    [House Hearing, 119 Congress]
    [From the U.S. Government Publishing Office]

              LEGISLATIVE PROPOSALS TO MAINTAIN AND IM-
                   PROVE THE PUBLIC HEALTH WORKFORCE,
                   RURAL HEALTH, AND OVER-THE-COUNTER
                   MEDICINES
    =======================================================================

                                    HEARING

                                   BEFORE THE

                             SUBCOMMITTEE ON HEALTH

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                        ONE HUNDRED NINETEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 JULY 16, 2025

                                   __________

                               Serial No. 119-31

    [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
    61-475 PDF               WASHINGTON : 2026
    =======================================================================

                        COMMITTEE ON ENERGY AND COMMERCE

                            BRETT GUTHRIE, Kentucky
                                     Chairman
    ROBERT E. LATTA, Ohio                FRANK PALLONE, Jr., New Jersey
    H. MORGAN GRIFFITH, Virginia           Ranking Member
    GUS M. BILIRAKIS, Florida            DIANA DeGETTE, Colorado
    RICHARD HUDSON, North Carolina       JAN SCHAKOWSKY, Illinois
    EARL L. ``BUDDY'' CARTER, Georgia    DORIS O. MATSUI, California
    GARY J. PALMER, Alabama              KATHY CASTOR, Florida
    NEAL P. DUNN, Florida, Vice          PAUL TONKO, New York
        Chairman                         YVETTE D. CLARKE, New York
    DAN CRENSHAW, Texas                  RAUL RUIZ, California
    JOHN JOYCE, Pennsylvania             SCOTT H. PETERS, California
    RANDY K. WEBER, Sr., Texas           DEBBIE DINGELL, Michigan
    RICK W. ALLEN, Georgia               MARC A. VEASEY, Texas
    TROY BALDERSON, Ohio                 ROBIN L. KELLY, Illinois
    RUSS FULCHER, Idaho                  NANETTE DIAZ BARRAGAN, California
    AUGUST PFLUGER, Texas                DARREN SOTO, Florida
    DIANA HARSHBARGER, Tennessee         KIM SCHRIER, Washington
    MARIANNETTE MILLER-MEEKS, Iowa       LORI TRAHAN, Massachusetts
    KAT CAMMACK, Florida                 LIZZIE FLETCHER, Texas
    JAY OBERNOLTE, California            ALEXANDRIA OCASIO-CORTEZ, New York
    JOHN JAMES, Michigan                 JAKE AUCHINCLOSS, Massachusetts
    CLIFF BENTZ, Oregon                  TROY A. CARTER, Louisiana
    ERIN HOUCHIN, Indiana                ROBERT MENENDEZ, New Jersey
    RUSSELL FRY, South Carolina          KEVIN MULLIN, California
    LAUREL M. LEE, Florida               GREG LANDSMAN, Ohio
    NICHOLAS A. LANGWORTHY, New York     JENNIFER L. McCLELLAN, Virginia
    THOMAS H. KEAN, Jr., New Jersey
    MICHAEL A. RULLI, Ohio
    GABE EVANS, Colorado
    CRAIG A. GOLDMAN, Texas
    JULIE FEDORCHAK, North Dakota
                                     ------

                               Professional Staff

                         MEGAN JACKSON, Staff Director
                    SOPHIE KHANAHMADI, Deputy Staff Director
                   TIFFANY GUARASCIO, Minority Staff Director
                             Subcommittee on Health

                          H. MORGAN GRIFFITH, Virginia
                                     Chairman
    DIANA HARSHBARGER, Tennessee, Vice   DIANA DeGETTE, Colorado
        Chair                              Ranking Member
    GUS M. BILIRAKIS, Florida            RAUL RUIZ, California
    EARL L. ``BUDDY'' CARTER, Georgia    DEBBIE DINGELL, Michigan
    NEAL P. DUNN, Florida                ROBIN L. KELLY, Illinois
    DAN CRENSHAW, Texas                  NANETTE DIAZ BARRAGAN, California
    JOHN JOYCE, Pennsylvania             KIM SCHRIER, Washington
    TROY BALDERSON, Ohio                 LORI TRAHAN, Massachusetts
    MARIANNETTE MILLER-MEEKS, Iowa       MARC A. VEASEY, Texas
    KAT CAMMACK, Florida                 LIZZIE FLETCHER, Texas
    JAY OBERNOLTE, California            ALEXANDRIA OCASIO-CORTEZ, New York
    JOHN JAMES, Michigan                 JAKE AUCHINCLOSS, Massachusetts
    CLIFF BENTZ, Oregon                  TROY A. CARTER, Louisiana
    ERIN HOUCHIN, Indiana                GREG LANDSMAN, Ohio
    NICHOLAS A. LANGWORTHY, New York     FRANK PALLONE, Jr., New Jersey (ex
    THOMAS H. KEAN, Jr., New Jersey          officio)
    MICHAEL A. RULLI, Ohio
    BRETT GUTHRIE, Kentucky (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. Diana DeGette, a Representative in Congress from the State
      of Colorado, opening statement.................................     7
        Prepared statement...........................................     9
    Hon. Brett Guthrie, a Representative in Congress from the
      Commonwealth of Kentucky, opening statement....................    11
        Prepared statement...........................................    13
    Hon. Frank Pallone, Jr., a Representative in Congress from the
      State of New Jersey, opening statement.........................    15
        Prepared statement...........................................    17

                                   Witnesses

    Jacqueline Corrigan-Curay, M.D., Acting Director, Center for Drug
      Evaluation and Research, Food and Drug Administration,
      Department of Health and Human Services........................    19
        Prepared statement...........................................    22
    Candice Chen, M.D., Acting Associate Administrator, Bureau of
      Health Workforce, Health Resources and Services Administration,
      Department of Health and Human Services........................    36
        Prepared statement...........................................    38
    Thomas Morris, Associate Administrator, Federal Office of Rural
      Health Policy, Health Resources and Services Administration,
      Department of Health and Human Services........................    46
        Prepared statement...........................................    48

                                 Legislation\1\

    H.R. ___, the Newborn Screening Saves Lives Reauthorization Act
      of 2025
    H.R. ___, Title VII Reauthorization
    H.R. ___, Title VIII Reauthorization
    H.R. 2493, the Improving Care in Rural America Reauthorization
      Act of 2025
    H.R. 2821, the FDA Modernization Act 3.0
    H.R. 2846, To amend title II of the Public Health Service Act
    H.R. 3302, the Healthy Start Reauthorization Act of 2025
    H.R. 3419, To amend the Public Health Service Act to reauthorize
      the telehealth network and telehealth resource centers grant
      programs
    H.R. 3686, the SAFE Sunscreen Standards Act
    H.R. 4273, Over-the-Counter Monograph Drug User Fee Amendments

                               Submitted Material

    Inclusion of the following was approved by unanimous consent.
    List of documents submitted for the record.......................    94
    Letter of July 14, 2025, from Kyle Zebley, Executive Director,
      ATA Action, to Mr. Griffith and Ms. DeGette....................    95
    Letter of July 15, 2025, from SUNucate Coalition to House
      Subcommittee on Health.........................................    97

    ----------

    \1\ The bills have been retained in committee files and are available
    at https://docs.house.gov/Committee/Calendar/
    ByEvent.aspx?EventID=118501.
    Letter of July 15, 2025, from Paul Melmeyer, Executive Vice
      President, Public Policy and Advocacy, Muscular Dystrophy
      Association, to Mr. Griffith and Ms. DeGette...................    99
    Statement of the American Academy of Pediatric Dentistry, July
      16, 2025.......................................................   101
    Statement of the Association of American Medical Colleges, July
      15, 2025.......................................................   104
    Letter of July 15, 2025, from Kenneth Mendez, President and Chief
      Executive Officer, Asthma and Allergy Foundation of America, to
      Mr. Guthrie and Mr. Pallone....................................   106
    Letters of June 13 to July 15, 2025, from SUNucate Coalition, et
      al., to Mr. Joyce..............................................   109
    Letter from Rochelle D. Sibbio, President and Chief Executive
      Officer, Habitat for Humanity of Summit County, to Mr. Landsman   116
    Letter of July 15, 2025, from Steve Furr, Board Chair, American
      Academy of Family Physicians, to Mr. Griffith and Ms. DeGette..   118
    Statement of the Association of American Medical Colleges, July
      15, 2025.......................................................   124
    Article, ``Medicaid Cuts and the Telehealth Paradox: The Hidden
      Cost of Balancing the Budget,'' CTeL...........................   126
    Letter of July 15, 2025, from Brett Kessler, President, and
      Elizabeth Shapiro, Interim Executive Director, American Dental
      Association, to Mr. Griffith and Ms. DeGette...................   129
    Statement of the Environmental Working Group, July 16, 2025......   131
    Statement of the Muscular Dystrophy Association and the Parent
      Project Muscular Dystrophy, July 16, 2025......................   138
    Letter of July 15, 2025, from Paul Melmeyer,Executive Vice
      President, Public Policy and Advocacy, Muscular Dystrophy
      Association, to Mr. Griffith and Ms. DeGette...................   140
    Letter of July 15, 2025, from Elizabeth S. Watson, Director of
      Federal Government Affairs, American Federation of State,
      County, and Municipal Employees, to Mr. Griffith and Ms.
      DeGette........................................................   142
    Article of June 18, 2025, ``Medicaid Cuts Threaten To Shutter
      Telehealth Programs Across Health Care System,'' by Cara Smith,
      Inside Health Policy...........................................   143
    Letter from Breast Cancer Prevention Partners, et al., to Mr.
      Guthrie and Mr. Pallone........................................   145
    Letter of July 15, 2025, from Kenneth Mendez, President and Chief
      Executive Officer, Asthma and Allergy Foundation of America, to
      Mr. Guthrie and Mr. Pallone....................................   147
    Article of April 17, 2025, ``HHS eliminates advisory committee on
      newborn screening ahead of vote on rare disorders,'' by Aria
      Bendix, NBC News...............................................   150

        LEGISLATIVE PROPOSALS TO MAINTAIN AND IMPROVE THE PUBLIC HEALTH
            WORKFORCE, RURAL HEALTH, AND OVER-THE-COUNTER MEDICINES

                                  ----------

                            WEDNESDAY, JULY 16, 2025

                      House of Representatives,
                                Subcommittee on Health,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:00 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, Harshbarger,
    Bilirakis, Carter of Georgia, Dunn, Crenshaw, Joyce, Balderson,
    Miller-Meeks, Obernolte, Bentz, Kean, Rulli, Guthrie (ex
    officio), DeGette (subcommittee ranking member), Ruiz, Dingell,
    Kelly, Barragan, Schrier, Veasey, Fletcher, Ocasio-Cortez,
    Auchincloss, Carter of Louisiana, Landsman, and Pallone (ex
    officio).
        Also present: Representatives Latta and Fedorchak.
        Staff present: Jessica Donlon, General Counsel; Kristin
    Fritsch, Professional Staff Member, Health; Sydney Greene,
    Director of Finance and Logistics; Jay Gulshen, Chief Counsel,
    Health; Emily Hale, Staff Assistant; Annabelle Huffman, Clerk,
    Health; Megan Jackson, Staff Director; Brayden Lacefield,
    Special Assistant; Molly (Brimmer) Lolli, Counsel, Health;
    Sarah Meier, Counsel and Parliamentarian; Joel Miller, Chief
    Counsel; Seth Ricketts, Special Assistant; Jackson Rudden,
    Staff Assistant; Emma Schultheis, Policy Analyst, Health; Lydia
    Abma, Minority Policy Analyst; Shana Beavin, Minority
    Professional Staff Member; Keegan Cardman, Minority Staff
    Assistant; Waverly Gordon, Minority Deputy Staff Director and
    General Counsel; Tiffany Guarascio, Minority Staff Director;
    La'Zale Johnson, Minority Intern; Elizabeth Kittrie, Minority
    Health Fellow; and Una Lee, Minority Chief Counsel, Health.
        Mr. Griffith. The Subcommittee on Health will come to
    order, and I will take first a brief moment for a point of
    personal privilege.
        This is my first hearing as the new subcommittee chair, but
    I would be remiss if I didn't recognize the great work that my
    colleague Buddy Carter did.
        I understand he is trying to get a demotion and go over to
    the Senate, and I wish him well in that endeavor. But it made
    it so that he had to step aside. But that does not mean he is
    not going to be an integral part of the running of this
    committee and of the philosophies and policies that he has
    championed.
        I think we are in agreement at least 99.9 percent of the
    time. And I will look to him for help and guidance on a number
    of the issues.
        So thank you, Buddy. We appreciate your service.
        [Applause.]
        Mr. Griffith. That said, I now recognize myself for 5
    minutes for an opening statement.

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

        Today's legislative hearing is necessary to continue
    essential programs that are vital to our healthcare
    infrastructure. Many of the bills before us expire at the end
    of this fiscal year and must be reauthorized.
        One of the bills that will be discussed today is H.R. 4273,
    the Over-the-Counter Monograph Drug User Fee amendments, led by
    Mr. Latta and Ranking Member DeGette.
        The Coronavirus Aid, Relief, and Economic Security--CARES--
    Act, which passed in 2020, modernized the regulation of over-
    the-counter monograph drugs and products. It also created a new
    user fee program to support this new framework, also known as
    O-M-U-F-A, or colloquially, OMUFA.
        And I hope I pronounced the colloquialism right. But it is
    another one of those fees that we have that make important
    things happen.
        Generally a company can market an over-the-counter drug if
    they either submit a new drug application or go through the
    over-the-counter monograph process. Prior to 2020, that
    involved a lengthy, burdensome, three-phase rulemaking process.
        This led to Congress creating a new regulatory framework
    that allows FDA to issue administrative orders determining a
    product is generally recognized as safe and effective--or
    GRASE--and simultaneously establishing a new user fee program
    to help ensure this process is effective and is streamlined.
        This is the first reauthorization of OMUFA. We hope to work
    in a bipartisan way to address any outstanding issues to ensure
    this program is functioning how Congress initially intended,
    including minimizing regulatory burdens, supporting innovation,
    and increasing access to products in a safe and efficient
    manner.
        We will also consider other legislation that will help
    encourage the FDA to be more flexible in their review process.
        H.R. 3686, the SAFE Sunscreens Standards Act, led by Dr.
    Joyce and Mrs. Dingell, would require the FDA to consider the
    use of certain real-world, evidence-based, and nonanimal
    testing methods when it comes to evaluating new sunscreen
    active ingredients in the United States.
        We are behind other countries in bringing innovative
    sunscreens to the market, and this bill will help to bridge the
    gap. During our last hearing on OMUFA we had a robust
    discussion about the need for more innovative sunscreens to be
    available in the United States, and I look forward to the
    discussion around these policies today.
        Along similar lines, the FDA must keep pace with current
    technological advancements, which includes greater utilization
    of nonanimal testing methods. H.R. 2821, led by Representatives
    Carter and Barragan, would help support FDA's efforts to do
    just that.
        Congress gave the FDA the ability in 2022, when FDA
    Modernization 2.0 was signed into law, but the FDA has failed
    to fully implement these practices. This legislation would
    require the FDA to finally update its regulations to account
    for nonanimal testing.
        This bill does not require--does not require--nonanimal
    testing. It simply provides an option that--if companies wish
    to pursue less costly methods, such as computer AI modeling or
    organ chip testing.
        There are also two important reauthorizations in front of
    us today that serve a vital role in helping our medical
    workforce, which are the Title VII and Title VIII
    reauthorizations.
        These programs allocate resources for scholarships and
    educational assistance so students from underserved
    backgrounds, who are often from rural areas, can pursue medical
    careers and help support the medical workforce that Americans
    widely rely upon.
        It is crucial for Congress to take a close look at these
    programs to ensure resources are going to areas and patients
    who need it most.
        We are also discussing legislation that will continue
    grants for certain healthcare services in rural areas to help
    to increase the use of telehealth, so patients can access care
    more easily. Reauthorizing the Telehealth Resource Centers
    Grant Program will support our telehealth infrastructure that
    has become a lifeline for both providers and patients across
    the country, especially in rural areas.
        Considering each of these reauthorizations is an important
    step forward to ensure the program is working as intended. I
    look forward to hearing from our witnesses today regarding the
    importance of these programs and to ensure that they are
    reauthorized in a timely manner.
        That said, I would also say that the Health Subcommittee
    has great advantages in many ways, one of those being that when
    somebody is sick or needs healthcare, they don't look at what
    party they identify with or what their philosophical background
    is.
        This subcommittee has a long history--and I hope to be a
    part of continuing that long history--of doing bipartisan work
    for the betterment of the American people and the American
    patients.
        And I know that my colleague, the ranking member, Ms.
    DeGette, feels the same way. We have worked on issues over the
    years that I have been in Congress. And I appreciate the
    opportunity to work with you as the ranking member.
        [The prepared statement of Mr. Griffith follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. And I now recognize Ms. DeGette for her 5-
    minute opening.

     OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF COLORADO

        Ms. DeGette. Thank you so much. And I want to congratulate
    you, Chairman Griffith, on your new role as chair of this
    subcommittee.
        We have worked together on the Oversight Subcommittee with
    Mr. Griffith as chair, with me as chair, and most days we got
    along. We at least agreed on parliamentary procedure, and there
    is that.
        Mr. Griffith. Absolutely.
        Ms. DeGette. So we have worked a lot together over the
    years. We do have our ideological differences, which we
    discuss, because we represent very different constituencies.
        But as you have heard, we do share a belief in this
    committee, in this institution, and we believe that we must
    achieve good things for the American people when it works
    effectively.
        And we want our constituents to live longer and healthier
    lives. That is what this is about.
        So today we are considering important legislation to
    reauthorize FDA's over-the-counter medicines program, critical
    health workforce development programs, and more.
        I am particularly proud of our past work on over-the-
    counter medicines, and the chairman mentioned this briefly.
    Five years in, we have seen early successes.
        I want to thank my colleague from Ohio, Mr. Latta--I don't
    see him here--for introducing the legislation with me for this
    first reauthorization of the over-the-counter medicines
    program, and I look forward to seeing continued success of the
    program in the next 5 years.
        We were supposed to do this last week, but the Republicans
    postponed it because I guess they were celebrating the passage
    of, frankly, the worst piece of legislation, both in process
    and substance, that I have seen in my time in Congress.
        The Republicans jammed through the Big Bad Bill and its
    handouts to the wealthiest Americans literally under the cover
    of night, including in our committee, while real legislating to
    help our constituents was nonexistent.
        Between cuts to Medicaid and the Affordable Care Act and
    the choice not to extend tax credits for healthcare coverage,
    17 million people will now be without health insurance.
        I don't see anything beautiful in that. I don't see
    anything that is going to help the health of Americans.
        I think the law rolls back much of the progress that we
    have made in getting people enrolled early in healthcare when
    we passed the Affordable Care Act in the first place.
        Medicaid expansion was a lifeline to hospitals struggling
    to keep their doors open, not just for poor people but for
    everybody in their community, and now, faced with a financial
    cliff, many of those hospitals might close.
        So just last week, during our unplanned recess, I visited a
    Planned Parenthood clinic in my district that can no longer
    serve individuals covered by Medicaid for routine--not
    abortions--but for routine medical exams like Pap smears,
    breast exams.
        They have already had to cancel hundreds of appointments
    for people coming into these things, and these are people who
    are not going to be able to find doctors anywhere else.
        Frankly, these cuts are just mean. They don't save money.
    And my colleagues across the aisle have preached for decades
    about fiscal responsibility. But I guess that giving
    billionaires more tax cuts and kicking millions of Americans
    off their healthcare is more important.
        The Big Bad Bill makes our mounting national debt even
    worse, increasing it by trillions of dollars to finance these
    tax cuts, and now much of it is law.
        Much of it won't go into effect for years. So I hope that
    we could work together in a bipartisan way to clean up this
    mess of a law before it hurts more people--and apparently so
    does Senator Hawley, who after voting for the law just 2 weeks
    ago introduced a bill that would reverse many of the cuts in
    Medicaid that he just voted for.
        So, I mean, I pride myself in working in a bipartisan way
    on bills that will improve the health of our constituents and
    of all Americans. But I feel, and all of my colleagues on this
    subcommittee feel, that we have been frozen out of the work of
    this subcommittee from the beginning of the year, from issues
    that should be noncontroversial, to the Big Bad Bill that we
    just passed a couple of weeks ago.
        And so let's turn a new page, Mr. Chairman. Let's have a
    new era in our committee and go back to what we used to do,
    working together in a bipartisan way.
        I yield back.
        [The prepared statement of Ms. DeGette follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. The gentlelady yields back.
        I now recognize the chairman of the full committee,
    Chairman Guthrie, for 5 minutes for his opening statement.

     OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
               CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

        Mr. Guthrie. Thank you, Chairman Griffith. I congratulate
    you on your new role, and excited as you lead your first Health
    Subcommittee hearing today as chairman.
        And I thank all the witnesses for being here before us
    today.
        I think Representative Carter had to run upstairs. There
    are two hearings kind of going on today upstairs. So I just
    want to commend him on his excellent work as we talked about
    yesterday, and point out--I want to say this correctly because
    I don't want to be misquoted, that he was at the funeral of his
    granddaughter's cousin--so it was not his granddaughter--his
    granddaughter's cousin, who all three of them were at Camp
    Mystic.
        And, fortunately, his granddaughter survived, but so sad
    for the Hunt family in the loss of their--and all the others.
        Buddy did a great job leading this committee, and he is
    going to continue to help Americans from a new role he is
    seeking here in Washington, DC. I am excited for him.
        But we are here today to discuss the reauthorizations of
    FDA's Over-the-Counter Monograph Drug User Fee Program, known
    as OMUFA, as well as several health workforce and rural
    healthcare programs administered by HRSA, which are all set to
    expire on September 30 of this year.
        This is the first reauthorization of OMUFA, and I look
    forward to hearing from the FDA's Dr. Jacqueline Corrigan-
    Curay--I think that is correct--on the implementation of the
    program and outcomes of the first 5 years of the program.
        The original bill reformed the regulation of over-the-
    counter drugs, products that so many of us and our constituents
    use every day, to reduce the bureaucracy, increase
    transparency, and allow innovation to flourish.
        The safety and efficacy of these products is critical,
    which is why reauthorizing this program in a timely manner is
    so important.
        And I am also looking forward to hearing from our witnesses
    about ways we can improve participation in the healthcare
    workforce and increase access to care in rural areas.
        Rural areas, like my home State of Kentucky, face a unique
    set of challenges, ranging from limited access to emergency
    services and specialized medical care, to higher rates of
    chronic conditions like high blood pressure and obesity.
        It is imperative for lawmakers to understand these nuances
    and ensure Federal support is targeted to those areas that need
    it the most.
        I am hopeful that this hearing will provide us with an
    update on how these various programs are operating and any gaps
    that may need be addressed to streamline and improve healthcare
    outcomes.
        I appreciate my good friend from Colorado as she ended her
    opening statement saying that it is time for us to find
    opportunities to work together. I believe this is one of those
    great opportunities, and we will have others.
        Some of the great pieces of legislation that are lasting
    and standing came out of this committee, like Cures. You worked
    with Cures with our previous chairman, Fred Upton, and
    hopefully we can follow some of those pathways and find ways to
    work together.
        When we were on the other side of this majority, on the
    minority side, we had issues that we didn't support that came
    out in a partisan way, but we found ways to work together, and
    I know that we will be able to do that on other issues as well.
    So thank you for that.
        And I thank the witnesses for your participation today, and
    I look forward to today's discussion and working together.
        And I will yield back.
        [The prepared statement of Mr. Guthrie follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. The gentleman yields back.
        I now recognize the ranking member of the full committee,
    Mr. Pallone, for 5 minutes for an 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. Congratulations on
    your new post. I have always believed that the Health Committee
    was one of our most important subcommittees.
        Now, I know we are here today to discuss several pieces of
    health legislation, but we can't forget that Republicans just
    cut more than a trillion dollars from our healthcare system and
    17 million Americans stand to lose their health insurance. That
    is an increase in our Nation's uninsured rate of more than 50
    percent.
        These are people who will not have access to the healthcare
    they need, who will get sicker, who will be overwhelmed with
    medical debt, and, sadly, some may die sooner.
        Moreover, hundreds of hospitals, nursing homes, and home
    care providers will be forced to close.
        We heard from hospitals, doctors, the elderly, and people
    with disabilities who have lined our hallways and this hearing
    room pleading for their healthcare.
        We heard from families who are afraid of falling farther
    and further behind, from patient groups who fear for people
    with cancer, substance use disorders, and countless others.
        But Republicans ignored these concerns. They will literally
    do anything, including taking healthcare away from their own
    constituents, to give giant tax breaks to the ultrarich who do
    not need them.
        And with that said, we are here to discuss several pieces
    of legislation.
        First, we are considering the bipartisan reauthorization of
    the Over-the-Counter Monograph Drug User Fee Program.
        Congress authorized this program in 2020 because of the
    need to more quickly provide safe and effective over-the-
    counter drug products to consumers. I was vocal in my concerns
    at the time that the FDA OTC program was drastically
    underresourced. We gave FDA the authorities and resources it
    needed to allow the program to keep up with evolving science
    and technology and introduction to new formulizations for
    consumers.
        The authorization also allowed FDA the ability to more
    swiftly revise or update monographs in response to safety
    concerns, and this was critical to ensuring the products that
    consumers use are safe. And that is why I have concerns with
    the sunscreen bill.
        As drafted, the sunscreen bill undermines the existing
    bedrock safety and efficacy framework set forth in statute.
    However, I look forward to continuing bipartisan discussion to
    get to a solution that provides more options for consumers
    while ensuring that those options are safe and effective.
        We also consider today the FDA Modernization Act 3.0, which
    would require the agency to publish a final rule on alternative
    testing methods. And I am pleased to hear from FDA that we will
    continue to see guidance come out of the agency, as we have in
    the past, unimpacted by Trump's 10-for-1 Executive order.
        We will also discuss important workforce reauthorizations,
    including the reauthorization of many of the Health Resources
    and Services Administration's Title VII and Title VIII health
    professions development programs.
        We continue to face nationwide shortages in health
    providers, and continuing all of the Title VII programs is
    essential to creating a robust network of providers.
        Similarly, the Title VIII programs address all aspects of
    the nursing workforce, from education and recruitment to
    practice and retention. As the nursing shortage continues to
    grow, it is imperative that we reauthorize all of these crucial
    programs to support the nursing workforce.
        Despite their proven track record in bolstering the health
    workforce, some of these important programs may be eliminated
    by the Trump administration because they include words like
    ``diversity'' and ``representation.'' In reality, what these
    programs are doing is helping us build a health workforce that
    is actually reflective of our country and is large enough to
    meet the needs of all of our communities.
        Eliminating these programs will only exacerbate the health
    workforce shortages, and vulnerable communities will suffer the
    most.
        We are also examining a few bills that support parents and
    infants across the country, including reauthorization of the
    Healthy Start Program.
        This program partners with local providers to improve
    health outcomes before, during, and after pregnancy, with the
    ultimate goal of reducing infant mortality and lowering rates
    of preterm birth, low birth weight, and maternal illness. I am
    pleased to see it included in this hearing and want to stress
    the importance of reauthorizing this program for the future.
        And relatedly, we are considering legislation that will
    reauthorize the newborn screening program. While I am concerned
    the Trump administration is disbanding the advisory committee
    that supports this life-saving work, by reauthorizing this
    committee and program we will show that Congress stands with
    families nationwide who rely on this critical program.
        So thanks again to the witnesses for being here. I look
    forward to the discussion.
        And with that, our new chairman of the subcommittee, I
    yield back the balance of my time.
        [The prepared statement of Mr. Pallone follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. The gentleman yields back.
        We now conclude with Member opening statements.
        The chair would like to remind Members that, pursuant to
    committee rules, all Members' opening statements will be made a
    part of the record.
        We want to thank our witnesses for taking the time to
    testify before the subcommittee.
        Although it is not the practice of this subcommittee to
    swear in witnesses, I would remind our witnesses that knowingly
    and willfully making materially false statements to the
    legislative branch is against the law under Title 18, Section
    1001, of the United States Code.
        You will have the opportunity to give an opening statement,
    followed by questions from Members.
        Our witnesses today are Dr. Jacqueline Corrigan-Curay, JD,
    M.D., Acting Director for the Center for Drug Evaluation and
    Research, U.S. Food and Drug Administration.
        Thank you for being here.
        Dr. Candice Chen, M.D., MPH, Acting Associate Administrator
    for Health Workforce, U.S. Health Resources and Services
    Administration;
        And Mr. Tom Morris, MPA, Associate Administrator for Rural
    Health Policy, U.S. Health Resources and Services
    Administration.
        Per committee custom, each witness will have the
    opportunity for a 5-minute opening statement, followed by a
    round of questions from Members. The light on the timer in
    front of you will turn from green to yellow when you have 1
    minute left.
        I now recognize Dr. Jacqueline Corrigan-Curay for 5 minutes
    to give her opening statement.
        The floor is yours.

    STATEMENTS OF JACQUELINE CORRIGAN-CURAY, M.D., ACTING DIRECTOR,
        CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG
       ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES;
     CANDICE CHEN, M.D., ACTING ASSOCIATE ADMINISTRATOR, BUREAU OF
    HEALTH WORKFORCE, HEALTH RESOURCES AND SERVICES ADMINISTRATION,
      DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND THOMAS MORRIS,
     ASSOCIATE ADMINISTRATOR, FERAL OFFICE OF RURAL HEALTH POLICY,
      HEALTH RESOURCES AND SERVICES ADMINISTRATION, DEPARTMENT OF
                       HEALTH AND HUMAN SERVICES

              STATEMENT OF JACQUELINE CORRIGAN-CURAY, M.D.

        Dr. Corrigan-Curay. Thank you very much.
        Good morning, Chair Griffith, Ranking Member DeGette, and
    members of the subcommittee, and thank you for the opportunity
    to speak with you today.
        I want to talk about something that benefits nearly every
    American household: over-the-counter medication. These are the
    products that millions rely on every day--an antiseptic when
    your child has a scrape, antihistamines when our pollen count
    goes up, or an antacid after a large meal.
        They are trusted, they are essential, and they must be
    safe, effective, and up to date. That is where the OTC
    Monograph User Free Program, or OMUFA, comes in.
        Prior to 2020, our ability to regulate OTC drugs hadn't
    been modernized in decades. It was slow, outdated, and
    inflexible. Reform was overdue.
        When Congress passed OTC monograph reform as part of the
    CARES Act, it was a bipartisan success that has brought real
    change. Critically, the user fees that Congress authorized,
    OMUFA, are what facilitated and supported OTC monograph reform
    and has set this program up for success.
        Now, with congressional support and timely reauthorization,
    we have the opportunity to realize the full potential of OTC
    monograph reform, ensuring a more nimble regulatory process,
    fostering innovation to better serve patients and consumers,
    and enhancing transparency and accountability from FDA and the
    industry.
        So what have we accomplished?
        In just 5 years, OMUFA has helped FDA modernize the OTC
    drug review process, transforming it from a paper-heavy
    rulemaking system to a responsive electronic one.
        We delivered five key guidances. These provide clarity to
    manufacturers and enhance public health protection.
        We posted 33 final administrative orders and five proposed
    administrative orders, providing transparency to manufacturers
    on what is expected to legally market a particular OTC drug.
        And I want to highlight one recent proposed order, because
    we believe it can really foster some exciting innovation for
    children and families.
        If finalized, this order would let companies create new,
    easier-to-take forms of OTC medications, like chewable tablets,
    tablets that melt in your mouth, and thin films. These would be
    for certain medications that currently only come as tablets and
    capsules, and would help people who have trouble swallowing
    those meds.
        OMUFA has also helped us hire 85 dedicated staff members.
    These are scientists, safety reviewers, and regulatory experts
    who help ensure that the products on our shelves are safe and
    effective.
        And, importantly, it has opened the door to more innovative
    products, like new sunscreen ingredients, through the new
    administrative order process.
        If Congress does not reauthorize OMUFA this year, that
    momentum will come to a grinding halt. The impact would be
    immediate and damaging.
        Engagement on development programs and activities to
    oversee the safety and quality of OTC monograph products would
    slow or stop as dozens of FDA staff and clinical quality and
    safety experts would lose their jobs.
        Critical progress on the proposed and final orders from our
    FDA monograph forecast would be shelved, and these include
    essential updates on labeling drug fact ingredients, including
    for products intended for pregnant women and children.
        No new agreements from the recent commitment letter could
    be implemented, including important steps like improving
    meeting management with sponsors and more quickly assessing the
    quality of facilities bringing new OTC products to the U.S.
    market.
        And perhaps most concerning, we risk sliding backwards,
    losing the transparency, predictability, and innovation that
    OMUFA was designed to create.
        Without reauthorization, the system that was finally fixed
    can begin to fail.
        The recently negotiated agreement for the next 5 years of
    OMUFA includes smart, achievable goals. We are going to
    increase opportunities for industry-FDA interactions to foster
    innovation, improve transparency of the User Fee Program,
    invest in product quality and safety, and continue to publish
    the annual guidance forecast that gives industry and public
    health stakeholders a clear roadmap for the future.
        These aren't just words. They are a commitment to the
    public, a commitment to keep this progress going.
        Every delay in regulation or review affects real people.
    Without OMUFA, innovations are stalled, safety improvements are
    delayed, and consumers may unknowingly continue to use products
    that haven't been adequately reviewed with modern science.
        In closing, Congress made a smart investment in 2020 when
    it created OMUFA. That investment is paying off, but we can't
    stop now. Reauthorizing OMUFA means continued modernization,
    supporting innovation and, most importantly, keeping American
    families safe.
        Thank you, and I look forward to your questions.
        [The prepared statement of Dr. Corrigan-Curay follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. The gentlelady yields back.
        I now recognize Dr. Chen.

                    STATEMENT OF CANDICE CHEN, M.D.

        Dr. Chen. Chairman Griffith, Ranking Member DeGette,
    members of the subcommittee, thank you for the opportunity to
    testify on behalf of the Health Resources and Services
    Administration and to speak about our critical----
        Mr. Griffith. If you could move your mic a little closer so
    we can get a little bit louder.
        Yes, thank you.
        Dr. Chen. Is that better? OK.
        My name is Candice Chen. I am the Associate Administrator
    of the Bureau of Health Workforce. I am also a pediatrician,
    and for most of my career I have practiced primary care in a
    children's health center about 5 miles from here in southeast
    Washington, DC.
        The health workforce faces significant challenges, and when
    communities face health workforce shortages, access to care,
    quality, and costs are all negatively affected.
        HRSA's National Center for Health Workforce Analysis is the
    leading Federal entity that collects, analyzes, and reports on
    the U.S. health workforce. Our National Center conducts
    workforce projections on over a hundred healthcare occupations,
    the majority of which are projected to face shortages in the
    next 10 to 15 years.
        These include a shortage of over 87,000 primary care
    physicians, 210,000 nurses, or RNs, and over 400,000 behavioral
    health providers.
        And we know this workforce is poorly distributed across the
    U.S., with rural and other underserved communities experiencing
    the greatest shortages.
        HRSA's health workforce programs aim to address these
    shortages across the U.S. Through scholarship and loan
    repayment programs, we support the recruitment and retention of
    critical healthcare professionals in rural and underserved
    areas.
        One of our best known programs is the National Health
    Service Corps, which offers scholarship and loan repayment to
    primary care, oral health, and mental health professionals in
    exchange for at least 2 years of clinical service in a health
    professional shortage area.
        The program has a specific focus on supporting the
    substance use disorder workforce as well as rural and Tribal
    communities, and it is in high demand.
        In fiscal year 2024, the National Health Service Corps
    received over 14,000 applications and made nearly 7,000 awards.
    And due to the multiyear service commitments, the National
    Health Service Corps is currently supporting over 17,000
    healthcare professionals, providing healthcare in every State
    and the District of Columbia and in the U.S. territories.
        The Nurse Corps Program similarly is an important
    scholarship and loan repayment program that supports nursing
    students and nurses in practice who commit to work in
    healthcare facilities in underserved communities. These include
    primary care clinics, hospitals, nursing home settings, many
    other settings.
        The Nurse Corps Program also provides loan repayments for
    nurse faculty, an area of the workforce that our schools of
    nursing have told us is particularly challenging to recruit
    for. The faculty are essential to train the future workforce.
        In fiscal year 2024, the Nurse Corps Program received
    nearly 10,000 applications and made 1,200 awards.
        The Teaching Health Center Graduate Medical Education
    Program funds 81 primary care residency programs in community-
    based settings across the Nation.
        Seventy-five percent of teaching health centers are in
    Federally Qualified Health Centers, and this year the Teaching
    Health Center Program is supporting just over 1,200 medical and
    dental residents.
        The program has a strong track record. Eighty-five percent
    of graduates go on to practice in medically underserved
    communities.
        HRSA is also focusing on the critical behavioral health
    workforce needed to address mental and behavioral health
    disorders, including substance use disorders, that is rising in
    communities across the Nation.
        Behavioral health workforce programs provide grants to
    support the training of behavioral health professionals. These
    programs increase the number of students and graduates, they
    enhance curriculums, they train for rural and underserved
    communities, and they promote the team-based behavioral health
    integrated with primary care that is really needed.
        Last year, the Behavioral Health Workforce Program
    supported the training of over 11,000 individuals and graduated
    over 7,000 new behavioral health providers.
        I know at the start of my testimony I shared that I am a
    primary care pediatrician, but I should also share that I have
    personally benefited from these HRSA programs, which supported
    my training and career.
        And as a healthcare provider and a beneficiary of these
    programs, I know firsthand how important both the health
    workforce and these programs are to the health and well-being
    of American communities.
        I and my colleagues at HRSA are deeply committed to
    strengthening the health workforce, addressing the challenges
    and gaps and ensuring that people in all communities across
    America have access to high-quality healthcare providers.
        Thank you for this opportunity and for the committee's
    bipartisan support for the health workforce programs. I look
    forward to your questions.
        [The prepared statement of Dr. Chen follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. Thank you very much.
        I now recognize Mr. Morris for his 5 minutes for an opening
    statement.

                       STATEMENT OF THOMAS MORRIS

        Mr. Morris. Chairman Griffith, Ranking Member DeGette,
    members of the subcommittee, thank you so much for the
    opportunity to testify today on behalf of the Health Resources
    and Services Administration, an agency within the U.S.
    Department of Health and Human Services.
        As someone who has worked in rural health for more than 25
    years, I am honored to have the opportunity to talk about the
    importance of reauthorizing congressional programs that provide
    essential services and telehealth services to rural and
    underserved areas, addressing important challenges like
    addressing chronic disease.
        The challenges facing rural communities are well known. We
    see higher rates of mortality, lower life expectancy, higher
    rates of chronic disease, and also challenges of recruiting and
    retaining the needed doctors, nurses, and other clinicians in
    rural communities.
        There are also structural challenges, such as geographic
    isolation, limited clinical infrastructure, and higher poverty.
        Despite all these challenges, rural communities are
    amazingly resilient, creative, and innovative in leveraging the
    resources they have to develop innovative approaches to address
    their unique needs.
        I saw this firsthand living in rural eastern North Carolina
    during the early part of my career. I have seen that same
    dynamic play out time and again in the many rural and Tribal
    communities I have had the benefit of visiting during my time
    at HHS. I appreciate the opportunity to talk to you today about
    these programs.
        It was in the late 1990s that Congress had the foresight to
    create several new grant and telehealth programs, and they were
    really worth noting the creativity that you brought to this
    need, in the sense that there was a lot of flexibility built
    into all of these programs.
        And I think that is really important because you want to
    make sure the programs can meet the needs of the community in
    the Upper Midwest and Great Plains as easily as it does in the
    Deep South or the Mountain West.
        This emphasis on flexibility ensures that communities can
    come up with their own solutions that meet their unique
    identified needs.
        I believe the Rural Health Care Services Outreach Program
    is a real success story. This program has helped rural
    communities increase access to primary care, behavioral health,
    and oral healthcare services. We have seen it improve outcomes
    for patients with diabetes, heart disease, and hypertension.
        We have also been able to help provide funding to help
    hospitals work with local health departments, community health
    centers, rural health clinics to form networks of care that
    better serve their rural regions.
        And we have also seen it be used to expand access to
    services otherwise not available. Examples like this include
    pulmonary rehab and medication-assisted treatment, just to
    identify a few.
        All told, more than 500,000 rural residents across more
    than 300 rural communities received services through these
    grants in our most recent cohort.
        Telehealth, as the committee knows, is also an important
    lifeline for rural communities. It helps bridge time and
    geographic distances to link rural residents to healthcare
    otherwise not available in their community.
        For more than 30 years, HRSA has been able to invest in
    telehealth networks thanks to Congress' ongoing support.
        These grants bring together all the key partners. That is
    including the specialists at academic health centers, working
    with rural hospitals, community health centers, all with an eye
    towards bringing care to where the patients are.
        I have seen this link rural residents to services such as
    behavioral health, cardiology, neurology, dermatology, that
    otherwise they would have had to drive long distances to get
    to.
        It has created telestroke programs that provide really
    important timely care for those at risk of serious stroke
    damage, and it has helped connect patients getting services in
    their home.
        I think the common link in all of these programs is a
    commitment to its community partners working collectively to
    address their unique challenges.
        I have seen these programs continue on well after the
    Federal funding, and I think that is because all the partners
    have a stake in the ongoing success of the program.
        We thank you for your consideration of the reauthorization
    of these programs. We look forward to working with you on any
    questions you might have about them. And I thank you for the
    opportunity to be here today and look forward to your
    questions.
        [The prepared statement of Mr. Morris follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

        Mr. Griffith. The gentleman yields back.
        We will now begin questioning. I ask that Members not begin
    a new question to our witnesses as their 5 minutes is about to
    expire. I would encourage Members to use that process where
    they can submit written questions for the record.
        I now recognize myself for 5 minutes.
        Dr. Chen, in your written testimony you mentioned our
    country will have a shortage of over 87,000 primary care
    physicians and nearly 210,000 nurses by 2037. And these
    shortages are not evenly distributed. They are especially acute
    in rural areas, like the area I represent.
        I understand there are common challenges shared by multiple
    types of communities.
        Given this disparity that you highlighted, would it make
    more sense to better target our Title VII and Title VIII
    resources to include geographic need instead of just looking at
    that based on race or ethnicity, as some of the programs are
    currently operating?
        Dr. Chen. Thank you for the question, and it is a very good
    question, particularly as I sit here next to the head of the
    Federal Office of Rural Health Policy.
        Rural health workforce faces significant and very unique
    challenges, and it does take intentionality in addressing rural
    health workforce shortages.
        I would say Tom Morris is probably one of the people that I
    work the most with at HRSA to coordinate some of our programs.
        However, there are ongoing workforce challenges in urban
    and suburban communities. For example, out of that 87,000-
    primary-care-physician shortage that we are projecting, 18,000
    of that is in rural communities, 69,000 is actually in nonrural
    communities.
        And so it really does require that we consider all
    communities and all communities facing those challenges.
        Mr. Griffith. I appreciate that. And you mentioned the
    National Health Service Corps and the Nurse Corps in your
    opening statement, and I have got one of these curious
    questions that comes to me when witnesses are testifying.
        Did you grow up in the DC area?
        Dr. Chen. I did. I grew up----
        Mr. Griffith. OK. Because one of the things I love about
    the--I call it the ``Northern Exposure'' model that the
    National Health Service Corps--for those who don't know, it is
    an old TV show where a doctor goes to Alaska because he needs
    to pay off his student loans and he goes up there with a 5-year
    commitment.
        And it was a nice show, but it also shows how sometimes you
    go to another place and you end up staying. And that is why I
    was curious as to what area you had originally come from. I was
    thinking maybe you came to DC because of the National Health
    Service Corps. But we are glad you are here.
        That said, do you think we need to authorize more funding
    for the National Health Service Corps and the Nurse Corps in
    order to expand those opportunities for rural and underserved
    areas?
        Dr. Chen. We defer funding decisions to Congress, of
    course. However, as I mentioned, the National Health Service
    Corps is able to award about 50 percent.
        The Nurse Corps is only able to award about 6 percent of
    all new applications in a year. So there is a lot of
    opportunity there.
        Mr. Griffith. Yes, and of course this committee only can do
    authorization. We can't do the actual expenditure. That goes to
    Appropriations. But I appreciate that.
        Mr. Morris, love you are talking about telehealth. I have
    always loved telehealth. And, in fact, I carried the House
    version of the telestroke bill when it first came forward.
        The resource centers, the telehealth resource centers,
    which we are looking to reauthorize in the bills today, serve a
    vital role across the country, especially in rural areas like
    my district.
        The University of Virginia is currently the resource center
    for my district and all the Mid-Atlantic. Does HRSA distribute
    resources based on need, or are the allocations the same for
    each center?
        Mr. Morris. For our Telehealth Network Grant Program, like
    many of our programs, it is a combination of those things.
    Certainly need is a key factor in it, but we also want to make
    sure they have a viable work plan to move forward and that they
    have the personnel necessary to carry it out. So it is a
    combination.
        Mr. Griffith. OK. I appreciate that.
        The University of Virginia has experienced a 24 percent
    increase in telehealth visits from their program from fiscal
    year 2024 to fiscal year 2025.
        As we look to extend telehealth flexibilities and coverage,
    do you think that we need to expand the number of centers that
    we have, thus reducing the geographic footprint that each
    center serves?
        Mr. Morris. Well, thank you for the question.
        It is interesting, we have been focusing on telehealth in
    rural areas for more than 30 years. And your record goes back,
    I think--I talked to Karen Rubin yesterday--back to the mid-
    1990s when you were advocating for this.
        And so with the pandemic, we saw the benefits of telehealth
    universally. And so the technology is getting less expensive
    each year. You can now use a personal computer.
        And so we are moving less from a hub-and-spoke model to a
    distributed. And so the more access points, the better. It can
    be in your home. It can be in the clinic. It is a continually
    evolving technology, but it is certainly being tailored more to
    the patient. So the more access points, the more access.
        Mr. Griffith. All right. I appreciate that.
        And we all lost friends. I lost a dear friend in the COVID
    crisis. The one thing that came out of that was healthcare
    providers suddenly realized that telehealth was not as alien as
    they originally thought, and it was greatly expanded, and we
    should continue that.
        I see that I am out of time. I was about to start a
    question and I can't do that. I said that myself.
        So I yield back and now recognize the ranking member of the
    subcommittee, Ms. DeGette, for her 5 minutes of questions.
        Ms. DeGette. Thank you so much, Mr. Chairman.
        And, Dr. Corrigan-Curay, I want to thank you for your work
    on OMUFA and thank you for your testimony today. I do think
    that this is something--we have worked on it for many years.
    And when I would talk to my constituents about over-the-counter
    drugs, they couldn't believe that we weren't regulating them.
        So I am glad the program is working, and I do think this is
    something that we can absolutely get moving quickly so that it
    can be reauthorized by the end of the year.
        Dr. Chen, I want to talk to you a little bit more about
    Title VII and the issues that we are having in training new
    healthcare workers.
        The chairman talked about shortages in rural areas, and
    that is a real problem, but in districts like mine--my district
    is the city and county of Denver--we have challenges with some
    of our local community health centers in underserved areas as
    well.
        Is this what we see nationwide, is there can be shortages
    everywhere?
        Dr. Chen. No, absolutely. We are facing, as I said,
    significant overall shortages in a number of different
    occupations, but it is almost always in our rural and
    underserved. And community health centers obviously are
    designed to serve underserved communities that have the hardest
    times recruiting and retaining.
        Ms. DeGette. Yes, and I think it is about 75 million people
    live in a primary-care-shortage area in this country. So it is
    a real problem. Is that right?
        Dr. Chen. Yes, that is correct.
        Ms. DeGette. It is about 22 percent of the country lives in
    an area without a bare minimum necessary primary care
    physician. That is not even including the nurses or the mental
    health professionals, right?
        Dr. Chen. That is correct, yes.
        Ms. DeGette. So here is my question: How many additional
    physicians do we need to train to eliminate the primary care
    shortages and to get to the bare minimum nationwide?
        Dr. Chen. As I shared earlier, we are projecting that for
    primary care physicians by 2037 we are facing a shortage of
    87,000.
        Ms. DeGette. We need 87,000 by 2037? So that means we have
    got a lot of work to do.
        Now I want to talk about something that is becoming even
    more of an issue for me and most of the people on this
    subcommittee.
        We have an acute shortage of geriatricians now, which is
    alarming at how fast the population is aging. Is that correct?
        Dr. Chen. Yes, that is correct.
        Ms. DeGette. OK. And that is why Title VII includes
    programs for education and training in geriatrics. Is that
    right?
        Dr. Chen. It does.
        Ms. DeGette. Now, the Title VII geriatrics programs support
    the career development of junior faculty in geriatrics, and
    they help train the primary care workforce on issues relating
    to aging, among other things. Is that right?
        Dr. Chen. Yes, that is correct.
        Ms. DeGette. In the 2022-2023 academic year, over 67,000
    healthcare professionals, students, patients, and caregivers
    received training under the Title VII geriatrics programs. Is
    that right?
        Dr. Chen. I don't know the numbers off the top of my head.
        Ms. DeGette. OK. Do you know how many people received the
    training in the 2023-2024 year?
        Dr. Chen. It should likely be about the same.
        Ms. DeGette. About the same. OK.
        So this year the administration, instead of reporting those
    numbers in the fiscal year 2026 congressional justification for
    HRSA, the administration instead proposed to eliminate Title
    VII geriatrics programs, and I think that is kind of the wrong
    way to go. I think Congress needs to double down on this work.
        So, Mr. Chairman, that is one thing I want to talk to you
    about, is the geriatrics program.
        In academic year 2022-2023, 59 percent of the graduates who
    received one of the scholarships worked or trained in medically
    underserved communities 1 year after graduation, and 30 percent
    in primary care settings.
        So I want to ask you, Dr. Chen, are students who go to
    school with this kind of a scholarship more likely to work in a
    medically underserved area after graduation?
        Dr. Chen. We do find that across our programs that students
    that are supported by either our grant programs or our
    scholarship programs are more likely to practice in high-need
    specialties as well as----
        Ms. DeGette. Yes, I am sorry. This is the Scholarships for
    Disadvantaged Students program.
        Dr. Chen. Oh, OK.
        Ms. DeGette. I am sorry, I apologize, I skipped a line.
        Dr. Chen. Yes, yes, absolutely.
        Ms. DeGette. OK. And how many--have any Scholarships for
    Disadvantaged Students grants been awarded this year?
        Dr. Chen. We did not award Scholarships for Disadvantaged
    grants this year.
        Ms. DeGette. Why is that?
        Dr. Chen. We did have competitions that were canceled. And
    with those canceled competitions, we did not make----
        Ms. DeGette. Those were canceled by the Trump
    administration?
        Dr. Chen. Well, the funding decisions were made across the
    administration between the agency, the Department, OMB----
        Ms. DeGette. And DOGE?
        Dr. Chen. I cannot speak to DOGE.
        Ms. DeGette. OK. Thank you.
        Thank you, Mr. Chairman.
        Mr. Griffith. The gentlelady yields back.
        I now recognize the chairman of the full committee, Mr.
    Guthrie, for his 5 minutes of questions.
        Mr. Guthrie. Thank you, Mr. Chair.
        And thank all of you being here today.
        And, Dr. Corrigan-Curay, first, before I get started on my
    question, I see Brian Fahey sitting behind you. And I saw him
    walking around here, and I was just thinking it was normal.
    Then he goes and sits behind you.
        So do you realize you got one of the top healthcare
    staffers from Capitol Hill to join you?
        So I really appreciate Brian's service in my office and on
    our committee and now in his role in the executive branch. So I
    appreciate you having great, great--he is a great--you will
    enjoy working with him. He has two beautiful girls too, so they
    are--I saw him start his young family in my office.
        So, first, I want to start with, I appreciate what FDA has
    done on the work to implement OMUFA over the last 5 years.
        My question: What do you think has been successful with
    OMUFA, and then what would you like to see different?
        Dr. Corrigan-Curay. Under OMUFA I, it was really let's
    build this program and starting from scratch and getting our
    electronic system, getting those foundational guidances,
    getting the staff who could do the work.
        And then by a year, we started to get meetings with
    companies to start innovation, and we received our first new
    OMOR for a sunscreen.
        I think OMUFA II really reflects the learnings from OMUFA
    I. So one is that we need to provide more opportunities for
    innovation, and we are going to do that by certain meetings
    need to go longer if it is a complex question. We are going to
    offer opportunities to look at protocol synopsis.
        We understand there are still questions about the GRASE
    standard, and so we are going to elicit what those questions
    are and do some more education.
        We are going to provide more clarity on when you are doing
    a proposed order for a new active ingredient, including some
    clarity on the confidentiality of the data that comes along
    with that and how we treat that.
        We also understand there is room to grow in the quality
    area of OMUFA. And so one of the things that we are going to do
    is, we are going to try--we are going to staff up and get those
    assessments in new facilities. So a facility comes online and
    starts selling their drug, and we start asking them questions
    and understand their facility.
        And we are also going to release those what we call
    information requests--they are the questions we ask--because
    that gives industry more insight into what we are expecting.
    And of course we will--any warning letters that might come out,
    we will.
        And we are going to update our risk model. So when we are
    deciding where to go for an inspection, it is specific to the
    kind of risk factors we might see in an OTC facility.
        Finally, a lot of transparency we have. So we got our
    indexing up of our older documents. We want to further give
    those documents.
        We are going to have transparency not only around those who
    don't pay their fees, but those who do pay their fees. We are
    going to give transparency around exclusivity.
        And we are generally going to continue to work with those
    companies on innovative. We have some proposed orders, as I
    said, the one about changing the dosage forms. So we are really
    hoping to move forward on that.
        So those are some of the examples. Thank you.
        Mr. Guthrie. Thank you. Thank you for your answer.
        Mr. Morris, I mentioned in my opening statement about rural
    health. Can you elaborate on the metrics HRSA uses to measure
    and improve health outcomes through the Rural Health Care
    Services Outreach Program?
        Mr. Morris. I am sorry, sir. Could you repeat the question?
        Mr. Guthrie. Can you elaborate on the metrics HRSA uses on
    the healthcare program to measure and improve health outcomes
    on rural healthcare services?
        Mr. Morris. And sort of how we measure----
        Mr. Guthrie. In the outreach program.
        Mr. Morris. How we measure the impact of our----
        Mr. Guthrie. How do you measure the impact of that program?
        Mr. Morris. Yes, sir.
        For the Rural Health Care Outreach Program, we look at
    three main areas.
        We track do they improve health outcomes. That is one area.
        We also look at whether they are able to continue the grant
    after--continue the project after Federal funding. Because
    these grants are essentially startup funding. They are not
    ongoing grants in perpetuity.
        So the idea is, we are funding an idea in a community, and
    the hope is that they are going to keep it sustainable. And we
    find that about over 90 percent of the grantees continue the
    project after Federal funding.
        And we do find that, like in our most recent cohort, more
    than 90 percent of the grantees were able to show improved
    health status for the people they served.
        The third area we look at is economic impact, because these
    dollars have a secondary role in these communities. So for
    every dollar invested in our most recent cohort, it generated
    another $2 in economic activity.
        Mr. Guthrie. OK. Thank you.
        And, Dr. Chen, we are estimated to be over 170,000
    physicians short in the next decade. Title VII and Title VIII
    were created to help increase participation in the healthcare
    workforce.
        How can these programs be improved--I have about 30
    seconds--or streamlined to better meet the need, Title VII and
    VIII, to help attract more physicians?
        Dr. Chen. I think the most important thing is that they are
    reauthorized.
        These programs have been very impactful. We find that our
    health profession training programs rely on them to support
    training that is, again, focused on areas of need, whether it
    is specialties and professions that are in need, as well as
    integrating content into curriculum and training, for example,
    behavioral health into primary care, as well as training for
    rural and underserved communities.
        So we do find that these programs are very effective.
        Mr. Guthrie. OK. Thank you.
        My time is expired, and I will yield back.
        Mr. Griffith. The gentleman yields back.
        I now recognize the ranking member of the full committee,
    Mr. Pallone, for 5 minutes of questioning.
        Mr. Pallone. Thank you, Mr. Chairman.
        I wanted to ask a few questions of Dr. Corrigan-Curay.
        First, starting with sunscreen, which is an important topic
    right now at the Jersey Shore, which I represent. For the
    summer of course, everybody uses sunscreen and worries about
    the type.
        At our stakeholder hearing in April, we heard that the
    current review system has caused delays in getting new
    sunscreens to market. We also heard the importance of ensuring
    safety of the product.
        So given those concerns, I don't think that the language in
    the sunscreen legislation we are considering today is the right
    approach. In fact, in a statement from the Environmental
    Working Group, they said, and I quote, that the bill ``would
    lower the bar for sunscreen safety.''
        So, Mr. Chair, I would like to offer the statement from the
    Environmental Working Group on the sunscreen bill into the
    record.
        Mr. Griffith. Without objection, so ordered.
        [The information appears at the conclusion of the hearing.]
        Mr. Pallone. Thank you, Mr. Chairman.
        So, Dr. Corrigan-Curay, from what I can tell, because they
    are regulated as drugs, for sunscreen products to come to
    market FDA requires rigorous safety data.
        What are some of the harms that the agency is concerned
    about? Briefly, because I have got two more questions for you.
        Dr. Corrigan-Curay. Sure. Thank you.
        The harms that we are worried about is, if these products
    are absorbed systemically, they can have systemic effects
    across.
        So that can be the endocrine system, your hormones in
    development. They can also affect cells and we could have
    abnormal growth or tumors.
        So these are the kinds of tests that any drug that reaches
    systemic levels we test for, whether it is an over-the-counter
    or a prescription drug. Those are the kind of tests that we do.
        Mr. Pallone. Well, thank you.
        So what kinds of studies does FDA need to show products are
    safe from these risks? In other words, has the FDA worked with
    manufacturers in getting data that show products are safe from
    these risks that you just mentioned?
        Dr. Corrigan-Curay. Yes. So the first thing we had done
    was, we published the MUsT studies, which is the first thing
    you need to do and see what level these are absorbed.
        And then once they--if they are absorbed, then we have
    studies that--including animal studies--that will tell us
    whether there are any unexpected toxicities.
        And we are very much supportive of what we are doing, the
    roadmap that Dr. Makary and the work that we have done to
    reducing, or even eliminating, animal studies.
        But at this time for some of those more complex, multiorgan
    system toxicities we are using animal studies. We don't have a
    replacement.
        Mr. Pallone. But are these Federal studies, or are these
    studies that the companies are doing that make sunscreen?
        Dr. Corrigan-Curay. These are the studies that the company
    would do. We did the MUsT studies ourselves to show that they
    could be done and to provide sort of a roadmap for that.
        Mr. Pallone. OK.
        Well, let me go to the provider workforce issue.
        HRSA's National Center for Workforce Analysis has said
    there is a projected shortage of over 187,000 physicians and a
    projected 6 percent shortage of registered nurses by 2037.
        However--oh, this actually is of Dr. Chen. I am sorry. I
    want to move to you.
        However, Dr. Chen, many of the programs within Title VII
    and VIII were proposed to be eliminated in the President's
    budget even though health workforce shortages only continue to
    increase.
        So if I could ask, Dr. Chen, if Congress reauthorizes these
    programs and appropriates funding for them, can you confirm
    that HRSA will follow the law and carry out these programs?
        We are always worried that we authorize things or we fund
    things and then the administration zeros them out or just
    freezes the funding.
        Can you comment on that?
        Dr. Chen. What I can say is that if Congress authorizes and
    appropriates for these programs, we will implement them.
        Mr. Pallone. All right. Well, that is really important. I
    really appreciate your telling me that. Because I do think that
    these workforce programs are more important than ever, and any
    attempt to eliminate them is really going to exacerbate the
    country's workforce shortages.
        The other thing I would say too is, I know that we have
    relied a lot in the past on going overseas to get doctors and
    to get nurses.
        And, I mean, that is fine in theory because we have such a
    shortage, but I really would much prefer that we train those
    people here and don't have to rely on other countries, because
    a lot of times I think it drains the doctors and the nurses in
    the other countries.
        I mean, people tell me that that is not the case, but it is
    hard for me to believe that it is not the case.
        So thank you.
        And thank you, Mr. Chairman.
        Mr. Griffith. The gentleman yields back.
        I now recognize the new vice chair of the Health
    Subcommittee, Mrs. Harshbarger of Tennessee.
        Mrs. Harshbarger. Thank you, Chairman Griffith. I
    appreciate that. And it is an honor to be the vice chair.
        It is the first reauthorization of OMUFA, and it is
    important that we get it right. And we have made a lot of
    progress in the first 5 years of this, but I don't think we
    have realized the full potential of what Congress set out to
    achieve on behalf of consumers with this.
        So we need to work through that to improve the regulatory
    certainty and minimize regulatory burdens where possible. And I
    have got a lot more questions for you.
        But, anyway, we will start with Dr. Chen.
        I represent a very rural area in east Tennessee, and I also
    cochair the Congressional Bipartisan Rural Health Caucus. And
    we continue to hear that patients in rural areas have a much
    harder time accessing quality healthcare services, which is
    often due to a lack of providers in the immediate area. And we
    need to ensure that taxpayer resources are reaching the
    communities that need it most.
        And the term ``disadvantaged'' is used throughout Title VII
    and Title VIII of the Public Health Service Act. And my
    question is, how does the Secretary define such a term?
        Dr. Chen. The definition that we use in our programs often
    is directed by statute, and if there is a particular program
    that you are interested in, we can follow up with you
    afterwards with the specifics.
        Mrs. Harshbarger. OK.
        Mr. Morris, I joined Representative Emanuel Cleaver to
    introduce bipartisan legislation to expand the scope of rural
    health grants to include mobile integrated health and community
    paramedic grantees, enabling Americans in rural communities to
    receive centralized mobile and preventative care through local
    paramedics. And it is an increasingly popular initiative in
    healthcare known as Community Paramedic.
        Currently, EMS is considered a service provider of
    transportation. However, EMS has progressed over the years to
    become a crucial part of the healthcare system.
        What are your thoughts on reform of the current EMS system,
    and does HRSA see the value of Community Paramedic as a part of
    the future of EMS and healthcare as a whole?
        Mr. Morris. Thank you for the question. Yes, the use of
    community paramedicine local integrated care has been growing
    for the last 10 years. And it is another example, I think, of
    the creativity that rural communities can bring to this.
        I think what spurred its creation was you had EMTs and
    paramedics with downtime between calls, and somebody had the
    idea that they could go do blood pressure checks and home
    visits, and it extended a somewhat constrained workforce. So I
    think it has worked well.
        We funded a number of those programs through the Rural
    Health Outreach over the years, and I am sure we are going to
    continue to fund them because they really do work.
        I think the larger challenges are how to sustain them.
    There are some pathways forward where it might work well in a
    value-based care system, but we are also on a fee-for-service
    system. So part of the challenge is figuring out the best way
    to cover those services.
        Mrs. Harshbarger. Yes, really a lot of different ways to
    pay for different services. Telemedicine is another.
        So they fundamentally believe in the right care at the
    right place at the right time. And that mentality means that
    the emergency department isn't always the best place for that
    patient, and often, those patients can be treated in place or
    via telehealth.
        Do you see how that is not only good for the patients, but
    also for really the financial portfolio of the healthcare
    system as a whole?
        Mr. Morris. Yes, ma'am.
        Mrs. Harshbarger. Dr. Corrigan-Curay, independent
    pharmacies are the bedrock of our communities. And can you tell
    us how CDER is operationalizing the OTC-ACNU pathway in order
    to expand the role of consumer health products and helping
    consumers manage their health?
        Dr. Corrigan-Curay. Sure. You are referring to our
    additional condition of use, which is a PDUFA program. Yes,
    there is lots of flexibility in operationalizing. A company
    will come in, and they will establish that the usual sort of
    drug facts label is not sufficient for selection, and then
    there will be another condition of use that will be put on.
    Whether that would be going to a website, whether you could
    have something within a pharmacy, some questions, electronic
    kind of questions, but something that you would have to satisfy
    that condition of use before you access the product.
        And we really think that this is going to be key to getting
    more of those products that we just can't get that self-
    selection through the label, and perhaps for chronic diseases.
    And so we will be working with companies on how to innovate in
    this area.
        Mrs. Harshbarger. OK. That is very, very good. As a
    pharmacist, that makes me feel good. And then there are certain
    things that should be kept behind the counter, but we will talk
    about that later.
        Thank you, and I yield back.
        Mr. Griffith. The gentlelady yields back.
        I now recognize the gentleman from California, Dr. Ruiz.
        Mr. Ruiz. Thank you, Mr. Chairman.
        I represent a very rural district in southern California,
    and I am an emergency physician by background. So I have seen
    the real need for investments and improvements in rural
    healthcare systems.
        Patients experience unique barriers to carry in rural
    communities, like long distances to the nearest clinic and
    transportation challenges, long ambulance wait times that delay
    critical care, and provider shortages. That is why continued
    investments in workforce pipelines and programs to improve
    patients' access to care and quality of care are so important.
        The committee is considering a bipartisan bill today that
    would reauthorize several programs that help strengthen
    healthcare in rural communities: H.R. 2493, the Improving Care
    in Rural America Reauthorization Act of 2025 by Representatives
    Carter and Schrier that I support.
        The bill would reauthorize three important programs: the
    Rural Healthcare Services Outreach Program, the Rural Health
    Network Development Planning Program, and the Small Healthcare
    Provider Quality Improvement Program.
        Mr. Morris, in what ways have you seen these programs lead
    to improved access to care in rural communities, and how does
    HRSA measure the impacts of these grants?
        Mr. Morris. Thank you for the question. The programs--let
    me speak to the outcomes first. I noted earlier that we have
    three primary ways that we measure the impact they are having
    on our community.
        The first is we look at whether they are improving health
    status. And so our most recent cohort, which is around 90
    percent of the grantees, were able to show improved health
    status for the folks they served.
        The second way is these are essentially----
        Mr. Ruiz. So better health?
        Mr. Morris. What is that?
        Mr. Ruiz. So better health?
        Mr. Morris. Yes, better health.
        So these are startup funds. They tend to be the 4-year
    grant. In the case of the planning grants, it is a 1-year
    grant. So they are not grants that somebody gets in perpetuity,
    but just to get a good idea off the ground.
        So one of the things we look at is sustainability, and
    typically a little more than 90 percent of our grantees are
    able to keep the project going after the grant ends.
        Mr. Ruiz. So they add new healthcare services.
        Mr. Morris. Yes. So the Federal funding got it started, but
    the community kept it going. And one of the ways that we do
    that is we don't fund a single entity, we fund a consortium of
    folks. So we have a health department coming together with a
    hospital or a clinic. And we find if you have more people
    involved in the program, they feel more invested.
        Mr. Ruiz. So more access to care because there are more
    services and there are better health outcomes.
        What aspects of rural health do you see the greatest need
    for improvement?
        Mr. Morris. Well, I think you look at the five leading
    causes of death, and in every State in the country you see
    people in rural areas tend to die at a higher rate for
    avoidable or excess death. So cardiac disease, diabetes,
    injury, pulmonary disease, diabetes, all of those are high-need
    areas.
        Mr. Ruiz. Would access to a hospital nearby affect health
    outcomes in rural communities?
        Mr. Morris. Definitely. I mean a hospital can often----
        Mr. Ruiz. So if a hospital would close, it would put in
    jeopardy the health outcomes of that community?
        Mr. Morris. When any healthcare entity closes in a
    community, you have----
        Mr. Ruiz. The Big Ugly Bill is projected to close about 20
    percent of rural hospitals. That is a big problem. That is
    going to take us backwards in improving the health.
        Also vital to the improvement of healthcare quality and
    access in rural communities are programs to support the
    physician workforce pipeline. Title VII of the Public Health
    Service Act promotes education and training for healthcare
    professionals. Title VII programs help bolster our healthcare
    workforce. So we must ensure these programs continue to have
    the resources needed to help our communities.
        According to HRSA's own data, our health system is
    projected to be short by at least 187,000 physicians by 2037.
    As we face increased provider shortages, I am concerned about
    recent actions that not only make it harder for those who want
    to pursue medical education.
        The Republicans' Big Ugly Bill capped Federal student loans
    for professional schools at 200,000, which is far below the
    average cost of attending medical school, and eliminated--
    completely eliminated--the Graduate PLUS Loan Program that
    helped them fill the gap between their loans and the cost of
    medical school.
        So this will be particularly devastating for economically
    disadvantaged students from underserved communities, exactly
    where we need the physicians the most. As we know, physicians
    are more likely to practice medicine where they grow up, and we
    need more providers in underserved communities. To make matters
    worse, the Trump administration has proposed cutting numerous
    workforce development programs from Title VII.
        Dr. Chen, what impact would cutting these programs have on
    the healthcare workforce?
        Dr. Chen. Well, as I have mentioned, our programs
    definitely have had positive impacts on all the things that you
    are talking about, and we recognize that funding decisions have
    impact.
        Mr. Ruiz. So eliminating them would have negative impacts?
    It is OK to say yes.
        Dr. Chen. Yes.
        Mr. Ruiz. Thank you. I yield back.
        Mr. Griffith. The gentleman yields back.
        I now recognize the gentleman from Florida, Mr. Bilirakis.
        Mr. Bilirakis. Thank you very much, Mr. Chairman. I
    appreciate it. Congratulations on your chairmanship. I know you
    will do a great job.
        So, Mr. Chairman, thank you again for the opportunity to
    discuss a number of important reauthorizations to support the
    public health workforce, rural health, of course, and over-the-
    counter medicines, all of which reach every aspect of our daily
    lives. I look forward to learning more from our witnesses on
    how our committee can improve these critical programs.
        First, I would like to highlight the Newborn Screening
    Saves Lives Reauthorization. Newborn screening is one of our
    Nation's most successful public health programs, as you know,
    serving nearly 4 million infants each year and saving thousands
    of babies' lives.
        As cochair of the Rare Disease Caucus, I am acutely aware
    of how identifications and interventions significantly improve
    health outcomes for those born with rare diseases. I remain
    committed to strengthening the critical program while embracing
    innovation that allows it to keep pace with the rapid advances
    in diagnostic science and technology.
        I also am interested in learning more about the Over-the-
    Counter Monograph Drug Reauthorization and promoting innovation
    in the over-the-counter space for American consumers.
        So the question, the first question is for Dr. Corrigan-
    Curay. I hope I got that right. As you are well aware, ma'am,
    the monograph sets the conditions under which the OTC drug
    products are generally recognized as safe and effective, also
    known as GRASE. We have heard from stakeholders in our last
    hearing that more clarity could be provided around the
    standards for GRASE determinations.
        Can you provide a high-level overview of the current
    standards the FDA uses when making these determinations, and
    how do you think the FDA can clarify and improve the GRASE
    standards, please?
        Dr. Corrigan-Curay. Yes. Thank you for that question. So
    the GRASE standard is safe and effective, and it is a standard
    that is similar to what we use for drugs that aren't over-the-
    counter. And it is important that they be just as safe and
    effective, because these are drugs that, of course, are used
    not under the supervision of a physician.
        That being said, each program we look at individually, and
    we look at the data that we need to establish that. And we will
    work with a company, and we can have back-and-forth. That is
    part of our meetings. That is part of things like the protocol
    synopsis, so that we can have that discussion and determine
    what is the data that is necessary to meet that standard.
        And under OMUFA II, we have committed to do further
    education in this area, and we will be soliciting from industry
    where their questions are so that we are most responsive to
    them.
        Mr. Bilirakis. Thank you so much.
        Dr. Chen, as you know, Florida has a high and growing
    population of older Americans, and, simply, we need more
    healthcare professionals trained in geriatrics in our State or
    any other State, for that matter.
        We are fortunate to have two Geriatric Workforce
    Enhancement Programs in Florida that are working hard to train
    doctors, nurses, social workers, and caregivers on how to more
    effectively care for older adults, especially those with
    chronic conditions and Alzheimer's disease, and I will add
    Parkinson's as well.
        Would you explain why these programs are important to our
    ability to provide efficient care to this population, and how
    effective are these programs in incorporating new and improved
    technologies and treatments in geriatric care?
        Dr. Chen. Thank you. Actually, that was an excellent
    summary, I think, of what the Geriatric Workforce Programs do.
    They are grants to organizations, healthcare organizations, who
    then work to train the workforce. But actually in the training
    of the workforce, they are also delivering care. So it is a
    real combination. And as you stated, the aging of our
    population means that this workforce is needed.
        Mr. Bilirakis. Thank you very much.
        Anybody else on the panel want to add something to that?
    Well, I appreciate it very much.
        And I will yield back, Mr. Chairman. Thank you.
        Mr. Griffith. The gentleman yields back.
        I now recognize the gentlelady from Michigan, Mrs. Dingell.
        Mrs. Dingell. Thank you, Mr. Chair. Thank you for holding
    this important hearing on a range of critical public health
    topics, including the Over-the-Counter Monograph Drug User Fee
    Program that is expiring this year. I am very proud to have
    helped write it with my colleague, Diana DeGette, and my
    colleagues on the other side of the aisle in a bipartisan
    effort to create the program and its enactment in the CARES
    Act.
        Through discussions involving Members, patients, doctors,
    pharmacists and advocates, I am glad we were able to take the
    first step towards reauthorizing OMUFA before it expires this
    year on September 30th.
        But as we work towards a reauthorization that will improve
    access to safe, effective over-the-counter products, I am very
    concerned about the ability to implement this reauthorization
    without a strong FDA workforce. In April, more than 3,500 FDA
    employees were laid off, a roughly 15 percent reduction in
    force.
        Secretary Kennedy has announced that he would reverse a
    portion of the broad cuts without specifying how this would
    occur. Firing key drug safety officials in the name of
    efficiency, I believe, is shortsighted, it is not the way that
    our healthcare system should be run, and that it risks American
    safety.
        The Trump administration has stated that anticipated cuts
    to the FDA workforce will not affect product reviewers or
    inspectors. Even if these positions are spared from
    terminations, gutting the agency workforce leaves them with
    more responsibility and fewer resources. The idea that they
    will not be impacted is simply not realistic, especially when
    the FDA is already understaffed and behind on inspection
    deadlines.
        Dr. Corrigan-Curay, I understand you can't answer questions
    about RIF, so I won't put you in the position of asking you a
    question on that specifically. However, we do need to ensure
    the agency has the necessary staffing to enable product
    evaluations without compromising FDA's dedication to scientific
    integrity, public health, regulatory standards, patient safety,
    and transparency. The user fees are central to that.
        So what I will ask is the impact on staffing if this
    program is not reauthorized on time. For example, what happens
    to staff in the workflow and availability of patients?
        Dr. Corrigan-Curay. Thank you for that question. You are
    correct. If this program was not authorized on time,
    approximately 44 percent of the scientists, reviewers, and
    others working in this area would have to be terminated.
        And what would happen is we would stop meeting on
    development programs. The proposed orders we have out,
    including the one on changing the dosage forms, would not get
    done and delayed. The new sunscreen that we are trying to work,
    we would miss those deadlines and we would fall back on the
    innovation that we are working on.
        Mrs. Dingell. Thank you. So my colleagues, we have got to
    work together on this.
        As a cochair of the Skin Cancer Caucus, I would like to
    turn to the issue of sunscreen regulation and recognize we have
    skin care patients and advocates in the audience today. Thank
    you for being here and for your advocacy and dedication to the
    cause of skin cancer prevention.
        I have introduced a bipartisan bill, the SAFE Sunscreen
    Standards Act, alongside my fellow cochair, Representative John
    Joyce, which would streamline the FDA review process of the
    effectiveness and safety of new ingredients for nonprescription
    sunscreens.
        But we do want to make sure everybody is safe. Sunscreen is
    critical in the prevention of skin cancer, yet there are
    concerns that the current FDA regulations regarding sunscreen
    active ingredients aren't sufficient. There hasn't been an
    approved new active ingredient in sunscreen since 1999. You can
    go to Europe, you can get much better product than you can get
    here.
        Dr. Corrigan-Curay, I first want to get your opinion on the
    current situation of the sunscreen testing requirements. Do you
    see opportunities for Congress to act to alter the requirements
    on testing to increase the available active ingredient list?
        Dr. Corrigan-Curay. Thank you for that question. I think we
    are willing to work with you on legislation. We do want new
    sunscreens on the market. We want to make sure they are safe.
    We do have a new product, the first OMOR was for a sunscreen.
    So we hope that perhaps we will break that 1999 record.
        But these are drugs, and when we see that they are
    systemically absorbed at a rate that they could have systemic
    effects, we need to evaluate that. And we are willing to look
    at ways to evaluate it, provided we get the information that
    will allow us to determine it is safe.
        Mrs. Dingell. I am going to submit more questions for the
    record because I am out of time, but I do think we have got to
    figure out how the FDA balances health and environmental
    concerns with the need to access the most updated sunscreen
    technology and medicine.
        So I am going to have questions for the record and yield
    back, Mr. Chairman.
        Mr. Griffith. The gentlelady yields back.
        I now recognize the gentleman from Georgia, Mr. Carter.
        Mr. Carter of Georgia. Thank you, Mr. Chairman, and thank
    all of you for being here.
        I am pleased that two of my bills are included in today's
    hearing, the Improving Care in Rural America Reauthorization
    Act and the FDA Modernization Act.
        Improving rural healthcare is one of the top issues on my
    priority list. As we like to say in the State of Georgia, there
    are two Georgias. There is Atlanta and there is everywhere
    else, and I represent everywhere else. So it is important,
    particularly in rural south Georgia.
        And we know that rural communities have a lot of obstacles.
    We know they have workforce problems. We know that they have
    distance and transportation issues.
        That is why the Improving Care in Rural America
    Reauthorization Act will reauthorize the Rural Health Care
    Services Outreach Programs. And those programs fund locally
    driven projects that focus on improving access to care and
    quality improvement and things that we want to improve on.
        Mr. Morris, let me ask you. Many rural communities have
    higher rates of chronic diseases, like diabetes and
    hypertension. What specific interventions funded through the
    outreach program have been most effective in reducing chronic
    diseases in rural areas?
        If you will remember, when Secretary Kennedy took over at
    HHS, he made it clear--and he has made it clear ever since
    then--that he really wants to address chronic disease. It
    impacts over 26 million people in our country, and it is
    something that he has made as a priority. And we on this Health
    Subcommittee want to make it a priority as well.
        Mr. Morris. Thank you for the question, and thank you for
    your sponsorship of the reauthorization of this program.
        You know, when we review the applicants of this program, it
    is a good indication of where the greatest needs are, because
    the communities are able to identify what they want to work on
    and how they are going to address it. And so we do see a lot of
    our applicants coming in looking at chronic disease.
        I think the things we have seen that have been really
    effective over the years are early screenings, so you can
    identify somebody who is at risk of a chronic disease and then
    getting them into a care plan.
        So a lot of our grantees include both screening programs
    and then care coordination as well. We see a lot of use of
    community health workers to help people pay attention to their
    meds and keep track of what they need to do to manage their
    chronic disease.
        These grants, because they are essentially startup funding,
    they can also provide the initial salaries for a new doctor or
    a new nurse practitioner, and that can help get the project
    going as well.
        Mr. Carter of Georgia. Do you do anything with diets,
    because we are known as the cardiac belt because of our diets.
    We have such good food and such good cooks down South.
        Mr. Morris. I miss that food, sir, but I take your point.
    And certainly I know of an example in your district in Baxley,
    Georgia, the Appling Partners in Health. And a big part of what
    they are doing is looking at how to teach people how to cook
    more healthy foods as a way to address----
        Mr. Carter of Georgia. But it is not as good. I mean it is
    just--anyway, Dr. Corrigan-Curay--thank you, Mr. Morris.
        Dr. Corrigan-Curay, I appreciate the administration's focus
    on reducing animal testing and including FDA's roadmap for
    reducing animal testing in preclinical safety studies. We all
    know that millions of animals are being killed unnecessarily,
    and we want to do something about this.
        That is why I have introduced the FDA Modernization Act
    3.0, which will allow for the development of safe and effective
    treatments and therapies without unnecessary animal suffering.
    We have a law for animal-free testing methods on the books, and
    it is time we put it to use by expanding testing options.
        When does the agency anticipate making updates to its
    recommendations or guidance on this matter?
        Dr. Corrigan-Curay. Thank you for that question. We are
    committed to reducing--and even eliminating, if we can--animal
    testing. We have been successful in certain areas. We don't
    test eye irritation or skin irritation with animals, and we
    will make sure that our guidances and our rules make it clear
    that we are open to companies coming in with these alternative
    methods.
        We had a very great meeting with NIH. Lots of science was
    discussed, and I think we are really on a good road to move
    forward in this area.
        Mr. Carter of Georgia. Good. Thank you, Dr. Corrigan.
        Mr. Chairman, I was very pleased to see OMUFA
    reauthorization on today's agenda along with my FDA
    Modernization Act 3.0. One key tenet of the FDA Modernization
    Act are the provisions on nonanimal testing methods for 505(g)
    or all monograph drugs. This will open the door for greater
    innovation and innovation products for consumers.
        I look forward, Mr. Chairman, working with you to include
    this language into the OMUFA. So thank you, and I will yield
    back.
        Mr. Griffith. The gentleman yields back.
        I now recognize the gentlelady from Washington, Dr.
    Schrier.
        Ms. Schrier. Thank you, Mr. Chairman. Thank you, Ranking
    Member. And thank you to all the witnesses for being here
    today.
        As a pediatrician, I first want to talk about newborn
    screening. I am so happy that our committee is considering the
    Newborn Screening Saves Lives Reauthorization Act, which is
    legislation that I colead with Dr. Morrison.
        The heel prick blood test that every newborn in this
    country gets is a simple, low-cost, effective tool to identify
    and treat so many rare diseases. In fact, I was recently at a
    food bank in my district, and one of the volunteers there was a
    teenager who I diagnosed when she was born with PKU,
    phenylketonuria. And she is doing so well and thriving in high
    school because of this early detection and treatment, which she
    has been so good about doing.
        And I just want to tell you that, or tell everybody that
    without that newborn screening and early treatment, she would
    not have been diagnosed until permanent developmental delays
    and seizures and other just terrible outcomes. So this was
    really a godsend for her.
        And this is the common denominator with all these diseases.
    They are rare, but early detection and treatment helps these
    kids live totally normal lives. And sometimes that is with
    diet, sometimes medication, sometimes gene therapy.
        And I just want to emphasize the importance and say that I
    really look forward to working with this committee to advance
    this important bill.
        I also wanted to touch on rural health. And we have been
    talking about the doctor shortage and the Improving Care in
    Rural America Reauthorization Act, which I colead with
    Congressman Carter.
        My district is 10,000 square miles, and so it includes a
    lot of rural communities that depend on scarce providers and
    vulnerable hospitals. And this bill will help expand access.
        However, I just would be remiss if I did not point out that
    almost all House Republicans voted to cut a trillion dollars
    from Medicaid just a couple weeks ago. And I just want to say
    that this One Big Ugly Bill will close rural hospitals, and it
    will impact the very communities that we are talking about
    helping. And so, this just feels somewhat hollow to be
    supporting this bill and at the same time taking away with the
    other.
        I was wondering if you could just touch on in maybe 30
    seconds, Mr. Morris, the impact of Medicaid cuts on rural
    hospitals and the already existing shortage of primary care
    doctors.
        Mr. Morris. Thank you for the question. I will defer the
    workforce portion of the question to my colleague. The passage
    of the bill, we are still reviewing that language and----
        Mr. Griffith. Can you move the mic a little bit closer?
        Mr. Morris. I will defer the primary care question to my
    colleague. On the passage of the bill, we are still reviewing
    the language in the bill. And obviously it will be implemented
    by the Centers for Medicare and Medicaid Services, and we are
    there as a resource as they work through it.
        Ms. Schrier. We anticipate--the data shows that it will
    close one in four rural hospitals, just to let you know what
    you will find when you look at the data.
        I also wanted to talk about the physician and nurse
    workforce, because we are considering the reauthorizations of
    Title VII and Title VIII health workforce programs. And this
    ensures that we have the physicians, nurses, dentists that we
    need to serve patients, particularly in rural areas.
        And we do need a bigger pipeline, and we need these
    programs, and I support these programs. And again, though, I
    just have to say that this feels hollow to hear my colleagues'
    support for Title VII and Title VIII when they just voted to
    severely limit financial aid for medical and nursing students,
    capping the amount that they can take out, making it so that
    interest starts accumulating immediately, making them more
    expensive and lengthier to pay off, and that these are the
    exact students that we are talking about who would benefit from
    Titles VII and VIII. In addition, the Trump administration has
    proposed gutting most of the nurse workforce programs within
    Title VIII.
        Dr. Chen, it is great to see you again, a fellow
    pediatrician. What will happen to our health system if your
    agency loses funding for nurse workforce programs, like the
    Nurse Faculty Loan Repayment Program and the Nurse Education,
    Practice, and Retention program, and loans become more
    difficult to pay off?
        Dr. Chen. I think I can--I will just reemphasize that we do
    know that our programs are impactful, that they have made a
    difference in terms of workforce shortages and distribution of
    the workforce.
        I think what we realize, though, is that the President's
    budget is the beginning of the conversation, that Congress
    ultimately makes the final decision. And we are ready to work
    with you on this.
        Ms. Schrier. We think so. I hope that this Congress stands
    up for bills that we passed in a bipartisan way and does not
    let this President do a runaround our power of the purse.
        Thank you, and I yield back.
        Mr. Griffith. The gentlelady yields back.
        I now recognize the gentleman from Texas, Mr. Crenshaw.
        Mr. Crenshaw. Thank you, Mr. Chairman.
        We all know the FDA plays a very critical role in
    protecting the health and safety of Americans, but we also know
    some of the systems have not kept up with modern science and
    consumer needs.
        It is one of the reasons I am proud to support the
    bipartisan reauthorization of the Over-the-Counter Monograph
    User Fee Program. And it has some smart updates to it. I think
    it helps the FDA keep everyday medicines like allergy meds,
    cold remedies, sunscreens safe and up to date, but without
    adding red tape.
        It brings more transparency, scientific flexibility and
    accountability to assist in that over 90 percent of Americans
    rely on. OTC products help people manage their health. They
    avoid unnecessary doctor visits, and that is good for families,
    good for our rural communities. It is good for a sustainable
    workforce. So fixing the system, making it work better for
    everyone, I think, is in our interest.
        Dr. Corrigan-Curay, this legislation formally allows the
    use of voluntary consensus standards and alternative testing
    methods for monograph updates. Help us understand that. How
    does that change the scientific flexibility and efficiency of
    the review process?
        Dr. Corrigan-Curay. Well, I think the voluntary consensus
    standards, using those, you know, they are known, they are
    transparent, they can be relied on. And, you know, alternative
    standards, we have asked in OMUFA II, we want to have a new
    tier, what we call a tier 2 proposed order so that we can
    update some of the outdated tests that may be in some of the
    monographs.
        So I think we are willing to work with that and try and
    use--how do we get--use the most up-to-date testing that gets
    us to the answer that we need and, of course, update some of
    these testing standards that were in the monographs.
        Mr. Crenshaw. We are talking about over-the-counter
    monographs. What about applying those kind of standards to
    other pathways in FDA? Do you have any comments on that? I
    don't want to throw you something out of left field there,
    but----
        Dr. Corrigan-Curay. Sure. And all of us, when we are
    looking at any alternative method to gather data--for example,
    the alternatives to animal testing--we are going to use those
    across the board. So if they can answer a question of safety in
    an OTC drug and they can answer it in a prescription drug, then
    we are going to use it.
        I would mention that there are many places we don't use
    animal studies. For example, in our biosimilar program, when we
    are approving new biosimilars. Most of our generics don't need
    animal studies. Those are a lot of medications that are used
    every day. But any test that is fit for purpose we will use
    across for other products.
        Mr. Crenshaw. Yes. And I will reiterate over and over, and
    I hope one of our goals in this committee is, while maintaining
    safety standards for the American people but making the FDA an
    efficient process, that does not destroy the last remaining
    innovative industry in the world, which is in the United
    States. And I hope that is a goal of our administration, and I
    think it should be a goal of this committee.
        Mr. Morris, in many rural communities, access to a
    physician can be limited to a part-time clinic or a distant
    hospital. For residents in those areas, how essential is it to
    have reliable, over-the-counter medications available for
    managing common health needs?
        And to follow up, are you hearing concerns--whether from
    patients, providers, States--that outdated or ineffective OTC
    drugs are still in circulation, simply because the FDA hasn't
    had the resources to review them?
        Mr. Morris. Congressman, thank you for that question. It is
    outside of my knowledge base. I defer to my colleague at FDA on
    that. I would think the same challenges----
        Mr. Crenshaw. Feel free to jump in. That is fine.
        Dr. Corrigan-Curay. You know, we are overseeing and looking
    at the safety/effectiveness. As you know, we have an order to
    update the acetaminophen safety for a rare side effect. We also
    have the proposed phenylephrine order we are trying to work
    through, which would--you know, on efficacy, the lack of
    efficacy there.
        And so we also, on our agenda, we are going to do some
    updates in the pediatric dosing for acetaminophen by weight-
    based, as well as update NSAIDS for some issues for pregnant
    women. So we are continuing to work through. And I think we are
    effectively making sure that they are safe and effective.
        Mr. Crenshaw. OK. I appreciate that.
        And I will have more questions. I am almost out of time, so
    I yield back.
        Mr. Griffith. The gentleman yields back.
        I now recognize the gentleman from Texas--another gentleman
    from Texas--Mr. Veasey.
        Mr. Veasey. Thank you, Mr. Chairman.
        I want to thank the witnesses for being here today. There
    is one area of public health where the stakes could not be
    higher, and that is newborn screening. Every year, nearly 4
    million babies are born in the United States, and newborn
    screening identifies about 14,000 babies each year with
    potentially life-threatening or life-altering conditions. For
    those children, getting an early and accurate diagnosis can
    mean the difference between a healthy life and irreversible
    harm or even death.
        In 2003, under President George W. Bush, the Advisory
    Committee on Heritable Disorders in Newborns and Children, or
    ACHDNC, was established to save lives and spare families from
    suffering.
        Across Democratic and Republican administrations, that
    committee has determined which conditions belong on the
    Recommended Uniform Screening Panel, or RUSP, the gold standard
    that guides States on which conditions to screen for at birth.
    The RUSP is the reason 14,000 families annually can get a
    timely diagnosis, early interventions, and have a fighting
    chance for their children.
        Despite this progress, I was saddened to learn from a
    family in my district in April that HHS quietly and really
    abruptly dissolved this committee. There were no hearings or no
    warnings, no consultation with families. And this reckless
    decision put children's lives at risk, plain and simple. And
    let me tell you why.
        Before the committee was shut down, it was on the verge of
    voting to add a new condition onto the screening panel, and
    that is Duchenne muscular dystrophy, or DMD. And DMD is a very
    devastating genetic disease that primarily affects boys and
    causes muscles to degenerate and weaken over time.
        Children often appear very healthy at birth, but without
    early detection, symptoms like difficulty walking and frequent
    falls begin to happen at around the age of 3 or 4. Eventually,
    DMD patients lose the ability to walk. Their heart and
    breathing muscles weaken, and many die in their early 20s and
    early 30s from respiratory or heart failure.
        Mr. Chairman, I would like to enter into the Congressional
    Record an NBC article that tells the story of Jennifer McNary
    and her two sons.
        Mr. Griffith. And what is the organization?
        Mr. Veasey. I want to enter it into the record.
        Mr. Griffith. No, I know you want to enter it into the
    record of the committee, but I am trying to figure out--you
    gave initials or something. What is the organization that
    printed it?
        Mr. Veasey. NBC News.
        Mr. Griffith. Oh, NBC News. I am sorry, I just couldn't
    hear that. And do you have a date on that?
        Mr. Veasey. Yes. This article is dated April 17, 2025, sir.
        Mr. Griffith. Without objection, so ordered.
        [The information appears at the conclusion of the hearing.]
        Mr. Veasey. Thank you. Jennifer is a mother who has lived
    through both devastation and hope associated with newborn
    screening. Jennifer's eldest son, Austin, was diagnosed with
    DMD at age 3, when he was already struggling to walk. Austin
    and his family bravely fought for years, but his diagnosis came
    too late to change his trajectory of his disease. Sadly, Austin
    died this past February at age 26.
        Jennifer's second son was born into a different world, a
    world shaped by newborn screening. Max was also diagnosed with
    DMD at birth, allowing him to receive physical therapy and
    steroids and to become one of the first patients able to
    tolerate a new gene therapy treatment.
        Max walked until he was 17, 7 years longer than his older
    brother. Now Max is 23, uses a wheelchair and needs help
    getting in and out of bed, but he is still alive and he is able
    to live semi-independently and he is able to go out with
    friends. And he is here because of newborn screening and early
    intervention.
        That is the difference this committee makes. That is the
    difference that RUSP makes, and that is the difference this
    legislation makes. This is not hypothetical. It truly is life
    or death for many families. And we would be striving to close
    that gap, not allowing the future of newborn screenings to
    wither on the vine.
        Doctors and advocates across the country warn that
    dissolving ACHDNC puts us at risk of returning to a patchwork
    system where children's chances of survival really does depend
    on their ZIP Code. And our newborn screening system saves
    thousands of lives each year, but it cannot function in the
    dark.
        So I am glad this hearing includes a discussion draft of
    the Newborn Screening Save Lives Reauthorization Act of 2025,
    but I am going to be frank. I am really outraged at where we
    stand today, with no functioning ACHDNC and no roadmap for its
    reinstatement. This simply cannot wait.
        Mr. Chairman, thank you.
        Mr. Griffith. The gentleman yields back.
        I now recognize the gentleman from Pennsylvania, Dr. Joyce,
    for his 5 minutes of questioning.
        Mr. Joyce. Thank you, Mr. Chairman. And congratulations on
    your new role as the chairman of the Health Subcommittee. We
    look forward to working with you.
        I would further like to thank you for including the SAFE
    Sunscreen Standards Act in this hearing. This is my bipartisan
    legislation, also introduced by Representative Dingell,
    Representative Ross, and Representative Dave Joyce of Ohio.
    This represents a yearlong work product from the congressional
    Skin Cancer Caucus aimed at fixing a serious health crisis that
    we are facing each and every day in the United States.
        Today, nearly one in five Americans will develop skin
    cancer in their lifetime. Squamous cell carcinomas, basal cell
    carcinomas are estimated at over 5 million cases each year. In
    2025, it is estimated that over 200,000 cases of melanoma will
    be diagnosed. And in the last 15 years, we have seen that
    number of new invasive melanomas diagnosed to be increased by
    almost 50 percent.
        We also know that the vast majority of these cancers are
    caused by ultraviolet damage from the sun. This means that the
    use of sunscreen decreases the risk of these skin cancers
    occurring dramatically.
        As a dermatologist, the best sunscreen is the one that
    someone will actually use. And, unfortunately, this is an area
    that the United States has fallen behind the rest of the world
    in approving new sunscreen products.
        I know that it has been stated before in this hearing, but,
    Dr. Corrigan-Curay, since 1999, over 25 years ago, how many new
    sunscreen ingredients and formulations has the FDA approved for
    use in the United States?
        Dr. Corrigan-Curay. We have not approved a new one, but we
    do have a new order.
        Mr. Joyce. That is frightening. Zero is the answer since
    1999. That was most of my time as a practicing dermatologist in
    the United States. No new sunscreens.
        Mr. Chairman, I would ask unanimous consent to introduce
    into the record letters of support from the Skin Cancer
    Foundation, AIM at Melanoma, the SUNucate Coalition, and the
    and PASS Coalition.
        Mrs. Harshbarger [presiding]. Yes, sir, without objection.
        [The information appears at the conclusion of the hearing.]
        Mr. Joyce. Thank you. These letters represent consensus,
    consensus support for this bill from physician groups from the
    American Academy of Dermatology, melanoma research groups, and
    those involved in actual day-to-day patient care.
        The risk for these patients is real. I worked in this area.
    I saw it every single day of my career as a physician. For
    children and adolescents who develop just one single blistering
    sunburn this summer, they will double their chances of
    developing melanoma in their lifetime. One blistering sunburn,
    double your chances of a potentially deadly disease.
        And the FDA has failed for over two decades to keep pace
    with innovation in this space. So while I understand the
    minority does have concerns on environmental issues here, the
    risk of cancer and ultimately death is something that must be
    considered in this balance.
        Dr. Corrigan-Curay, other countries that regulate sunscreen
    ingredients as drugs have found ways to ensure high safety
    standards while ensuring that their populations get access to
    newest innovative techniques and products. This represents
    right now a failure at the FDA.
        Are you willing to commit to working with this committee
    and stakeholders on ways to increase access while ensuring the
    safety for the American consumer?
        Dr. Corrigan-Curay. Thank you. We are willing to work. I
    think we share the same goal of having additional choices. We
    do have very effective sunscreens. I do want to say that there
    are sunscreens on the market that are effective. But we
    understand that having additional options is important, but
    also understanding the safety of those options.
        Mr. Joyce. Thank you. Both Representative Debbie Dingell
    and I stand ready to work with everyone on this committee to
    make sure that the text of this policy meets the stated goals
    and have the desired impact at the FDA and account for any
    patient safety concerns. We respect and understand that.
        But American citizens are dying today as we are holding
    this hearing from metastatic melanoma. We can have that impact.
    We must take the next step to have that impact. I strongly urge
    consideration of this bill.
        And, Mr. Chairman, I yield back.
        Mrs. Harshbarger. The gentleman yields back.
        And now I will recognize the gentlewoman from Texas,
    Representative Fletcher.
        Mrs. Fletcher. Thank you so much, Madam Chairwoman.
        And thank you to Ranking Member DeGette.
        Thank you to all the witnesses for your testimony today. It
    has been very helpful. And I appreciate that all of you are
    public servants who care about the health and well-being of
    people across this country and have dedicated your careers to
    doing that, and we are here to talk about those things in your
    recommendations today. So I really want to thank you not only
    for your testimony but for your work.
        At the same time, I have real concerns that, once again,
    even if we reauthorize these programs, we won't have the
    funding or the staff to carry out these important
    recommendations and implement the information that we are
    hearing.
        I brought up this concern in April when we first were at
    our hearing on the Over-the-Counter Monograph User Fees
    Reauthorization. And I just don't understand why we are having
    another hearing on this, on reauthorizing a program that
    supports FDA's work, while simultaneously allowing the Trump
    administration to gut the FDA's workforce.
        This applies to the program reauthorizations under
    consideration today in these bills that fall under HRSA as
    well. And if everyone doesn't know, HRSA is slated to be
    eliminated completely as an agency under HHS, under Secretary
    Kennedy. We had him here a couple weeks ago. We need to have
    him back here, because these are hugely important questions.
        This is going to be eliminated as a subagency, and it is
    all part of the administration's effort to shrink government.
    And many of the critical workforce programs that we are talking
    about that HRSA oversees were slashed in President Trump's
    budget that this Congress is considering and seeming to move
    through without opposition, without objection to cutting the
    Federal workforce, to cutting these agencies, to cutting the
    work that is being done to help people in our communities and
    to keep them safe and to help them be healthy and healthier.
        And it is not included in the authorizations that we are
    talking about today, but one example of a workforce program
    that was eliminated in the President's budget that we talked
    about a little bit earlier is the Children's Hospitals Graduate
    Medical Education Program, the residents in children's
    hospitals.
        This has traditionally been a bipartisan program with a ton
    of support, and it is the only Federal program dedicated to
    training pediatricians. And our resident pediatrician already
    asked her questions, but we know, we know from people across
    our districts that this program helps train the doctors who
    take care of our children. And it is eliminated in the
    President's budget. It is completely eliminated. The President
    has decided this is no longer worthy of support.
        So my questions, I have questions that I am going to ask
    the witnesses, but my real question is for the Republicans on
    this committee. If we reauthorize these programs, and in the
    next budget the President eliminates them, are you going to
    vote against them? Are you going to do anything to object and
    to fight for the programs that everyone here is saying they
    wanted?
        We are introducing bipartisan bills about reauthorizing
    programs that we are letting the Trump administration--and when
    I say ``we,'' I mean half of this body, the majority in this
    body, over the strong objections of the people on my side of
    the aisle are letting the administration run roughshod, are
    doing whatever the President wants without question in cutting
    agencies, in cutting funding, in cutting staff, in saying they
    want to get rid of all these things.
        Will you vote against that? Will you object? Will you stand
    up for the things that we are talking about today? If we pass
    the Over-the-Counter Reauthorization and there are no staff to
    review over-the-counter drugs, are you going to care about
    firing all of them then?
        We can put a stop to this here in Congress. We can do that.
    We can say no. We can vote no. And I would like to see that
    happening in this committee and in this Congress.
        So, Dr. Chen, I took longer than I thought to ask my
    questions of my colleagues on the other side of the aisle, so I
    have a question for you that I am going to submit for the
    record. You talked a little bit earlier about your experience,
    and in your testimony, obviously, you talked about the various
    programs. And I would like for you to speak about how the
    Children's Hospitals Graduate Medical Education program helps
    address the pediatric workforce shortages as well.
        I am out of time, so I will look forward to your answer in
    writing in the record.
        And I will yield back. Thank you so much.
        Mrs. Harshbarger. The gentlelady yields back.
        And now I recognize the gentleman from Ohio, Mr. Balderson,
    for 5 minutes.
        Mr. Balderson. Thank you, Madam Chair. Good to see you over
    there.
        Thank you all for being here today. And my questions will
    be directed predominantly to Dr. Corrigan-Curay.
        Thank you for being here. This committee has heard concerns
    that the FDA moves goalposts in regard to what is asked of
    sponsors during reviews. Do you believe that this has been an
    issue within the over-the-counter drug program as well?
        Dr. Corrigan-Curay. I would say we don't try to move
    goalposts. But when we ask for a study, you can ask for a study
    to answer a question, and those are scientific studies. It is
    possible that the study doesn't yield the information that is
    necessary and we need additional information. But we do our
    best to only ask for the information that we need and to be
    least burdensome in our approach to the information we are
    asking to evaluate for safety and effectiveness.
        Mr. Balderson. Thank you. Do you think the FDA can provide
    greater consistency and predictability, moving forward?
        Dr. Corrigan-Curay. That is always our goal, and we will
    take that criticism that we may not be meeting that goal and
    try and implement greater consistency and predictability.
        Mr. Balderson. OK. I will follow up with you again also,
    Doctor. Congress has made clear its intent for the FDA to
    incorporate real-world evidence and new alternative testing
    methods during its review and approval processes.
        However, we have heard concerns that the agency has been
    slow to implement these tools. Can you explain how the FDA is
    currently using RWE and NAT in sunscreen evaluations and what
    steps the FDA is taking to ensure that this aligns with both
    the letter and the spirit of congressional direction?
        Dr. Corrigan-Curay. Thank you for that question. We
    certainly will rely on real-world evidence when it is
    appropriate and it can answer the question.
        You know, in the area of sunscreens, it may seem somewhat
    counterintuitive that they are used all the time and so there
    must be a lot of data and real-world data that we should be
    accessing in making our determinations.
        There are a couple things when you are trying to look for
    what we are saying causality is here. Does it cause some
    effect? You need to know what the exposure is. And unlike a
    prescription drug where we have in medical records exactly how
    much you took, when you took it, when we are talking about
    sunscreens, they can be used over many years. It is very
    difficult for people to quantify or remember which sunscreen,
    how long. And that can be a key issue that we need, but we will
    continue to look at whatever data we can.
        In terms of the alternative methods, as I said, we are very
    excited about the roadmap. We are working hard to develop the
    science that we can replace/reduce animal testing. Skin
    irritation is no longer done with animals. Eye irritation is no
    longer done with animals. And we continue to look for other
    alternative methods, and we certainly will apply them to
    sunscreens.
        Mr. Balderson. OK. Thank you.
        Lastly, 5 years ago Congress worked with the first Trump
    administration to enact the OTC Monograph Drug User Fee Act
    program. I know this was a critical step in modernizing the
    regulation of OTC products for the American people and taking
    key steps to empower consumers with more choices in meeting
    their healthcare needs.
        A key goal of enacting OMUFA was to improve the regulatory
    certainty around FDA's OTC work. But, as Congress assesses what
    has worked well in the first 5 years of this program and where
    we have opportunities to improve with this year's
    reauthorization, what suggestions do you have for how there can
    be more transparency with sponsors to further improve
    regulatory certainty when it comes to these products?
        Dr. Corrigan-Curay. Thank you. We certainly have learned
    from OMUFA I and that is reflected in OMUFA II. You know, we
    are going to provide more guidance or education on the GRASE
    standard, but we are first going to seek clarity from sponsors
    in terms of what are the questions they have.
        We know we need to provide more guidance on when you are
    bringing in a proposed order for a new active ingredient, more
    guidance on how we treat confidential data, also on
    exclusivity. We are going to do transparency on exclusivity,
    transparency on fees, who is paying fees and who is not paying
    fees.
        We are going to continue to provide guidance in areas that
    industry needs to understand that predictability and what our
    expectations are.
        Mr. Balderson. OK. Thank you very much.
        And, Mr. Chairman, I yield back.
        Mr. Griffith [presiding]. The gentleman yields back.
        I now recognize the gentleman from Massachusetts, Mr.
    Auchincloss.
        Voice. I think she was here.
        Mr. Griffith. We didn't have that, but that is fine with
    me. I am just trying to follow the rules. OK. Then I apologize,
    and I recognize the gentlelady from New York, Ms. Ocasio-
    Cortez.
        Ms. Ocasio-Cortez. Thank you, Mr. Chairman.
        And thank you to our witnesses for being here today.
        Less than 2 weeks ago, we saw Republicans vote to
    completely gut Medicaid, which covers nearly half of all births
    in the United States. And they did this despite the fact that
    the United States, the richest country in the world, also has
    the highest rate of maternal deaths among all wealthy
    countries.
        Black women, in particular, in America are dying at more
    than three times the rate of White women in childbirth. And we
    also have the highest rate of infant deaths overall compared to
    other high-income countries. We are also the only country that
    doesn't guarantee healthcare as a basic human right.
        Dr. Chen, as a medical provider, can you speak to why the
    United States has such high rates of infant and maternal
    mortality?
        Dr. Chen. This is not actually my area of expertise, so I
    don't want to speak out of turn. Our Maternal and Child Health
    Bureau does cover this issue very, very closely, and we are
    happy to follow up with you afterwards.
        Ms. Ocasio-Cortez. I understand. I also think it is
    important that we talk about the Healthy Start program. Healthy
    Start is a federally funded, bipartisan program whose sole
    purpose is to reduce infant deaths and improve the health of
    pregnant women and new mothers.
        There are more than 115 Healthy Start programs across the
    country in both Republican and Democratic districts. In fact,
    Healthy Start was actually created by a Republican President,
    George H.W. Bush, in 1991.
        Healthy Start programs, like the ones in my community in
    the Bronx, provide education for new parents so that they can
    safely care for their baby and one-on-one support through home
    visits. They ensure that families are connected to the services
    they need, like housing, food, transportation and prenatal and
    postpartum care.
        Dr. Chen, your agency oversees the Healthy Start program,
    correct?
        Dr. Chen. Yes, in the Maternal and Child Health Bureau.
        Ms. Ocasio-Cortez. And as I mentioned earlier, it was
    created under Republican President George H.W. Bush, but since
    then Healthy Start has been reauthorized several times on a
    bipartisan basis. The last time it was reauthorized was during
    President Trump's first administration.
        And that is because Healthy Start works. Women in Healthy
    Start receive earlier and more frequent prenatal care. Fathers
    are more engaged, and babies are born healthier under this
    program.
        I am proud to be leading the reauthorization of this with
    Representative Malliotakis and continuing the bipartisan
    tradition of this program. I would like to urge my colleagues
    to support this commonsense, bipartisan effort to reauthorize
    Healthy Start.
        I also want to briefly turn to another bill we are
    discussing today about sunscreen, which was led by my
    colleagues, Representatives Joyce and Dingell, which was spoken
    to earlier today.
        With respect to sunscreen, as skin cancer is the most
    common cancer in the United States and for people who work long
    hours outside, like farm workers and construction workers,
    adequate sun protection is essential. Yet the Food and Drug
    Administration, or the FDA, has not approved any new sunscreen
    filters since 1999. Yet our counterparts in Europe and Korea
    and many other markets around the world have been able to bring
    much more technologically advanced filters to the market.
        And the reason this is important is that it is not just a
    cosmetic issue. The easier sunscreens are to apply and the more
    elegant these formulations are, then the easier and more
    commonly adopted they will be for people to use.
        If they are uncomfortable, if they smell bad, if they have
    all of these other issues, folks who work on farms, folks that
    work in construction, and people who work in the sun are less
    likely to use them, and it elevates cancer risks for working
    people.
        And so I am deeply supportive of efforts within the FDA to
    help streamline a safe process for approving these new filters,
    ensuring, yes, we want to make sure that there aren't endocrine
    disruptions or any other kinds of issues, ensuring the safety
    of these. But surely we can come to a process where we don't
    have to wait 25 years between filters when we are being
    outperformed by the rest of the world.
        So I want to express my support for those efforts and
    ensure that we can get this moving, because it is just simply
    unacceptable.
        And Dr. Corrigan-Curay, why is the United States so far
    behind other countries when it comes to available sunscreens?
        Dr. Corrigan-Curay. So in some countries, these are
    regulated not as drugs, but they are regulated as cosmetics.
    And we regulate them as drugs, and we have done some testing.
    We know they are systemically absorbed, and we need to, you
    know, look at that data.
        If we had that data in hand, we would be ready to review as
    many sunscreens as was submitted.
        Ms. Ocasio-Cortez. Thank you very much.
        And I yield back to the Chair. Thank you.
        Mr. Griffith. The gentlelady yields back.
        I now recognize the gentlelady from Iowa, Dr. Miller-Meeks.
        Mrs. Miller-Meeks. Thank you and congratulations, Chair
    Griffith.
        And I thank the witnesses for testifying before the
    subcommittee today.
        I have the privilege of representing Iowa's first
    congressional district, which is largely rural, and in many
    cases, medically underserved. And having been one of the
    physicians who practiced in these underserved rural areas, I
    know fully how being an advocate for rural Americans' access to
    healthcare is a priority for me. And I look to a productive
    conversation with our witnesses.
        Mrs. Miller-Meeks. Dr. Chen, the Geriatrics Workforce
    Enhancement Program, GWEP, is a Title VII-funded program that
    plays a critical role in building a well-equipped healthcare
    workforce that meets the challenges of an aging population.
        At the University of Iowa, the program has reached over
    40,000 learners, spanning nearly all of Iowa's 99 counties,
    promoting age-friendly care to address the complex needs of
    older Iowans in rural and underserved areas with limited access
    to specialized care.
        Can you speak to the importance of such programs as our
    demographics continue to shift and older adults are projected
    to outnumber youth by 2034?
        Dr. Chen. Thank you so much for the question and the focus
    on the geriatric--on the older adult population and the
    healthcare workforce that is needed to take care of it.
        You are absolutely right. As our population is aging, one
    of the things that is driving our projected workforce shortages
    is the aging of the population. As people get older, their need
    for healthcare tends to increase. And their need for healthcare
    also changes as they get older. It becomes much more complex.
        And so having those specialists, being able to engage in
    direct care, as well as working on the system to provide better
    care and access are important, and that is what the Geriatric
    Workforce Enhancement Programs do.
        Mrs. Miller-Meeks. Thank you.
        Dr. Corrigan-Curay, earlier this year I sent a letter to
    the FDA expressing concern with one aspect of the agency's
    then-proposed rule on additional conditions for nonprescription
    use, or ACNU.
        The rule went into effect in May, and I am concerned that
    it contains a provision in the preamble that would allow for
    simultaneous marketing of otherwise same prescription drug
    after approval of a nonprescription drug--I know it is
    complex--with an additional condition of nonprescription use.
        Historically, when all uses of a product are switched to
    nonprescription use, FDA has, as required by statute,
    determined that the prescription product must no longer be
    available.
        Would you support the FDA reconsidering this portion of the
    preamble to avoid consumer confusion and encourage more
    prescription-to-nonprescription switches?
        Dr. Corrigan-Curay. Thank you for that question.
        It is a complicated issue, but in this case, unlike an
    over-the-counter without a condition of use, that over-the-
    counter, we have determined, can just be accessed at any store
    shelf wherever it is being sold.
        With the additional condition of use, it means that there
    is going to be some sort of perhaps technology that is used
    before you obtain access.
        We also realize that there may be consumers who do not want
    to use that technology, and we want to have the opportunity for
    them to potentially access that as a prescription drug. That is
    the rationale underlying that.
        Mrs. Miller-Meeks. Thank you.
        Dr. Chen, in your written testimony you state that ``HRSA
    serves as the primary Federal agency for improving healthcare
    access and improving the health of Americans, particularly
    those in underserved areas, by growing and strengthening the
    healthcare workforce and connecting skilled providers to
    communities in need.''
        For 3 years now, I have led an annual bipartisan
    appropriations letter that in part advocates for the Public
    Health Workforce Loan Repayment Program, in addition to which I
    was the director of public health in Iowa for several years.
        Infectious disease doctors additionally collaborate with
    public health departments, especially in preparation of, and in
    response to, public health threats.
        Do you believe that the workforce programs, such as the
    Public Health Workforce Loan Repayment Program and the Bio-
    Ppreparedness Workforce Pilot Program, are worthwhile
    investments?
        Dr. Chen. Well, I can't speak on pending legislation.
        The workforce obviously is very important for a number of
    different reasons, both for the public health side as well as
    the bioterrorism, infectious disease workforce, and if Congress
    were to fund those programs, we would aim to implement them.
        Mrs. Miller-Meeks. Since you mentioned that you can't speak
    on them--and my time is expiring--if you could respond in
    writing if there are manners in which the Federal Government
    can help with our workforce needs, that would be helpful.
        With that, I yield back. Thank you.
        Mr. Griffith. The gentlelady yields back.
        And now I recognize the gentleman from Massachusetts, Mr.
    Auchincloss.
        Mr. Auchincloss. Thank you, Chairman.
        We are having this legislative hearing on a number of bills
    that affect the Food and Drug Administration at a time when the
    FDA is under unusual and extraordinary strain from the
    conspiracizing and conflicts of interest of the Secretary of
    Health and Human Services, and I am hoping to work with the
    Commissioner of the FDA to help insulate the career scientists
    at this gold standard agency from political pressures and
    ideology that is not evidence-driven.
        I have been concerned by some of his recent statements. He
    has praised Calley Means as a great scientific mind when I
    think all evidence is to the contrary. He has linked FDA
    approvals to pricing, which is contrary to the FDA mandate of
    safe and effective. And most recently has introduced this
    Commissioner's National Priority Voucher Program, which I don't
    believe has any statutory authority.
        And these are issues that need to be addressed because, if
    the FDA is accommodating purges of career scientists under his
    leadership and breaching its statutory mandate, it is hard to
    have confidence in its ability to implement many of these
    pieces of legislation, including the FDA Modernization Act.
        Dr. Corrigan-Curay, could you just briefly give us your
    experience at the FDA over your career? How long have you
    worked there, and what roles have you had?
        Dr. Corrigan-Curay. I have worked there for approximately 9
    years. I started as the lead in the Office of Medical Policy. I
    then moved up into the Office of the Center Director. I was
    Acting Director of Operations and then moved into Principal
    Deputy, and most recently moved into the Acting Center Director
    role.
        Mr. Auchincloss. So it is safe to say that you understand
    the FDA's mandate and operations pretty well?
        Dr. Corrigan-Curay. Yes, I do.
        Mr. Auchincloss. And is there any part of the FDA's mandate
    that has to do with pricing?
        Dr. Corrigan-Curay. We do not directly address pricing, but
    our competition areas--biosimilars and generics--we are very
    aware that the----
        Mr. Auchincloss. I understand that the role for generics
    and biosimilars is to reduce the cost of drugs, and generics
    have proven very successful in doing that. Biosimilars have
    made progress. We have got more work to do. I get why we
    approve those.
        But is your approval pathway linked to the price of the
    drug, or is it linked to safety and efficacy of the drug?
        Dr. Corrigan-Curay. Our approval pathway is linked to
    safety and efficacy of the drug.
        Mr. Auchincloss. So when the Commissioner says that the
    price of a drug is going to influence the approval pathway,
    does that conform to the mandate?
        Dr. Corrigan-Curay. I am not aware of what he said. I don't
    know whether he is talking about access and competition----
        Mr. Auchincloss. Well, what he was talking about was the
    Commissioner's National Priority Voucher Program and how he
    might decide to allow drugs to use this fast track.
        Before we get into the CNPV, though, give me a brief
    overview of existing Accelerated Approval pathway pathways.
    What do they do for companies?
        Dr. Corrigan-Curay. So the Accelerated Approval pathway is
    an approval pathway, and what we do is, we can approve on a
    surrogate end point that is reasonably likely. It leaves some
    uncertainty. And then we get the confirmatory evidence after.
        We also have a number of programs, like Breakthrough and
    Fast Track, which are also programs in which we work with
    companies. We will have more touch points to get them with a
    drug that is promising either in a preclinical or clinical
    basis.
        Mr. Auchincloss. And these programs are approved by
    Congress, yes?
        Dr. Corrigan-Curay. They are.
        Mr. Auchincloss. Explicitly?
        Dr. Corrigan-Curay. They are.
        Mr. Auchincloss. In your understanding, is there anything
    within the FDA regulations that would allow for a Commissioner
    to create a new approval pathway without congressional statute?
        Dr. Corrigan-Curay. My understanding, you know, we can have
    various times that we approve. We have goals of when we want to
    approve something. So we can try and approve--we may say a
    supplement takes 6 months, but under Breakthrough we can get
    rolling submissions, we could potentially get that done faster.
        Mr. Auchincloss. I understand that you want to, as an
    agency, you want to have a tight feedback loop. I am saying, is
    there anything in the FDA's current authorizing statute that
    allows a Commissioner to create a brand-new Accelerated
    Approval pathway subject to his discretion?
        Dr. Corrigan-Curay. I don't think this is an Accelerated
    Approval. I think it is a challenge to us to try and move
    faster in certain areas where there are unmet needs. And I am
    sure we could get back to you in writing with more detail on
    that.
        Mr. Auchincloss. Right. But as you said, it cannot be
    linked to price, and it can't be linked to anything that
    Congress doesn't expressly authorize. So what would be the
    basis for a National Priority Voucher Program?
        I mean, does he just get to decide which drugs get
    preferred? Is this like fear or favoritism, whatever he thinks
    is necessary?
        Dr. Corrigan-Curay. Well, my understanding is we are going
    to get more information about this in the process. On our
    website, I think there are things like unmet medical needs,
    some of the areas where we typically try and move a little
    faster.
        Mr. Auchincloss. Yes. The challenge here is the biotech
    companies need to be competing on safety and efficacy, and they
    absolutely deserve a quick turnaround time from the agency, and
    you should give them that, and PDUFA should help negotiate
    that.
        But what we can't allow to have happen is the
    Commissioner's pet projects or his favorites or his opinions
    override preclinical phase 1, phase 2, phase 3 data. And this
    program right here, which is without basis in congressional
    statute, is a fear or favoritism pathway.
        Mr. Griffith. The gentleman's time has expired. The
    gentleman yields back.
        I now recognize the gentleman from New Jersey, Mr. Kean.
        Mr. Kean. Thank you, Mr. Chairman.
        New Jersey is a hub of ingenuity in many industries,
    including in over-the-counter drugs. A number of OTC companies
    have a strong presence in New Jersey, where they manufacturer
    and they develop their innovative products.
        Unlike prescription drugs, Americans see these products on
    store shelves every day and use them for common ailments or to
    help their kids when they are sick. In fact, many of these
    products and their active ingredients have been on shelves in
    some cases for decades.
        But this does not mean that these companies are not
    innovative. Additions of already approved active ingredients to
    an existing monograph can increase the effectiveness of a
    product, creating a more convenient route of administration for
    a product, and also increase a patient's adherence and
    therefore their overall health.
        Enabling innovation is one of the reasons that 5 years ago
    Congress, industry, and the FDA worked together to reform the
    OTC drug approval process.
        Now we get the opportunity to evaluate these reforms and
    make any changes needed to ensure that the OTC monograph
    program continues to foster innovation.
        Dr. Corrigan-Curay, could you please give us a quick
    summary of the two distinct approval pathways at FDA that were
    established 5 years ago in the CARES Act and the difference
    between the two?
        Dr. Corrigan-Curay. In terms of the OTC monograph, this was
    really to change from sort of a rulemaking to a regulatory
    provision.
        I am not sure of the other approval pathway--I am sorry--
    that you are referencing from the CARES Act.
        Mr. Kean. So I ask this because I have heard concerns from
    some OTC manufacturers that when they choose the more
    streamlined pathway, initiate a change to a monograph through
    OMOR, their concern is that there is a lack of clarity at FDA
    on what data they need to determine whether a proposed change
    is a GRASE.
        And this leads to more of a drawn-out and back-and-forth
    between the FDA and manufacturers that can delay the approval
    of innovative products.
        Wouldn't you agree that knowing at the beginning of the
    process what the guardrails and expectations are for an OMOR
    can provide certainty to manufacturers and increase their
    investment in innovative ideas?
        Dr. Corrigan-Curay. Yes. Thank you.
        We would, and we are going to give more clarity. That is
    one of our objectives in OMUFA II, to give more clarity about
    an OMOR where you are bringing a new active ingredient into the
    market.
        And we definitely are also going to, across the industry,
    provide more education on the GRASE standard so it is well
    understood and our expectations are understood under that
    standard.
        Mr. Kean. Thank you.
        Dr. Chen, changing gears here, I wanted to highlight one of
    the bills that we are considering here today, to reauthorize
    the Title VII public health workforce programs.
        I have recently heard from the Virtua Health College of
    Medicine and Life Science and Rowan University that is a
    recipient of the Geriatric Workforce Enhancement Program that
    is reauthorized in this legislation.
        Since there are not enough specialists in geriatrics, this
    college is adapting by working with educational institutions in
    New Jersey, like Rutgers, and health systems, like Hackensack
    Meridian Health, to educate all members of the healthcare
    workforce in how to effectively care for New Jersey's aging
    population.
        Can you speak to how this effort in New Jersey to broadly
    educate healthcare providers instead of relying solely on
    geriatric specialists will continue to help our seniors?
        Dr. Chen. Thank you for your interest, again, I think, in
    the geriatrics programs.
        Taking care of older adults with complex illnesses--
    oftentimes multiple chronic conditions, dementia--takes a real
    team. And it takes both the combination, I think, of
    specialists and people who have been trained to provide that
    specialized care, as well as the integration with primary care
    and the wider healthcare system. And that is what the Geriatric
    Workforce Education Program supports.
        Mr. Kean. Thank you.
        I yield back.
        Mrs. Harshbarger [presiding]. The gentleman yields back.
        And I will call on the gentleman from Ohio, Mr. Landsman,
    for his 5 minutes.
        Mr. Landsman. Thank you, Madam Chairwoman and the Ranking
    Member, for having today's hearing, and for all of you
    witnesses for being here today.
        When OMUFA was first signed into law--and we have got 5
    years under our belt--it was aimed at increasing the efficiency
    at the FDA so that they could update the monographs more
    quickly, keep up with consumer healthcare needs, and create a
    simpler pathway to the market for innovative products with
    safe, established ingredients.
        And like everybody else, my constituents rely on these
    over-the-counter drugs, and they want to be able to have a set
    of options, lots of options, and the most innovative and best
    products on the shelves when they go shopping.
        The challenge has been that over the course of the last 5
    years, despite the attempt of this law to make things more
    efficient, there have been few sponsor-initiated OTC monograph
    changes. There haven't been many.
        And so the questions here for you, Dr. Corrigan-Curay, as
    the Acting Director of the Center for Drug Evaluation and
    Research, have you seen the implementation of OMUFA? I mean,
    are you watching this? I mean, what can you say?
        Dr. Corrigan-Curay. Yes. Thank you for that question.
        I think what we have to realize, we do have one, of course,
    new OMOR for sunscreen, and we have also issued orders to
    update safety labeling for acetaminophen. We issued an order on
    phenylephrine and its efficacy or lack thereof.
        When you build a program from really scratch--it is not
    like when we had the PDUFA, we were approving PDUFA drugs--
    there is a time to build, and then we started meeting our
    meeting goals in year 3, and that is when we start to get the
    innovation.
        So there is a lag in terms of building the first program
    and then seeing an OMOR come to fruition.
        But we have on our agenda, we are going to continue to
    update labels. We are willing to work with companies. We have
    told them the data that we need to examine.
        And we will continue to work on innovation, including by
    giving them more opportunities to interact with us. So in OMUFA
    II we will expand meetings if needed. We will look at protocol
    synopsis. We will do more education on the GRASE standard.
        Mr. Landsman. I mean, the time to build I get. Three years
    seems like a long time, but I don't--I do this, I don't do what
    you do.
        So that piece aside, why have there been so few sponsors?
    Or is it really just that it took you a while--I mean, you just
    named a few, 5 years later.
        And, I mean, are you expecting an explosion of approvals
    now, or are there still--I mean, it would be helpful to
    understand--for example, folks in my district have said that
    some of the data required for an over-the-counter monograph
    change is more rigorous than they would have expected for some
    products. You mentioned time with your staff.
        Is data, the requirements, is that a big part of why we are
    seeing so few being approved?
        Dr. Corrigan-Curay. Well, I think one thing is that we need
    the data. The standard of safety and effectiveness, the GRASE
    standard, is one that needs to be rigorous because these
    products are over the counter. They can be bought anywhere.
    They are not under the provision of a healthcare provider.
        So we need to work with the companies so they understand
    what that data is. We will work on--each individual case is
    different. We will have that conversation.
        Mr. Landsman. Do you feel like you have the flexibility--of
    course, rigorous data is really important. The question is,
    when does it become that there is so much data that you are
    just keeping products from--there is just too much bureaucracy
    and it is taking too long?
        I mean, do you feel like you have the flexibility, in your
    reviews of these monographs, to allow for innovation while
    still ensuring product safety? Or do these applicants have to
    meet these--the same stringent standards?
        Dr. Corrigan-Curay. They have to meet the standard for
    safety and effectiveness, but how they get there, we think we
    can be flexible. We can look at alternative testings. We have
    the ability to figure out which data is fit for use.
        Mr. Landsman. I have run out of time. I will submit my
    questions. And thank you.
        I yield back.
        Well, can I--sorry.
        One of the things that would be great--I am sorry--is to
    get a sense--and we can follow up--but what can I tell my folks
    that you all are going to do, or are doing, that will make this
    process what was envisioned 5 years ago? But I will follow up.
        Thank you, Madam Chair, for giving me that. I yield back.
        Mrs. Harshbarger. The gentleman yields back.
        And now I recognize the gentleman from Ohio, Mr. Rulli, for
    5 minutes.
        Mr. Rulli. Well, it is good to see Ohio in the house, so
    God bless you, sir.
        I just want to take a second, and I want to thank Mr.
    Morris for all your hard work at HRSA. It means the world to
    us. We appreciate it.
        I am proud to join, as an original cosponsor, to Chair
    Carter's bipartisan H.R. 2493, Improving Care in Rural America
    Reauthorization Act. It extends grants and helps rural
    residents who have trouble accessing healthcare.
        And I think this is a really interesting bill for myself
    because I think this is one of the first times that I have
    actually seen on the Hill, versus the State House years that I
    did, where we have bipartisan support for a cause.
        So I think it is really reassuring and refreshing to see
    such a bipartisan approach to this problem.
        And it is a problem. I am going to give two quick examples
    of personal tragedies that I have seen within my district in
    the last year.
        Directly north of my district in Warren, Ohio, was a
    hospital called Trumbull Memorial Hospital, where actually my
    son was born. This hospital got gutted by Steward Health out of
    Boston, Massachusetts, for some shenanigans they were doing
    within their financing of the actual hospital.
        The hospital closed, so the biggest ER within a 45-to-50-
    mile radius was shut down.
        The problem is with that, when you live in northern
    Trumbull County or southern Ashtabula, Ohio, which is all in
    the eastern part of Ohio, you would now have to go to the
    Cleveland Clinic or University Hospital within the city limits
    of Cleveland, or you would have to drive down to Youngstown or
    Pittsburgh.
        Some of these areas are an hour away. So if you are having
    a heart attack or a stroke or another medical emergency, there
    will not be logistic times to get you to that ER. These are the
    kind of problems that we are dealing with, with rural
    hospitals.
        Besides that, another example is down in Marietta, Ohio,
    which is the very southern part of my district, almost a 4-hour
    drive from Trumbull County.
        These are examples of the problem within rural America that
    we are facing, that both parties can go across party lines and
    we could join hands together and fix these problems.
        In Marietta, they realized that there wasn't a possibility
    of them having a children's hospital unless you went to
    Nationwide, which is in the city of Columbus. That is 2\1/2\
    hours away. In order to get you into Pittsburgh for another
    emergency is an hour and a half away.
        People will die.
        There is a major problem in this country with rural
    hospitals that we have to fix, and it is something that every
    elected official has brought onto the Hill to try to do.
        The reauthorization funds program that provides insulin and
    blood pressure medications, strengthens telehealth--and
    telehealth is going to be incorporated with all this broadband
    work that we are doing, because we have to give them the tools
    to actually make telehealth work--and also manages chronic
    diseases.
        Health outcomes should never depend on someone's ZIP Code.
    I think that is atrocious in a country that is the epicenter of
    the world, that we have problems just because we have poor
    rural America that does not have access.
        On the heels of the Big Beautiful Historical Bill, contrary
    to popular belief, there is a $50 billion investment in rural
    healthcare.
        This is what happens when you get to the finish line of any
    piece of legislation, and the two parties and everyone starts
    working together. We realized that there was a hole with the
    rural hospitals, and we got $50 billion in investment in rural
    healthcare, which will have a profound impact.
        I am very happy to support this legislation. I am happy to
    go across the aisle.
        And with that, I yield my time to the Chair.
        Mr. Griffith [presiding]. The gentleman yields back.
        We are going to pause for just a minute. I believe we have
    some other witnesses who are expected--or some other Members
    who are expected.
        The gentleman from Ohio, Mr. Latta, is recognized for 5
    minutes.
        Mr. Latta. Well, thank you, Mr. Chairman.
        Multiple things here this morning.
        Mr. Griffith. Hold the clock for just a second. Let him at
    least get turned into his page. I just did the same thing
    upstairs.
        I apologize to our witnesses, but we have multiple hearings
    going on, and we are trying to let every Member who is
    interested in the subject matter ask their questions.
        And I just ran upstairs to the Environment Subcommittee and
    asked my questions, and ran back down here. And I appreciate my
    vice chair filling in and helping me out. We both did that at
    some point today. But I appreciate our witnesses.
        And now I believe the gentleman is ready.
        Mr. Latta. Well, thank you, Mr. Chairman, and appreciate
    your indulgence.
        And to our witnesses, thank you very much for being here
    today. This is a really important hearing, critical to the
    public health workforce, rural health, and over-the-counter
    medicines.
        The Over-the-Counter Monograph Drug User Fee Program,
    OMUFA, at the Food and Drug Administration gives consumers
    access to manage their own care in a safe and affordable
    manner.
        Five years ago I worked with my Energy and Commerce
    colleagues to modernize how the FDA regulates most OTC
    medicines with the enactment of the OMUFA program.
        These revolutionary changes made the 40-year-old system
    more efficient, transparent, and open to innovation. I am very
    proud, once again, to be leading this reauthorization of such a
    critical program.
        The OMUFA program has drastically reduced the burden on our
    healthcare system by lowering the number of visits consumers
    need to make to a doctor to obtain a prescription for a simple
    treatment.
        Again, 5 years ago, when Congress initially passed my
    legislation to reform OTC monographs, I entered into the record
    a statement of intent on data required for general recognition
    of safety and effectiveness for nonprescription drugs.
        The statement reads, ``General recognition of safety shall
    ordinarily be based upon published studies which may be
    corroborated by unpublished studies and other data.''
        Unfortunately, in the 5 years, I am concerned that the FDA
    has not fully acted in accordance with the congressional intent
    by requiring superfluous information. I am concerned that these
    delays to innovation prevent consumers from benefiting from new
    and improved products.
        If I could ask my first question to Dr. Corrigan-Curay.
    Hope I pronounced that properly.
        In the last 5 years, how has FDA worked to improve the
    process for expediting the review and administrative order
    process for monographs?
        Dr. Corrigan-Curay. Thank you.
        In this first 5 years, what we have done is we have changed
    this from a paper-based rulemaking to an electronic
    communication system. We have given fundamental guidances so
    the expectations are very clear. We started meeting with
    companies on their programs. We are meeting all those goals.
        We had the first OMOR for a sunscreen. We have issued 33
    final orders, and we have five proposed orders, to update some
    of the safety labeling, as well as a new order that we are
    going to--proposed order that would allow innovation in terms
    of dosage forms.
        So you could go from tablet or capsule to an oral
    disintegrating or a chewable, and so that would allow children
    and those who have trouble swallowing.
        So we have done a lot. There is more to do. In OMUFA II, we
    want to provide more opportunities for interactions with the
    FDA and companies, so they know our expectations looking at
    their protocol synopsis.
        We will work on issues on quality. We will work on
    transparency--transparency in exclusivity, transparency in
    fees, and who is paying the fees and who is not paying the
    fees.
        So we think we are on a good path to continue this
    innovation.
        Mr. Latta. Just to follow up on that. What is your
    timeline? Because you said there are more things to do and more
    to get these things through the process. Is there any kind of a
    timeline that you are anticipating?
        Dr. Corrigan-Curay. Well, right now we are working with
    companies and we are working on--or the proposed orders. We
    need to get the comments finished, the comments, and put them
    through.
        The sunscreen, that is in, so this would be for a new
    sunscreen ingredient. We are working along with our timelines
    that we have in our commitment letter.
        The new things under OMUFA II would be really to sort of
    continue to grow the program in a way that fosters innovation
    by working--providing other opportunities to interact with FDA
    and understand our expectations, provide more clarity and
    education on the GRASE standard, which I think is what you were
    saying. There may be some confusion about what our expectations
    are.
        We certainly don't want superfluous studies. We want
    studies that answer the question. And that is all that we need.
        Mr. Latta. Thank you.
        And I am interested, and I believe this subcommittee would
    benefit from reviewing the study that was required in my
    previous OTC modernization legislation.
        So, again, it is just--you brought up one of the issues out
    there I know we have heard in this subcommittee for a good
    number of years, is just like on sunscreen. And I am sure it
    came up, some other Members have already brought it up. But the
    Europeans, they always say, are so much far ahead of us on
    this, and so we want the United States to lead.
        So I look forward to working with you.
        And I appreciate the chairman and for the work that is
    going to be done in this subcommittee.
        And I also just want to take a point of personal privilege
    and congratulate you on the gavel here in the Health
    Subcommittee.
        I yield back.
        Mr. Griffith. I thank the gentleman for his congratulatory
    remarks and for yielding back.
        I see no further Members of Congress wishing to ask
    questions, so I would like to thank all the witnesses for being
    here today. We do appreciate it.
        Members may have additional written questions for you all.
    I remind Members that we have 10 business days to submit those
    questions for the record.
        I would ask the witnesses to respond to the questions
    promptly. That, of course, doesn't start until we get them to
    you.
        Members should submit their questions by the close of
    business on Wednesday, July 30.
        Without objection, the subcommittee is adjourned--oh, I ask
    unanimous consent, before we adjourn, to insert in the record
    the documents included on the staff hearing document list.
        Without objection, so ordered.
        [The information appears at the conclusion of the hearing.]
        Mr. Griffith. And the subcommittee is adjourned.
        [Whereupon, at 12:28 p.m., the subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]
        [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

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