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

                      EXAMINING THE FDA'S REGULATION OF OVER-
                             THE-COUNTER MONOGRAPH DRUGS

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

                                    HEARING

                                   BEFORE THE

                             SUBCOMMITTEE ON HEALTH

                                     OF THE

                             COMMITTEE ON ENERGY AND
                                     COMMERCE

                            HOUSE OF REPRESENTATIVES

                          ONE HUNDRED NINETEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 APRIL 1, 2025

                                   __________

                               Serial No. 119-14

    [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
    60-082 PDF                  WASHINGTON : 2025

    -----------------------------------------------------------------------------------

                        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                PAUL TONKO, New York
    DAN CRENSHAW, Texas                  YVETTE D. CLARKE, New York
    JOHN JOYCE, Pennsylvania, Vice       RAUL RUIZ, California
        Chairman                         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

                       EARL L. ``BUDDY'' CARTER, Georgia
                                     Chairman
    NEAL P. DUNN, Florida, Vice          DIANA DeGETTE, Colorado
        Chairman                           Ranking Member
    H. MORGAN GRIFFITH, Virginia         RAUL RUIZ, California
    GUS M. BILIRAKIS, Florida            DEBBIE DINGELL, Michigan
    DAN CRENSHAW, Texas                  ROBIN L. KELLY, Illinois
    JOHN JOYCE, Pennsylvania             NANETTE DIAZ BARRAGAN, California
    TROY BALDERSON, Ohio                 KIM SCHRIER, Washington
    DIANA HARSHBARGER, Tennessee         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. Earl L. ``Buddy'' Carter, a Representative in Congress from
      the State of Georgia, opening statement........................     1
        Prepared statement...........................................     4
    Hon. Diana DeGette, a Representative in Congress from the State
      of Colorado, opening statement.................................     8
        Prepared statement...........................................    10
    Hon. Brett Guthrie, a Representative in Congress from the
      Commonwealth of Kentucky, opening statement....................    13
        Prepared statement...........................................    15
    Hon. Frank Pallone, Jr., a Representative in Congress from the
      State of New Jersey, opening statement.........................    18
        Prepared statement...........................................    20

                                   Witnesses

    Kevin Menzel, Member, Board of Directors, Consumer Healthcare
      Products Association, and President, Focus Consumer Healthcare.    22
        Prepared statement...........................................    25
        Answers to submitted questions...............................   165
    Douglas M. Troutman, Interim Co-Chief Executive Officer, American
      Cleaning Institute.............................................    31
        Prepared statement...........................................    33
    Kim Wezik, Director of Advocacy, Melanoma Research Foundation....    38
        Prepared statement...........................................    40
    Scott Faber, Senior Vice President, Government Affairs,
      Environmental Working Group....................................    44
        Prepared statement...........................................    46
    Carl D'Ruiz, Senior Science, Advocacy, and Business Development
      Manager, DSM-Firmenich, and Former Chair, Personal Care
      Products Council...............................................    53
        Prepared statement...........................................    55

                               Submitted Material

    Inclusion of the following was approved by unanimous consent.
    List of documents submitted for the record.......................   107
    Statement of Dan Bigman, Small Business Owner....................   108
    Paper from Public Access to SunScreens Coalition.................   112
    Letter of March 28, 2025, from Peter Marks, Director, Center for
      Biologics Evaluation and Research, Food and Drug
      Administration, to Sara Brenner, Acting Commissioner of Food
      and Drugs, Food and Drug Administration........................   119
    Article of March 25, 2025, ``Closed-door debut of the MAHA
      Commission is a shaky start, scholars say,'' Center for Science
      in the Public Interest.........................................   121
    LinkedIn post from Robert Califf.................................   124
    Letter of March 31, 2025, from E. Cartier Esham, Executive
      Director, Alliance for a Stronger FDA, to Mr. Guthrie, et al...   125
    Statement of March 28, 2025, by Friends of Cancer Research.......   127
    Statement of March 27, 2025, by Brian Ronholm, Director of Food
      Policy, Consumer Reports.......................................   129
    Article of March 27, 2025, ``FDA's policy, communications staff
      likely to be among agency's 3,500 staff cuts,'' by Zachary
      Brennan, Endpoints News........................................   130
    Article of April 1, 2025, ``Firings sweep across FDA, gutting
      leadership and whole offices,'' by Zachary Brennan, Endpoints
      News...........................................................   133
    Statement of March 28, 2025, by Yolanda C. Richardson, President
      and Chief Executive Officer, Campaign for Tobacco-Free Kids....   135
    Article of March 27, 2025, ``FDA Cuts Could Stall Biotech Deals,
      Shake Investor Confidence, Experts Warn,'' by Maaisha Osman,
      Inside Health Policy...........................................   136
    Article of March 4, 2025, ``Gutting FDA Won't Make America
      Healthy,'' by Reshma Ramachandran and Joseph S. Ross, MedPage
      Today..........................................................   138
    Article of March 28, 2025, ``Wanted: More `details' about FDA
      cuts,'' by Lauren Gardner and David Lim, Politico..............   144
    Press releae of March 27, 2025, by UsAgainstAlzheimer's..........   149
    Article of March 27, 2025, ``FDA staff struggle to meet product
      review deadlines after DOGE layoffs,'' by Patrick Wingrove,
      Reuters........................................................   151
    Article of March 28, 2025, ``RFK Jr. forces out Peter Marks,
      FDA's top vaccine scientist,'' by Dan Diamond, The Washington
      Post...........................................................   153
    Statement of March 27, 2025, by Wayne A. I. Frederick, Interim
      Chief Executive Officer, Cancer Action Network, American Cancer
      Society........................................................   156
    Article of March 27, 2025, ``RFK Jr. brings FDA under tighter
      control with HHS workforce cuts,'' by Lizzy Lawrence, et al.,
      STAT...........................................................   158
    Statement of March 28, 2025, by Doctors for America..............   162

       EXAMINING THE FDA'S REGULATION OF OVER-THE-COUNTER MONOGRAPH DRUGS

                                  ----------

                             TUESDAY, APRIL 1, 2025

                      House of Representatives,
                                Subcommittee on Health,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:16 a.m., in
    the John D. Dingell Room 2123, Rayburn House Office Building,
    Hon. Earl L. Carter [chairman of the subcommittee] presiding.
        Members present: Representatives Carter of Georgia, Dunn,
    Griffith, Bilirakis, Crenshaw, Joyce, Balderson, Harshbarger,
    Miller-Meeks, Cammack, Obernolte, James, Bentz, Houchin,
    Langworthy, Kean, Guthrie (ex officio), DeGette (subcommittee
    ranking member), Ruiz, Dingell, Kelly, Barragan, Schrier,
    Trahan, Veasey, Fletcher, Ocasio-Cortez, Auchincloss, Landsman,
    and Pallone (ex officio).
        Also present: Representative Latta.
        Staff present: Ansley Boylan, Director of Operations;
    Jessica Donlon, General Counsel; Sydney Greene, Director,
    Finance and Logistics; Jay Gulshen, Chief Counsel, Health;
    Emily Hale, Staff Assistant; Megan Jackson, Staff Director;
    Sophie Khanahmadi, Deputy Staff Director; Molly Lolli, Counsel,
    Health; Joel Miller, Chief Counsel; Chris Sarley, Member
    Services/Stakeholder Director; Emma Schultheis, Clerk, Health;
    Kaley Stidham, Press Assistant; Matt VanHyfte, Communications
    Director; Lydia Abma, Minority Policy Analyst; Sam Avila,
    Minority Health Fellow; Jennifer Black, Minority FDA Detailee;
    Rasheedah Blackwood, Minority Intern; Keegan Cardman, Minority
    Staff Assistant; Tiffany Guarascio, Minority Staff Director;
    Elizabeth Kittrie, Minority Health Fellow; Una Lee, Minority
    Chief Counsel, Health; Andrew Souvall, Minority Director of
    Communications, Outreach, and Member Services; and Hannah
    Treger, Minority Intern.
        Mr. Carter of Georgia. The subcommittee will come to order.
        The Chair recognizes himself for 5 minutes for an opening
    statement.

         OPENING STATEMENT OF HON. EARL L. ``BUDDY'' CARTER, A
          REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA

        I want to welcome everyone to today's hearing on the Over-
    the-Counter Monograph Drug User Fee Program, referred to as
    OMUFA. I am especially pleased that we are talking about the
    reauthorization of this program, as almost 5 years to the date
    the initial bill--sponsored by my good friend from Ohio,
    Representative Latta, as well as one of Georgia's finest,
    Senator Johnny Isakson--was signed into law by President Trump
    in March of 2020.
        The enactment of this program reformed and modernized the
    regulation of OTC monograph drugs and authorized the FDA to
    assess and collect user fees dedicated to OTC monograph drug
    activities. Industry and public health stakeholders supported
    these reforms, which have provided FDA with additional
    resources and tools to streamline the monograph process to
    increase access to quality, commonly used drugs and self-care
    products for the American consumer. This program is designed to
    improve innovation while maintaining the FDA gold standard of
    safety.
        The current legislative authority for OMUFA expires
    September the 30th, 2025--again, September the 30th, 2025--at
    which point new legislation will be required to reauthorize the
    Over-the-Counter Monograph User Fee Program for another 5-year
    term.
        Over-the-counter medications are widely used to treat
    common ailments such as colds, headaches, and seasonal
    allergies. In fact, nearly 9 out of every 10 Americans use OTC
    medications regularly and trust these affordable remedies to
    get well and stay healthy. Safe, reliable, and affordable OTC
    drugs allow consumers to treat common ailments at home, usually
    without visiting a healthcare provider, saving the healthcare
    system billions annually.
        Of particular note is a company named Symrise. They own and
    operate a manufacturing plant in Georgia's First Congressional
    District that I have the honor and privilege of representing.
    Symrise manufactures aroma molecules and fragrance ingredients
    which are used in various consumer products across a number of
    product categories. They also manufacture two of the key UV
    filters that are commonly used in many OTC sunscreens on the
    market today.
        Sadly, Symrise's Colonel's Island plant experienced a
    serious fire in 2022. Symrise made the strategic decision to
    reinvest in the site and restore its capacity in my community
    at a time when other companies were leaving. They successfully
    completed renovations, and today the plant is again fully
    operational, back at its prefire capacity. This is a real
    success story, and we are grateful for their commitment to
    Georgia.
        We are also fortunate to have Mr. Kevin Menzel before our
    committee today. Mr. Menzel is president of Focus Consumer
    Healthcare, which is a wholly owned subsidy of Kobayashi
    Healthcare. Kobayashi was founded as a family company in 1886
    in Japan. They established a presence in the United States in
    1998 and maintained manufacturing and operations in Dalton,
    Georgia, employing 270 people with products ranging from OTC
    medicines and supplements to recreational products like
    HotHands hand warmers.
        Georgia's probusiness climate and infrastructure make it an
    ideal location for companies such as Kobayashi. In fact, just
    recently, Kobayashi began expanding its U.S. manufacturing
    footprint even further with a significant announced investment
    in Georgia, doubling capacity to support ongoing growth and
    expand employment.
        Success stories such as Symrise and Kobayashi highlight why
    it is critical for this subcommittee to reauthorize the Over-
    the-Counter Monograph Drug User Fee Program in a timely manner.
    This program demonstrated the ability to bring more jobs back
    to America while increasing access to safe, reliable, and
    affordable OTC drugs.
        I look forward to hearing from our witnesses today and
    working with my colleagues on both sides of the aisle to
    reauthorize this program on time and through regular order.
        [The prepared statement of Mr. Carter of Georgia follows:]
        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. I now recognize the gentlelady from
    Colorado, Representative DeGette, for 5 minutes for an opening
    statement.

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

        Ms. DeGette. Thank you very much, Mr. Chairman.
        The over-the-counter monograph drug user fee is an example
    of Congress identifying something that isn't working well and
    then fixing it. Congress fixed it. Elon Musk didn't fix it. His
    young DOGE guys didn't fix it. Congress fixed it.
        Now, we have some outstanding issues, and we are going to
    hear from our witnesses, though, that the new system is working
    a lot better than the old system worked, and we are still
    refining it through the user fee negotiation process. But,
    frankly, I can't believe we are all sitting here having routine
    hearings like nothing is going on, when I woke up to a headline
    this morning that says, ``Kennedy Lays Off Thousands Across the
    Health Bureaucracy.''
        What did he do? Well, he laid off thousands of people in
    the FDA, in the CDC, in the NIH. Entire divisions have been
    eliminated, and you know what? Congress established these
    divisions by statute. Congress established all of these
    agencies by statute. There is only one entity that can legally
    fix and improve this, and that is Congress, Mr. Chairman.
        So while we are sitting here having this hearing, our
    premiere research institutions, which are the gem of the entire
    world, are being dismantled before our very eyes, and we are
    just sitting here talking about sunscreen. We need to--you
    know, my staff wrote here, we need to hold hearings on the HHS
    reorganization. That is not true. We need to tell President
    Trump and Elon Musk and Kennedy they can't do this without our
    approval.
        Why are we giving away our Article I authority to do this?
    We need to hold hearings on the damage that are being done to
    our biomedical research institutions, and we need to figure out
    how we are going to make them stop decimating this right away.
    We need to have hearings on bird flu, measles, and diminishing
    ability to tackle public health issues until the next global
    pandemic.
        Now, are we so eager to cede our constitutional authority
    to a rogue administration and just passively observe while the
    President, Elon Musk, and RFK Jr. shred the accomplishments of
    a generation? So I just want to say, it was Congress that did
    the last NIH reauthorization in 2006, and it was Congress that
    passed Fred Upton's and my 21st Century Cures Act to modernize
    the NIH and FDA with universal, bipartisan approval from every
    single member of the Energy and Commerce Committee.
        Here is what is happening now, though. The administration
    canceled a grant for Florida Agricultural and Mechanical
    University, which is in Dr. Dunn's district, that supported the
    initiative re--innovative research in breast cancer and pain.
    That grant supported FAMU's recruitment of two investigators,
    one specializing in cancer biology, and the other in artificial
    intelligence. And the University of Colorado had a grant
    canceled that focused on a platform technology to rapidly
    develop vaccines for dangerous emerging threats, like viruses
    like Ebola. I am shocked that we would just sit by and watch
    grants like this be canceled.
        It is not only NIH-funded work that is being attacked,
    though. Last Friday, longtime Center for Biologics Evaluation
    and Research Director Peter Marks, who worked through the last
    Trump administration and helped design Operation Warp Speed,
    was forced out. We all worked closely with Dr. Marks, and I
    think everyone in this room has been impressed with his
    fairness, his rigor, and his drive to use his position to
    improve public health and save lives.
        So I want to quote from Dr. Marks' resignation letter at
    length. He wrote, ``Over the past 13 years I have done my best
    to ensure that we efficiently and effectively applied the best
    available science to benefit public health. ... I was willing
    to work to address the Secretary's concerns regarding vaccine
    safety and transparency ... However, it has become clear that
    truth and transparency are not desired by the Secretary, but
    rather he wishes subservient confirmation of his misinformation
    and lies.'' Let that sink in.
        Mr. Chairman, I ask unanimous consent to put Dr. Marks'
    letter into the record.
        Mr. Carter of Georgia. We will be right back with you.
        Ms. DeGette. Thank you.
        You know, subservient confirmation of the misinformation
    and lies, that is not how we make America healthy. That is how
    we end up with more dead kids. And so I just want to say that
    we should be ashamed that the Republicans on this committee are
    allowing Trump and Elon Musk to plunder cancer research, drug
    safety, and pandemic preparedness. Rome is burning, and we are
    talking about sunscreen.
        I yield back.
        [The prepared statement of Ms. DeGette follows:]
        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. The gentlelady yields.
        The Chair now recognizes the chairman of the full
    committee, Chairman Guthrie, for 5 minutes for an opening
    statement.

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

        Mr. Guthrie. Thank you, Chairman Carter.
        And thank you for our witnesses for being before us today.
        Today's hearing is about the FDA's Over-the-Counter
    Monograph Drug User Fee Program, known as OMUFA. While some may
    be more familiar with the Prescription Drug User Fee Act,
    PDUFA, or the Medical Deviser User Fee Fact, MDUFA, or even the
    Animal Drug User Fee Act, ADUFA, which we reauthorized last
    Congress, this is the first reauthorization of OMUFA.
        The Over-the-Counter Drug User Fee Program was established
    under the Coronavirus Aid, Relief, and Economic Security Act,
    the CARES Act, in 2020. This bill reformed the regulation of
    the over-the-counter monograph drugs and authorized the FDA to
    assess and collect user fees dedicated to the regulatory
    activities related to the OTC products. That may seem like a
    lot of jargon, but the decision to reform how OTC drugs are
    regulated was a critical one for patients walking into a
    pharmacy, gas station, or convenience store where they may
    access such treatments.
        Over-the-counter drugs include allergy medicines, cold and
    cough remedies, and common pain relievers, all routinely used
    medicines for our constituents around the country. In addition,
    products such as sunscreen and topical antiseptics are also
    regulated OTC monograph review process. Ensuring the safety and
    effectiveness of these drugs is critical.
        Unfortunately, prior to the CARES Act, the OTC monograph
    rulemaking process was burdensome, inefficient, time consuming,
    and stagnant for innovation, with FDA itself acknowledging it
    had limited speed and flexibility in responding to urgent
    safety issues.
        During testimony before this committee on September 17,
    2017, the then-Director of the Center for Drug Evaluation and
    Research testified that, prior to the CARES Act, there were
    approximately 88 simultaneous rulemakings and 26 broad
    therapeutic categories covering approximately 800 active
    ingredients for over 1,400 different therapeutic uses.
        And according to a July 2022 GAO report, 7 of the original
    26 original monograph categories had no final monograph in
    effect, and of the 17 that did have a monograph, 12 had
    proposed changes associated with them. This means that over-
    the-counter drugs on the market had not received final
    determination regarding their safety and effectiveness.
        It was therefore critically important that we took the
    steps we did to reform the monograph process from a three-phase
    rulemaking process to administrative order process. This was
    done to reduce unnecessary bureaucracy, increase transparency,
    enhance the ability for public and stakeholder input, promote
    the opportunity for innovation to flourish, and maintain the
    necessary checks to ensure the safety and effectiveness of
    these drugs.
        The current authority for this program is set to expire at
    the end of this fiscal year, September 30, so it is absolutely
    important that we continue this process and move forward on a
    5-year reauthorization. The discussion we will have today is
    critical as we consider the first reauthorization of this new
    program that impacts so many Americans in their daily lives.
    These are the issues that affect our constituents on a daily
    basis, and they expect this committee to be attuned to their
    needs.
        In closing, this program is important to ensuring FDA is
    effectively and efficiently reviewing OTC drugs and products.
    Whether it is helping to ease a headache or treatment of a
    cold, OMUFA plays a critical role in the health and well-being
    of Americans.
        I thank the witnesses for being here to participate today.
    I look forward to the discussion of the reauthorization of this
    program, and I yield back.
        [The prepared statement of Mr. Guthrie follows:]
        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. The gentleman yields.
        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.
        An examination of user fees for over-the-counter drugs is a
    discussion that we should have, were it not for the Trump
    administration's dismantling our public health infrastructure
    before our eyes. There is no logic in holding a routine
    discussion on user fees before understanding the Trump
    administration's plan, masterminded by the reckless, uninformed
    antics of Elon Musk, DOGE, to slash the Food and Drug
    Administration's workforce by an additional 3,500 public
    servants. And it is hard to see how a drastic cut of nearly 20
    percent of the total FDA staff will not impact the critical
    functions of the agency.
        The administration is hemorrhaging our public health
    agencies and expertise without them while committee Republicans
    silently sit by and watch. Let's be clear what is happening
    here. The Trump administration's goal is to hollow out the
    agencies to find savings for their giant tax breaks for their
    billionaire friends, including Elon Musk himself. But it is
    also crystal clear that the administration is looking to get
    rid of those who refuse to bend to their antiscience agenda and
    medical quackery.
        Just last Friday evening, the Trump administration pushed
    out Dr. Peter Marks, the Director of the Center for Biologics
    Evaluation and Research. Dr. Marks' hands was forced by the
    Trump administration's unprecedented assault on settled science
    regarding vaccine safety and efficiency.
        As Dr. Marks correctly noted in his resignation letter--I
    know Ms. DeGette mentioned it, but this quote I have to repeat.
    He said, this is a quote: ``Truth and transparency are not
    desired by the Secretary, but rather he wishes subservient
    confirmation of his misinformation and lies.'' Dr. Marks
    couldn't have said it better.
        Democrats, too, have experienced the administration's
    disdain for truth and transparency as we have tried to obtain
    basic information for the administration on the layoffs at HHS.
    HHS has refused repeatedly to provide an update on the status
    of its terminations, both those made in the first round and the
    additional 3,500 layoffs moving forward.
        The lack of transparency and stonewalling is unacceptable.
    And let's be clear, it shows that HHS knows that these
    terminations and the wholesale elimination of entire HHS
    operating divisions are indefensible and unlawful. Dr. Marks is
    not the first expert to be purged from the agency, and I am
    sure he is not going to be the last. The attacks continue, yet
    our Republican colleagues refuse to demand answers or hold this
    administration accountable.
        Today, committee Democrats are once again demanding answers
    from the administration about last week's layoffs and
    reorganization announcement, and we would hope that Republicans
    would finally recognize that it is time for them to start
    asking questions as well. After all, these actions could
    significantly impact the FDA's job when it comes to over-the-
    counter drugs.
        FDA regulates the drugs, medical devices, and cosmetics
    Americans use, the food they eat, and much more. FDA's mission
    is to ensure the safety and security of these products before
    they reach consumers. And I fear that the administration's
    forced layoffs at FDA will result in dangerous products
    slipping through the cracks while promising new products will
    face delays in getting to Americans.
        And I am not the only one sounding the alarm. Industry
    experts have raised concerns that these terminations will delay
    timely patient access to products regulated by FDA by months if
    not years, and impact surveillance efforts, including delayed
    inspections. Reports already show that, since the first round
    of terminations, FDA has been struggling to meet
    congressionally mandated deadlines as staff are being assigned
    double the number of new product applications for review.
        With a workforce stretched this thin, it seems inevitable
    that unsafe products will make their way into Americans'
    grocery stores and medicine cabinets. And even though HHS
    claimed user fees reviews would not be affected, we are hearing
    from industry that 50 percent of the positions eliminated will
    be user fee-related.
        And so while I hope we can look forward to a smooth
    reauthorization of this critical user fee program, I am
    disappointed that our Republican colleagues do not see the
    urgency in conducting oversight of the illegal terminations
    that will impact the very program they plan to discuss today,
    among many others.
        And with that, Mr. Chairman, I yield back the balance of my
    time.
        [The prepared statement of Mr. Pallone follows:]
        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. The gentleman yields.
        This concludes member opening statements. The Chair would
    like to remind Members that, pursuant to committee rules, all
    Members' opening statements will be made part of the record.
        We want to thank all of our witnesses for being here today
    and taking the time to testify before the subcommittee. Our
    witnesses today are Mr. Kevin Menzel, member of the board of
    directors of the Consumer Healthcare Products Association and
    president of Focus Consumer Healthcare; Mr. Douglas Troutman,
    the interim co-chief executive officer of the American Cleaning
    Institute; Ms. Kim Wezik, director of advocacy for the Melanoma
    Research Foundation.
        I hope I pronounced that right. I am from south Georgia, so
    our pronunciation down in south Georgia is a little different
    from a lot of other places, but----
        Ms. Wezik. You got it.
        Mr. Carter of Georgia. I got it? Good. Thank you.
        Mr. Scott Faber, the senior vice president of government
    affairs for the Environmental Working Group.
        And Mr. Carl D'Ruiz, the senior science, advocacy, and
    business development manager for beauty and care, North
    America, for DMS--DSM, excuse me, Firmenich. Is that OK?
        Mr. D'Ruiz. You got it.
        Mr. Carter of Georgia. I got it. Amazing.
        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.
        Again, we thank all of you for being here. We look forward
    to this hearing today. It is an extremely important subject. We
    are going to stay focused on why we are here, that is to
    discuss the extension of this very vital program.
        At this time, I want to recognize Mr. Menzel for 5 minutes
    to give an opening statement.

        STATEMENTS OF KEVIN MENZEL, MEMBER, BOARD OF DIRECTORS,
    CONSUMER HEALTHCARE PRODUCTS ASSOCIATION, AND PRESIDENT, FOCUS
      CONSUMER HEALTHCARE; DOUGLAS M. TROUTMAN, INTERIM CO-CHIEF
      EXECUTIVE OFFICER, AMERICAN CLEANING INSTITUTE; KIM WEZIK,
       DIRECTOR OF ADVOCACY, MELANOMA RESEARCH FOUNDATION; SCOTT
    FABER, SENIOR VICE PRESIDENT, GOVERNMENT AFFAIRS, ENVIRONMENTAL
     WORKING GROUP; AND CARL D'RUIZ, SENIOR SCIENCE, ADVOCACY, AND
    BUSINESS DEVELOPMENT MANAGER, DSM-FIRMENICH, AND FORMER CHAIR,
                     PERSONAL CARE PRODUCTS COUNCIL

                       STATEMENT OF KEVIN MENZEL

        Mr. Menzel. Thank you. Chairman Carter, Ranking Member
    DeGette, and members of the subcommittee, my name is Kevin
    Menzel, and I am the president of Focus Consumer Healthcare, as
    well as a member of the board of directors of the Consumer
    Healthcare Products Association, or CHPA.
        Focus Consumer Healthcare manufactures and markets a broad
    portfolio of over-the-counter, or OTC, medicines and other
    health and wellness products that help Americans manage
    everyday healthcare needs. I started Focus Consumer Healthcare
    in 2014 to revitalize a number of OTC brands marketed under OTC
    monographs. Our firm was subsequently acquired by Kobayashi
    Healthcare, headquartered in Dalton, Georgia, where they have
    an OTC monograph user fee-paying manufacturing facility.
        CHPA is the national trade association representing the
    leading manufacturers and marketers of OTC medicines in the
    United States. CHPA's member companies produce the vast
    majority of OTC products available to consumers today, which
    are safe, effective, affordable therapies that empower millions
    of Americans to prevent and self-treat many common, everyday
    health conditions.
        Thank you for the opportunity to appear before you to
    discuss the OTC Monograph User Fee Program, or OMUFA.
    Reauthorizing OMUFA this year will continue the bipartisan
    effort this committee helped lead more than 5 years ago to
    modernize the regulatory framework that governs most of the OTC
    medicines in the United States.
        The availability of OTC medicines is not only a matter of
    convenience, it is a vital part of our Nation's public health
    infrastructure. These products save consumers money, reduce the
    strain of our healthcare system, and support informed health
    decisions by enabling individuals to manage common, everyday
    conditions on their own. The strengths and benefits of OTC
    medicines fit seamlessly with renewed national attention on
    healthy living, more affordable healthcare, transparency, and
    freedom of choice. In fact, every dollar spent on OTC medicine
    saves the healthcare system over $7 from fewer doctor visits
    and lower-cost OTC medicines compared to prescription
    medicines.
        Most of the OTC medicines in our homes today are regulated
    under the OTC monograph system. This system currently covers
    more than 300 active pharmaceutical ingredients used in more
    than 100,000 OTC products. The OTC monograph system is how the
    FDA regulates well-established OTC drug ingredients and
    determines whether they meet legal and scientific standard of
    General Recognition of Safety and Effectiveness, or GRASE.
        Rather than requiring individual applications for each
    finished OTC product, monographs establish rules and conditions
    for specific active ingredients within various therapeutic
    categories. This allows manufacturers to market OTC products
    without going through the product-specific New Drug
    Application, or NDA, process that is required for newer OTC
    ingredients or prescription drugs.
        The OTC monograph system functioned effectively for many
    decades, but over time it became backlogged due to slow notice
    and comment rulemaking and understaffing. It was slow to add
    new safety labeling as new scientific data emerged and created
    barriers to innovation, making it more difficult to quickly
    meet the ever-increasing self-care needs of consumers.
        In 2020, as part of the CARES Act, Congress updated the law
    governing the OTC monograph system and created a new user fee
    program, OMUFA. This bipartisan law signed by President Trump
    had broad stakeholder support, modernized the OTC monograph
    system, and provided FDA with dedicated resources to implement
    critical reforms.
        The current statutory authority for OMUFA is set to expire
    on September 30, 2025, and we strongly support its timely
    reauthorization for a second 5-year cycle referred to as OMUFA
    II. Over the past 5 years, FDA has taken a series of steps to
    implement OTC monograph reform as they committed to in the
    original user fee goals letter.
        As we noted when we met with FDA and in our goals letter
    for OMUFA II and as we speak with you today, as you begin to
    work to reauthorize OMUFA, CHPA has four key priorities to
    ensure continued success and modernization of the OTC monograph
    system. First, OMUFA did not change the longstanding standard
    of General Recognition of Safety and Effectiveness, also known
    as GRASE. This foundational principle ensures that OTC drug
    ingredients are supported by a robust body of scientific
    evidence. The GRASE standard relies primarily on published
    studies and where appropriate is supplemented by unpublished
    research, real world data, and significant market experience.
    It is essential that FDA maintains this standard, as GRASE
    determinations are not dependent on NDA submissions interviews.
        Second, OMUFA needs to remain a lean, efficient program.
    For OMUFA II, FDA's goal letter targets adding 11 full-time
    equivalents, or FTEs, which would total 112 FTEs. We see this
    as nearing steady state in terms of staffing and fees paid.
        Third, interaction between industry sponsors and FDA is
    critical to a successful program. OMUFA meetings often require
    lengthy scientific dialogue due to the long history of the
    monographs and data supporting them. FDA's OMUFA II goals
    letter tries to address this.
        Fourth, roughly 200 registered monograph facilities have
    not paid their user fees and are in arrears. FDA's research
    shows that this is a predictor of poor product quality. We
    support efforts to address these user fee arrears list.
        Taken together, these four priorities reflect a shared goal
    to move beyond successfully establishing infrastructure, as was
    done in the first OMUFA cycle, to ensuring that OMUFA II
    advances in fostering innovation, finalizing GRASE
    determination and supporting FDA's ability to protect and
    promote public health.
        In closing, I want to thank again the subcommittee for the
    opportunity to provide testimony today. CHPA and the broader
    OTC industry are committed to being constructive partners as we
    work together on the reauthorization of OMUFA. I look forward
    to your questions.
        [The prepared statement of Mr. Menzel follows:]
        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. The gentleman yields.
        The Chair now recognizes Mr. Douglas Troutman for 5 minutes
    to give an opening statement.

                    STATEMENT OF DOUGLAS M. TROUTMAN

        Mr. Troutman. Chairman Carter, Ranking Member DeGette,
    members of the subcommittee, my name is Douglas Troutman, and I
    am with the American Cleaning Institute. I appreciate the
    opportunity to appear today to discuss the Over-the-Counter
    Monograph Drug User Fee Program, or OMUFA.
        ACI is the home of the $60 billion U.S. cleaning products
    industry. Our members include suppliers and formulators for
    soaps, detergents, and general cleaning products and topical
    antiseptic drug products sold in the U.S. These products
    promote public health and are used by consumers at home for the
    care of family members and other daily needs like food
    preparation or cleaning. These products reduce bacteria on
    hands and keep Americans healthy in numerous make spaces like
    airports, hospitals, and schools.
        ACI represents the manufacturers and suppliers of four
    topical and lawfully marketed antiseptic ingredients: ethanol,
    benzalkonium chloride, benzethonium chloride, and
    chloroxylenol. FDA deferred these actives from final rulemaking
    because it seeks more data to evaluate the safety and
    effectiveness of them before making a final determination of
    GRASE. ACI members are diligently working on the studies to
    help FDA make this determination.
        First, I would like to address what we call the ``free
    rider'' problem. ACI is leading a multiyear, multimillion-
    dollar effort to fulfill agency requests for additional safety
    and efficacy studies. To date, ACI has submitted multiple
    reports showing ongoing progress to FDA's requests. Those data
    gaps, though, are very costly and highly resource intensive
    over time. However, the ACI member companies funding the
    requested studies are a fraction of the antiseptic market that
    will ultimately benefit from the data. In short, ACI members
    are shouldering all the costs, which we will do.
        The benefits derived from the data will support the
    continued marketing by all antiseptic manufacturers, including
    nonparticipating companies. A simple image may help. Think of a
    railroad. ACI members who were told to follow the FDA policy
    made railroad tracks, but only ACI member companies built and
    paid for the locomotive and the passenger car, which represent
    the data in the studies. Anyone can ride if they did not
    contribute to building the locomotive and the vehicles. No one
    also must help to pay for the vehicle's investment. The
    valuable benefit conferred on nonmember contributors
    discourages participation in data collection at a time when
    that very participation is critical to finalizing an FDA
    determination.
        We have two options for you to consider as solutions: (1)
    modify the facility or user fees for sponsors that actively
    participate in the data generation process; or (2) extending or
    at the very least maintaining the exclusivity period. These are
    discussed more fully in my written submission.
        The second item to be addressed that we would like to talk
    with you about is timely and productive communication from FDA
    to the public. ACI appreciates engagement guidance from FDA to
    date. However, the agency should prioritize resources to
    facilitate informal agency feedback to promote collaboration to
    finish the studies and make a determination.
        And this is not an abstract matter. There is a California
    Assembly Bill 916 that would actually ban the hand soaps and
    body washes containing three legally marketed actives:
    benzalkonium chloride, benzethonium chloride, and
    chloroxylenol. The calls to ban the legal use of these
    ingredients are typically accompanied by unsubstantiated claims
    questioning their safety and effectiveness. But ACI believes
    that more consistent communication by FDA can help reassure the
    public that progress is being made toward GRASE on deferred
    ingredients so as to avoid ban proposals.
        Moreover, the FFDCA contains an express preemption
    provision for national regulatory uniformity for
    nonprescription drugs. In short, Federal law has primacy in
    this space, and the California bill would be federally
    preemptive, we believe. ACI believes more timely communication
    by FDA is needed to update and reassure listeners that diligent
    work is ongoing. FDA should clarify that these products are
    lawfully marketed, play an important role in public health, and
    the Federal agency work primacy.
        We appreciate the opportunity to provide remarks today. We
    remain committed to working with the committee and the agency
    to achieve mutually shared objectives. And I thank you for your
    time and look forward to your questions.
        [The prepared statement of Mr. Troutman follows:]
       [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. Thank you, Mr. Troutman. The
    gentleman yields.
        The Chair now recognizes Ms. Kim Wezik for 5 minutes to
    give an opening statement.

                         STATEMENT OF KIM WEZIK

        Ms. Wezik. Thank you. Chairman Guthrie, Ranking Member
    Pallone, subcommittee Chairman Carter, and subcommittee Ranking
    Member DeGette, thank you for inviting me to offer my
    perspective on the first reauthorization of the Over-the-
    Counter Monograph User Fee Act, or OMUFA.
        My name is Kim Wezik, and I am the director of advocacy for
    the Melanoma Research Foundation, the largest independent
    organization devoted to melanoma, the deadliest form of skin
    cancer. I am here this morning to testify on behalf of the
    Public Access to Sunscreens, or PASS, Coalition, which is a
    multistakeholder coalition dedicated to helping prevent skin
    cancer and improving public health by ensuring Americans have
    access to safe and effective sunscreens and evidence-based
    education on sun-safe practices.
        I hope to bring the patient perspective to this committee's
    deliberations on the importance of reauthorizing OMUFA and
    using this bill to turn the tide on the scourge of skin cancer.
    I have the privilege and the challenge of supporting
    individuals whose lives have been upended by a skin cancer
    diagnosis, either for themselves or their loved ones. This is a
    disease that disfigures, kills, and financially exhausts real
    people. It is also largely preventable.
        Many of the patients I serve share with me how they missed
    the opportunity to protect their skin in their youth before
    many of us were even aware of the deadly effects of ultraviolet
    exposure over a lifetime. They are steadfast in their interest
    to prevent other Americans from getting a melanoma diagnosis,
    and they are deeply concerned about the lack of action by the
    Federal Government to ensure Americans have access to over-the-
    counter products available around the rest of the world to
    prevent skin cancer.
        The last time the United States approved a new over-the-
    counter sunscreen active ingredient was the 1990s, meaning that
    we are generations behind the rest of the world, and that is
    unacceptable. Skin cancer is the most common cancer in the
    United States, and unlike many cancers whose origin is unknown
    or complex, we know that sun exposure is the primary cause of
    skin cancer. That means that skin cancer is preventable with
    access to the appropriate skin cancer prevention products, like
    sunscreen, and techniques, like sun-safe behaviors.
        However, according to the World Cancer Research Fund, the
    United States represents approximately one-third of all global
    skin cancer diagnoses. Over 5 million Americans are treated for
    skin cancer each year at a cost of over $8 billion, according
    to the Surgeon General. And according to the Skin Cancer
    Foundation, the estimated number of new melanoma cases
    diagnosed in 2025 are projected to increase by 5.9 percent.
        A future where U.S. skin cancer rates continue to outpace
    the rest of the world does not have to be the future our
    families live in. With some commonsense reforms that we
    recommend for inclusion in the OMUFA reauthorization, the PASS
    Coalition hopes we can bring new, safe, and effective skin
    cancer prevention products to market in a timely way.
        In 2012, the PASS Coalition came together in a bipartisan
    effort to protect Americans from skin cancer. In 2014, this
    committee passed the Sunscreen Innovation Act by a vote of 46
    to 0, the Senate passed the bill by unanimous consent, and the
    President signed the bill into law. We hoped that legislation
    would usher in a new era of skin cancer prevention,
    streamlining the sunscreen filter approval process and
    increasing the number of filters available in the U.S. for a
    variety of skin textures, tones, and conditions.
        Unfortunately, over a decade later, no new filters have
    been approved in the U.S., limiting Americans' choice to under
    10 UV filters, while there are over 30 UV filters approved
    globally. We find ourselves today at risk not just of stymied
    progress but in a situation where the FDA has called into
    question the existing sunscreen filters currently on the
    market.
        The current challenges stem from two primary issues. The
    first is the FDA's use of a relatively obscure testing method
    for sunscreens not used in any other country. It is called the
    maximum usage trial, or MUsT test. And the second issue is the
    insistence on animal testing for sunscreens, which is banned in
    most other developed nations.
        The PASS Coalition would like to work with this committee
    to ensure that the OMUFA reauthorization addresses these
    challenges, not by reducing the safety and effectiveness of
    sunscreen but by ensuring that the FDA considers testing
    alternatives to the MUsT trial and animal testing.
        The American people rely on Congress and the administration
    to keep us safe, but a failure to approve new sunscreen filters
    leaves us vulnerable to unnecessary skin cancer diagnoses and
    deaths. Other countries around the world have achieved this
    balance. We urge Congress to address these concerns in the
    OMUFA reauthorization, and appreciate the opportunity to serve
    as a resource for this committee. I look forward to your
    questions.
        [The prepared statement of Ms. Wezik follows:]
       [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. Thank you, Ms. Wezik.
        The Chair now recognizes Mr. Scott Faber for 5 minutes to
    give an opening statement.

                        STATEMENT OF SCOTT FABER

        Mr. Faber. Great. Thank you, Mr. Chairman and Ranking
    Member DeGette. Again, my name is Scott Faber. I am the senior
    vice president for government affairs for EWG. I am also an
    adjunct law professor at Georgetown's Law School. And before I
    worked for EWG, I was the head of government affairs for the
    Grocery Manufacturers Association, or what is now known as the
    Consumer Brands Association.
        I worked with many of you to help enact FSMA, now 15 years
    ago, and I mention that because of the announcements that were
    made this morning to fire so many FDA staff. And let me just be
    blunt: Having worked on FSMA with many of you, I know that many
    people will be sickened or worse by foodborne illness because
    of the decision to fire 3,500 FDA staff this morning.
        I don't know about you, but my phone is blowing up with
    people who have worked at the Agency for 15 years or more, who
    spent their whole careers trying to make sure that our food is
    safe, and only found out they were fired when they went to
    badge in to their jobs this morning. We will all be less safe
    because of the decisions that were made to lay those people
    off. Our lifesaving drugs will take longer to get approved.
    Many of the everyday products that we bring into our homes, our
    cosmetics, our sunscreens will be less safe because the people
    who review the chemicals in those products were fired this
    morning. And, of course, that includes sunscreens and other
    subjects that are--other products that are the subject of
    today's hearing.
        Let me just make a few points about sunscreens. First,
    everyone should use sunscreen, but many of our sunscreens fail
    to adequately protect consumers from both UVA and UVB rays. In
    addition, many consumers are confused about the SPF system,
    which is leading some consumers to mistakenly believe that
    their sunscreen is providing them with broad spectrum
    protection. And some of the ingredients in sunscreens are
    linked to health harms.
        The good news, as you have heard just now, is that safer
    ingredients are available, but the current system has failed to
    make them available to our consumers. And with the exception of
    DSM, companies have so far been unwilling to finance the
    studies needed to ensure the safety and effectiveness of these
    promising new ingredients.
        So to fund the studies necessary to prove safety, Congress
    should consider changes to the fee system in order to finance
    these needed studies and to give the FDA the power to order
    studies as you have done for other chemicals. Of course, we
    should quickly phase out harmful ingredients, as Congress
    required in the CARES Act. Unfortunately, the FDA has failed to
    meet your legislative deadline to determine whether some of the
    ingredients that are now being used in sunscreens are still
    safe to be on our bodies.
        Cutting 3,500 staff, firing 3,500 staff this morning will
    only result in more delay in that decision-making process. And
    allowing sunscreens to continue to have ingredients that are
    linked to health harms will certainly not make America healthy
    again.
        Consumers are right to expect that our sunscreens, our
    cosmetics, our food, all of the everyday products we bring into
    our homes are safe. Unfortunately, many of our sunscreens do
    not adequately protect consumers and pose needless health risks
    even though better alternatives are available. Allowing legacy
    ingredients that are less effective and less safe to remain on
    the market while more effective and safer ingredients are
    available makes little sense. Cutting 3,500 FDA staff who
    review the safety of these products makes even less sense.
        Thank you for the opportunity to testify.
        [The prepared statement of Mr. Faber follows:]
       [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. Thank you, Mr. Faber.
        The Chair now recognizes Mr. Carl D'Ruiz for 5 minutes to
    give an opening statement.

                        STATEMENT OF CARL D'RUIZ

        Mr. D'Ruiz. Thank you. Chairman Carter, Ranking Member
    DeGette, Chairman Guthrie, Ranking Member Pallone, and
    distinguished members of the subcommittee, it is really an
    honor to be able to testify before you today to discuss how FDA
    regulates OTC drugs with a focus on the regulation of sunscreen
    ingredients. I appreciate the committee's work to ensure the
    timely reauthorization of OMUFA.
        My name is Carl D'Ruiz. I am the senior manager of beauty
    and care business in North America for DSM-Firmenich and former
    chair of the Personal Care Products Council's Sunscreen
    Consortium. For more than 25 years, I have dedicated my career
    to advancing sunscreen standards in the United States,
    including leading efforts to seek FDA approval of bemotrizinol,
    an advanced sunscreen ultraviolet filter that it first
    submitted to FDA in 2005 and that has been globally available
    since 2001 but is still waiting United States approval.
        At DSM-Firmenich we are proud to be a global leader in
    health nutrition and bioscience, employing more than 55,000
    Americans across 21 States, with many facilities located in the
    districts of the members of this subcommittee. As the world's
    leading manufacturer of UV filters with 40 years of experience,
    we are also the first and only company to pursue the approval
    of a new sunscreen filter through FDA's recently established
    OMOR Tier 1 process.
        The urgency of this issue cannot be understated. Skin
    cancer is now the fastest-growing cancer in America. Each year
    6.1 million adults are treated at an annual cost of nearly $9
    billion. Fortunately, unlike most cancers, skin cancers are
    largely preventable so long as proper precautions are taken,
    with sunscreens being one of the most effective forms of
    protection against the harmful skin cancer-causing UV
    radiation.
        Unfortunately, due to regulatory barriers, Americans are at
    a significant disadvantage relative to other countries globally
    with access to the most innovative, safe and effective,
    efficient sunscreens. The FDA has not approved new filters
    since 1999, more than 25 years ago. The United States
    manufacturers have access only to 16 UV filters, compared to
    nearly 30 in Europe and other countries. Of those 16, only 7
    are commonly used by the industry. This severely limits our
    ability to develop modern sunscreens that meet the preferences
    and needs of diverse skin types and tones.
        Despite bipartisan efforts like the Sunscreen Innovation
    Act of 2014 and the provision of the CARES Act of 2020 aimed at
    streamlining sunscreen approvals, no new UV filters have been
    approved under these frameworks. The reauthorization of OMUFA
    presents an excellent opportunity to apply the lessons that we
    have learned with the sunscreen approval process to ensure that
    regulatory hurdles are not barriers to innovation.
        As part of the reauthorization, we strongly encourage the
    committee to consider these three points of reform: First, we
    must move away from the ineffective and costly animal testing
    methods and leverage modern toxicological approaches and
    innovative methodologies specifically in reviewing OTC drug
    actives like sunscreens. This includes adopting nonanimal,
    mechanism-based methods, including in silico models, new
    approach methodologies, and other cutting-edge and nonclinical
    risk and safety assessment tools.
        Second, encourage innovation by streamlining the regulatory
    framework by aligning the United States' confidentiality and
    data protection standards with global practices. Currently
    companies invest significant amounts of money, up to $20
    million for DSM-Firmenich, to pioneer new UV filters. But
    without data protection or proper data protection, competitors,
    particularly Asian or Chinese companies, can benefit from this
    investment and obtain the data without contributing to
    development costs.
        Third, we must address the declining consumer confidence in
    sunscreens. Frustrated by limited options, Americans
    increasingly purchase internationally approved sunscreens
    online, bypassing FDA oversight entirely. The FDA's continued
    reliance on animal testing for ingredients used safely for
    nearly 50 years further erodes consumer trust.
        As the committee looks to advance a timely OMUFA
    reauthorization, I encourage commonsense reforms to nurture
    sunscreen innovation, including prioritizing the development of
    nonanimal testing methodologies, ensuring continued FDA
    interaction with regulated industries, and aligning
    confidentiality standards with global practices.
        Thank you for the opportunity to participate in this
    hearing. I look forward to working with you to advance these
    important initiatives that will help Americans from skin cancer
    and the harmful effects of the sun. Thank you.
        [The prepared statement of Mr. D'Ruiz follows:]
        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

        Mr. Carter of Georgia. Thank you, Mr. D'Ruiz. The gentleman
    yields.
        I want to thank all of you for your testimony.
        We will now begin questioning, and I recognize myself for 5
    minutes.
        Ladies and gentlemen, over-the-counter medications are
    widely used to treat common ailments such as colds, headaches,
    and seasonal allergies. In fact, more than 240 million
    Americans use OTC products every year and trust these
    affordable remedies to get well and stay well.
        Before Congress authorized Over-the-Counter Monograph Drug
    User Fee Program in 2020, the OTC monograph system was slow and
    it was outdated, leading to new products being stuck in the
    pipeline for years with no light at the end of the tunnel.
    Professionally, as a pharmacist, I know how important it is for
    patients to have access to safe and reliable and affordable OTC
    drugs. I have recommended them in my professional career many
    times and continue to recommend them to people.
        That is why I was proud to support the enactment of this
    program, which reformed the regulation of OTC monograph drugs
    and authorized the FDA to assess and collect user fees
    dedicated to OTC monograph drug activities. To date, we are now
    seeing additional investment domestically in research and
    development leading to new, innovative OTC medicines that will
    continue to save Americans and our healthcare system money. As
    a result, consumers now have access to over 100,000 of these
    over-the-counter products.
        Mr. Menzel, I want to ask you, how has OMUFA enabled the
    FDA to respond faster to emerging safety issues?
        Mr. Menzel. Thank you, Mr. Carter. So the key aspect of
    OMUFA is predictability, and whenever you have a predictable
    monograph system, it allows for innovation, and it allows for a
    focus on safety from the FDA. Imagine if you had a new drug
    application system that required all of the reviews for
    products that are generally recognized as safe and effective,
    it would be a waste of resources. So this monograph system and
    the OMUFA reforms allow for a focus on safety and efficiency,
    as well as innovation.
        Mr. Carter of Georgia. Great. Thank you for that answer.
        Mr. DuReez--D'Ruiz, excuse me--are there any new modern
    alternative testing methods that could replace the use of
    animal testing?
        Mr. D'Ruiz. Yes, sir. These methods are widely used
    throughout the world to approve different types of chemicals,
    including sunscreens. These are called new alternative methods.
    They include advanced in silico testing methodologies and in
    vitro methods, which were actually developed by the cosmetics
    industry, since in most of the world sunscreens are cosmetics,
    and there are animal bans in place prohibiting the testing of
    sunscreens due to that legislation.
        So science is funny. Science doesn't stand still; it
    evolves. Over the last 5, 10 years, we see light-speed changes
    in terms of the toxicological methods that are used to verify
    the safety of different types of products and ingredients
    worldwide. These are accepted by the Environmental Protection
    Agency. These are used by the Center for Food and Drugs--in
    FDA. However, in CDER these are not yet accepted, but the
    science is there right now. With the advent of artificial
    intelligence it will get only better, and I think this is the
    way that we can facilitate the approval and innovation process
    for new ingredients which are much needed to protect American
    consumers without sacrificing safety.
        Mr. Carter of Georgia. Good. And you do feel like,
    obviously, that it would really accelerate the approval process
    by using AI, by using new alternative methods?
        Mr. D'Ruiz. Yes, sir. As a result of using these different
    types of methods for evaluating safety, we see that our global
    counterparts are able to approve sunscreens in about 3 years
    period. In the United States, if we follow FDA's guidelines
    under the 2016 guidelines for determining generally recognized
    as safe and effective and also the PharmacoConnect MUsT
    guidelines, it would take about 10 years to conduct all those
    studies, not including the review cycle associated with FDA
    review. So if we put our money where we get the biggest bang
    for the buck, it would be with regards to----
        Mr. Carter of Georgia. OK.
        Mr. D'Ruiz [continuing]. Establishing modern methods that
    replace the outdated, archaic methods which are based on
    animals.
        Mr. Carter of Georgia. All right. Thank you for that.
        Mr. Menzel, real quick, what changes can we expect to see
    in the reauthorization of OMUFA?
        Mr. Menzel. Thank you. With the reauthorization there's
    improvements in the quality of surveillance and compliance with
    GMP, or good manufacturing practices. As I mentioned, there is
    the addition of 11 full-time employees, which we see also as
    important in terms of being self-funded. And we believe
    addressing the arrears list is important to make sure all the
    companies are paying their fair share. And then expanding, as
    was just mentioned by my panel member, the nonanimal testing
    methods to accelerate the sunscreen approvals.
        Mr. Carter of Georgia. Good. Thank you very much for that
    response. I yield back.
        And at this time, I will recognize the ranking member,
    Representative DeGette, for 5 minutes of questioning on the
    ODUFA.
        Ms. DeGette. Thank you so much, Chairman, and I am so happy
    to talk about ODUFA and the reauthorization, particularly in
    the context of what Secretary Kennedy did this morning by
    gutting FDA. As we have been discussing, he is reducing the
    head count at FDA by firing 3,500 people, or about 20 percent
    of the agency. Now, FDA has an enormous statutory
    responsibility that involves regulating about 20 percent of our
    economy.
        And, Mr. Faber, I really want to thank you for recognizing
    sort of the elephant in the room today as we talk about
    reauthorizing this agency, but yet the agency itself is being
    gutted. And as you said, people are going to die. People are
    going to be sickened by foodborne illness because of these
    layoffs. And also, if you lay off 3,500 people, I believe you
    said that there will be more delay in approving drugs, devices,
    et cetera. Is that generally accurate?
        Mr. Faber. That is right.
        Ms. DeGette. And so HHS this morning said, well, don't
    worry, the firings will not impact drug, device, and food
    reviewers or inspectors. So I guess I want to ask you, because
    you are intimately familiar with this agency, is every FDA
    employee who supports a product review review staff?
        Mr. Faber. No.
        Ms. DeGette. What are some of the other functions that they
    perform?
        Mr. Faber. There are many other people who serve on review
    teams as biostatisticians, as other kinds of scientists
    providing administrative support, writing guidances,
    interacting with industry. There are a lot of roles on a review
    that are not done by reviewers.
        Ms. DeGette. So if you fire these other people who don't
    have that title reviewer or inspector, are product reviews
    likely to be adversely impacted by those firings?
        Mr. Faber. There is no question that the reviewers would
    have to take on more responsibilities and that they would have
    less time to conduct the reviews, and, ultimately, that means
    reviews would take much longer to complete, that is right.
        Ms. DeGette. They would take a lot longer.
        Mr. Faber. That is right.
        Ms. DeGette. One of the issues that we have had--and not
    just with sunscreens and all that, but with drugs and devices
    in general--we have had issues that Congress in its statutory
    authority of oversight of the agency has undertaken to try to
    figure out how we can expedite those reviews of new drugs, new
    sunscreens. Is that right?
        Mr. Faber. That is right.
        Ms. DeGette. So if you lay off 20 percent of this agency--
    by the way, without congressional approval--what do you think
    it is going to do overall to reviews, not just for sunscreen
    but for other products?
        Mr. Faber. Well, it means new drugs will be delayed, new
    OTC drugs will be delayed. It means that the new methods that
    some of the witnesses talked about, nonanimal methods, will not
    be validated, will not be available to expedite the review of
    new sunscreen ingredients. It means many of the things Congress
    has asked FDA to do, like test for the presence of asbestos in
    talc-containing cosmetics, will be delayed. Many things will be
    delayed.
        Ms. DeGette. Well, let me give you another example.
    Congress directed FDA to issue a rule relating to cosmetic
    fragrance allergens. Is that correct?
        Mr. Faber. That is correct.
        Ms. DeGette. And by what date? Do you know?
        Mr. Faber. It was by June 2024.
        Ms. DeGette. 2024. And so has FDA published such a rule?
        Mr. Faber. FDA has not published that rule, no.
        Ms. DeGette. Do you think these firings are going to help
    expedite the publishing of that rule?
        Mr. Faber. All of the folks who support the review and
    regulation of cosmetics are not funded by fees, so they will be
    among the first that were likely--
        Ms. DeGette. Oh.
        Mr. Faber [continuing]. Fired today.
        Ms. DeGette. OK. So when Mr. Menzel is talking about 11
    employees, that seems kind of like a minimal thing. But they
    are funded by fees. But these other people, they are going to
    be laid off?
        Mr. Faber. They almost certainly have been laid off.
        Ms. DeGette. What are some of the other functions that will
    be laid off?
        Mr. Faber. Unfortunately, virtually none of our food safety
    functions are funded by fees, so the thousands of people who
    make sure that we don't get sick or worse when we have our
    lunch and dinner today, many of those people were fired this
    morning. They are people who work in labs. They are people who
    are microbiologists. They are people who support inspectors.
    They are the folks who make sure that we don't get sick when we
    eat.
        Ms. DeGette. So, see, this is why I think it is important
    for Congress to exercise its oversight, because what is going
    to happen here, Secretary Kennedy can't--probably won't fire
    the people who are funded by fees, but he will fire the other
    people. There is no real scientific basis for restructuring
    your agency just based on who pays people's salaries, is that
    right?
        Mr. Faber. That is right.
        Ms. DeGette. Now, Congress directed the Food and Drug
    Omnibus Reform Act in 2022 to do good manufacturing for
    cosmetic facilities, and these are all due in the next year.
    Now, that would be done by FDA employees other than inspectors
    and reviewers, is that right?
        Mr. Faber. That is correct.
        Ms. DeGette. So what do you think the cuts to FDA will
    impact their ability to produce this work?
        Mr. Faber. The GMPs for cosmetics, to make sure that our
    cosmetics are produced in ways that don't become contaminated,
    has already been delayed and will almost certainly not be
    finished.
        Ms. DeGette. Thank you. I yield back.
        Mr. Carter of Georgia. The gentlelady yields.
        The Chair now recognizes chairman of the full committee
    Representative Guthrie.
        Mr. Guthrie. Thank you. I appreciate that.
        And, obviously, if review was completed in July 2024 then
    we are almost a year out, so the previous administration didn't
    accomplish the mission given to them and the people that they
    had.
        And it is our job, and I am agreeing with my friend from
    Colorado that we have to have the proper oversight to make sure
    the things that Congress directs the administration is in
    place. I know President Trump talked campaign, he talked--I
    mean, everybody knew that coming into this they were going to
    try to make--work to make government more efficient. But it is
    also our responsibility as they do that to make sure that our
    mission is accomplished and have the proper oversight to do
    that. And so we will. We are going to make sure these things
    are done and done correctly.
        And so, but the other part of it is--
        Ms. DeGette. Mr. Chairman, will you yield? I just want to
    say thank you--
        Mr. Guthrie. OK.
        Ms. DeGette [continuing]. For that.
        Mr. Guthrie. Thank you.
        We need to make sure that we accomplish the mission, and
    that is--I am former military, and so thanks for that.
        So two things. One, we have to have oversight that it is
    being done, and but we also have to get what needs to be done
    correct. And so that is what I want to focus on now, and then
    we will, we will make sure that we are all up to date on what
    is going on.
        So to get--I just want to kind of go down the list, and I
    have got almost 3\1/2\ minutes. So I want each of you to say
    what is the one thing that says, boy, you guys got it right in
    the reauthorization--I mean, in the original authorization, and
    the second thing is, this is something that really needs to be
    improved. And I will cede the point we have to make sure we
    have I don't know how many people in place but people in place
    to get it done.
        So, Mr. Menzel, if you will start--not--excuse me, yes, Mr.
    Menzel.
        Mr. Menzel. Well, I think in terms of what was right, this
    reauthorization and the previous OMUFA bill allowed for
    innovation and allowed for predictability. Those two things are
    critically, critically important for the over-the-counter drug
    industry. And without that innovation and predictability, it is
    going to delay healthcare innovation.
        In terms of what can we expect, I think the questions
    concerning the head count cuts are completely valid, and it is
    a concern. The full-time employees that are being funded by
    this program we would expect to allow for efficiency, but I
    think it is a question that----
        Mr. Guthrie. Well, what would you like in the legisla--I
    get that, but what would you like in the--and I understand
    that. That is a fair point--what in the legislation do you
    think we should put in?
        Mr. Menzel. I think the legislation, as written, is
    accurate. I mean, I think a reauthorization to move forward, as
    written, is effective and----
        Mr. Guthrie. OK. Mr. Trout--I only have about 2\1/2\
    minutes.
        Mr. Menzel. Yes.
        Mr. Guthrie. Mr. Troutman?
        Mr. Troutman. Yes, thank you for the question. I echo a lot
    of the remarks by Mr. Menzel. The confidence, the clarity, the
    certainty, the rules of road that are there right now, we would
    continue to really rally behind those because we know what the
    expectation is for data safety or efficacy or the things that
    we need to supply in these types of ingredients.
        And then we do look for more collaboration and feedback
    from the agency in that--to know that we are staying on the
    right path that way, so we can get to the final determination.
        Mr. Guthrie. OK. Ms. Wezik?
        Ms. Wezik. Thank you. I would just echo what the others
    have said as far as what is going right with the original bill.
    From our perspective, you know, we feel very strongly that
    there are other ways to achieve safety data on sunscreens, such
    as moving away from animal testing and the MUsT trial, and at
    least considering other methodologies as supplemental.
        Mr. Guthrie. OK. Thank you. Yes, I think my Senator, Rand
    Paul, kind of led that fight in the last Congress, so thank you
    for that.
        Mr. Faber?
        Mr. Faber. I will just say two quick things. One is, we
    still haven't sent a signal to industry to produce the studies
    that FDA needs to really evaluate whether these chemicals,
    especially the ones that penetrate our skin and get into our
    bloodstream, are indeed safe, and we still haven't yet sent the
    right signal to FDA to just decide whether the 10 active
    ingredients that we have been using for decades should continue
    to be allowed in our sunscreens.
        Mr. Guthrie. OK. So Mr. Ruiz--D'Ruiz? I am sorry.
        Mr. D'Ruiz. Yes.
        Mr. Guthrie. Dr. Ruiz is on our committee. Sorry.
        Mr. D'Ruiz. Yes. So I think we need to realize that skin
    cancer doesn't discriminate on the basis of age, gender, race,
    or skin color, and we need to encourage commonsense reforms to
    nurture sunscreen innovation, to provide access to modern,
    safe, and efficient, sustainable UV filters.
        This includes the prioritization, transparency,
    accountability, and funding of new approach methods in the
    development and validation of new ingredients, the continued
    interaction between FDA and regulated industries with regards
    to the use of alternative methods to support those ingredients
    but which they have asked for further data, and aligning of the
    confidentiality in data and privacy standards with global
    practices.
        Mr. Guthrie. OK. Thank you. Perfect.
        I yield back.
        Mr. Carter of Georgia. The gentleman yields. The Chair now
    recognizes the chairman of the full committee, Representative
    Pallone, for 5 minutes of questioning.
        Mr. Pallone. Thank you, Mr. Chairman. You know, I wanted to
    say with regard to Chairman Guthrie, I know you talked about
    the agency becoming more efficient, but the problem that I see
    is that these cuts are just indiscriminate, right?
        We don't have any information to suggest that these 20
    percent cuts in the workforce----
        Mr. Guthrie. Would you yield?
        We need to have some answers.
        Mr. Pallone. That is why we need to have a hearing. We need
    to have a hearing where you guys, you drag Kennedy in, you drag
    the FDA in, and you say, ``Look, why are you doing this? If you
    are saying it is going to make it more efficient, I would like
    to know.''
        I mean, that is the problem, we are not getting that. You
    know, we feel it is your obligation to have a hearing and get
    these answers. I am just, you know----
        Mr. Guthrie. We will get to the--right for it, but your
    point is well taken.
        Mr. Pallone. All right. Well, thank you.
        Let me--Dr. Faber, some of my questions were asked by Ms.
    DeGette, but one of the things that I worry about is when I
    talk to industry people, you know, the industry always talks to
    me, whatever it is, in medical products, whatever, about good
    versus bad actors, and they are always afraid that if the FDA
    doesn't have the ability to enforce things, to go after
    adulterated products or unproven products, that, you know, the
    bad actors are going to sell stuff that they shouldn't and the
    good actors are going to get a bad reputation.
        So let me ask you about FDA's ability to take enforcement
    actions, to go after the bad actors. How is this going to be
    impacted by these cuts, if you will?
        Mr. Faber. Well, thank you for the question. One of the
    reasons that we worked together on the Food Safety
    Modernization Act and with John Dingell on FSMA was to make
    sure that industry had a partner at the FDA, because our supply
    chains were so long and so complicated that we couldn't police
    them without a partner at FDA.
        We needed someone to help us make sure that the bad actors
    weren't selling us contaminated ingredients, as PCA was and
    which ultimately led to FSMA being enacted.
        So without enforcement, the likelihood that companies will
    sell us contaminated ingredients, like we recently saw with
    cinnamon and applesauce pouches, will significantly increase.
        Mr. Pallone. And I mean, that is so important because,
    again, you know, we keep talking about the gold standard, but I
    just find increasingly now people don't feel that they can rely
    on FDA's advice if they are not, you know, actually looking at
    this stuff, enforcing the law. And this is the problem.
        What about the impact on FDA's ability to catch--I mean,
    what about--well, let me put it this way.
        Are you concerned that the way the administration is
    treating the Federal employees is going to harm FDA and HHS'
    ability to recruit and retain top talent?
        Because I was told--I don't know if Ms. DeGette mentioned
    this, but I was told that right now there are civil servants at
    HHS who are showing up to do their work but are being told that
    their position has been terminated--as they show up for work.
        And I mean, that is a terrible way to treat employees. I
    think it is rather shameful.
        So how does this all--doesn't this impact the ability to
    recruit and to retain top talent?
        Mr. Faber. We are losing people with decades of expertise
    who are going to be extraordinarily hard to replace, and the
    people who have expertise are not going to want to work at a
    place where they will be summarily fired without the courtesy
    of a phone call or an email, that is right.
        Mr. Pallone. Yeah. I mean, I was at the other hearing--
    thank you--at the other hearing that we are having this morning
    on, I guess, cyber attacks and medical devices, and I kind of
    raised this same issue again because, you know, I just don't
    see--it is so easy--an example, I had a doctor that I talked to
    who said, you know, ``I don't know that I can rely on CDC or
    FDA for advice anymore about how to treat patients,'' right?
        In the past, people relied on the FDA, CDC, all these
    things, for what we called the gold standard, meaning that I
    would--you know, I could--I figured if it had a stamp of
    approval, whether it was a type of treatment or a medical
    device or a dietary supplement, that I could rely on that.
        But this is all being undermined now, and that is my fear.
    I don't know if you want to comment. You have 30 seconds.
        Mr. Faber. Well, I will just say two things. I will say, to
    your point--your first point, industry relies on FDA not just
    to police bad actors but to provide approvals, to provide
    guidance, to clarify what they can and can't say on their
    products.
        And consumers rely on FDA to make sure that the labels are
    clear, that they are not confusing, that they have nutrition
    information, they know when their food is contaminated, when
    they should throw it away because it might make them sick.
        And in the absence of trusted leaders and credible
    institutions like FDA, consumers are going to turn to third
    parties that don't have the same evidence-based, science-based
    judgments and expertise, that is right.
        Mr. Pallone. Well, thank you.
        Thank you, Mr. Chairman.
        Mr. Carter of Georgia. The gentleman yields.
        The Chair now recognizes the vice chair of the
    subcommittee, the gentleman from Florida, Dr. Dunn, for 5
    minutes of questioning.
        Mr. Dunn. Thank you very much, Mr. Chair, and thank you,
    again, to our witnesses for being with us today. As a medical
    doctor, I know that over-the-counter treatments are vital to
    the health of our patients. They serve as a frontline option
    for patients. You need readily available option care for common
    medical problems.
        And as a Representative from the Sunshine State, I am
    particularly interested in sunscreens. I am so glad that
    everybody else is today as well.
        Every year, millions of tourists visit Florida. Many, of
    course, visit our beautiful beaches. However, the rates at
    which Americans are diagnosed with skin cancer, such as
    melanoma and others, has really become quite concerning. We are
    all aware of the dangers of extended, unprotected sun exposure.
        And we also know that the appropriate sunscreens are
    helpful in preventing these skin cancers. And I am concerned
    that the current regulatory framework does not support new,
    innovative sunscreens to market.
        The last time the FDA approved a new active ingredient for
    sunscreen in the United States was the 1990s. We know that
    there's a bunch of new products that are currently available in
    other countries, but regulatory challenges have prevented those
    sunscreens from coming to the United States.
        Ms. Wezik, I want to commend you, by the way, on the body
    of work that you have done to ensure safe and effective
    sunscreens are found in the U.S.
        Can you speak to the difference in sunscreen products that
    are available here in the United States to compare with other,
    you know, countries that have so many more options?
        Ms. Wezik. Yes. Thank you for that question. In the United
    States, we have mineral sunscreens, we have chemical
    sunscreens. Those are available globally as well.
        The main difference, to me, is the number and the types of
    UV filters that are available in the United States versus other
    countries. In some cases, we are 20, 30 years behind in terms
    of what is available here versus countries like Australia or
    the European Union or Asia.
        Mr. Dunn. In your opinion, these are qualitatively better
    sunscreens?
        Ms. Wezik. Yes. They have advanced technology that we just
    don't have available here.
        Mr. Dunn. And they are safe, in your opinion?
        Ms. Wezik. Yes.
        Mr. Dunn. That is good. So also to Ms. Wezik, in your--
    another opinion. Have the products that have been available
    overseas led to increased usage of sun protection in those
    countries compared to what they were doing before?
        Ms. Wezik. Well, that I am not sure, but since the United
    States is responsible for about a third of all global skin
    cancer cases, I would say that, you know, clearly there is
    something they are doing right over there in Australia----
        Mr. Dunn. That we are not doing right now?
        Ms. Wezik. Yes. In Australia, you hear slip, slap, slop.
        Mr. Dunn. Do you think if we introduced a bunch of these
    new sunscreens in the U.S., that there would be good uptake on
    them?
        Ms. Wezik. Yes. I do think introducing better products that
    fit more skin textures, tones, and conditions--the best
    sunscreen is the one you will use, and we need to make products
    available for more people.
        Mr. Dunn. Imagine that, a better mouse trap. How about
    that, so awesome.
        Ms. Wezik, what can this committee--what can this committee
    do and what can the FDA do to help foster these country--what
    can we do to help get these things to market, get them approved
    in the United States?
        Ms. Wezik. I think the OMUFA vehicle is really what we need
    the committee to do. We need to reexamine and encourage the FDA
    to move away from the MUsT trial, to move away from animal
    testing, consider other types of studies as either supplemental
    or a replacement for the way they currently assess safety.
        I am not a scientist. I am not trying to tell the FDA which
    test to use, but I think other countries have figured out how
    to get safety data without going down these--the MUsT trial and
    the animal testing roads. So clearly we can figure out a way to
    get safe sunscreens without using those two methodologies.
        Mr. Dunn. Are you aware of epidemiological research coming
    out of these other countries that have apparently robust use of
    these sunscreens for years that we could just look up?
        Ms. Wezik. I am sure there is real-world, human data that
    we could get our hands on. I am happy to dig into that to you
    and----
        Mr. Dunn. Actually, this is--I would be grateful. I think
    this entire committee would be grateful. I suspect the FDA
    would be too. So I thank you for that.
        And I am certainly hopeful that these new protections will
    be available soon in the United States. I think we all do. I
    look forward to working with my colleagues on the committee and
    over at FDA to get that done.
        With that, Mr. Chairman, I yield back.
        Mr. Carter of Georgia. The gentleman yields.
        The Chair now recognizes the gentleman from California, Dr.
    Ruiz, for 5 minutes of questions.
        Mr. Ruiz. Thank you, Mr. Chairman.
        The Food and Drug Administration plays an essential role in
    ensuring the safety and effectiveness of medications, medical
    devices, and food. We rely on the FDA to ensure consumers have
    access to safe and reliable prescription medications, over-the-
    counter drugs, and more.
        The reauthorization of the Over-the-Counter Monograph
    Safety Innovation and Reform Act, or OMUFA, is timely and
    necessary so that FDA can ensure it has the resources necessary
    to carry out its essential functions and provide critical
    regulatory oversight of over-the-counter medications.
        Do you want to know what else is essential to making sure
    FDA has the resources it needs to keep Americans safe? A
    skilled workforce, experts, scientists, with unique
    qualifications to evaluate food and medications for consumer
    safety.
        But sadly, House Republicans continue to support or remain
    silent and turn a blind eye in the face of this
    administration's alarming efforts to disrupt and dismantle the
    FDA by blindly slashing its workforce along with that of other
    agencies that play a key role in public health and advancing
    medical science.
        The so-called Department of Government Efficiency fired
    about 700 FDA employees as part of its initial Governmentwide
    purge of the Federal workforce. And now Secretary Kennedy has
    announced plans to cut an additional 3,500 employees from the
    FDA.
        So how can anyone with a shred of common sense believe that
    cutting about 20 percent of employees won't have dire
    implications for the agency's ability to carry out its core
    functions?
        These staffing cuts are going to have a direct impact on
    FDA's ability to review, inspect, and evaluate the safety of
    the medications and food Americans rely on and use every day.
        This is a fact whether my Republican colleagues will admit
    it or not.
        Mr. Faber, how would significantly reducing staffing levels
    at FDA potentially impact the reviews process for medications
    and other products?
        Mr. Faber. Everyone on this panel would like to see FDA go
    faster and review promising new ingredients and to weed out the
    ingredients that may be less effective and less safe. Today's
    announcement to fire 3,500 staff will make it harder for FDA to
    do that work.
        Mr. Ruiz. So it would mean that it would take much longer--
    --
        Mr. Faber. Much longer.
        Mr. Ruiz [continuing]. For that to happen.
        Also, due to reductions in staffing, would you expect any
    impact on supply chain, and will this affect pharmacies' and
    stores' ability to keep important medications that many
    Americans rely upon stocked on shelves, especially in rural
    areas?
        Mr. Faber. Well, there is no question that life-saving
    drugs, over-the-counter drugs, everyday products will take
    longer to be reviewed and ultimately made available to
    consumers, that is right.
        Mr. Ruiz. And how would the proposed staffing cuts affect
    innovation in the drug and medical device space?
        Mr. Faber. Well, without scientists who to join the
    reviewers on review teams to decide whether promising new
    drugs, promising new sunscreen ingredients, other over-the-
    counter drugs are indeed safe and effective, those products
    will simply remain unavailable.
        And formulators will go elsewhere. They will go to other
    countries where they can get their drugs OK'd and approved
    faster and make those products available to their consumers,
    not to our consumers.
        Mr. Ruiz. You know, there is a theme that we experience
    almost like a broken record. It keeps happening. You see a lot
    of cuts and decreases in budgets and funding to operate these
    agencies and programs in a timely fashion.
        Then they aren't able to perform their duties in a timely
    fashion, or mistakes are made because of the overburdened
    environment that they exist in. And then, you know, my
    colleagues start bitching and hollering about why aren't they
    doing their job.
        You hear it, and they want to bash government employees for
    not doing their job after they just cut and stressed them out
    by giving them an unmanageable workload for such critical
    points. But then they want to yell at them and say they are not
    doing their job.
        And their solution is more cuts. And the cycle continues.
    And so this is what we are going to experience. We are going to
    experience delays, backlogs. We are going to experience
    mistakes, and you are going to see that they are going to come
    in and they are going to be yelled at, and their punishment is
    going to be more cuts that will lead to more delays.
        And with that, I yield back.
        Mr. Carter of Georgia. The gentleman yields.
        The Chair now recognizes the gentleman from Virginia, Mr.
    Griffith, for 5 minutes of questioning.
        Mr. Griffith. Ms. ``Wez-ik''--did I say it correctly?
        Ms. Wezik. ``Wee-zik.''
        Mr. Griffith [continuing]. ``Wee-zik.'' And I apologize--I
    was at another hearing. I had to leave shortly after this one
    started and go to another hearing. And I apologize in advance
    that, when I finish my questions here, I will be going back to
    that hearing for a bit before I go to the floor.
        If I understood what I heard, though, when I came in, when
    you were answering Dr. Dunn's questions, we are 20 to 30 years
    behind the Australians on sunscreen?
        Ms. Wezik. Yes, that is correct.
        Mr. Griffith. So clearly there's problems that have existed
    for some time in developing new sunscreens. Is that correct?
        Ms. Wezik. Yes.
        Mr. Griffith. Now, it may take congressional action, so I
    don't want to be, you know, accused of beating up on the FDA
    workers, but don't you think we could import some of the
    studies and tests we have done in reliable nations like
    Australia or the U.K.?
        I understand there are other nations that may not do the
    testing that we do, but some of these nations do testing, and
    if the Australians have products on the market for 20 to 30
    years, we probably have a pretty good feeling that they are
    safe. Wouldn't you agree with that?
        Ms. Wezik. Yes. So the issue is that we rely on, the FDA
    has insisted on the MUsT trial, Maximum Usage Trial, as well as
    animal testing, to ensure safety data. Other countries don't
    have those two regulatory frameworks, and so they are able to
    approve other filters, whereas we are kind of stuck in neutral
    here.
        Mr. Griffith. And when it comes to something like
    sunscreen, which is not taken internally but is spread on the
    skin, can't we pretty much--I mean, I am just trying to figure
    out why we can't import data from someplace like Australia that
    has been using these products for 20 to 30 years.
        Ms. Wezik. Yes. So if we change--if we reauthorize OMUFA,
    with that, what we are asking for, which is to allow
    supplemental data, such as real-world, human data, to your
    point, the hope is that we would see new filters come to market
    certainly much faster than things have been going.
        Mr. Griffith. Yes. I am happy to help in any way I can on
    that. It seemed to me also that if we could somehow import the
    data that other nations that we rely on--like our friends in
    Australia, like our friends in the U.K. and France and some
    other places--that we could actually make it more efficient and
    maybe even do it with fewer workers.
        I am not going to ask you to comment on that, but this is
    of concern to me because, like so many of us, I have a 17-year-
    old who knows more than Mom and Dad. So last week he went on a
    mission trip to a sunny area of the country to help clean up
    trash and work in some construction settings. And because he
    had read reports--and he does read a lot--that our current
    sunscreens can cause cancer, he decided not to use sunscreens.
        You can imagine the result. I got back Lobster Boy, but it
    was all--I mean, he contemplated all the decisions himself, and
    he is 17, and he has told us any number of times he knows what
    he is doing.
        But it sure would have been nice if he would have had a
    product out there that was safe that he hadn't read those
    reports on, because he is correct, there are reports out there
    that the sunscreens currently approved by FDA are now showing
    signs that they may actually be causing the problem more than
    solving it--or at least equal. Is that fair?
        Ms. Wezik. Our position with--at the PASS Coalition and the
    MRF, the best sunscreen is the one you will use. And so whether
    that is a mineral sunscreen, which physically blocks the sun,
    or a chemical sunscreen, that is personal preference. That is,
    you know, what your son is most comfortable with. We encourage
    him to wear ``a'' sunscreen.
        Mr. Griffith. I would agree, but he determined, based on
    reports he read, that none of the products available to him in
    the United States were safe, in his mind.
        Again, I am not agreeing with him. I am just saying what he
    thought.
        Mr. D'Ruiz, do you have any comments you want to make on
    the comments I have made and the comments that Ms. Wezik has
    made?
        Mr. D'Ruiz. Yes, absolutely. I am in agreement. I think
    from a global perspective, we have to understand that the data
    globally is protected on the compensation reimbursement
    requirements. So if a company wants to use somebody else's
    data, they would have to compensate them, in most of the
    European countries.
        The fact that these methods are scientifically being
    employed in many parts of the world is intriguing in that FDA
    continues to rely on their animal testing, which has not seen
    toxicology as a gold standard anymore due to false positives
    and interspecies differences.
        But for the most part, I think we can build upon the
    knowledge or data that already exists and, in fact, has existed
    for 30 years with this ingredient that we are bringing forward.
    It has been available for 24 years and has been used safely, as
    evidenced by pharmacovigilance data, which is collected by the
    TGA, the Therapeutic Goods Authority of Australia, which
    regulates sunscreens, which is collected by Health Canada,
    which is also collected by FDA on existing ingredients.
        So we have a body of evidence on human adverse events which
    show that there aren't any remarkable adverse events associated
    with these ingredients, and we should build upon this common
    network of knowledge to fortify our knowledge in terms of
    bringing these ingredients quickly to the United States,
    because people only use what they want to use, and right now
    they are voting with their feet and buying it off the internet.
        Mr. Griffith. I yield back. Thank you.
        Mr. Carter of Georgia. The gentleman yields.
        The Chair now recognizes the gentlelady from Michigan,
    Representative Dingell, for 5 minutes of questioning.
        Mrs. Dingell. Thank you, Mr. Chairman, and thank you for
    holding this important hearing on this program that is expiring
    this year.
        I am proud to have been a colead to the bipartisan Over-
    the-Counter Monograph Drug User Fee Program, OMUFA, with Chair
    Guthrie, DeGette, and Latta. And through discussions across the
    aisle involving Members, patients, doctors, pharmacists, and
    advocates, I am committed to a thorough and fair
    reauthorization review process.
        I am troubled since we cannot ensure we are safely and
    effectively monitoring both over-the-counter and prescription
    drugs without a strong FDA workforce.
        Yet the Trump administration is creating tremendous
    uncertainty by firing and then rehiring the FDA workforce. On
    February 24th, DOGE fired 700 employees and then had to rehire
    many of them back after realizing that many of them were safety
    experts.
        And then last week, Secretary Kennedy announced a plan to
    cut 3,500 employees from the FDA.
        Firing key drug safety officials in the name of efficiency
    is shortsighted. It is not the way our healthcare system should
    be run, and quite frankly, it risks Americans' safety.
        So having said that, to ensure that the over-the-counter
    drugs are safe, we expect them to follow a General Recognition
    of Safety and Effectiveness, also known as GRASE.
        Preliminarily, we know that the Trump administration is
    enacting staffing cuts but on the other hand is touting the
    importance of GRASE and is saying, ``It is essential that the
    FDA maintains the standard.''
        Are staffing cuts at the FDA hampering the program?
        Mr. Menzel. Well, I do agree with you, I believe the FDA
    has been gold standard. I don't envy the position that you all
    are in to navigate all of these variables. I can't speak to the
    administration's decision.
        In a situation like this, from an industry perspective,
    what I would say is the OMUFA reauthorization, especially
    considering all the staffing cuts and the impacts it could
    potentially have, is so, so critical so that there is a clear
    path.
        There's going to be a lot of variables that aren't clear
    paths right now with the FDA, but this particular situation
    with the OMUFA reauthorization and the safety, effectiveness of
    over-the-counter drugs is one of those.
        Mrs. Dingell. Thank you. This part seems obvious, but it
    needs to be stated. An essential aspect of a successful
    government program is communicating. I have heard serious
    concerns from stakeholders that they are not being included in
    the conversations regarding the upcoming reauthorization.
        Now, Mr. Menzel, you mentioned that the FDA needs to be
    transparent and open to ensure a successful OMUFA
    reauthorization. If the administration decides to act
    independently and without frequent meetings, what is the risk?
        Mr. Menzel. Historically, FDA has been a very good partner
    to myself and to industry. Again, I can't speak to the impact
    of the job cuts or the potential rehiring or whatever happens
    as the FDA moves forward.
        But, again, I would just restate they have been the gold
    standard, they have been good partners in industry--at least
    for us--and reauthorization of OMUFA is critical for my company
    and our industry to allow that to keep happening.
        Mrs. Dingell. Thank you. OK, well, I am cochair of the Skin
    Cancer Caucus, so I want to end with sunscreen regulation.
    Sunscreen is critical in the prevention of skin cancer, as we
    have been discussing. Yet there are concerns that the current
    FDA regulations regarding sunscreen active ingredients are not
    sufficient.
        As we have said, there has not been an approved new active
    ingredient in sunscreen since 1999. Dr. Wezik, I first want to
    get your opinion on the current situation of the sunscreen
    testing requirements.
        Does Congress need to alter the requirements on testing to
    increase the available active ingredient list?
        And then because we are running out of time, what is the
    biggest issue facing the melanoma community with regards to
    this monograph reform?
        Ms. Wezik. Yes, we need Congress to help guide the FDA on
    where those gaps are. Again, just to reiterate, it is animal
    testing and the MUsT trial. Those are the two biggest issues
    with why we are not getting new filters.
        As far as what the melanoma community, you know, needs and
    the impact here, this is a preventible cancer. I have the
    privilege of working with advocates from hopefully preventing
    melanoma in the first place, all the way through navigating
    treatment and care for metastatic disease.
        It is brutal. It is parting your hair on the other side of
    your face to hide a big scar. It is missing work because your
    only option is a clinical trial at that point.
        And so we really appreciate Congress' support to help us in
    that prevention space, because we don't want people to get to
    that point where it is stage 4. It doesn't have to happen.
        Mrs. Dingell. Thank you. I yield back, but I would point
    out it has been since 1999 that we have done anything. I yield
    back, Mr. Chair.
        Mr. Carter of Georgia. The gentlelady yields. The Chair now
    recognizes the gentleman from Florida, whose team is in the
    Final Four this weekend, Representative Bilirakis, for 5
    minutes of questions.
        Mr. Bilirakis. I appreciate that plug very much, Mr.
    Chairman, and thank you for holding this hearing on the FDA's
    regulation of over-the-counter drugs.
        Access to safe and affordable over-the-counter drugs is an
    important issue for all Americans, and I look forward to
    learning more about how the FDA can improve the process of the
    user fee program and help incentivize American innovation in
    the drug market.
        One issue that I am particularly interested in is the role
    of four manufacturers in the over-the-counter drug market. In
    my new role as a member of the House Select Committee on
    China--and Dr. Dunn is also a member--it is my duty to help
    facilitate ideas between my work there and the jurisdiction of
    this great Health Subcommittee, led by my good friend.
        I am concerned with increasing stories of safety issues and
    violations at four manufacturing facilities for the over-the-
    counter drugs and the impact to American consumers.
        In 2024, dozens of drug recalls exposed a link to tainted
    factories in China and India that manufacture children's over-
    the-counter drugs.
        In 2023, bacterial contamination of eye drops at an
    overseas manufacturer blinded 14 people and killed 4.
        Mr. D'Ruiz, in your testimony you mentioned the role that
    Chinese companies play in the over-the-counter market,
    particularly as it impacts innovation.
        What steps can the FDA currently take to both promote
    innovation in the market and protect against safety issues? If
    you could answer that question, I would appreciate it, sir.
        Mr. D'Ruiz. Yes, sir. So this is all related to the
    confidentiality provisions which do not currently exist under
    the OTC monograph process because it is a public rulemaking. So
    any study data that is generated on behalf of a sponsored
    company supporting an ingredient will be publicly made
    available on the FDA docket, visible to anybody who wants it.
        These tests or studies that have been conducted usually
    cost hundreds of thousands to millions of dollars.
        Now, those companies which are competing with the sponsor
    are at an advantage of obtaining that data free of charge and
    then supporting the marketing or the development of the same
    ingredient without paying a cent and getting lunch for free.
        It is further exasperated in that these are all USP-grade
    ingredients on the monograph, right? So in order to be sold, it
    has to meet the quality and purity standards of the United
    States pharmacopoeia.
        If there is only 18 months' exclusivity for a sponsor who
    generates all these studies to get the ingredient approved by
    FDA on the monograph, after that 18 months it becomes a generic
    drug subject to USP, and anybody can manufacture it.
        Having that data for free is unfair and presents a big
    problem in terms of innovation and return on investment and is
    not supporting other companies from wanting to do this.
        So if we do not fix that, you will have a system, but
    nobody is going to want to be in the system, because there is
    no return on investment, given the way it is currently set up.
        Mr. Bilirakis. Thank you very much for that answer.
        Preliminarily, your testimony discusses the need for the
    FDA to improve the arrears process, the list of facilities that
    have not paid their user fees.
        Can you elaborate further on the arrears list and how
    addressing this would help provide additional transparency for
    consumers?
        Mr. Menzel. Absolutely. So what the arrears list is, as
    mentioned, it is around 200 facilities that have not paid their
    user fee. Historically, those companies are also, because they
    haven't paid, they are also very poor-quality companies.
        So if FDA focuses their attention on those particular
    companies, not only would those fees likely be paid, but a lot
    of the quality issues that have been mentioned are coming out
    of companies like that.
        So it is a target list, if you will, to correct the
    nonpayment but also to highlight companies that have poor
    quality histories.
        A simple publication of that arrears list would likely
    cause some of those companies to either pay and improve their
    quality or disclose what is going on with them.
        Mr. Bilirakis. All right. Thank you very much.
        Thank you, Mr. Chairman. I yield back.
        Mr. Carter of Georgia. The gentleman yields.
        The Chair now recognizes the gentlelady from Illinois,
    Representative Kelly, for 5 minutes of questioning.
        Ms. Kelly. Thank you, Chair Carter and Ranking Member
    DeGette, for holding this hearing on the FDA user fee
    authorizations. It is imperative that we ensure our regulatory
    system, particularly in the realm of over-the-counter
    medications, work to protect all Americans, regardless of their
    background or economic status.
        I firmly believe in the power of science and trust the
    expertise of the dedicated scientists and professionals at the
    FDA who work tirelessly to safeguard public health.
        Unfortunately, we are at a time where the narrative of
    combating waste, fraud, and abuse has taken away from science
    and efficiency.
        As we have talked about last Thursday, the Department of
    Health and Human Services, directed by Elon Musk's Department
    of Government Efficiency, announced it would slash its
    workforce by one-quarter and consolidate several agency
    functions, leaving few offices or programs untouched.
        HHS Secretary Robert F. Kennedy, Jr., declared the
    Department would lay off 10,000 workers on top of another
    10,000 who already have been forced to navigate early
    retirements, buyouts, or restructuring.
        These specific layoffs will impact on about 4,200 employees
    at the Food and Drug Administration which is almost 20 percent
    of the total agency workforce.
        Mr. Faber, what potential risk and transparency do these
    workforce reductions create, and how would the potential
    workforce gaps impact vulnerable populations who rely on clear,
    accessible information to make informed decisions about their
    health?
        Mr. Faber. Yes, thank you for the questions. While you have
    heard the administration say they won't cut reviewers or
    inspectors, they notably left out all of the folks who are in
    charge of making sure our labels are clear, that consumers know
    what is in the products that they are eating or putting on
    their bodies, that consumers are alerted when products have
    been contaminated in some way so they can clear their pantries,
    and the people who do postmarket surveillance so we know when
    things do go wrong, so that we can respond and take action.
        So all of those people were presumably fired today, and
    they will not be--no longer be helping consumers and industry
    share these basic facts with us.
        Ms. Kelly. So it leaves all Americans in a very unhealthy
    way--or could be. I am glad to see FDA's commitment to real-
    world evidence reflected in the user fee agreements.
        Innovation has also come with time which is why my
    colleague, Rep. Balderson, and I created a caucus on digital
    health, to encourage modernization. Unfortunately, massive
    reduction-in-force notices that--notices put forward by the
    Trump administration will not help innovation come faster to
    patients across the Nation.
        Mr. D'Ruiz, you mentioned in your testimony that regulatory
    barriers can often limit consumer access to innovative products
    such as in the development of new UV filters which could be
    helpful to minimize gaps in skin protection for communities of
    color.
        In your opinion, how can FDA modernize its regulatory
    framework to encourage innovation while also ensuring consumer
    safety?
        Mr. D'Ruiz. Right. So thank you for that question. It is
    important to realize that industry has been working for the
    last 5 years, since the 2019 monographs, which became the 2021
    proposed administrative order, in terms of providing them with
    a framework by which they would be able to review the safety of
    the existing filters on the market using evidence approaches,
    which include, you know, human, real-world evidence, which
    include additional in silico methods, which include a variety
    of other modern toxicological techniques.
        And we have presented that to the agency as a proposal in
    terms of modernizing the way that they look at things, with an
    eye that this can be used to build upon the science, to
    generate the internal knowledge base that is required to
    facilitate the innovation process with existing ingredients
    that are used elsewhere in the world that currently have an
    extensive amount of data associated with them.
        So it is important to realize that we have the ability to
    do this. It is being done. We just need to do it right and use
    what is available in order to protect the American consumer
    from skin cancer and the harmful effects of the sun.
        Ms. Kelly. Thank you so much and thanks to all the
    witnesses. I appreciate your time. Thank you.
        I yield back.
        Mr. Dunn [presiding]. The gentlelady yields back, and I now
    recognize the gentleman from Texas, Mr. Crenshaw, for 5
    minutes.
        Mr. Crenshaw. I thank you, Mr. Chairman. Thank you all for
    being here.
        I will start with you, Mr. Menzel, on the question of
    efficiency and maybe just talk about the monograph process more
    generally. As it compares to the traditional new drug
    application process, does it do as intended: cut red tape,
    speed up the pathway?
        Mr. Menzel. Yes, the short answer. A new drug application
    for every monograph-type product right now would be a burden to
    the system. Products wouldn't get approved.
        Importantly, right now with the monograph system and with
    OMUFA, you have products that are generally recognized as safe
    and effective in terms of the active ingredients currently in
    our industry, and it does allow for innovation in terms of
    form, in terms of other inactive ingredients that are really
    important to the consumer.
        So innovation is ongoing. It doesn't always have to be an
    active-ingredient innovation, but let me just say that that is
    very, very important to the consumer--texture, taste, all of
    those things that drive a product to perform well, so, yes.
        Mr. Crenshaw. Have you seen an improvement in the system
    since the user fee program was put in place?
        Mr. Menzel. I think the framework is there for the user fee
    program. I think the first 5 years, a lot of the infrastructure
    was built with the FDA. Our anticipation is that the next 5
    years will allow for more innovation and more processes, now
    that the infrastructure is in place, for more innovation to
    actually come to market.
        Mr. Crenshaw. Yes. I guess, did the user fee program, in
    your calculation, your observation, create a faster approval
    process or not?
        Mr. Menzel. Yes.
        Mr. Crenshaw. Are we seeing--and what are the roadblocks,
    then, if we were to reform this or improve it?
        Mr. Menzel. I mean, I think the current roadblocks, you
    know, some of the items that we have mentioned in terms of the
    full-time employees, that funding needs to remain in place so
    that those employees can be approving the products that come
    through, and then, you know, communication and continued
    transparency with the FDA.
        Mr. Crenshaw. All right. That gets to my next question I
    was going to ask you--and Mr. Troutman, if you would like to
    weigh in on this--about communication. I think it is a big
    deal, between industry and regulators, and we need to get it
    right.
        Transparency provides that clarity that we need to
    innovate, bring products to market efficiently. You have to get
    to know what is wrong with your testing or with your process,
    and FDA doesn't always do a great job telling you that.
        Does the user fee program create that? Has it improved
    communication, or is it still an issue?
        Mr. Troutman. Thank you for the question, Mr. Crenshaw. It
    has been a bit of an issue over the course of the program just
    in--we have submitted a number of progress reports which are
    part of my written testimony, from ACI, with regard to when and
    how things are going with the safety or data submissions that
    are part of that work that FDA has asked us to do.
        But the actual response from the agency on the progress or
    whether that is on track or where that may be, has been few and
    far between. So we would like a little bit more flexibility
    there and resource dedication to making sure that that
    communication is ongoing.
        Mr. Crenshaw. Yes, I agree. Anyone want to add anything to
    that?
        I think that is something this committee needs to address.
    I am not sure exactly how.
        Mr. Menzel, another question on modernizing our system
    here. You know, there's Australia and parts of the EU that use
    what is called a behind-the-counter pathway, a middle ground
    between prescription and over-the-counter drugs. It allows you
    to consult directly with the pharmacist at the counter to get
    access to certain medications like insulin without a full
    doctor's visit. A lot of this does seem like common sense.
        Last year the FDA finalized the additional condition for
    nonprescription use rule, creating new pathways to move some
    prescription drugs into nonprescription category. So would a
    behind-the-counter system work in the U.S., and what are the
    tradeoffs?
        Mr. Menzel. I mean, I think it is something that has to be
    looked at with the FDA. I think there is pros and cons.
    Certainly the pros--increased access and price transparency--I
    think, are two really big important items.
        There's some learnings from other countries. I wouldn't
    want to move every situation over to behind-the-counter because
    then you limit access.
        But I think certainly for us, I mean, I think if it
    improves access to the consumer, it ensures safety, and it is
    an established product, then it is a pathway that we should
    evaluate in coordination with the FDA.
        Mr. Crenshaw. Thank you. I yield back.
        Mr. Dunn. The gentleman from Texas yields, and I now
    recognize the gentlelady from California, Ms. Barragan, for 5
    minutes for questioning.
        Ms. Barragan. Thank you, Mr. Chairman.
        As we have this hearing today on the FDA, can't help but
    notice that just last week the Trump administration announced
    that they will fire 10,000 employees across the Department of
    Health and Human Services. This includes plans to cut thousands
    of jobs at the FDA, about one-fifth of the workforce.
        These Federal workers protect our country's public health
    by ensuring the drugs Americans take are safe, including over-
    the-counter drugs.
        How can we have this hearing to look at how the FDA
    regulates over-the-counter drugs while Republicans severely cut
    the FDA staff?
        These cuts will slow down the approval of drugs, which
    means that Americans will have to wait longer to access new
    life-saving medications for diseases that affect us, and that
    is unacceptable.
        Mr. Faber, the FDA employees about 19,700 employees to
    ensure the safety of food, drugs, and medical devices. Of
    those, over 7,000 employees are under the FDA's drug review
    division, the Center for Drug Evaluation and Research, which
    reviews nonprescription drugs, including over-the-counter drugs
    such as sunscreen.
        How has FDA's current staffing levels been able to keep up
    with timely review of drug applications and other safety
    reviews?
        Mr. Faber. Well, the FDA has done an excellent job of
    reviewing drugs and over-the-counter drugs, and I think
    everyone on this panel would agree that we all trust FDA to
    tell us what science is necessary, what studies are necessary,
    in order to ensure that the drugs, especially our over-the-
    counter drugs, are safe but also are effective, that they block
    both the UVA and UVB rays that can lead to skin cancer.
        Unfortunately, the current policies that we have in place
    are not providing a strong enough signal to industry to pay for
    and provide the studies that FDA--not industry--that FDA is
    insisting is necessary to know whether our sunscreens are
    ultimately safe and effective.
        Ms. Barragan. And do you see any of the reduction in the
    workforce having an impact on these reviews?
        Mr. Faber. Absolutely. Even if we, as the Secretary has
    said, protect reviewers and inspectors, there are many
    thousands of people who are part of review teams who play other
    roles. There's biostatisticians or economists or other experts
    who contribute to these reviews.
        If we want to update the science that FDA applies to these
    questions of safety and effectiveness, we need to have
    toxicologists, epidemiologists, biostatisticians, economists,
    others who are not reviewers and who would know--and many of
    whom were fired today.
        So if we do want to advance the science and have better
    science applied to this question of whether or not these
    ingredients that are used in other countries are safe, we need
    to have qualified people at the FDA to make those
    determinations.
        I know you would not want to take my word for it or the
    other witnesses' word for it, but ultimately don't we all want
    a qualified person at the FDA deciding whether the things we
    rub on our bodies and our families' bodies every day are
    actually safe and whether they are actually blocking the sun's
    harmful rays.
        Ms. Barragan. Thank you.
        Mr. Faber, last Friday FDA's top vaccine official, Dr.
    Peter Marks, was pushed out of the administration after serving
    in the agency's leadership since 2016. Dr. Marks had expressed
    his willingness to work with HHS Secretary Robert F. Kennedy,
    Jr., to address any concerns about vaccine safety. But the
    Secretary just wanted unquestioned confirmation of his
    misinformation and lies over vaccine safety.
        This is just another example of the Trump administration's
    antiscience approach in their decisionmaking.
        What would be the ramifications to our country's public
    health if we push out our scientific experts on drugs, food,
    and medical devices?
        Mr. Faber. Well, if we don't have qualified experts
    reviewing the safety of these products, obviously, many of
    these products, as well as our food, will be less safe, and
    people will get sick, or worse.
        They won't be able to have access to life-saving
    treatments, our antibiotics won't continue to be effective.
    Many of the other things we bring into our homes may pose risks
    that we are not aware of.
        But more importantly--and Ranking Member Pallone alluded to
    this earlier--people will lose faith in the FDA as a source of
    expertise. And ultimately we want a regulator that we can all
    trust to give us good advice about the safety of products.
        And in the absence of that, we will turn to faith healers
    and fraudsters, not the people who really are looking at the
    science.
        Ms. Barragan. Right. I want to move quickly to the FDA. The
    Congress has authorized the FDA to collect user fees from
    manufacturers that market, process, and develop over-the-
    counter drugs in order to support the FDA's workforce and
    product evaluations.
        If Congress fails to reauthorize the user fee program on
    time, how would underserved populations be disproportionately
    affected?
        Mr. Faber. Well, many people lack access to information
    about the products they bring into their homes. They don't have
    the luxury of time to go online and research products as many
    of us do. And so they will be at greater risk of products that
    pose health harms, no question.
        Ms. Barragan. Great. Thank you.
        I yield back.
        Mr. Crenshaw [presiding]. The gentlelady yields back.
        The Chair now recognizes the gentleman from Pennsylvania,
    Mr. Joyce.
        Mr. Joyce. Thank you, Chairman, for holding this hearing
    today and for our panel for testifying.
        As a Johns Hopkins-trained dermatologist, I have personal
    experience treating skin cancer, and I am aware of how
    devastating this can be for a diagnosis for patients and for
    their families.
        On a personal level, I never met my grandfather. He died of
    skin cancer before I was even born.
        We know that sun exposure is the primary cause of skin
    cancer. As a doctor and as a Member of Congress, I continually
    advocate for the importance of regular sunscreen and the use of
    it for skin cancer prevention and also regular skin evaluations
    and examinations for early detection.
        And despite attempts by Congress to ensure that the newest
    and most effective sunscreens can reach the U.S. market, we are
    still far behind the rest of the world in approving innovative
    UV filters in sunscreens, and this has led to real public
    health alarms.
        I ask unanimous consent to submit the white paper from the
    Public Access to SunScreens Coalition on the history of this
    issue for the record.
        Ms. Wezik, can you speak to the current rates of skin
    cancer diagnosis in the United States and how that compares to
    rates in other countries?
        Ms. Wezik. Yes, thank you. So in 2014, which was when the
    Sunscreen Innovation Act passed, through 2022, there were over
    700,000 new cases of skin cancer in the United States and
    75,000 deaths in that same 8-year timespan.
        Again, as I stated in my remarks earlier, the United States
    is responsible for about a third of all skin cancer cases
    globally. So clearly we have an outsized, I think, problem with
    how we prevent skin cancer, how we message skin cancer
    prevention. It is a huge opportunity for us to the public
    health space.
        Mr. Joyce. And during that time period and since 1999, not
    one single new skin protection in a sunscreen--none approved,
    correct?
        Ms. Wezik. Correct.
        Mr. Joyce. And yet we have seen other approvals. We have
    seen the development of Opdivo, of Keytruda, for the treatment
    of metastatic melanoma. But we are not starting at the
    beginning. We are not working where we should be working.
        To the numbers that you just stated, the incredibly
    alarming numbers of increased skin cancers, these are troubling
    numbers. They are troubling numbers worldwide, but they are
    specifically troubling numbers here in the United States.
        Would you agree that this public health risk, Ms. Wezik,
    warrants the inclusion of legislative provisions in OMUFA to
    resolve this issue?
        Ms. Wezik. Yes, absolutely.
        Mr. Joyce. Thank you. I agree with that completely.
        The United States is home to the world-leading medical
    innovation. In fact, I often talk about innovation being the
    cornerstone of American medicine, being the cornerstone of how
    I practice medicine.
        Unfortunately, the FDA's inaction has prevented that
    innovation, allowing the rest of the world to access new active
    sunscreen ingredients that are unavailable to Americans.
        Mr. D'Ruiz, can you expand upon some of the barriers that
    are hindering the great innovation by not utilizing the
    clinical allies that our friend--not utilizing the clinical
    information that our friends and allies have access to?
        Mr. D'Ruiz. Well, I mean, people don't die from using
    sunscreen. They die from not using sunscreen, number 1. And I
    think there is a large body of evidence worldwide indicating
    that the use of sunscreen filters which have been developed
    over the last 10 years are much more efficient--you use less,
    less exposure--they are much more effective in reducing the
    harmful effectives of UVA and B, and 3, they are more
    sustainable in terms of environmental impact.
        So from that perspective, that body of data has propelled
    the industry globally outside of the U.S. to develop new UV
    filters at a rapid pace.
        The technologies go beyond what used to be just synthetic
    filters, and now new technologies which are nowhere near being
    reviewed in the United States in terms of natural UV filters,
    filters that are biotechnology-based, nobody is investing in
    any of this because of the costs involved in the United States,
    the lack of data protection, and the fact there is no
    exclusivity.
        So you have a system, and we are very proud to be the only
    ingredient manufacturer to be in the system, and I can tell you
    that we have been in touch with FDA, and it is working.
        Mr. Joyce. Do you feel access to these natural filters can
    prevent skin cancers, can prevent deadly melanomas from
    occurring?
        Mr. D'Ruiz. I think the science is evolving at the most
    rapid pace we have seen in generations and that the technology
    that is now being generated from biotechnological--biotech
    innovations simply are astounding and should be considered in a
    new framework in terms of reviewing how these filters can be
    approved to augment what we have and even accelerate beyond
    what the rest of the world is doing in terms of technology--
        Mr. Joyce. Again, innovation here in America.
        Mr. D'Ruiz. Yes.
        Mr. Joyce. It is my goal that we can work as a committee to
    streamline and unleash the process of developing these natural
    abilities to filter the harmful ultraviolet rays in order to
    unleash that innovation in the skin care protection ability of
    your industries.
        It is our duty to protect the American people from skin
    cancer.
        Mr. Chairman, thank you. My time is expired. I yield back.
        Mr. Crenshaw. The gentleman yields back.
        The Chair now recognizes the gentlelady from Washington,
    Ms. Schrier.
        Ms. Schrier. Thank you, Mr. Chairman, and thank you, Madam
    Ranking Member, and thank you to all of our witnesses for being
    here today. I am really grateful for your commitment to making
    sure that our drugs, devices, and foods are safe.
        As a doctor, it is important for me to trust that an over-
    the-counter product that I recommend to a patient isn't going
    to harm them and will work as intended to.
        And whether that is the efficacy and safety of my daily
    sunscreen or the really important standardization of infant and
    children's Tylenol concentration many years ago that has
    prevented accidental overdoses, we all rely on a well-funded
    and staffed FDA to carefully review those products.
        The Over-the-Counter Monograph Safety Innovation Reform Act
    was designed to accelerate and streamline OTC drug approval,
    and we are discussing reauthorization this morning.
        It is really hard to have a good-faith discussion about
    reauthorizing this program when the Trump administration, just
    this morning, fired 3,500 FDA staff. In fact, they just
    couldn't get in the building. That is how they found out.
        And this action is only going to make approval of over-the-
    counter products and prescriptions slower and less safe. There
    is just no way that cutting 20 percent of FDA's employees will
    have zero impact on drug and medical device review that the FDA
    was already struggling to keep up with.
        Mr. Faber, I need to know, again, that the OTC products I
    recommend are safe and effective. This includes sunblock. As we
    have heard, the FDA has not approved a new sunblock since 1999,
    and the rest of the world has twice the options that we have.
        Do you believe that the FDA have adequate staffing to
    effectively review the safety of sunscreen ingredients before
    today?
        Mr. Faber. No.
        Ms. Schrier. And then can you comment on how today's firing
    of 20 percent of FDA's staff will change their capability?
        Mr. Faber. Today's decision to fire 3,500 staff will be
    devastating to the efforts to bring safer, more effective
    sunscreens to American consumers, a goal all of us share,
    because the people who will advance the science that allows us
    to know which of these ingredients are indeed safer or
    effective were fired this morning.
        Ms. Schrier. It is outrageous.
        I want to turn my attention, just with the remainder of my
    time, to vaccinations. Dr. Peter Marks decided to resign this
    weekend from the FDA Center for Biologics Evaluation and
    Research. He was the head of the department responsible for
    ensuring the safety and effectiveness of vaccines. Basically,
    he was told by HHS Secretary RFK, Jr., that he better either
    get on board with the misinformation and doubt about vaccines
    or get fired or resign. And he chose, nobly, to resign, but
    that is a loss for the country and for the world.
        And, frankly, you know, I have spent now many years trying
    to combat the misinformation that RFK, Jr., and others like him
    have been spreading willfully for the past decades. I am
    outraged about this resignation, and I am outraged that others
    are being muzzled right now. And I just worry, as a
    pediatrician, who has only seen one case of measles in a child
    under 1--who had been traveling--that these diseases that I
    haven't even seen are going to come back and cause meningitis
    and death and pneumonia--and measles, as we are seeing right
    now, totally unnecessarily.
        And I also want to be clear that I will lay every single
    one of these outbreaks at the feet of our Health and Human
    Services Secretary, RFK, Jr.
        Would any of you like to comment about the risk to
    vaccination in this country?
        Mr. Faber. Well, I will just volunteer that I am not the
    only one who is probably sitting here today because I am taking
    a medication that was approved by the FDA. We all depend on the
    FDA to keep us safe, to provide us life-saving drugs, to make
    sure our antibiotics work. And the notion that we are
    undermining this incredible resource, this incredible national
    resource, in this way is putting all of us at risk. It is
    making it harder for the industries here and industries
    generally to produce the life-saving drugs that we all depend
    on.
        Ms. Schrier. That is right. Drugs--we didn't even talk
    about baby formula today.
        Thank you very much. I yield back.
        Mr. Crenshaw. The gentlelady yields back.
        The Chair now recognizes the gentlelady from Tennessee,
    Mrs. Harshbarger.
        Mrs. Harshbarger. Thank you, Mr. Chair.
        Thank you to the witnesses for being here today.
        I will start with Mr. Menzel. How does OMUFA increase
    supply chain resilience? Because we have had some shortages in
    OTCs like your ibuprofens, your acetaminophens, those type of
    things.
        Mr. Menzel. Yes. So the key to supply chain is
    predictability.
        Mrs. Harshbarger. Yes.
        Mr. Menzel. And, you know, the OMUFA reauthorization is
    critical in terms of predictability so that the supply chain
    can be sourced from various other places. I will say, too,
    that, you know, there has been a great effort within our
    industry, even with us personally, where we have increased
    supply chain resilience by, as you heard in the notes,
    increasing manufacturing in the United States. But you can't do
    that if you don't have predictability----
        Mrs. Harshbarger. Yes.
        Mr. Menzel [continuing]. Of what those active ingredients
    are going to be, and that is what the reauthorization allows
    for.
        Mrs. Harshbarger. Yes, exactly. Because when you--you know
    that over 90 percent of your ibuprofen comes from China, that
    is a problem. There's FDA-registered facilities, but they might
    not necessarily be FDA-inspected facilities. And we know
    there's small and large manufacturers that participate in this
    OMUFA user fee program, and maybe we need to look at that
    publication of the arrears list, and maybe the FDA could also
    put out an import alert for foreign nonpaying facilities if
    over 200 haven't paid.
        Mr. Menzel. I agree.
        Mrs. Harshbarger. So, and this is to Mr. Menzel and Mr.
    D'Ruiz.
        Mr. Menzel, you said the OTC Monograph Drug User Fee
    Program improved the FDA's ability to review and update OTC
    monographs. And can you provide an update on the number of OTC
    monograph order requests submitted and approved by OMUFA? Do
    you have that number?
        Mr. Menzel. I think I do.
        Mrs. Harshbarger. If you don't, don't worry about it. You
    can get it back to me. I am just, I am curious about that.
        Mr. Menzel. Oh.
        Mrs. Harshbarger. Somebody has got it.
        Mr. Menzel. It should have been an obvious number. There is
    one that has been public. It goes back to the discussion that I
    had, that the first 5 years created the infrastructure. We
    would certainly expect with reauthorization that that number
    would dramatically increase over 5 years.
        Mrs. Harshbarger. Yes, I just--I would be curious.
        Mr. D'Ruiz, has OMUFA affected small and mid-sized OTC drug
    manufacturers, since there's two types of facility fees? You
    know, you have got your MDF and your CMO fees. I guess my
    question would be, Has it discouraged or limited participation
    by smaller companies?
        Mr. D'Ruiz. Has what? Sorry.
        Mrs. Harshbarger. You have got your small and mid-sized OTC
    drug manufacturers.
        Mr. D'Ruiz. Right.
        Mrs. Harshbarger. Has these user fees discouraged or
    limited participation by smaller companies?
        Mr. D'Ruiz. Well, I think under the GMP requirements for
    OTC drugs you have a standardized----
        Mrs. Harshbarger. Yes.
        Mr. D'Ruiz [continuing]. Method for ensuring that the
    safety of these ingredients and the quality and purity is in
    place per FDA standards.
        Mrs. Harshbarger. Well, you do, and that is expensive.
        Mr. D'Ruiz. And these apply to both large and small
    organizations.
        Mrs. Harshbarger. Yes.
        Mr. D'Ruiz. So, for the most part I think those
    requirements must be adhered to, but----
        Mrs. Harshbarger. I agree.
        Mr. D'Ruiz [continuing]. The problem is that if people are
    buying sunscreens that are on the internet that are not
    regulated by FDA, what is the problem there? They are skirting
    the system.
        Mrs. Harshbarger. Listen, you could make it in your garage,
    in some cases.
        Mr. D'Ruiz. So we have got a bigger problem, right.
        Mrs. Harshbarger. Exactly.
        Mr. D'Ruiz. So I think it is important to realize that the
    industry does not do anything that is not safe and effective
    for its consumers, and that we will continue to do so
    regardless of what environment we are in, and we uphold those
    standards as responsible citizens.
        Mrs. Harshbarger. Yes. And, I mean, I am a compounding
    pharmacist. For God's sakes, I have to have CGMP if I am doing
    sterile or nonsterile, so--and I am held to very high
    standards.
        So, Mr. Menzel, do you think OMUFA--how does it compare to
    other FDA user fee programs in terms of efficiency and industry
    burden?
        Mr. Menzel. Yes. I mean, I think the principle of the
    program is that it distributes the burden, and, you know, so
    our organization pays one fee but because the burden is
    distributed it is not an overtaxing burden.
        Mrs. Harshbarger. Yeah.
        Mr. Menzel. And I think, in that regard, it is effective
    and----
        Mrs. Harshbarger. I think that is probably having that base
    and----
        Mr. Menzel. Exactly.
        Mrs. Harshbarger [continuing]. For smaller entities. It
    gets everybody a level playing field.
        Mr. Menzel. Absolutely.
        Mrs. Harshbarger. Do you think it has increased the--had an
    impact on the cost of OTC----
        Mr. Menzel. I do not.
        Mrs. Harshbarger [continuing]. Medications?
        OK. That is very good.
        I think my time is up. I have got many more questions, but
    I yield back, sir.
        Mr. Crenshaw. The gentlelady yields back.
        The Chair now recognizes the gentlelady from Texas, Mrs.
    Fletcher.
        Mrs. Fletcher. Thank you, Mr. Chairman.
        And thank you to the witnesses for your testimony today. I
    understand from your testimony and from our work that this is
    an important program that needs to be reauthorized by September
    of this year if it is going to continue.
        Is it going to continue? If we reauthorize it, will it
    continue? If we even fund 11 positions, will they still be
    there?
        While we have been sitting here today, we have gotten
    reports from multiple people that HHS employees are lined up
    around the block at the building just down the street swiping
    their badges to see if they are still employed. If you scan
    your badge and it is green, you can go in; if you scan your
    badge and it is red, you are fired. Is this really happening in
    the United States of America, to the people who work to keep us
    safe, to the people that we are talking about this morning in
    this hearing?
        Where is the evidence that these staffing cuts are
    necessary, let alone a good idea in the context of the agency's
    mission? Where is the evidence that cutting 20 percent of the
    employees on top of the thousands already fired is a good idea?
    We keep hearing--even in this room, even on this committee,
    from members of this committee--that Musk and DOGE and Kennedy
    are focused on fraud, waste, and abuse.
        They are, but they aren't eliminating it. They are engaging
    in it.
        Firing thousands of scientists and civil servants who work
    to keep us safe from disease, who protect us from harmful
    products, who carry out critical research to advance new cures
    and treatments is a total waste.
        Telling them that they are fired from jobs they have worked
    at for years, even decades, to protect and serve the American
    people by a green or red light when they arrive at the building
    where they work and try to swipe in--that is an abuse.
        And telling all of us that those dedicated scientists and
    public servants cannot be trusted and replacing them with
    quacks who deny the efficacy of modern medicine and vaccines,
    telling people in my home State of Texas during a measles
    outbreak to use vitamin A and cod liver oil instead of the MMR
    vaccine--a total fraud.
        While we have been sitting here, former FDA Commissioner
    Robert Califf said, ``The FDA as we know it is finished, with
    most of the leaders and institutional knowledge and a deep
    understanding of product development and safety no longer
    employed.''
        So I ask again, Mr. Chairman, does it really matter whether
    we have this hearing today? Does it really matter whether we
    reauthorize this law? What will happen then?
        The answer to that question is actually in your control.
    Congress can and must assert its authority here. We must
    conduct oversight. We must ensure that the legislation that we
    pass after hearings like this is implemented as directed, that
    the funding that we appropriate for health and research safety
    is spent as directed.
        Mr. Faber, I am sorry that I am running out of time here to
    ask you all of the questions about our efforts to prohibit the
    use of certain hazardous chemicals like formaldehyde and
    mercury from personal and professional care products that are
    used at homes and in salons and sold in the United States. I
    prepared a bunch of questions for you, but what we are seeing
    and hearing this morning is outrageous, so I am going to submit
    those questions to you for the record----
        Mr. Faber. Thank you.
        Mrs. Fletcher [continuing]. Because I think that that is
    critically important work that we can and should continue to do
    on this committee, and I hope we will.
        But, Ms. Wezik, I want to close by thanking you for your
    work. As someone who lost my most beloved uncle to metastatic
    melanoma many years ago, whose life was extended by more than
    15 years after his stage 4 diagnosis in 1997 when it was almost
    unheard of to survive, he lived for another 15 years because he
    enrolled in a cutting-edge clinical trial at MD Anderson Cancer
    Center in Houston.
        And I am so proud now to get to represent so many of the
    scientists and researchers and professionals who work there and
    throughout the Texas Medical Center in the city of Houston. As
    someone who represents those people, I urge this committee and
    this Congress to fight back against the cuts to research
    funding, against the cuts to personnel at NIH, at FDA, and to
    the overall destruction of HHS that we are witnessing in
    realtime at this moment.
        With that, I yield back.
        Mr. Crenshaw. The gentlelady yields back.
        The Chair now recognizes the gentlelady from Iowa, Mrs.
    Miller-Meeks.
        Mrs. Miller-Meeks. Thank you very much, Mr. Chairman.
        And I thank the witnesses for testifying before this
    subcommittee today.
        I just recently heard about legislation being carried out
    as it was enacted, and that brings to mind something very
    important to me as a physician, and that was the No Surprises
    Act, which it seems that the last Secretary of HHS, in fact,
    did not go with the intent of Congress or how that law was
    supposed to be delivered and has left both patients and
    providers in the lurch once again.
        We are here to discuss the first reauthorization of the
    Over-the-Counter Monograph Drug User Fee Program, otherwise
    known as OMUFA. And, yes, it is important that we actually
    discuss that and do the oversight for this important program
    because it facilitates over-the-counter drugs being made
    available to people across the Nation.
        OMUFA, which was established by the CARES Act during the
    COVID-19 pandemic, allows the FDA to enter into agreements with
    the regulated industry to ensure the agency can meet, review
    goals and guidelines established between the FDA and industry.
    As it was noted, these agreements are vital to the FDA's
    ability to provide a timely and comprehensive review of drug
    applications to ensure patients can access safe and effective
    options, in this case without direct physician oversight.
        Increasing access to OTC medications is critically
    important to Americans living in rural areas, who already face
    access challenges due to their geographic location. Whether it
    is Zyrtec or over-the-counter birth control, it is key that we
    as lawmakers empower patients to make their own informed
    healthcare decisions by giving them access to approved
    treatments and remedies. And, in fact, as a State senator in
    2019 in Iowa, I introduced oral contraception over the counter
    at that time.
        Mr. Menzel, thank you for being here today. Can you please
    describe what you believe to be the biggest challenges facing
    the OTC industry today, and do you believe current FDA data
    requirements for prescription-to-prescription switch are
    critically valuable?
        Mr. Menzel. In terms of the challenges, you know, I think,
    just like any industry, we have to navigate consumer demand,
    transparency in the supply chain, the challenges with import,
    et cetera. Those are all very important. You know, I actually
    was involved in a few Rx-to-OTC switches, and I saw a few
    sneezes in the room, and so for anybody that is using an
    allergy medication, really nearly all of the allergy
    medications that are available to the consumers are product of
    the Rx-to-OTC switch. We, the company that I was at, navigated
    that in 2010 effectively with the FDA, and they were good
    partners. And that has been a good process to allow for good
    products to come available to the consumers.
        Mrs. Miller-Meeks. I am aware that Perrigo, the
    manufacturer that produces Opill, the first OTC-approved birth
    control, is a member of the Consumer Health Products
    Association. Do you believe that Congress, through meaningful
    FDA reforms, should continue to facilitate increasing access to
    the number of approved OTC oral contraceptive products for
    women? And, secondly, do you believe these products are a
    benefit to those in rural areas?
        Mr. Menzel. Yes. I mean, I think the OTC process allows for
    consumer access to drugs that they normally wouldn't have
    access to. Health deserts are real things, and I think the OTC
    industry helps mitigate that to some extent. Certainly
    something that still needs to be addressed, but I absolutely
    believe that the access to OTC drugs, the utilization of
    pharmacists and pharmacies for self-medication, for advice at
    that level improves healthcare outcomes in the U.S.
        Mrs. Miller-Meeks. Well, in addition to, as you mentioned,
    the allergy medications--which I am suffering through at this
    point in time, both in DC and back in Iowa--you know, one of
    the products that has come on board and as a woman I thought
    was extraordinarily beneficial was Monistat, or antifungal
    medications for vaginitis, which most women, if they have had
    one yeast infection, they know exactly what it is and they know
    how to treat it.
        And so this advance of prescription-to-OTC switch has been
    very helpful in that regard and helpful in rural areas,
    especially as we are trying to undergo PBM reform, which is
    causing small, rural, and independent and community pharmacies
    to close around the Nation. So with that, my time is ending.
    Thank you so much for your testimony.
        And I yield back, Mr. Chair.
        Mr. Crenshaw. The gentlelady yields back.
        The Chair now recognizes the gentlelady from New York, Ms.
    Ocasio-Cortez.
        Ms. Ocasio-Cortez. Thank you, Mr. Chair.
        And I appreciate the majority calling in particularly some
    of the focus on sunscreen here in this hearing as well, in
    addition to many of the over-the-counter treatments that we are
    examining here today. The Food and Drug Administration, as has
    been noted, the FDA has not approved any new sunscreen filters
    since 1999. In fact, this has allowed many other countries to
    far outpace the United States in the technology of what is
    available to us, and this has an impact on working people,
    construction workers, farm workers who are exposed to very high
    degrees of sun exposure and radiation, really suffer, as well
    as everyday people, from not having access to these filters.
        I am using a Korean sunscreen this morning, because the
    filter--as someone who is more melanated, U.S. filters
    oftentimes don't really cut it. And advocates, consumers,
    myself, even my Republican colleagues all agree that we need
    new sunscreen filters in the United States, and we should at
    some point discuss ways in which we can improve the sunscreen
    that is available in the United States.
        However, it is difficult for us to be having this
    conversation when in the conduct of this hearing, as these
    hearings are proceeding, not too far away there are blocks and
    blocks of lines of HHS and FDA employees who are waiting
    outside of a building and tapping their badge to see if they
    can get inside that building right now. And if that badge turns
    green, they are still employed, and if that badge turns red,
    that is how they find out that they have been fired.
        FDA employees are not just this kind of vague idea of a
    bureaucrat. These are scientists. These are individuals
    responsible for assessing what can come to market and what can
    also be brought over the counter. And, in fact, just last week
    we received notification that the Trump administration will be
    cutting 3,500 employees from the FDA. A skeleton crew.
        So, Mr. Faber, what do the employees at the FDA do when it
    comes to reviewing OTC drugs and medical devices?
        Mr. Faber. Well, they do everything from making sure that
    these ingredients are safe--that is, that they don't pose any
    risk of harm, cancer, reproductive harm, neurological harm,
    harm to our hormone systems--as well as making sure that they
    are effective, that they actually block both UVA and UVB rays
    so that we are not at greater risk of skin cancer.
        Ms. Ocasio-Cortez. And would cuts to the FDA's workforce
    limit the FDA's ability to review and approve new over-the-
    counter drugs like sunscreen but, of course, many others?
        Mr. Faber. Absolutely. If we cut the funding for people who
    aren't reviewers, that doesn't mean FDA won't be able to
    complete these reviews. All the other experts--the
    biostatisticians, the economists, the label experts--all of
    those people are part of a review team that make these
    sunscreens available to us.
        Ms. Ocasio-Cortez. And what are some examples of drugs that
    the FDA has been able to make available over the counter
    without a prescription in recent years?
        Mr. Faber. Well, we have heard some great examples,
    Claritin, allergy medications; Opill, oral contraceptions;
    Narcan, or naloxone, has been a great innovation that is now
    available over the counter. Anything that delays access to
    over-the-counter products is a step backwards.
        Ms. Ocasio-Cortez. Absolutely. And for so many people, you
    know, as was noted, not just in rural areas but also in urban
    areas like mine, the added obstacle of having to see a doctor
    can prevent someone from getting really critical and important
    treatment for them. And to bring something over the counter can
    be just as seismic as bringing it to the market in the first
    place for a lot of people who have trouble accessing these
    drugs. And not only are these significant medical
    breakthroughs, but they make it more affordable and accessible.
        Mr. Faber, what could happen to products, for example, like
    baby formula? You know, baby formula is also regulated by the
    FDA. Many people may not know that some things that are
    considered an over-the-counter, OTC, or within the purview of
    the FDA are in the purview of FDA. And we saw a couple of years
    ago that there were shortages around baby formula. What could
    happen to products like baby formula if there are not enough
    FDA staff to review?
        Mr. Faber. One of the reasons that infant formula was
    contaminated and that babies died was because yesterday we
    didn't have enough people to inspect food manufacturing
    facilities, including infant formula facilities, and they
    weren't being properly trained to do so. Today, by firing 3,500
    people, we have made that problem even worse.
        Ms. Ocasio-Cortez. And, you know, going back to that baby
    formula issue, there was also a market issue where a lot of--
    there has been this shift in saying companies can review
    themselves, they can investigate themselves, they can
    investigate their own supply chains. And I cannot think of
    something worse for people than not having an independent
    investigator whose job is to be responsive to the public in
    order to verify that the safety of our food and drug supplies
    are right.
        Do you have anything else to add, Dr. Faber?
        Mr. Faber. I will just say, this committee passed the Food
    Safety Modernization Act 15 years ago for two reasons: One was
    to make sure that we inspected facilities more often; and the
    second was to make sure that inspectors were properly trained
    to know what to look for. And we did that in part because the
    food industry wanted a partner at the FDA that could help them
    police these long, complicated supply chains. Today we made the
    job of industry to keep our food safe much harder.
        Ms. Ocasio-Cortez. Thank you.
        Mr. Dunn [presiding]. The gentlelady yields back.
        And I now recognize the gentleman from Oregon, Mr. Bentz,
    for 5 minutes.
        Mr. Bentz. Thank you, Mr. Chair.
        I thank all of you for being here.
        I am looking at the staff reports. It says, historically,
    monographs are established and amended through a three-phase
    public rulemaking process. FDA and stakeholders reported
    challenges with this process, and then it lists three things,
    but one of them is a lack of flexibility for industry to
    propose innovative modifications.
        Mr. Menzel, innovative modifications, there must have been
    some, to try to speed things up. Can you share with us what
    those might be, and have there been some, or are there some in
    mind?
        Mr. Menzel. In terms of innovative modifications, that
    would mostly be around inactive ingredients. And so what is
    critical to the OMUFA and the monograph system is whenever you
    have the monograph in place you have a cookbook, if you will,
    as it relates to the active ingredients, and that is stable.
    The innovation that can then be around inactive ingredients,
    forms, et cetera, as long as the claims and the active
    ingredients are adhered to.
        Mr. Bentz. The entire concept, as I understand it, of the
    CARES Act and later OMUFA, the fees that were paid by the
    industry, was to kind of speed things up, to try to coordinate,
    do something to make this all happen--
        Mr. Menzel. Correct.
        Mr. Bentz [continuing]. Faster.
        Mr. Menzel. Right.
        Mr. Bentz. I notice over time that the number of people
    working for the FDA has increased substantially, close to
    20,000 people now working for the FDA. We have heard a lot
    about the 3,500 that are being cut, but there is still--we
    start with 20,000 folks. Now, somehow that number was not
    adequate to speed things up, and thus, OMUFA. It says here,
    again, in the staff report, FDA in turn commits to adhere to
    certain performance goals and negotiated by the FDA and
    regulated industry representatives. You indicated that the
    framework was being put in place to make this work.
        Is it going to work? We have got 20,000 people. Now we have
    fewer. But it wasn't working at the time, thus the legislation.
    Is this legislation going to help speed things up?
        Mr. Menzel. Yes, I think so. I still believe that the
    infrastructure in place was a big issue. I think the first 5
    years was built for that. I think the FDA did meet performance
    goals. There were some guidance documents and hiring efforts
    that were delayed.
        But, again, the FDA has been a fair and constructive
    partner in all this, and, you know, the guidance that has been
    implemented by the FDA has been somewhat delayed, and I think
    that is another thing, in terms of transparent talks with the
    FDA, that this group has already addressed.
        Mr. Bentz. Thank you.
        I am going to you, Mr. D'Ruiz. I note in your report you
    mentioned the fact that no new filters have been approved in
    the U.S., limiting Americans choice to 10 over time. And, I
    guess, I am--I am sorry. I am speaking to the wrong--I am
    looking at the wrong report.
        Let me flip back to you Ms. Wezik. And what you mentioned
    is that there are 10 UV filters, but there are over 30 approved
    globally. And, again, you kind of state that this is because of
    an insistence on animal testing on sunscreens.
        Is there something happening in that space that the agency
    just refuses to acknowledge that it could be doing these things
    differently, as is the case around the world? What is going on
    with--why are we going so slowly, is the question.
        Ms. Wezik. Yes, and it is a very valid one, I think. In the
    United States we regulate sunscreen as a drug and not a
    cosmetic. There are places in the world have the inverse in
    effect, so they have different safety standards that they have
    to meet, safety and efficacy. So that is issue one.
        Issue two is that, even within the countries that do
    regulate sunscreen as a drug, like we do, they have different
    testing criteria. So, for us, we insist on the maximum usage
    trial, the MUsT test, as well as animal testing, to get that
    safety and efficacy data.
        Mr. Bentz. Let me hop back, because it doesn't seem like
    throwing more people at the problem is going to solve it. It
    seems like it is more of a policy issue.
        Do you think that Congress should be stepping in here and
    saying, ``Hey, stop this type of testing,'' or do you have some
    other approach that we should use?
        Ms. Wezik. We have asked Congress, both with, you know,
    various Hill days with my organization as well as when the PASS
    Coalition came to the Hill, to address that regulatory
    framework to, you know, move away from MUsT trials and animal
    testing or to at least consider, as Mr. D'Ruiz said, to
    consider other data as supplemental or alternatives to those
    two issues.
        Mr. Bentz. Thank you so much. Yield back.
        Mr. Joyce. The gentleman yields.
        And I now recognize Mr. Auchincloss from Massachusetts for
    5 minutes for questioning.
        Mr. Auchincloss. Thank you, Chairman.
        Over the last week, as I have been preparing for this
    hearing, I have been reading about OMUFA and have learned a lot
    about what strikes me as a very effective program that is a
    hallmark of how Congress should operate, which is to see a
    problem, to work in a bipartisan format to get stakeholder
    input, to implement round one, which as you described, Mr.
    Menzel, is laying the infrastructure, getting feedback on that,
    heading into round two to make improvements to the program.
        And I was struck by something you said in your testimony,
    Mr. Menzel, about the FDA is a fair and productive partner in
    this, which I think is descriptive of an organization that is
    not just about a bureaucracy, but it is really a culture and a
    standard. And once that culture and standard is impaired, it
    engenders uncertainty throughout the business environment, it
    undermines our standing globally, and it can take us decades to
    recover what was once the gold standard of biomedical
    regulation.
        And so, while I appreciate the discussion we are having
    today about this important topic, it is the wrong hearing to be
    having. The hearings that we have to be having is for my
    colleagues on the other side of the aisle to bring in, first of
    all, this gentleman, Mr. Brad Smith, who is the DOGE healthcare
    lead under Elon Musk.
        And I am going to read from reporting this morning, I
    believe, in Politico: ``Brad Smith cofounded a telehealth
    startup called CareBridge in 2019, before in 2021 founding
    Russell Street Ventures, and later Main Street Health, a rural-
    focused provider network. He has since sold CareBridge, but he
    remains tied to Main Street Health, which is subject to
    regulation by CMS''
        So his companies are subject to regulation by CMS, and he
    is the one who is running the reductions in force across Health
    and Human Services.
        ``He worked closely with senior CMS officials in crafting
    the reduction-in-force plan, ultimately incorporating
    suggestions that reduce the overall impact on the agency, a
    contrast from other HHS agencies where he played a smaller
    role, according to one of the people familiar with the matter.
        ``Smith and his top aide, Rachel Riley, quote, `keep
    everything close to their chest.' The playbook isn't clear,
    whereas everything else is. They are isolationists.''
        I would love to bring in Mr. Brad Smith and in a bipartisan
    format talk about whether there is perhaps a conflict of
    interest in having the person whose companies, whose business
    career that he has taken a sabbatical from, is subject to CMS.
    There is a conflict with that when he works with the CMS
    regulators to spare their jobs in the cuts that he is in charge
    of.
        Does that inspire confidence amongst any of you, that you
    are working with regulators who are not subject to fear or
    favor but are following the evidence? Do any of you think that
    that is a good way for the Federal Government to inspire
    confidence in the business community, when someone who could be
    a competitor of yours, for all we know--who knows what his
    venture capital firm is going to do next?--is going to get
    preferential treatment by CMS for billing codes and
    reimbursements?
        Is that the kind of climate that we want to create in a
    free and open market here in the United States? I don't think
    so.
        I would also love to ask him about his views on efficiency,
    because one of the great stupidities of DOGE's actions in
    healthcare has been conflating the concept of efficiency with
    return on investment. When you cancel the lease for the Office
    of Pharmaceutical Quality in St. Louis that employs some of the
    most highly trained scientists in the Federal Government to
    detect toxins in the pharmaceutical supply chain, are you
    saving a few million dollars in rent payments for the Federal
    Government?
        Sure. Yes. OK, you saved some money.
        Does that have a return on investment when you now have
    toxins in the pharmaceutical supply chain that go undetected
    for years that lead to multibillion-dollar recalls, that lead
    to toxicity in illness in the broader population?
        Over and over again, Mr. Brad Smith seems to think that
    taking a chainsaw to the gold standard culture and organization
    of the FDA somehow is saving money, and what it is actually
    doing is it is a bad investment for the American people.
        This is the hearing that we need to be having right now,
    not talking about a great piece of bipartisan legislation that,
    even if we get it right, he is going to take a chainsaw to
    anyway. And my colleagues on the other side of the aisle won't
    stand up to him to do anything about it, so why are we even
    wasting our breath on legislation that won't be enforced?
        I yield back.
        Mr. Dunn. The gentleman yields.
        I now recognize the gentleman from Michigan, Mr. James, for
    5 minutes for his questions.
        Mr. James. Thank you, Mr. Chairman.
        Michigan's 10th Congressional District is home to growing
    pharmaceutical manufacturers and packaging firms that play a
    critical role in getting safe and effective over-the-counter
    medicines to consumers. I have heard from small business
    owners, like those at BMI Injection Molding just outside my
    district in Chesterfield, Michigan, who are struggling to keep
    up with the cost and complexity of FDA monograph updates.
        These firms don't have the compliance departments or the
    resources of big pharmaceutical companies, yet they are being
    hit with the same fees and the same paperwork. If we want
    American manufacturing to remain strong, if we want
    pharmaceutical independence, we need to ensure that these
    businesses can stay competitive.
        Mr. D'Ruiz, what specific challenges do smaller OTC drug
    manufacturers face in keeping up with FDA monograph updates,
    and how can we ensure that they remain competitive without
    excessive regulatory hurdles?
        Mr. D'Ruiz. Thank you for that question. Obviously, the
    smaller companies because of their size and their income don't
    have the internal resources to have staff on board to comply.
    But at the same time, you know, there are organizations such as
    the Personal Care Products Council, the Independent Beauty
    Association, which provide that level of detail. Also, small
    companies do not really have the capacity to own their
    manufacturing and generally go out to contract manufacturing
    organizations.
        The contract manufacturing organizations are the ones that
    are registered, that are responsible for complying with the GMP
    requirement under OTC drug regulations, and those are the
    responsible parties in terms of ensuring that those drugs are
    manufactured according to quality standards. The owner will be
    liable, as their name appears on the product, for any health-
    related incidents.
        So from that perspective, they need to make sure that the
    safety of the product that they sell are fully vetted out. And
    most of the time, they refer to outside consultants for that
    type of, kind of a virtual team to put together the package of
    information for that particular product, and that is how it
    generally works.
        Mr. James. So, Mr. D'Ruiz, how can we here in this body,
    how can we help with some of these excessive regulatory
    hurdles? What would your advice be?
        Mr. D'Ruiz. Well, I think, you know, outreach and
    communication are important, right. One of the biggest issues
    with sunscreens is people don't read the label, right, and that
    is--you reapply every 2 hours, right, and they don't know it is
    a drug. I mean, simple stuff like that in terms of outreach,
    communication, knowledge sharing on both the industry side and
    on the congressional side, I think.
        You know, this is OMUFA, right. OMUFA is all about bringing
    new ingredients, right. We have provided the first one in the
    bucket. We have paid the fee. We are under review. Everything
    is working properly in terms of FDA engaging.
        I think if you make a few tweaks on the incentives, this
    could be a great program. Those would be the confidentiality,
    again, the incentives in terms of exclusivity. And then I think
    you would see a lot more innovation coming forward, which would
    include the smaller companies, which by definition are all
    about innovation, right.
        Mr. James. Perfect. Thank you so much for that answer.
        I am going to move on to Mr. Menzel. Mr. Menzel, I would
    just like everybody to know, every parent in Michigan knows how
    essential OTC medications are, from pain relievers to cold
    medications for their children. But if regulatory fees are
    driving up production costs, those expenses eventually get
    passed down to families at the pharmacy counter. At a time when
    families in Michigan are already dealing with rising costs, we
    need to ensure that regulatory policies aren't making it harder
    for them to access basic healthcare essentials.
        Again, Mr. Menzel, do you believe the current user fee
    structure is contributing to increased costs for consumers, and
    what steps can we take to ensure Americans continue to have
    affordable access to essential OTC drugs?
        Mr. Menzel. Yes, thanks for the question. In terms of small
    companies, whenever I started Focus Consumer Healthcare, it
    didn't get smaller than $0 in sales. So I started at zero and
    then built it up and with cough and cold medicines and
    everything you just described. For us, it works exactly the way
    the other witness testified, is that all those fees are paid by
    third-party manufacturers.
        In terms of overall cost, if you think about a product, I
    mean, it is a $25,000 fee for the third-party manufacturer, so
    it is a distributed cost. For us, whenever OMUFA went into
    place, it did not create a cost-of-goods increase, so the
    third-party manufacturers did not increase their cost to us, so
    we did not increase our cost to the consumer.
        So I can speak, my experience, over the last 5 years, there
    was no cost-of-goods increased that was tagged to us that
    required us to increase price to the consumer. And so in my
    personal experience with the company that I started and with
    other members of the board of directors with Consumer
    Healthcare Products Association, those were not issues that
    drove up cost. Certainly, COVID and everything else increased
    our cost of goods and decreased our margins, but that was not
    one of them.
        Mr. James. Thank you, everyone, for your participation.
        Thank you, Mr. Chairman, for your patience. I yield.
        Mr. Dunn. Thank you. The gentleman yields back.
        I now recognize the gentleman from Ohio, Mr. Landsman, for
    5 minutes for his questions.
        Mr. Landsman. Thank you, Mr. Chair and Ranking Member.
        As I have sat here over the last hour or two, it occurs to
    me that we are living in two different worlds, and this has to
    be top of mind for all of you. I mean, in one world, everything
    is normal and we can have a legitimate conversation about over-
    the-counter drugs and sunscreen and what we can do to help
    American companies and innovation and provide safe products to
    Americans.
        But then we live in this world, this other world where the
    world's richest man--and the largest donor, arguably, having
    given hundreds of millions of dollars to Trump and my
    colleagues on the other side of the aisle--he is burning the
    Government to the ground. So as we are sitting here having--we
    are trying to have a normal conversation about sunscreen, and
    10,000 public employees at the Department of Health and Human
    Services, public employees who are dedicated to our health and
    safety, have been fired--thousands--from the FDA.
        The FDA is ostensibly a different, broken now organization,
    just in a matter of hours. And we have heard about the lines
    outside of the building just down the street, where they don't
    know, workers don't know, whether or not they have lost their
    jobs. They are going to find out with when they swipe their
    cards.
        And I just--at some point, we have to stop pretending that
    we are living in any other world than the world in which it
    seems as if a foreign adversary has taken over the Federal
    Government, crashed the economy, is burning the Federal
    Government to the ground, upending our relationships with, you
    know, countries all over the country and focus entirely on
    that.
        Mr. Faber, in the wake of 10,000 people losing their jobs,
    3,500 at the FDA, will food safety get better or worse?
        Mr. Faber. Because virtually none of our food safety
    funding is generated by user fees, those people will be the
    people who are most likely--will most likely lose their jobs.
    The people who make sure our food is safe by inspecting it, by
    running labs, by looking for pathogens, by alerting industry
    when pathogens are present, by alerting us when pathogens are
    present--all of those people were likely fired today.
        Mr. Landsman. So with that in mind, is food safety going to
    get better or worse?
        Mr. Faber. Much worse.
        Mr. Landsman. Baby formula, we talked about. Safer, less
    safe?
        Mr. Faber. Less safe.
        Mr. Landsman. The approval of over-the-counter drugs, is
    that going to be slower or faster?
        Mr. Faber. Much slower.
        Mr. Landsman. Medical devices, the approval of those
    devices, slower or faster?
        Mr. Faber. Much slower.
        Mr. Landsman. The safety of those medical devices?
        Mr. Faber. Less safe.
        Mr. Landsman. Consumer choice, is that going to go up or
    down?
        Mr. Faber. Consumers will have fewer choices and will be
    taking more risks.
        Mr. Landsman. Vaccines, are we going to--is that going to
    be undermined, our ability to provide meaningful vaccines
    across the board?
        Mr. Faber. Firing thousands of people will do nothing to
    address the safety of our vaccines.
        Mr. Landsman. Innovation in the United States, especially
    in the context of food, drugs, medical devices, innovation, is
    it going up or down because of these firings?
        Mr. Faber. All of the companies that are sitting here
    before you with innovative new products will have to wait
    longer to offer them to our consumers.
        Mr. Landsman. If there are fewer products and fewer people
    checking to see the safety of those products--determine the
    safety of those products, higher prices, less safety. Is that
    fair?
        Mr. Faber. Fewer products, riskier products.
        Mr. Landsman. And those prices will most likely go up?
        Mr. Faber. For many reasons, yes.
        Mr. Landsman. And those products will be less safe?
        Mr. Faber. Many of the products that we count on, that we
    bring in our homes every day, our food, our cosmetics, already
    pose unnecessary risks because we are not providing--we weren't
    providing enough oversight yesterday. They will be more
    dangerous because of the decisions that were announced today.
        Mr. Landsman. That is the world we are living in. And I
    yield back.
        Mr. Carter of Georgia [presiding]. The gentleman yields.
        The Chair now recognizes the gentleman from New York,
    Representative Langworthy, for 5 minutes of questioning.
        Mr. Langworthy. Thank you very much, Mr. Chairman.
        Dr. D'Ruiz, as you know, we are here today to examine how
    the FDA regulates over-the-counter drugs like sunscreen and
    identify areas for improvement. With skin cancer rates on the
    rise, consumers need broad access to these protective products.
    In my district, in western New York and the southern tier
    counties, melanoma incident rates are among the highest in New
    York State, soaring almost 64 percent above New York's average
    and 25 percent higher than the national average.
        Given these alarming trends, ensuring the access to
    affordable and effective over-the-counter sunscreens, the most
    effective products that we can put forward in skin care, is a
    public health priority, as far as I am concerned. However, time
    and again, FDA regulations have stood in the way of innovation
    and evolving science.
        Dr. D'Ruiz, given these challenges, what steps can the FDA
    take to modernize its regulatory framework to ensure Americans
    have access to the most effective and up-to-date sun protection
    products?
        Mr. D'Ruiz. Well, I think the situation we are in right now
    is unacceptable. There are only two ingredients that are
    generally recognized as safe and effective, right, and these
    ingredients put at a disadvantage people of color, in that
    people of color do not want to have a white cast on their skin
    and therefore won't use it, so they are more susceptible to
    getting skin cancer.
        Imperatively, we need to change the system to bring more
    innovation in to protect all people of different skin types,
    melanin of which or not. And providing FDA with the information
    in terms of what is going on in the rest of the world in terms
    of how they regulate sharing that, bringing in the new science,
    which is already being used by other Government agencies in the
    United States--such as EPA, such as the Center for Food and
    Drug--that is the most important thing we can do in terms of
    protecting our people.
        And in New York City--I am a New Yorker. I grew up in New
    York City, so I appreciate that--we need to do something about
    it, because skin cancer is the largest cancer in the United
    States with the most prevalence and the most morbidity and
    mortality if it is not treated. And the beauty of it is that it
    is preventable, right. So if we can prevent instead of treat
    the disease, we are in a much better state all together. So I
    think that is kind of my view.
        Mr. Langworthy. Very good.
        On to quality and assurances. Dr. Menzel, like the supply
    chain for prescription drugs, the over-the-counter supply chain
    is complex. It requires raw materials, active pharmaceutical
    ingredients, inactive ingredients from sources all over the
    world. Consequently, quality assurance in this area can be
    complicated, and over the past few years we have seen a number
    of quality-related import alerts for over-the-counter monograph
    drug products.
        Mr. Menzel, what do you see is the most significant quality
    control challenges faced by the over-the-counter manufacturers,
    and what opportunities do you see for OMUFA II to focus on
    strong quality controls that can address these issues?
        Mr. Menzel. Yes. I would say, first of all, I think the
    industry as a whole regulates themselves very effectively. As I
    mentioned, I started out as a very small company, but we are
    proud that we have no quality issues and, you know, self-
    regulate very effectively. We monitor batch releases for all
    the products that are released to make sure that everything is
    safe and effective before it gets released, and that is the
    situation, I think, with the high, high percent of companies
    that are being represented here by CHPA.
        I do think that one of the issues are these manufacturers
    that are in arrears. That is an easy target list that should be
    targeted. Typically, the companies that haven't paid their fees
    are also the companies that are having these quality issues,
    and so that would be an easy target list. As mentioned, this
    could be published. It could be an initial target list that the
    FDA could go after to monitor facilities and determine if they
    are actually meeting quality requirements.
        But I would say, overall, the quality system within the FDA
    is first in class. It is a gold standard. And companies that
    adhere to those have maintained safe and effective products for
    the U.S. consumers.
        Mr. Langworthy. Well, thank you very much.
        Modernizing regulations and strengthening quality control
    are essential to assuring the safety and accessibility of over-
    the-counter drugs, and I look forward to working with my
    colleagues here on the committee to reauthorize OMUFA.
        And I thank the witnesses for being here today.
        And I yield back, Mr. Chairman.
        Mr. Carter of Georgia. The gentleman yields.
        The Chair now recognizes the gentlelady from Massachusetts,
    Representative Trahan, for 5 minutes of questioning.
        Mrs. Trahan. Thank you, Chair. Thank you, Ranking Member,
    and also to our witnesses here today.
        The Over-the-Counter Monograph User Fee Program is not a
    partisan issue. It is a commonsense, industry-supported
    initiative that keeps Americans safe, helps manufacturers bring
    new products to market faster, and ensures that the FDA can do
    its job efficiently.
        Now, I believe we have all been pretty clear on one thing,
    however. Elon Musk gutting the FDA puts the very foundation of
    user fees at risk. Now, we know what that means. It means fewer
    resources for inspections, slower responses to emerging safety
    concerns, and a regulatory system that just won't keep up with
    innovation.
        What happens when you cripple the FDA? Well, more dangerous
    drugs are put on shelves; more consumers are exposed to
    untested, contaminated, or fraudulent medications; more delays
    in approving new affordable over-the-counter treatments. So, so
    much for the MAHA movement. We have seen what happens when
    public health protections are weakened, whether it is the baby
    formula crisis, the rise in tainted medications, or the failure
    to catch deadly contaminants in common OTC drugs like
    sunscreen.
        Mr. Faber, can you just provide examples of past public
    health emergencies, such as contaminated OTC drugs or recalls,
    that were successfully managed due to proper FDA funding and
    what the consequences might have been without those resources?
        Mr. Faber. Well, there are so many examples of where
    postmarket surveillance has allowed us to quickly identify the
    source in particular of contaminated food. We can all think of
    recent examples with cucumbers and onions and carrots, and it
    was having that postmarket infrastructure in place that was
    able to identify the source of contamination, quickly address
    it, quickly tell consumers, ``Take that out of your fridge,''
    that saves lives.
        So while inspectors are really important and having
    properly trained inspectors is really important, having those
    people who are on the lookout for pathogens and then working
    with companies and ultimately consumers to get that stuff out
    of our pantries and refrigerators, saves lives. A lot of the
    people who do that work were fired today.
        Mrs. Trahan. Yes. And as a mom, I am totally reliant on
    those alerts when they do arise. And if Republicans argue that
    cutting red tape means reducing government oversight to promote
    efficiency and innovation, how do they justify weakening the
    FDA's ability to regulate OTC drugs, given that that could lead
    to more consumer lawsuits, product recalls, and public health
    crises? I mean, wouldn't the increased legal battles, the
    medical costs, the emergency interventions ultimately create
    more bureaucracy and inefficiencies rather than streamlining
    the system?
        Mr. Faber. Absolutely.
        Mrs. Trahan. The FDA plays a critical role in maintaining
    the safety and credibility of American OTC drugs, ensuring they
    meet high standards for consumers both at home and abroad. With
    the FDA playing a critical role in ensuring the safety and
    credibility of American OTC drugs, what would weakening its
    oversight mean for consumer trust and international market
    acceptance?
        Mr. Faber. Well, consumers, until today, depended on the
    FDA to make sure that their sunscreens were safe and effective.
    They are counting on the FDA to review the applications from
    companies like DSM, so that we can all be confident that these
    new ingredients are not only safe to put on our bodies but they
    are effective at blocking the sun's harmful rays.
        Today, the administration greatly undermined consumer faith
    in the judgment of the FDA by firing 3,500 staff without a
    plan. We don't know who is going to do those reviews. We don't
    know how they will be done. We don't know which science they
    will rely upon. That is what consumers need answers to.
        Mrs. Trahan. I appreciate those. I never expect to have
    enough time, but I did want to ask one more question, because
    we are going to be marking up and working on a bunch of bills
    tomorrow. I am curious: Would a gutted FDA be able to
    effectively regulate new categories of OTC drugs such as
    naloxone for opioid overdoses? Are we risking unnecessary
    delays in access to lifesaving medications?
        Mr. Faber. Absolutely.
        Mrs. Trahan. Thank you, Dr. Faber.
        Thank you. I yield back.
        Mr. Carter of Georgia. The gentlelady yields back.
        The Chair now recognizes the gentlelady from Florida,
    Representative Cammack, for 5 minutes of questioning.
        Mrs. Cammack. Well, thank you, Mr. Chairman.
        And thank you to our witnesses for being here today.
        In 2020, Congress took an important step by finally
    replacing a decades-old, outdated rulemaking process, as you
    know, with a more modern framework under the CARES Act. Now,
    this provided FDA a new administrative order system and
    resources to update monographs faster, supporting safe
    innovation and over-the-counter drugs.
        Now, this was a step in the right direction, as we can all
    agree, but clearly we have a lot of work to do. So even with
    this in place, we are hearing that innovation is still being
    stalled. Responsible companies are navigating a maze of delays,
    unclear guidance, and inconsistent enforcement. Meanwhile, bad
    actors continue to exploit loopholes, avoid user fees, and
    benefit from data that they didn't generate.
        So whether it is sunscreen--and there has been a lot of
    talk about sunscreen today--vitamins, or everyday cold and flu
    products, Americans deserve access to safe, effective, and up-
    to-date options. And manufacturers need a regulatory system
    that is efficient, fair, and, importantly, predictable. So as
    we look to reauthorize, I am interested to hear in how we can
    continue to improve the system, cut red tape, protect
    consumers, and reward responsible innovation.
        So I am going to jump in with you, Mr. Menzel. Given what
    you have said about the number of facilities not paying for the
    fees and the link to poor quality products, it raises real
    concerns about enforcement. In your view, how can Congress
    ensure that the FDA is fully using its existing authority to
    crack down on noncompliant manufacturers? That is the first
    part.
        Second part is, what steps can be taken to reinforce
    program integrity without adding new burdens to the companies--
    because that always seems to be the answer, just throw more at
    them, right--that are already doing things the right way?
        Mr. Menzel. Yeah, thank you. I think that the first and
    obvious is what we are all, I think, in alignment on today,
    which is reauthorize OMUFA.
        Mrs. Cammack. Right.
        Mr. Menzel. I think that, you know, that first step, I
    think, is essential. Whenever you think about the arrears list,
    I mean, I think there is--we have already mentioned three or
    four obvious items in terms of publishing the list, giving FDA
    guidance on what to do with those companies, inspections,
    priority inspections for those companies, I think that would
    move that along very quickly, and I think this committee can
    give guidance to the FDA as it is related to the arrears list.
        And your second question was?
        Mrs. Cammack. So the second part was, you have companies
    that are already doing things the right way. We don't want to
    punish them by putting additional burdens on them--
        Mr. Menzel. Right.
        Mrs. Cammack [continuing]. To try to capture those
    companies that are not in compliance.
        Mr. Menzel. Right.
        Mrs. Cammack. How can we handle that?
        Mr. Menzel. Yes, and I think that is an incredibly
    important point, that we need--we don't need more regulation as
    it relates to this----
        Mrs. Cammack. Thank you.
        Mr. Menzel [continuing]. And so there needs to be
    predictability. The OMUFA program allows predictability. The
    monograph program allows predictability, allows for innovation,
    and allows for speed.
        I think there's some gaps that we have all discussed that
    can be fixed, and I don't need to revisit those, but those key
    items--predictability, speed, and allowing for innovation--go
    along with not increasing regulations.
        Mrs. Cammack. OK. Mister--am I saying this right--D'Ruiz?
    Did I say that right? Sorry.
        Now, I know that sunscreen has gotten a lot of airtime
    today, as I mentioned--and, listen, I am a Floridian. I am
    basically clear, I get it. I look at the sun, I burn. I hear
    everyone loud and clear. It is an important issue, certainly
    for folks back home, but I want to get to the core issue when
    we are talking about this.
        No new UV filters have been approved since 1992--I was born
    in 1988--since I was 4 years old, despite repeated input from
    industry and experts. So what is actually preventing FDA from
    adopting that input and moving forward, and what tools do we
    need, the incentive, what do we need in order to fix it?
        Mr. D'Ruiz. Yes, it has been a long time, especially for
    me. I have been working on this----
        Mrs. Cammack. Way to make me feel old there, friend.
        Mr. D'Ruiz [continuing]. Since 1997. So, yeah, it has been
    a long time, and, you know, there have been various iterations
    in the law with the, you know, the time extent application, the
    Sunscreen Innovation Act,culminating now with the CARES Act and
    OMUFA, right?
        So now finally after all these years, we know what is
    required, we know what they need, and we also know that what
    they need doesn't quite jibe with what is going on with the
    rest of the world.
        And if you do do the animal testing, then you are shutting
    yourself out from being able to compete in the rest of the
    world which have animal testing bans. There are alternative
    ways of assessing risk which the industry has provided FDA with
    a framework.
        We have done a lot of the legwork. Now it is a matter of
    looking at what that framework is, how it can be applied. And
    we have conducted this using international experts, experts
    that are experts in carcinogenicity, developmental reproductive
    toxicity, and these will--submitted to the monograph in terms
    of the docket, but FDA is still relying on the existing
    framework, which requires the animal testing.
        If we were to be able to work through that, I think we
    would be able to make a lot of headway in terms of moving
    forward, and this would be something that we collaborate with,
    working in tandem in terms--our people know sunscreen. We do
    all the testing. We know how to formulate. We create the
    molecules. We can provide a lot of the data that they require
    in order to make decisions more efficiently and effectively,
    but we need the incentive to do that. Thank you.
        Mr. Carter of Georgia [presiding]. Thank you.
        Mrs. Cammack. Thank you.
        I yield, Mr. Chairman.
        Mr. Carter of Georgia. The gentlelady yields. The Chair now
    recognizes the gentleman from New Jersey, Representative Kean,
    for 5 minutes of questioning.
        Mr. Kean. Thank you, Mr. Chairman, and thank you to our
    witnesses for being here today. I am very interested in hearing
    how we can ensure and strengthen predictability of the approval
    process for the over-the-counter drugs.
        Mr. Menzel, first, I want to highlight the strong presence
    that the over-the-counter product manufacturers have in the
    great State of New Jersey. These are several companies
    headquartered in the State and even more who have manufacturing
    and development presence there.
        These companies not only spur innovation nationwide, but
    they provide jobs and livelihoods in New Jersey. I often
    highlight the great work done by prescription drug companies in
    New Jersey, but I do want to acknowledge the innovation that
    your member companies produce.
        We see these products on store shelves every day, and we
    use them to help our kids feel better in their childhood years.
    So I want to thank this New Jersey industry for its wonderful
    work.
        My questions. First, can you explain how the OTC user fee
    program, established by Congress in 2020, has helped drive
    innovation and growth in your industry, especially in New
    Jersey?
        And second, what pitfalls should Congress avoid as it moves
    to reauthorize the program for the first time?
        Mr. Menzel. The guidances that was given by OMUFA, which
    many members of this committee were critical to getting
    approved initially, provides for predictability and allows
    for--that predictability allows for innovation.
        I was actually a part, in a previous life a number of years
    ago, of one of those fine New Jersey companies before starting
    my own company, and I can say that having a structure and a
    framework that OMUFA provides, that the monograph system
    provides, allows for that innovation.
        I think some of the issues that you ask on how to improve,
    some of that is timing. Reauthorization OMUFA II would allow
    for some of the infrastructure that has been put in place to be
    capitalized on, but then additional transparency from the FDA
    in terms of timing and publication of notices, et cetera, as we
    have mentioned, is also critical for success over the next 5
    years.
        Mr. Kean. Thank you. On a separate topic, I also serve on
    the House Foreign Affairs Committee, so I am aware that many
    industries have global supply chains, even as they are
    currently trying to move more of these supply chains to the
    United States.
        Could you give me an update on the exposure that OTC
    products supply chain has abroad and what Congress can do to
    strengthen that supply chain?
        Mr. Menzel. Yes. It is an important issue. It is an
    important issue in terms of safety. It is an important issue
    for us to make sure that we don't run out of stock if there are
    issues in terms of the supply chain.
        I will say for us personally, we have initiated a pretty
    large investment in Georgia to increase onshore manufacturing
    for some of our products. We also have two products that we
    just initiated a technology transfer from Canada into the U.S.,
    to increase U.S. manufacturing.
        And so, you know, both of those items are not unique to us
    within the Consumer Healthcare Products Association. In a poll
    of members, the majority of products are actually already
    manufactured in the United States.
        A key aspect of consumer products is transparency and
    pricing. You know, I have products that sell for $4 or $5 a
    bottle. I can't just all of a sudden decide to charge the
    consumer $100, you know, for that same bottle.
        And so we have to be efficient in terms of our supply
    chain, and some of that efficiency is why we are looking at
    sourcing in the United States.
        Mr. Kean. Thank you.
        Mr. D'Ruiz--and before I get to my question, I want to
    acknowledge the presence that DSM-Firmenich has in the great
    State of New Jersey and the great work that your company does
    there.
        My understanding is your company's New Jersey work relates
    more to nutritional products and not to OTC products. I still
    want to highlight what you do in New Jersey.
        I know that many of my colleagues have already asked about
    how the FDA's approach to the approval of sunscreen filters and
    ingredients has hindered innovation.
        However, I want to focus on New Jersey and ask how these
    actions by the FDA have affected DSM-Firmenich's business and
    to be able to reinvest in other product lines like those in New
    Jersey?
        Mr. D'Ruiz. So being from New Jersey, I think we are
    leading the way. OK. We are the only brave company to stand out
    amongst everyone else that has decided to take the bull by the
    horns and do what FDA has required.
        We pay the user fee. We are the first company to do the
    OMOR. We are setting the standard and the pace of what is
    required for public health, and we are pretty proud of that.
        And I think in everything we do, it is all about the
    desirable, the obtainable, and the sustainable, and I think
    that is our company DNA. And as long as we can continue to
    provide this, as we do, for all consumers throughout the United
    States, being based out of New Jersey, as you said, I think we
    are doing a service to everyone in the United States.
        Mr. Kean. Thank you.
        I yield back.
        Mr. Carter of Georgia. The gentleman yields.
        The Chair now recognizes the gentleman from Ohio,
    Representative Latta, for 5 minutes of questioning.
        Mr. Latta. Well, first, Mr. Chairman, thank you very much
    for allowing me to waive on to the subcommittee today. I
    greatly appreciate it. And to our witnesses, thank you for
    being with us today.
        The Over-the-Counter Monograph Drug User Fee program at the
    Food and Drug Administration has produced more than a 100,000
    safe and effective over-the-counter drugs, giving consumers
    access to manage their own care in a safe and affordable
    manner.
        The OMUFA program also reduces the number of visits
    consumers need to make to a doctor to obtain a prescription for
    a simple treatment, reducing the burden on our healthcare
    systems.
        Mr. Menzel, if I can start with you, the OMUFA program has
    increased access and choice for consumers. Could you provide
    examples of how this is beneficial to the public within the
    United States?
        Mr. Menzel. Yeah, absolutely, but before I do, let me
    recognize yourself and Ms. DeGette and Crenshaw and Dingell for
    leading the initial OMUFA charge. I think that is incredibly
    important, and just to reinforce that, you know, so that
    everybody is reminded that this was a 10-year process to get
    approval--a bipartisan process with a lot of negotiation to
    move forward to the point at which we are now.
        So I think, you know, in terms of the benefit to the U.S.
    consumer, one of the items that I think continually needs to be
    reinforced is for every dollar spent in this space on over-the-
    counter medicines, it saves the United States' system $7 in
    terms of doctor visit cost savings, pharmaceutical,
    alternatives to pharmaceutical cost savings.
        The other thing that self-care does, is, it allows for a
    shrinking of these healthcare deserts where access would be
    limited, not just rural areas but also urban areas that are
    limited by access to healthcare.
        So this has been a fundamental, bipartisan approach that I
    think should be highlighted, especially in the days that we are
    now in, and so thanks to you and the other members that were a
    part of this.
        Mr. Latta. Well, and, again, just to follow-up, why is it
    so important for Congress to get this reauthorized and get it
    reauthorized now?
        Mr. Menzel. So that it can keep moving forward. I mean, I
    think we have laid the groundwork with the first 5 years. I
    think we are going to reap the benefits over the next 5 years,
    the way I see it.
        Mr. Latta. Well, you know, as I mentioned a little bit
    earlier, when you look at the--there's over 300 active
    pharmaceutical ingredients in more than 100,000 OTC products.
    When you think about that, just those numbers alone, and what
    you had mentioned about $1--putting $1 in to save $7 is a
    tremendous benefit to the public.
        Mr. Menzel. Right.
        Mr. Latta. And, again, you know, we kind of know this. What
    would be the effect to the consumer if this doesn't get
    reauthorized? Because, again, when you look at the number of
    the ingredients out there and the number of products, what
    would happen to all those products out there if the consumer--
    on that shelf in the drug store or someplace?
        Mr. Menzel. You know, if this process wasn't reauthorized,
    I think you would limit future innovation. I mean, I think that
    is the fundamental aspect of it.
        As it relates to the current products on the shelf, I mean,
    how devastating to the public could that be if, you know, those
    100,000 products weren't potentially available?
        But future innovation, you know, companies like mine as
    well as other companies being represented, are constantly
    innovating. You know, we are looking to put out new products
    every year, every quarter, for the consumer. That is how
    effective companies continue to grow, and this predictable
    process is what allows for that.
        Mr. Latta. Well, and, see, that is a fear of mine because,
    again, we want to make sure things are done--in this country we
    found out from COVID how bad our supply chain really is.
        And when you think about what you just said about the
    innovation, this is the great thing about the Energy and
    Commerce Committee. We touch so many different areas, but
    innovation is one of the things that we talk about in this
    committee all the time.
        Where would the innovation occur if it wasn't occurring in
    this country, if we didn't give that ability for these
    companies to go out and innovate?
        Mr. Menzel. I mean, I don't think it would occur. I think
    we--this industry, along with other industries, I think the
    U.S. is the lead horse in terms of driving innovation. And so I
    don't believe that without us driving, without this predictable
    process, that the innovation would occur at the same pace.
        Mr. Latta. Well, thank you very much, and, again, to our
    witnesses, thanks very much for being here.
        Mr. Chairman, I yield back the balance of my time.
        Mr. Carter of Georgia. The gentleman yields.
        At this time, I ask unanimous consent to insert into the
    record the documents included on the staff hearing documents
    list.
        Ms. DeGette. Mr. Chairman, does that include the letter I
    had requested?
        Mr. Carter of Georgia. Yes, it does.
        Ms. DeGette. Thank you.
        Mr. Carter of Georgia. Without objection, that will be the
    order.
        [The information appears at the conclusion of the hearing.]
        Mr. Carter of Georgia. I would like to thank our witnesses
    again for being here today. We appreciate you and appreciate
    you taking time out to be with us. Members may have additional
    written questions for all of you, and I ask that you respond to
    those in writing.
        I will remind Members that they have 10 business days to
    submit questions for the record, and I ask the witnesses to
    respond to the questions promptly.
        Members should submit their questions by the close of
    business on April 15th.
        Without objection, the subcommittee is adjourned.
        [Whereupon, at 1:28 p.m., the subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]
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