[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:]
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    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:]
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    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:]
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    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:]
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    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:]
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    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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