and FDA, with the 21st Century Cures 
Act. That was quite helpful in making sure that we are updating 
and adopting current breakpoints based on available new science 
so that those can be used readily in micro labs across the 
country. And so that has been incredibly important partnership 
and recognition and funding that has come.
    I would say most recently, with the Pathogen Genomics 
Centers of Excellence, like I have already alluded to, the 
complexity around antibiotic resistance tracking and genomics 
and even the way that the bacteria exchanged the resistance 
genes is really complicated. And so that effort is getting 
going, and that partnership, I think, will bear fruit.
    Mr. Tonko. Well, I certainly hope there is hope on the 
horizon in terms of battling antibiotic resistance and provide 
that kind of inspiration for Kellen and his family and many of 
those individuals that are waiting on that kind of progress.
    So thank you, one and all, for your exchange here. It is 
important to get updated. So thank you so much.
    And I yield back, Mr. Chair.
    Mr. Griffith. I thank the gentleman. I now recognize the 
gentlelady from Florida, Mrs. Cammack, for her 5 minutes of 
questioning.
    Mrs. Cammack. Thank you, Mr. Chairman, and thank you to our 
witnesses for appearing before us today. We will just jump 
right into it.
    And I hope I pronounce this right. Ms. ``Jezz-ick''?
    Ms. Jezek. Yes.
    Mrs. Cammack. Ah, yes. All right.
    [Laughter.]
    Mrs. Cammack. It is a good win on a Friday.
    As you know, in my home State of Florida, hurricane 
readiness, preparedness, response, these are significant issues 
that we all face. In your testimony you noted how resistant 
infections can impact our response and response time to 
national disasters like hurricanes. Can you tell us a little 
bit more about the connection between antimicrobial resistance 
and natural disasters, how we can be better prepared on the 
front end?
    Ms. Jezek. Absolutely. Thank you for the question. So with 
hurricanes, there are a couple of different things that can 
happen that can trigger an increase in infections. When we see 
widespread loss of activity, we see increased food spoilage and 
more foodborne infections. When we see decreases in access to 
safe water, and when we see interactions with floodwater, we 
start to see more infections from waterborne pathogens. When 
people need to leave their homes and have to go to emergency 
shelters, those shelters can be very crowded. That is a very 
easy area for infections to spread.
    Many of those infections can be resistant. Even when those 
infections are not resistant, if individuals are given 
antibiotics, that can help fuel future resistance.
    As we think about other types of natural disasters, 
wildfires, serious burns can very easily become infected with 
pathogens that are very difficult to treat.
    So as we think about preparedness for natural disasters, we 
need tools in the toolbox to deal with these infections, so we 
need those novel antimicrobial therapies and we need experts 
who know how to use them, who can figure out quickly--because 
hours matter in infectious disease----
    Mrs. Cammack. Yes.
    Ms. Jezek [continuing]. Who can really figure out quickly 
what does this patient have, and what is going to be the most 
effective treatment.
    Mrs. Cammack. Thank you. And just to build on that, so 
taking it from a natural disaster to maybe a national security 
threat, a natural--a national or even global incident, you talk 
about all the different ways in which antimicrobial resistance 
could lead to a national security crisis.
    And I know certainly we are alarmed of some of the things 
that we are hearing today, but when you think of it on a 
massive scale and how it could potentially lead to the 
proliferation of an antimicrobial resistance, can you share 
with the committee how it is a threat, this issue that we are 
discussing today is a threat to national security, and what we 
need to do to be better prepared on a national and global 
scale?
    Ms. Jezek. Absolutely. Well, as terrifying as it is to 
think about, pathogens can easily be weaponized, and the 
pathogens can be engineered to become more resistant and 
weaponized. And if they--if some bad actor were to weaponize an 
antibiotic-resistant pathogen and spread it across the United 
States, we are not prepared. We don't have the therapeutics 
that we need. We don't have the diagnostics that we need. We 
don't have as many infectious diseases experts as we need.
    Even getting away from bioterror specifically, any mass 
casualty event where you have a lot of people in a hospital, 
that can be--any kind of terrorist attack, it can be another 
pandemic--if our hospitals get overwhelmed, we start to see 
these infections really flourish, and we need more tools in the 
toolbox.
    Mrs. Cammack. Thank you for that. This is getting scarier 
as we go through this, so----
    Ms. Jezek. I am sorry.
    [Laughter.]
    Mrs. Cammack. My apologies to everyone on a Friday, but it 
is important. And you know, you hit on this, so I am going to 
shift to Ms.--I am going to--I hope I get it right--``Den-eh-
gen-Ma-call-ee''? OK.
    So your report discusses four areas for addressing this 
issue, AMR: surveillance, testing, treatment, and stewardship. 
Of these, which is the most important, and what should this 
committee be prioritizing?
    Dr. Denigan-Macauley. Yes, unfortunately, I can't tell you 
which is the most important because they all go hand in hand. 
As we had mentioned, this is a One Health approach. It is very 
complex.
    So, for example, if you create a new antibiotic, if you 
don't have judicious use of that antibiotic, you are just going 
to end up with resistance again. So really, they all go hand in 
hand. You have to understand the magnitude, you have to be able 
to track the spread for all the different things that we have 
talked about today.
    Mrs. Cammack. Thank you. And the GAO, based your work--
based on your work, what has the Federal Government done to 
combat AMR, and how successful have those efforts been?
    And I fear that I know the answer to this question, but for 
the record.
    Dr. Denigan-Macauley. Well, I do want to give credit. There 
has been a lot of work. And as we have talked about before, 
there have been tasks force. Having leadership and sustained 
attention is absolutely critical. It is something the GAO feels 
very strongly in, and having hearings like we are having today 
and continuing this attention. Our report came out in 2020--
unfortunately, in the midst of the pandemic. And so being able 
to continue and bring this to light--this is a pandemic. It is 
a public health threat.
    And so they do have many efforts underway. But as I had 
mentioned in my opening statement, there are more things that 
need to be done. We need better diagnostic tools. We need those 
tools to be able--we need doctors to use those tools. Even if 
we have them, you know, when the--when someone walks in with a 
screaming baby and they are, like, ``I have an ear infection,'' 
and the doctor only has a few minutes with them, are they going 
to take the time to decide whether or not, you know, they are 
giving the right antibiotic to treat the right bug, as has been 
mentioned before.
    So it is quite complicated, and there's a lot of things, 
but more is definitely needed, and GAO continues to track this 
as we go forward.
    Mrs. Cammack. Thank you. My time has expired.
    With that, Mr. Chairman, I yield back.
    Mr. Griffith. The gentlelady yields back. I now recognize 
the gentlelady from Illinois, Ms. Schakowsky, for her 5 minutes 
of questioning.
    Ms. Schakowsky. Thank you so much, Mr. Chairman. I want to 
thank our witnesses so much. This is so very, very important. 
This has been somewhat of a difficult morning with votes, et 
cetera, but I am so happy that you are here with your expert 
testimony.
    So I have really, throughout my life and career, really 
focused on older Americans. So it really was no surprise to me 
when the CDC pointed out that Medicare patients were most 
likely to actually die from drug-resistant infections than--in 
American hospitals than any other--than any other group. So I 
wanted to ask Dr. Mathers or any of you who would like to 
comment on this, are there any precautions, protocols that 
should be in place in hospitals right now that would be 
particularly more protective of older patients that are in 
hospitals?
    Dr. Mathers. Thank you so much for the question. And the 
geriatric population is of particular interest to me, and I 
think they are particularly vulnerable to antimicrobial-
resistant infections.
    So for me, it is critically important in antimicrobial 
stewardship--so just sort of day to day--they are one of the 
groups I worry about the most in the hospital, especially 
because of an infection called C. diff, which is related to 
antimicrobial overuse and is one of the recognized threats by 
the AR reports from CDC. And so unnecessary antibiotic exposure 
can disrupt the gut flora and then allow persons to become 
vulnerable to this bacterial infection that can cause death, in 
fact, but often causes a severe diarrhea. Elderly patients are 
more vulnerable to that infection. And so I am--I mean, just my 
day-to-day work is trying to make sure that we are not 
overusing antibiotics in geriatric populations.
    Also, again, back to the importance of diagnostics: If we 
had better diagnostics, is it really a urinary tract infection 
or is it some other infection that may be mimicking other 
symptoms in the geriatric population? More research--and 
research has been coming out.
    And again, I think it gets back to Amanda Jezek's--you 
know, we need experts to be able to diagnose, work with new 
diagnostics to make sure that we are diagnosing and using 
antibiotics properly in our geriatric populations so that we 
don't overuse antibiotics and put them--and select for more 
resistant infections, as well as put them at risk for 
infections that they wouldn't otherwise have following 
antibiotics.
    So I really appreciate the question, and----
    Ms. Schakowsky. Did you want to answer, someone else? I 
mean, anyone. This is a real----
    Ms. Jezek. Thank you. I would just expand. The protocols 
that are needed, infection prevention programs, antimicrobial 
stewardship programs, they are in place. In fact, they are 
typically required, but they aren't staffed appropriately.
    Even before the pandemic, we saw studies showing enormous 
gaps between recommended staffing levels for stewardship 
programs of infectious diseases physicians and pharmacists and 
the staffing levels that we actually had. And that is even at 
big, major academic medical centers. It is worse when you get 
into more rural hospitals. And they can't hire people. We 
consistently hear open positions, positions staying open for 
months, months at a time for ID physicians, for infection 
preventionists, for clinical lab personnel. We need to 
incentivize people to go into these careers.
    Ms. Schakowsky. Thank you.
    Yes, go ahead.
    Mr. Outterson. If I may.
    Ms. Schakowsky. Sure.
    Mr. Outterson. There was a milestone yesterday in that the 
first microbiome therapy for recurrent C. diff was approved by 
the FDA, and it kind of got lost in the news. It is a 
remarkable first-in-class approach. And that company has been 
working on that for more than a decade. CARB-X actually 
supports a more advanced version of their product, which is--we 
have been working with them for 5 years now--and it is a--you 
know, it takes time to get these things done, and--finally got 
across the line, first FDA approval ever. It is great.
    Second thing is data. Many people who die in hospital with 
a resistant infection, the death certificate does not say AMR. 
It says something else. And until we collect the data to know 
how many people are dying, we won't respond appropriately.
    Ms. Schakowsky. OK. In the few seconds, I just want to say 
that, overall, aren't we using too many antibiotics, and 
ultimately, especially for seniors, because through their 
lifetime--that this is a problem? Is this a yes?
    Dr. Mathers. Unfortunately, yes.
    Ms. Jezek. Yes.
    Ms. Schakowsky. OK.
    Dr. Denigan-Macauley. I will add, though, that we need 
better data on use.
    Ms. Jezek. Yes.
    Ms. Schakowsky. OK. Thank you so much.
    I yield back.
    Mr. Griffith. The gentlelady yields back. I now recognize 
the gentleman from Texas, Dr. Burgess, for his 5 minutes of 
questioning.
    Mr. Burgess. Thank you, Mr. Chairman, and just following up 
on that last question, let me just ask: Is anyone on the panel 
an M.D. and treats patients?
    OK. So you know when you are treating a patient, you are 
treating that patient, you are not treating a population. And 
the expectation of that patient and their family is you are 
going to get them better, and you are going to use every tool 
at your disposal to get them better.
    Dr. Mathers. Absolutely.
    Mr. Burgess. And the argument that, well, you know, we are 
holding this back so it might benefit someone else later on, 
that really doesn't fly in the clinics, does it?
    Dr. Mathers. I appreciate the question, and I agree. My 
day-to-day job is antibiotic stewardship, so talking to 
physicians about these difficult discussions, and then also 
talking to patients about these difficult discussions, and you 
have to be a really good doctor to know when you can, you know, 
hold back antibiotics.
    Diagnostics would help, if we could tell viral from 
bacterial infections sooner.
    Mr. Burgess. Sure.
    Dr. Mathers. As well as working with patients to talk 
through, ``I don't think an antibiotic is going to be helpful. 
I recognize you are very sick,'' and then also talking through 
and educating doctors. That is part of my bread and butter.
    You know, pancreatitis, maybe we don't need--even though it 
looks like an infection, it is actually an inflammatory 
response that doesn't require antibiotics often. And so working 
with my ICU doctors or my surgeons, I go on surgical rounds 
trying to help and educate other doctors. But there's not 
enough people trained like me, or maybe even that want to have 
these discussions.
    So I think it is a really good point, though. And I always 
want doctors to treat the patient in front of them.
    Mr. Burgess. Sure.
    Dr. Mathers. And I support that, and then I need to support 
them.
    Mr. Burgess. We have had hearings on this subject multiple 
times over the years. They are always important, and I always 
learn a lot when we do these. But I also have to remember the 
father of our country died from what began as a pharyngitis and 
turned into a peritonsillar abscess. They didn't have 
antibiotics back then, but it would have been a lifesaving 
intervention had it been available.
    Dr. Mathers. Yes, there is nothing more exciting when you 
save somebody's life with antibiotics in my ilk, as a 
physician.
    Mr. Burgess. Yes.
    Dr. Mathers. And so I want to preserve those so that the 
next generation of physicians and patients can benefit from 
that.
    Mr. Burgess. Well, I do thank each of you for being here, 
and I thank you for your insightful testimony that you have 
provided.
    Professor Outterson, if I could just ask you, I represent a 
part of Texas that is kind of outside the area where you 
normally think of San Joaquin Valley fever, but you are finding 
it outside of its normal distribution. So are there things that 
are going on now in your world that are working on fungal 
infections broadly, because there--that is emerging as a new 
threat, and then in particular the San Joaquin Valley fever 
problem?
    Mr. Outterson. So I actually grew up in Texas, spent 18 
years there in Clear Lake and, no, had never heard of valley 
fever at that time in Texas. But valley fever and other fungal 
infections are rising in importance and focus. People 
understand now, and it is--for example, fungal infections are 
on the CDC threat list, and people are taking it seriously.
    For CARB-X specifically, if that was your question----
    Mr. Burgess. Yes.
    Mr. Outterson. Our authorities from BARDA limits us at the 
moment to bacteria. And so that is a decision that is made by 
BARDA.
    Mr. Burgess. OK. Well, are there lessons learned from other 
countries that could help us in these decisions?
    Mr. Outterson. I think the key lesson is that, if you want 
a new drug to treat an infection today, you needed to have 
started 10 years ago. And so we need serious research efforts 
today.
    I was talking to a--Rob Purdy who is a, you know, a patient 
advocate on valley fever, he suffered from it personally 
himself, was talking this week. It is a much more serious 
condition than I think the average people in the public 
understand. We need to respond to it with the same level of 
seriousness.
    Mr. Burgess. Well, in fairness to this committee, we were 
talking about this 10 years ago. Unfortunately, we haven't done 
the follow-on that is necessary, and maybe this hearing and 
this year will be different.
    Dr. Mathers, you mentioned diagnostic tests, and everyone 
is now more familiar with diagnostic tests, one of the positive 
sides to coming through the COVID pandemic. But how can we 
encourage the greater use of diagnostic tests before 
prescribing an antibiotic?
    Dr. Mathers. Yes, I think that good diagnostic tests need 
to be available, and I think making sure that we have got the 
workforce to run good diagnostic tests--we do not. We have 
shortages and gaps. And I am just at University of Virginia. We 
have had openings in our clinical micro lab for--since 2020. 
And so we need people going into a career in medical 
microbiology----
    Mr. Burgess. Yes.
    Dr. Mathers [continuing]. So that we can give the result, 
we can run the tests, and give timely results so that it can 
help patients.
    In addition, I think, you know, research and development in 
diagnostic tests is also needed. Thank you.
    Mr. Burgess. Thank you, Mr. Chairman. You have been very 
indulgent. I will yield back.
    Mr. Griffith. I thank the gentleman for yielding back. I 
will say one of the concerns about having this hearing was that 
folks were afraid that everybody would want to blame the 
doctors, and the doctors are just trying to cure patients' 
problems.
    That being said, I now recognize another doctor on the 
committee, Dr. Ruiz, for his 5 minutes of questioning.
    [Laughter.]
    Mr. Ruiz. Thank you, and thank you for that statement.
    Antimicrobial resistance is a problem here at home and 
around the world. Resistant pathogens do not care about 
geographical borders, so we must make sure that we address this 
issue not just in the United States but globally.
    The World Health Organization reported in 2014 that, quote, 
``a postantibiotic era in which common infections and minor 
injuries can kill is a very real possibility for the 21st 
century,'' and declared antimicrobial resistance one of the top 
10 global public health threats facing humanity.
    So, Mr. Outterson, how does global collaboration improve 
our ability to tackle this problem?
    Mr. Outterson. Thank you for that question. You know, more 
than half of the funding from CARB-X comes from outside the 
U.S. Government. It is the U.S. Government, together with the 
governments of the United Kingdom and Germany--so three G7 
members--with charitable foundation support from Wellcome Trust 
and the Gates Foundation. This is a global problem.
    We always make our decisions at CARB-X looking not just at 
any one country but everywhere, because the best way to know 
what might threaten a U.S. hospital today or in 5 or 10 years 
is to visit a hospital in India or Pakistan or some other 
place. And you will see the sort of things that we will be 
seeing in a short period of time, or we could see today from 
somebody coming home on an airplane.
    You know, what Tom Patterson almost died from he contracted 
in Egypt----
    Mr. Ruiz. Yes.
    Mr. Outterson [continuing]. And then was flown back in 
emergency, you know, settings. So it has to be a global 
response----
    Mr. Ruiz. Thank you.
    Mr. Outterson [continuing]. You have to work together with 
other countries.
    Mr. Ruiz. Thank you.
    Dr. Denigan-Macauley, has the GAO identified any areas 
where the U.S. Government could better engage with 
international partners to address the increased spread of AMR?
    Dr. Denigan-Macauley. We have. And we do believe strongly--
and part of our methodology was to go over and to speak to how 
that better engagement could occur. We met with the WHO and 
with members over in the United Kingdom, as well. So we do 
believe that global engagement is very important, and we 
continue to track that.
    And honestly, they turn to us as leaders. So if the U.S. 
doesn't take action, then other countries do get worried. And 
that was a common message that we heard.
    Mr. Ruiz. This is very interesting. I was just thinking, I 
know we have infectious disease doctors on the panel, and my--
one of my medical school professors and mentor was Dr. Paul 
Farmer. And so I am thinking of the central plateau of Haiti, 
and how very few people have access to even the most basic 
antibiotics, period. And so here we are, trying to increase the 
access to lifesaving basic antibiotics for common infections, 
and at the same time we are trying to limit its use, its 
improper use in these areas, which pose a big challenge, 
especially in the most underserved, resource-poor settings.
    As in many other areas in healthcare space, there are 
workforce challenges at play. So, Ms. Jezek, your testimony 
says that there is a shortage of infectious disease physicians. 
And are there certain regions of our Nation or specialties that 
are most in need of infectious disease doctors or 
consultations?
    Ms. Jezek. Thank you for that question. So we know that 
nearly 80 percent of counties in the United States do not have 
a single infectious diseases physician, and the shortages are 
worse in more rural areas.
    I think what is even more disconcerting is looking at the 
future. We are not training enough infectious diseases 
physicians. So the most recent match where residents get placed 
into their specialty fellowship programs, only 56 percent of ID 
training programs filled their positions.
    Mr. Ruiz. Wow.
    Ms. Jezek. And that is not true across other medical 
specialties. Most specialties are filling all or nearly all of 
their programs, and this really has to do with a lot of the 
financial challenges. Infectious diseases doctors actually earn 
less money----
    Mr. Ruiz. Yes.
    Ms. Jezek [continuing]. Than general internal medicine 
physicians despite getting that additional training----
    Mr. Ruiz. Yes.
    Ms. Jezek [continuing]. Because of the way that we 
reimburse for physician care.
    Mr. Ruiz. Yes. Dr. Mathers, how do investments in building 
a skilled healthcare workforce contribute to better prevention, 
diagnosis, and treatment for AMR?
    Dr. Mathers. I think that the question is very timely. I 
think we need not just infectious disease physicians, but we 
need infection prevention personnel, epidemiologists, and we 
also need clinical microbiologists, and----
    Mr. Ruiz. You know, I think, you know, we have two problems 
with the physician shortage crisis that I have been working on. 
And I exist and live in communities where I did research before 
I ran for Congress, where we had one-time--full-time equivalent 
physician, 1 per over 9,000 residents. So we have an absolute 
physician shortage crisis.
    But we also have a--on top of that, a crisis of its 
distribution of our physicians. And we don't have a strategic 
plan or an idea or objectives to help create the incentives for 
where we need the doctors and where they are needed the most to 
be able to really increase access for the--our--the American 
people who need it the most.
    So it is something that I would like to work with the 
committee on establishing, so that we can take a bird's-eye 
strategic plan to help address critical areas in the provider 
workforce that would make the biggest difference to create a 
healthy population and keep our health safe.
    Thank you, yield back.
    Mr. Griffith. I thank the gentleman for yielding back. I 
now recognize the gentleman from Alabama, Mr. Palmer, for his 5 
minutes of questioning.
    Mr. Palmer. I thank the chairman.
    Director Denigan-Macaulay, what can we do to improve 
communication between healthcare facilities and to prevent the 
overuse or overprescription or misuse of antibiotics?
    Dr. Denigan-Macauley. So the Federal Government has taken a 
variety of steps to try and what we call stewardship and 
judicious use of the antibiotics. But there are barriers. There 
is only--the data is not sufficient that is coming in. We have 
to be able to say--we have to be able to understand the 
question earlier about the use.
    We have to be able to understand how much is being used, 
where the infections are occurring so that we can tailor the 
communication to those areas specifically. Agriculture doesn't 
want the finger pointed at them. Human Health doesn't want the 
finger pointed at them. So getting better data will help us to 
say with certainty where judicious use is needed, and to 
communicate and to make better communication.
    Mr. Palmer. Well, how rigorous is the reporting when you 
have--whether it is a rural hospital or a major metropolitan 
hospital or veterinarian, when they discovered the antibiotics 
are not working as they should, that the--because of 
resistance? Do we have a rigorous reporting requirement that 
would allow you to accumulate the data that you need?
    Dr. Denigan-Macauley. So we do not. As of right now, 
really, the rigorous reporting requirements are for the VA and 
DoD hospitals, for example. We--there is new legislation out 
there that hopefully we are going to get better reporting 
coming from the hospitals because of the CMS angle, the 
Medicare-Medicaid angle that we can get there. We don't have 
rigorous reporting coming in from the general community.
    And there can be silent infections, and we just don't have 
that reporting at the doctor level, either. So there is much 
work to be done.
    Mr. Palmer. Mr. Chairman, that is an area where I think we 
need to engage more vigorously on our side to try to get to a 
point where we are getting this data.
    One of the things, Ms.--I believe it was you, Ms. Jezek, on 
the third or fourth time you tried to give your testimony, you 
mentioned the--one of you mentioned the fact that these drug 
development companies are not able to recover their investment, 
their stranded cost. What suggestions do you have for that?
    Was that you? I believe it was you.
    Ms. Jezek. I think both Mr. Outterson and I both did, but I 
can start.
    So we pay for antibiotics based on the volume that is used, 
and we want to try to keep that volume as limited as possible, 
particularly for the really new, novel antibiotics for these 
multidrug-resistant infections, so that preserves their 
effectiveness. So we need a different way to pay for 
antibiotics. We need a way that will allow us to pay for the 
value that they provide to society rather than just paying per 
use.
    And I know it is not a legislative hearing, but I would be 
remiss if I didn't say the bipartisan PASTEUR Act that 
Representatives Ferguson and Peters just reintroduced yesterday 
would set up exactly that kind of subscription model that would 
allow the Federal Government to enter into contracts with 
antimicrobial developers to really pay for the value that these 
antimicrobial drugs provide, delinked from how much or how 
little of the drugs are actually used.
    Mr. Palmer. OK, I am going to--go ahead, if you would like 
to add to that.
    Mr. Outterson. I completely agree and would say that other 
G7 governments are taking the same approach. The UK has had 
their subscription model in place now for a couple of years, 
and they are about to revamp it and improve it. Japan announced 
that they are intending to do it on April 1st. They will say 
more about it at G7. Europe this week made their proposal 
public. And so everyone is hoping that the U.S. will also lead 
on this issue.
    Mr. Palmer. And one of my concerns, too, is the exposure 
this creates for our armed services. And I see this is a huge 
healthcare issue, but I also see it as potentially a national 
security issue and that we could be exposing our troops to 
things that we don't have the antibacterials to treat. I could 
see it with the number of immigrants that are coming into our 
country as well, that we could have a major healthcare crisis, 
but we could also turn it into a serious crisis dealing with 
our military. Have you looked at that, as well?
    Ms. Jezek. Absolutely. And combat wounds and combat burns 
are two of the easiest things that can become infected. There 
was a new study that came out a couple of weeks ago looking at 
infections in individuals in the current conflict in Ukraine 
and found some of these infections were enormously resistant to 
even some of our very new, novel antibiotics. And it is very 
frightening because, once we see these in a small population, 
they can spread very quickly.
    Mr. Palmer. Mr. Chairman, we have made remarkable progress 
in treating our wounded on the battlefield, particularly in 
that golden hour. And it would just--it is shocking to think 
that we could have someone survive a battlefield wound and then 
die from an infection.
    So I thank you for holding this hearing. I think it is 
extremely important. I look forward to what we are going to do 
going forward, and I yield back.
    Mr. Griffith. It is interesting that you mention that, 
because my understanding is that penicillin was considered a 
state secret when it first came out because of its advantages 
on the battlefield.
    Having said that, I now recognize--and thank you for 
yielding back--I now recognize the gentlelady from Arizona, the 
vice chair of this subcommittee--thank you for filling in when 
I went to vote--Mrs. Lesko.
    Mrs. Lesko. Thank you, Mr. Chair.
    Ms. Mathers, how long do University of Virginia medical 
students study antimicrobial resistance and how to combat it?
    Dr. Mathers. So that is a great question. I think that we 
actually need improved education in antimicrobial effectiveness 
and management.
    And so we have started at UVA giving stewardship lectures. 
Between myself and my partner, Heather Cox, who is a 
pharmacist, we give a joint stewardship lecture once they learn 
the basics of how antibiotics work and how we test them, and 
then we come back and talk through how to not overuse them, how 
to make sure that you understand your role as sort of the 
keeper of this precious resource.
    And so----
    Mrs. Lesko. So is it about an hour?
    Dr. Mathers. Yes.
    [Laughter.]
    Dr. Mathers. So later on it is about an hour.
    Mrs. Lesko. OK, all right. Thank you.
    Ms. Jezek, can you go into more detail about the efforts 
that your society, the Infectious Disease Society of America, 
is making to increase awareness of AMR and to educate 
physicians on AMR?
    Ms. Jezek. Absolutely. So we have developed a couple of 
different curricula at different levels, beginning with medical 
students and then on for physicians that are a little more 
advanced in their training, to learn about appropriate 
antibiotic use.
    For physicians that are becoming infectious diseases 
physicians, we have curricula to teach them about how to run an 
effective antimicrobial stewardship program, which is really, 
again, focused on making sure patients get the optimal 
treatment. We certainly don't want to, you know, deny 
antimicrobial drugs to people who need them, but we want to 
make sure they get the right drug.
    We also--our members do an enormous amount of 
communications through media briefings, through social media, 
through every communication channel that we can find. And they 
do this both through the Society and on their own, as 
individuals, to educate the public, to educate their 
communities about AMR. And we have actually found that 
oftentimes those individual physicians are some of the most 
effective messengers, because there has been an erosion of 
trust in some of the more maybe government-associated 
messengers on this. And so having those ID physicians in the 
communities as those messengers is so important.
    Mrs. Lesko. Yes, that is important.
    Mr. Outterson, I want to give you the opportunity to 
highlight the major accomplishments that CARB-X has done since 
its inception.
    Mr. Outterson. I think the key way to measure success at 
CARB-X is whether highly innovative products make it into human 
clinical testing. And I am happy to say that it was not 
prearranged, but our annual report came out yesterday, and we 
show exactly that sort of progress with the, you know, more 
than a dozen in the--outside of the diagnostics coming directly 
into human clinical testing. And then, for the diagnostics, a 
couple of them actually are now on the market in Europe.
    Mrs. Lesko. I--that is my last question, so I yield back.
    Mr. Griffith. I thank the gentlelady for yielding back. I 
now recognize the gentleman from North Dakota, Mr. Armstrong.
    Mr. Armstrong. Thank you, Mr. Chairman.
    According to the American Veterinary Medical Association, 
of the 118,000 veterinarians in the United States, only about 
5.3 percent, or around 6,000, are in the food animal space. 
There is a shortage of large-animal veterinarians throughout 
North Dakota, especially in rural areas where producers often 
need veterinarians to drive hours to inspect cattle and 
livestock.
    I understand that antimicrobial resistance is a global 
health and development threat that requires a multilateral 
approach to ensure we promote their appropriate use. And while 
the responsible usage of antibiotics is crucial, I am also 
concerned about the effects of the recently issued FDA rule on 
ranchers and farmers who do not overmedicate their animals. 
Ranchers are already under extreme economic pressure, and we 
have to balance the effect of antimicrobial--I have a really 
hard time saying that word----
    [Laughter.]
    Mr. Armstrong [continuing]. Policies with unintended 
consequences on the food supply. Medication of livestock by 
producers is expensive and takes up significant amount of 
producers' time. However, groups on both sides of this issue 
recognize that overmedication is something that can and should 
be prevented.
    Ms. Jezek, how do we ensure that the FDA's regulatory 
action in this space balances concerns with antimicrobial 
resistance with potential--potentially unintended consequences 
on the food supply?
    Ms. Jezek. Thank you for the question. I will say the 
animal health space is not my area of expertise, but I think 
that, as we have seen in human health, having good surveillance 
and data collection to understand where and how antimicrobials 
are being used and to understand how resistance patterns are 
tracking is critical to inform those efforts. And I think 
making sure we have that complementary data collection and 
surveillance on the animal and agricultural side is critical.
    And I think Dr. Mathers may have more.
    Dr. Mathers. I would just--you know, at clinical--as the 
CLSI are coming up with standards and testing and 
susceptibility--actually, as I understand it, working with 
veterinarians there--the ability to diagnose and understand 
what animals have resistant organisms by susceptibility testing 
is also a really important area to focus on, I think, and 
having more veterinarians in the space.
    So the vets that I work--at--in that space, trying to come 
up with standards because cows metabolize penicillin different 
than humans do, and that is different than chickens do. So we 
need research in each one of those so that we make sure that, 
when we are giving an antibiotic effectively to an animal, it 
is one that is going to work.
    Mr. Outterson. Mr. Armstrong, I think you can't just tell a 
rancher or a farmer no and not give them a good option. That is 
going to bankrupt them. So I think we also need to be 
researching vaccines in other ways so that there is--animals 
don't get sick.
    In Norway, the farmed salmon 20 years ago required 1 pound 
of antibiotic for every pound of salmon produced until they 
came up with a vaccine, and now Norwegian salmon has almost no 
antibiotics use. So I would strongly support giving farmers 
excellent tools so that they don't--aren't forced with this 
choice that you are describing.
    Mr. Armstrong. We--I am--it is interesting we brought 
Norway into this conversation. My father-in-law was a 
microbiologist and an oncologist in Oslo, Norway.
    But--and I think, like, you know, there's opportunities for 
educational campaigns, responsible stewardship, and all of 
those different issues. And I appreciate the research. And we 
do need more large-animal vets. We need them in places like 
North Dakota. We need them all over the country.
    I just get concerned we recognize we need all of those 
things, but far too often in this space what ends up happening 
is we pass a regulation and then try and figure it out later. 
And, I mean, between drought and travel and the lack of 
availability of real veterinary services in all of these places 
is--I appreciate the answers, I just--we have to do them both 
at once. We can't pass a regulation and then come back to this 
3 years later, 5 years later and say, ``Well, we don't have the 
resources to actually do this,'' because the rancher in western 
North Dakota is going to have to follow the regulation, 
regardless if the actual resources exist.
    Dr. Denigan-Macauley. Yes, I just wanted to mention the GAO 
does have a body of work looking at the veterinarian workforce. 
We agree that there is a crisis there. And we had asked OPM to 
step in and to help because one of the things we found, too, is 
that you are pulling the veterinarians from a very limited pool 
to, you know, to more lucrative jobs, for example, in the 
private sector, and they don't want to work in the food animal 
sector.
    And we also have a body of work looking at the animal side 
and surveillance that is needed on the farm and the diagnostic 
tools.
    Mr. Armstrong. I know two large-animal veterinarians in 
North Dakota that retired a decade ago. They are busier today 
than they were when they retired.
    And with that, I yield back.
    Mr. Griffith. Maybe these folks can work with the 
veterinarians in my district. I have the only district with two 
schools of veterinary medicine, although one is licensed to 
Harrogate. Virginia Tech always tells me that. They are not 
licensed in Virginia.
    [Laughter.]
    Mr. Griffith. And I say, yes, but I have been there, and it 
is in my district.
    That being said, I now recognize Mr. Carter of Georgia for 
5 minutes of questioning.
    Mr. Carter. Thank you, Mr. Chairman, and thank you for 
allowing me to waive on to this subcommittee, and thank you all 
for being here. This is extremely important.
    Professionally, I am a pharmacist, and I have witnessed 
over the years the excessive use of antibiotics that has led to 
a lot of this, and it has been a concern for many years.
    I am always in awe of the advanced--advancements that we 
have made in research and development. You know, I started 
practicing pharmacy when I--in 1980, when I was 10 years old, 
by the way.
    [Laughter.]
    Mr. Carter. But anyway, I have seen nothing short of 
miracles, and I mean that sincerely, nothing short of miracles 
as a result of research and development. And so I am a big fan 
of the pharmaceutical manufacturers from that aspect of it. But 
I am very, very concerned about the antimicrobial resistance 
and about the overuse of antibiotics.
    I get it. I know the pressure that physicians are under 
when you got a mother who has just been struggling with a 
child's ear infection and is just demanding that they--and no 
one was as demanding as my wife whenever she took our sons in. 
And so I get it, and I understand that. But this is something--
so I am glad we are--and I am glad that this subcommittee is 
looking at that, and that our full committee is looking at it, 
because it needs to be addressed.
    We had an example just 6 months ago where we had some 
contaminated eyedrops that were causing highly resistant eye 
infections, and this is--this was a never-before-seen strain of 
bacteria that left patients blind and in need of a corneal 
transplant. You know, that is the kind of thing we need to 
avoid in this country. That is why the time is now to invest in 
the pipeline.
    And I get it. I--look, I know we live in a capitalist 
society, and I know that--and pharmaceutical manufacturers are 
going to invest in the drugs that are going to give them and 
their investors--their stockholders, if you will--the biggest 
returns. I understand that, and I have a healthy respect for 
that. But that is where we in Congress need to be assisting and 
need to be making sure that we have got a pipeline out there of 
these antibiotics and, in particular, because they are not as 
profitable as maybe the cancer drugs are, or some of the other 
drugs. And that is why I was a cosponsor of the bipartisan 
PASTEUR Act legislation last Congress, and why I am again this 
year, in this session.
    Mr. Outterson, I wanted to ask you. In your testimony you 
said that pull incentives like subscriptions are now needed. 
Can you dumb that down for me, and tell me what pull incentives 
and subscriptions are?
    Mr. Outterson. Thank you for making the effort to be at 
this committee today and waiving on.
    Certainly, you know, the language sometimes is too 
professorial, and I apologize for that. But for antibiotics, we 
don't really want the drug that sells to a million people or 10 
million people, because that would represent a public health 
disaster. The best case is that infection control does a great 
job and everything else works perfectly, and we only need these 
new drugs for a small number of patients.
    Now, in some disease areas, that--they would then charge $1 
million for that drug for a small number of patients, and that 
is how the company makes money. In antibiotics, we really don't 
want the million-dollar drug. The PASTEUR Act or subscriptions 
tries to pay for the value to society for this drug, even if 
the volume, especially in early years, is quite low. And so the 
company goes away not bankrupt, we don't have any incentive to 
overuse it, but it is there when we need it for the patients 
who need it.
    And the last thing I will say is that, for CARB-X, the 
companies we support, the companies that are doing all the 
innovation in this space, the average size--about 20 full-time 
employees. Big Pharma has generally left. It is tiny startup 
companies that are doing a lot of the innovative----
    Mr. Carter. Right, and you articulated that well. Thank you 
for that. That is important for people to understand, and thank 
you for that explanation.
    Ms. Jezek, in your testimony you described the overuse of 
antibiotics. Through your research have you uncovered any 
reason for the overuse of antibiotics, besides what I mentioned 
in my experiences as a pharmacist?
    Ms. Jezek. I think there are a lot of reasons, and I think 
oftentimes when a patient presents and they are very, very ill, 
you don't know right away what is infecting them. But because 
hours can matter in treating an infectious disease, you need to 
treat them right away, empirically, while you wait for the test 
results from diagnostics to come back.
    I think we also don't have enough experts who really 
understand the best ways to use our antibiotics. So a lot of 
inappropriate antibiotic use is giving someone the wrong 
antibiotic or keeping them on it for the wrong duration. And so 
making sure that we have more people who are trained in how to 
use antibiotics is critical.
    Mr. Carter. So giving them a standing prescription so the 
mother won't be calling every 15 minutes.
    Ms. Jezek. I was that mom too. I get it.
    Mr. Carter. Been there and done that. Listen, I know.
    So thank you all. This is this is extremely, extremely 
important, and I want to compliment you and applaud you for 
what you are doing. I know this firsthand.
    And Mr. Chairman, again, I want to thank you for this 
hearing, and it is vitally important.
    So thank you all, and I yield back.
    Mr. Griffith. The gentleman yields back, and I appreciate 
it.
    And let me say to the witnesses, we appreciate you being 
here. This has been a great panel. Everybody has been engaged 
and passionate. And even with our technical difficulties and 
the vote series taking place, it says a lot when you have 
Members coming back, and the vote has been over for 45 minutes 
or more on a Friday. That tells you that folks are really 
interested in this issue, and we greatly appreciate it.
    Seeing no further Members wishing to ask questions, I would 
thank our witnesses again for being here.
    And pursuant to committee rules, I remind Members they have 
10 business days to submit additional questions for the record, 
and I ask the witnesses that they submit answers 10 days 
following the receipt of the questions from the Members who may 
have additional questions for you.
    Again, thank you all so very much for being here.
    That being said, meeting adjourned.
    [Whereupon, at 11:01 a.m., the subcommittee was adjourned.]

                                 [all]