[Senate Hearing 119-92]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 119-92

                         REAUTHORIZATION OF THE
                       OVER-THE-COUNTER MONOGRAPH
                         DRUG USER FEE PROGRAM
=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED NINETEENTH CONGRESS

                             FIRST SESSION

                                   ON

 EXAMINING THE REAUTHORIZATION OF THE OVER-THE-COUNTER MONOGRAPH DRUG 
                            USER FEE PROGRAM

                               __________

                              JUNE 4, 2025

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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        Available via the World Wide Web: http://www.govinfo.gov
                               __________
                               
                  U.S. GOVERNMENT PUBLISHING OFFICE
60-603 PDF               WASHINGTON : 2026
=======================================================================
       
          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                BILL CASSIDY, M.D., Louisiana, Chairman
RAND PAUL, M.D., Kentucky            BERNIE SANDERS (I), Vermont, 
SUSAN M. COLLINS, Maine                  Ranking Member
LISA MURKOWSKI, Alaska               PATTY MURRAY, Washington
MARKWAYNE MULLIN, Oklahoma           TAMMY BALDWIN, Wisconsin
ROGER MARSHALL, M.D., Kansas         CHRISTOPHER MURPHY, Connecticut
TIM SCOTT, South Carolina            TIM KAINE, Virginia
JOSH HAWLEY, Missouri                MAGGIE HASSAN, New Hampshire
TOMMY TUBERVILLE, Alabama            JOHN HICKENLOOPER, Colorado
JIM BANKS, Indiana                   ED MARKEY, Massachusetts
JON HUSTED, Ohio                     ANDY KIM, New Jersey
ASHLEY MOODY, Florida                LISA BLUNT ROCHESTER, Delaware
                                     ANGELA ALSOBROOKS, Maryland

               Matthew Gallivan, Majority Staff Director
           Danielle Janowski, Majority Deputy Staff Director
                Warren Gunnels, Minority Staff Director
               Zain Rizvi, Minority Deputy Staff Director
                            
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                        WEDNESDAY, JUNE 4, 2025

                                                                   Page

                           Committee Members

Cassidy, Hon. Bill, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Kaine, Hon. Tim, U.S. Senator from the State of Virginia, Opening 
  statement......................................................     2

                               Witnesses

Corrigan-Curay, Dr., Jacqueline, Acting Director, Center for Drug 
  Evaluation and Research, United States Food and Drug 
  Administration, Silver Spring, MD..............................     3
    Prepared statement...........................................     5

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
Banks, Hon. Jim:
    FDA Warning Letter, Hubei Kangzheng Pharmaceutical Co., Ltd..    35
    FDA Warning Letter, Kilitch Healthcare India Ltd.............    44
    FDA Warning Letter, Similasan AG.............................    58

 
                         REAUTHORIZATION OF THE
                       OVER-THE-COUNTER MONOGRAPH
                         DRUG USER FEE PROGRAM

                              ----------                              


                        Wednesday, June 4, 2025

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:01 a.m., in 
room 430, Dirksen Senate Office Building, Hon. Bill Cassidy, 
Chairman of the Committee, presiding.

    Present: Senators Cassidy [presiding], Marshall, 
Tuberville, Hawley, Banks, Husted, Moody, Baldwin, Murphy, 
Kaine, Hassan, and Hickenlooper, Markey, Kim, Blunt Rochester, 
Alsobrooks.

                  OPENING STATEMENT OF SENATOR CASSIDY

    The Chairman. The Senate--let's try one more time. The 
Senate Committee on Health, Education, Labor, and Pensions will 
please come to order.

    Over-the-counter drugs are part of the fabric of Americans 
maintaining their health, treating common ailments, including 
pain relief, allergies, and cold symptoms--I could use a little 
bit right now--at an affordable cost. They are available at 
every pharmacy and virtually every grocery store nationwide.

    Being readily available to Americans, OTCs save Americans a 
lot of money. The drugs generate an estimated $1.46 billion in 
annual sales from--in annual savings from fewer doctor's visits 
and prescription drug purchases. For decades, OTCs were 
required to go through a cumbersome review before going onto 
the market. This process, known as a drug monograph, typically 
took years to finalize.

    Many new OTC drugs were never fully approved. The review 
also made it more difficult for the FDA to update safety 
information on these drugs, sometimes delaying safety 
recommendations for several years.

    As a result of these challenges, Congress created the 
bipartisan over-the-counter monograph drug user fee program, 
OMUFA, in 2020 to streamline FDA review of OTC drugs, making 
these drugs more quickly available to Americans while still 
ensuring safety. OMUFA is set to expire at the end of this 
Fiscal Year. As Congress looks to reauthorize, we must see how 
we can further improve the program to better serve Americans.

    This is why today's hearing is so important. I highlight, 
today is the first time Congress will be hearing directly from 
the FDA about how they have implemented reforms to the OTC drug 
review and their plans to make more low-cost drugs directly 
available to Americans. I appreciate Dr. Corrigan-Curay coming 
before the Committee on behalf of the FDA.

    While the FDA has made progress in improving the OTC review 
pathways since 2020, there is more to do. FDA has failed to 
ease regulatory hurdles that allow prescription drugs to be 
sold OTC. These delays make it harder for consumers to directly 
access low-cost treatments.

    The agency continues to struggle with reviewing new 
sunscreens, despite the well-documented public health value of 
using sunscreen. FDA has not approved a new sunscreen filter 
since 1999.

    In contrast, peer countries in Europe and Asia have many 
more high quality sunscreen products available to consumers. 
The FDA needs to do a better job with sunscreen. I look forward 
to discussing how Congress can improve OMUFA and the OTC review 
process. And with that, I recognize Senator Kaine for his 
opening statement.

                   OPENING STATEMENT OF SENATOR KAINE

    Senator Kaine. Thank you, Chairman Cassidy, and thanks to 
my colleagues. Welcome, Dr. Corrigan-Curay. This is an 
important program because it is critically important for 
Americans to have access to safe and effective over-the-counter 
drugs.

    Recognizing the importance of regulating drugs that can be 
used without a prescription and the challenges facing the FDA, 
Congress passed the Over-the-Counter Monograph User Fee Program 
in 2020 to support the work of the FDA and expand access to 
medications that are safe and that are also easy to access and 
use.

    The magnitude of this is pretty big. U.S. consumers spent 
over $40 billion on over-the-counter drugs in 2024. Eight in 
ten U.S. adults use over-the-counter products as a first 
response to a minor injury. Over-the-counter drugs can save 
Americans money, can save the healthcare system money.

    Research has found that $51.6 billion in drug cost savings 
occur when lower priced over-the-counter products are used 
instead of higher priced prescription drugs. So that is really 
important both for the public treasury and for consumers. While 
over-the-counter drugs can generate savings, they can also be 
misused, leading to 178,000 hospitalizations each year due to 
adverse drug events.

    It is important that we get the balance right. Older adults 
represent one-third of over-the-counter drug users and over 65 
percent of these adverse drug events. So proper oversight is 
important. That is why we are here today. I was happy to 
support the initial passage of this user fee program.

    I am glad the Committee is back to marking up bipartisan 
legislation. Hope we will do more of it. I do want to just 
conclude by just putting on the table, we are obviously going 
to be grappling very soon with the reconciliation bill that 
deals pretty significantly with healthcare and with the FDA.

    Just in the last hour, the CBO released a report indicating 
that the House reconciliation bill would deprive 16 million 
Americans of health insurance. That is the House passed bill. 
That tells us what the stakes are as we grapple with the 
reconciliation bill. And obviously, I know my colleagues and I 
are going to be fighting very hard to avoid that. But let's 
just focus on the FDA.

    Since the Administration took office, 20,000 employees at 
the Department of Health and Human Services have been 
dismissed. And this includes over 3,500 FDA staff currently on 
administrative leave.

    Many other staff have been forced out or are leaving 
because of the chaos at the agency, including the Center for 
Drug Evaluation and Research, which we are here to talk about 
today. I asked Secretary Kennedy, who was before us, about the 
effect of some of these cuts. In particular, some detailed 
questions about how many of these folks laid off were veterans. 
I await an answer and haven't received it yet.

    The mission of the FDA, to ensure the safety and 
effectiveness of thousands of drugs and medical products, 
including in this program that we are focused on today, is so 
important. And the way to overhaul the agency is not to 
indiscriminately fire thousands of experts.

    I hope we get some answers about how the decisions were 
made on these layoffs and what impact they could have on the 
ability of the FDA to successfully implement the programs that 
we are here to discuss today. With that, Mr. Chairman, I yield 
back.

    The Chairman. Thank you. We are joined today by Dr. 
Jacqueline Corrigan-Curay, the Acting Director of the Center 
for Drug Evaluation and Research, or CEDR, at the U.S. Food and 
Drug Administration. In her role as Acting CEDR Director, Dr. 
Corrigan-Curay is responsible for ensuring that safe, 
effective, and high quality drugs are available to the public.

    She brings a long career in medical research, including 
numerous positions at FDA, as well as the NIH. Dr. Corrigan-
Curay holds degrees from Harvard Law School, the University of 
Maryland School of Medicine, and Harvard University. I look 
forward to hearing from her today and thank you for joining us. 
Is your microphone--?

STATEMENT OF JACQUELINE CORRIGAN-CURAY, ACTING DIRECTOR, CENTER 
 FOR DRUG EVALUATION AND RESEARCH, UNITED STATES FOOD AND DRUG 
               ADMINISTRATION, SILVER SPRING, MD

    Dr. Corrigan-Curay. Thank you. Can you hear me now? Good 
morning, Chairman Cassidy, Senator Kaine, and Members of the 
Committee, and thank you for the opportunity to speak with you 
today.

    I want to talk about something that benefits nearly every 
American household, over-the-counter medications. These are the 
products that millions rely on every day, an antiseptic when 
your child has a scrape, antihistamines when the pollen counts 
rise----

    The Chairman. Will you pull the microphone closer to you, 
please?

    Dr. Corrigan-Curay. Yes--and an antacid after a heavy meal. 
They are trusted, essential, and they must be safe, effective, 
and up to date. And that is where the OTC Monograph User 
Program, or OMUFA, comes in.

    Prior to 2020, our ability to regulate OTC drugs hadn't 
been modernized in decades. It was slow, outdated, and 
inflexible. Reform was overdue. When Congress passed the OTC 
monograph reform as part of the CARES Act, it was a bipartisan 
success that brought real change. Critically, the user fees 
that Congress authorized, OMUFA, are what facilitated and 
supported OTC monograph reform and has set the program for 
success.

    Now, with Congressional support and timely reauthorization, 
we have the opportunity to realize the full potential of the 
OTC monograph reform, ensuring a nimble regulatory process, 
fostering innovation to better serve patients and consumers, 
and enhancing transparency and accountability from the FDA and 
industry.

    What have we accomplished so far? In just 5 years, OMUFA 
has helped FDA modernize the OTC drug review process, 
transforming it from a paper heavy rulemaking system to a 
responsive electronic one. We have delivered five guidance 
documents providing clarity to manufacturers and enhancing 
public health protections.

    We have posted 33 final orders and 5 proposed 
administrative orders, providing transparency for manufacturers 
on what is expected to market a particular OTC drugs. And I 
want to highlight our most recent proposed order because we 
believe it will foster some exciting innovation for children 
and families. If finalized, this order would let companies 
create new, easier to take forms of OTC medications like 
chewable tablets, tablets that melt in your mouth, and thin 
films.

    These would be for certain medications that currently only 
come as tablets or capsules and could help people who have 
trouble swallowing them. OMUFA has also helped hire 85 
dedicated staff members, scientists, safety reviewers, and 
regulatory experts who help ensure the products on our shelves 
are safe and effective.

    Importantly, it has opened the door to more innovative 
products like a new sunscreen ingredient through the 
administrative order process. If Congress does not authorize 
OMUFA this year, the momentum would come to a grinding halt. 
The impact would be immediate and damaging.

    Engagement on development programs and activities to 
oversee the safety and quality of OTC monograph products would 
slow or stop as dozens of FDA staff with clinical quality and 
safety expertise would lose their positions. Critical progress 
on proposed and final orders from the FDA's monograph forecast 
would be shelved, and these include essential updates on 
labeling, drug facts, and ingredients, including for products 
intended for pregnant women and children.

    No new agreements from the recent commitment letter could 
be implemented, including important steps like improving 
meeting management with sponsors, and more quickly assessing 
the quality of facilities as companies bring new products to 
the U.S. And perhaps most concerning, we risk sliding backward, 
losing the transparency, predictability, and innovation that 
OMUFA was designed to create.

    Without reauthorization, the system that was finally fixed 
begins to break again. The recently negotiated agreement for 
the next 5 years of OMUFA includes smart, achievable goals, 
increasing opportunities for industry and FDA to interact to 
foster innovation, improving the transparency of the user fee 
program, investing in product quality and safety, and 
continuing to publish the annual guidance forecast that give 
industry and public health stakeholders a clear roadmap for the 
future. These aren't just words. They are commitment to the 
public.

    A commitment to keep this progress going. Every delay in 
regulation or review affects real people. Without OMUFA, 
innovations are stalled, safety improvements are delayed, and 
consumers may unknowingly continue to use products that haven't 
been adequately reviewed under modern science. This isn't about 
red tape, it is about real lives, real trust, and the 
medications that Americans buy off the shelf every day.

    In closing, Congress made a smart investment in 2020 when 
it created OMUFA. That investment is paying off, but we can't 
stop now. Reauthorizing OMUFA means continued modernization, 
supporting innovation, and most importantly, keeping American 
families safe. Thank you, and I look forward to your questions.

    [The prepared statement of Dr. Corrigan-Curay follows.]
            prepared statement of jacqueline corrigan-curay
                              Introduction
    Chairman Cassidy, Ranking Member Sanders, and Members of the 
Committee, thank you for the opportunity to testify today on the 
reauthorization of the Over-the-Counter Monograph Drug User Fee 
Program, commonly referred to as OMUFA.

    Over-the-Counter (OTC) drugs have long provided an effective, low-
cost way for Americans to take care of everyday health needs without 
having to visit a doctor and obtain a prescription, saving American 
consumers time, effort, and money. Nonprescription drugs, including 
those for allergies, pain, fever, and various other ailments are widely 
available through online and retail outlets, providing safe and 
effective healthcare options to American consumers nationwide. One 
powerful example of the impact of nonprescription drugs are the 
approvals of naloxone nasal spray, which is used to reverse opioid 
overdoses. Availability of this medication without a prescription 
allows this life-saving medication to be sold directly to American 
consumers in drug stores, convenience stores, grocery stores, gas 
stations, and online. Although regulated under an approved application 
rather than the OTC monograph system, this example demonstrates how 
critical nonprescription products can be to individuals' lives and 
public health.

    The work of this Committee, leading to enactment of OTC monograph 
reform and OMUFA in 2020 laid critical groundwork, establishing a long 
overdue, transformational framework for modernizing the regulation of 
many over-the-counter drugs. Now, with Congressional support and timely 
reauthorization of OMUFA, we have the opportunity to realize the full 
potential of the OTC monograph reform program--ensuring a more nimble 
regulatory process, fostering innovation to better serve patients and 
consumers, and enhancing transparency and accountability from FDA and 
industry.
                    History of Regulating OTC Drugs
    More than 100,000 OTC drug products are marketed in the United 
States under what is known as the OTC monograph system. A monograph is 
essentially a rule book or a recipe book that establishes conditions 
under which an OTC drug in a given therapeutic category (e.g., 
antacids, pain or cold medicines) is generally recognized as safe and 
effective (GRASE) for its intended use. Monograph conditions may 
include acceptable ingredients, doses, formulations, labeling, and 
testing. Products that meet the conditions outlined in a monograph \1\ 
may be marketed without FDA premarket approval, in contrast to other 
drugs that must be approved before being marketed.
---------------------------------------------------------------------------
    \1\  Products must meet the conditions outlined in a monograph, as 
established under section 505G of the FD&C Act, as well as other 
applicable requirements. Examples of other applicable requirements for 
OTC drugs include, but are not limited to, format and content 
requirements for OTC drug product labeling under 21 CFR 201.66, and 
conditions under 21 CFR 330.1, such as being manufactured in compliance 
with Current Good Manufacturing Practice (CGMP) regulations under 21 
CFR 210 and 211, and using only safe and suitable inactive ingredients.

    The OTC monograph process was established over 50 years ago and was 
largely envisioned as a ``once and done'' system. The science 
supporting these products was already considered established and 
innovation in this space was believed to be unlikely, which we now know 
is not true. The system utilized a three-phase multistep public 
rulemaking process to establish or change OTC monographs, significantly 
limiting the pace of innovation in these critical products. In 
particular, the time required for these process steps resulted in 
delays in finalizing monographs, challenges in responding quickly to 
urgent safety issues, and difficulty keeping pace with evolving science 
and a changing market.
                     Monograph Reform and User Fees
    In March 2020, the Coronavirus Aid, Relief, and Economic Security 
(CARES) Act, Public Law No. 116-136, added section 505G to the Federal 
Food, Drug, and Cosmetic (FD&C) Act. Section 505G reformed and 
modernized the framework for the regulation of OTC monograph drugs. 
These reforms, supported by OMUFA user fees, replaced rulemaking for 
monograph purposes with a more streamlined, efficient process--using 
Administrative Orders--that can be initiated by either FDA or industry 
(i.e., any person or group of persons marketing, manufacturing, 
processing, or developing a drug) to add, remove, or change a 
monograph. Under section 505G, industry can request that FDA issue an 
administrative order by submitting an OTC monograph order request 
(OMOR) to FDA. Section 505G also authorized establishment of new 
procedures under which FDA may meet with sponsor(s) or requestor(s) in 
advance of submission, and FDA has issued guidance regarding the 
process for those meetings. If FDA accepts the OMOR for filing, FDA 
will then review the OMOR and develop and issue a proposed order. FDA 
can also initiate the process by developing and issuing a proposed 
order; in both instances, there is an opportunity for public review and 
comment before a final order. FDA can also initiate an expedited 
process for developing and issuing an administrative order when a drug 
poses an imminent hazard to public health or a change in the labeling 
of a drug is expected to mitigate a significant risk of a serious 
adverse event associated with use of the drug.

    Notably, the CARES Act also facilitated these reforms by amending 
the FD&C Act to authorize FDA to assess and collect user fees from 
industry to support the Agency's OTC monograph drug activities. These 
activities involve evaluating OMORs, including reviewing safety and 
efficacy information for proposed new monograph active ingredients as 
part of GRASE determinations, developing and issuing proposed and final 
orders, conducting inspections of OTC monograph drug facilities, and 
monitoring OTC monograph drug safety, among other regulatory functions. 
This user fee program, commonly referred to OMUFA, also supports 
modernizing IT systems, and recruiting and training skilled staff. 
Typically, accompanying authorization of such user fee programs is an 
agreement negotiated between FDA and industry, often referred to as a 
``goals document'' or ``commitment letter'', in which FDA agrees to 
adhere to performance goals in terms of conducting fee-supported 
activities, including specific timeframes to review and respond to 
certain industry submissions. FDA reports on its accomplishment of 
these goals annually in publicly available reports, which increases 
transparency and accountability for review work.

    By improving the efficiency of FDA's OTC regulatory process, 
consumers will have increased access to innovative, effective and safe 
OTC drug products.
                                OMUFA I
                               Background
    Under the OMUFA program, industry-paid fees help support FDA's 
regulatory activities related to OTC monograph drugs. However, in order 
for FDA to annually collect and spend authorized OMUFA user fees, the 
fees must be appropriated, and FDA must allocate for OTC monograph drug 
activities a minimum of $12 million of appropriations (excluding user 
fees) multiplied by an adjustment factor. During each of the fiscal 
years under OMUFA I to date, FDA met both legal conditions.

    Under OMUFA, FDA collects two types of fees: facility fees and OMOR 
fees. FDA calculates both fees in accordance with our statutory 
authority. OMOR fee rates for fiscal year 2021 were specified in 
statute, and are adjusted for inflation each year. Tier 1 OMORs 
represent significant changes to a monograph (e.g., new ingredients, 
indications, or therapeutic categories), while Tier 2 OMORs represent 
more minor changes to the monograph. Additionally, the statute mandates 
a process FDA follows to calculate the target total revenue from 
facility fees each year. FDA establishes facility fee rates with the 
goal of generating that target total facility fee revenue amount. 
Facility fees are assessed on qualifying persons who own an OTC 
monograph drug facility, including contract manufacturing organization 
facilities which pay a reduced fee. Over the course of OMUFA I, the 
target revenue for facility fees ramped up from $23.3 million in fiscal 
year 2021 to $36.5 million in fiscal year 2025. The total target 
revenue for OMUFA I was $141.3 million over 5 years.
                        Building Infrastructure
    Overall, FDA has been successful in implementing OTC monograph 
reform and meeting the goals set out in the first OMUFA user fee goals 
document, i.e., under OMUFA I. Notably, the CARES Act amendments 
established a new statutory framework for regulating OTC monograph 
drugs, under section 505G of the FD&C Act, and concurrently established 
authority in the FD&C Act for the OMUFA user fee program. Simultaneous 
enactment of both these programs created additional steps for 
implementation. In contrast, the statutory framework for new drug 
applications had been in place for decades before authority for the 
prescription drug user fee program was enacted and implemented. 
Therefore, during this first 5 years of the OMUFA user fee program, FDA 
has been focused on building an entirely new OTC monograph drug 
regulatory program from the ground up, which meant hiring and training 
staff, developing new procedures, and creating a system that could 
efficiently handle the review of OMORs and issuance of proposed and 
final monograph orders. OMUFA I supported hiring of 105 full-time 
equivalents, spread over the 5-year period, to supplement the 35 that 
were estimated to be working on monograph issues when the program was 
negotiated. At the end of fiscal year 2024, FDA had filled 85 of the 
105 positions; however, three program staff have voluntarily left the 
FDA. Nine of the outstanding positions were agreed to be added during 
fiscal year 2025.

    During the first 3 years following passage of the CARES Act, the 
majority of FDA's effective capacity with respect to OTC monograph drug 
activities was focused on developing the system to implement the 
statutory mandates for OTC monograph reform and OMUFA, including 
associated infrastructure development activities. In particular, 
significant resources were dedicated to the development of the first IT 
system to manage OTC monographs and the reformed OTC monograph process, 
allowing for more transparency and public access to OTC monographs and 
related administrative orders.

    By Year 3, FDA's OTC monograph-related resources grew to the point 
where some OMUFA performance goals began for meetings with industry as 
agreed to in the OMUFA I goals document. In Years 4 and 5, FDA has been 
implementing the agreed upon timelines and progressive performance 
goals for reviewing OMOR submissions, meeting management, guidance 
development, and other activities.

    Specifically, FDA issued five draft and one final guidance related 
to OTC monograph drugs, including in fulfillment of statutory 
requirements. These guidances serve as ``how to'' guides for navigating 
the new system established by Congress, and were written while the 
system was being operationalized. FDA has been working diligently to 
finalize the remaining draft guidances in a timely manner. In 
accordance with the OMUFA I goals document, FDA has also posted an 
annual monograph forecast outlining FDA's intended monograph activities 
over the next 3 years. This level of planning helps provide 
predictability for industry while fostering FDA accountability for 
progress. All of these activities laid the groundwork for realizing the 
full benefit of OTC monograph reform in the coming years.
                             Taking Action
    In addition to building the extensive infrastructure needed to 
implement monograph reform, in years 4 and 5, FDA has begun to 
meaningfully use the modernized OTC regulatory process supported by 
OMUFA I. As required by statute, FDA has posted 33 final administrative 
orders that were deemed established by section 505G upon its enactment 
under the CARES Act.

    Additionally, in June 2024, FDA issued a proposed order (the first 
discretionary proposed order initiated by the Agency) to address a 
safety issue related to OTC monograph drug products containing 
acetaminophen. If finalized, this proposed order would require drug 
companies to add a warning to the labeling of these products to alert 
American consumers that the use of acetaminophen may cause severe skin 
reactions. Although FDA alerted the public to this safety concern in 
2013 via a drug safety communication, the complex rulemaking process 
applicable to OTC monograph drugs at that time limited the Agency's 
ability to rapidly modify the relevant monograph to require this 
warning to align labeling with nonprescription acetaminophen drug 
products with approved applications.

    Also in 2024, FDA issued a proposed order to amend the relevant OTC 
monograph to remove oral phenylephrine as an active ingredient for 
temporary relief of nasal congestion because it is not effective for 
this use. This proposed order also re-assesses the risks and benefits 
of this cough/cold active ingredient in children under 6 years of age. 
Before making the decision to issue the proposed order, FDA held an 
Advisory Committee meeting to discuss the GRASE status of oral 
phenylephrine as a nasal decongestant. Based on review of the current 
data and a unanimous recommendation from the Advisory Committee, FDA 
published the proposed order to inform the public and garner comments. 
If, after considering comments on the proposed order, FDA concludes 
that oral phenylephrine is not effective as a nasal decongestant, FDA 
would issue a final order amending the applicable OTC monograph to 
remove this ingredient as an oral nasal decongestant. \2\
---------------------------------------------------------------------------
    \2\  https://www.fda.gov/drugs/drug-safety-and-availability/fda-
clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine.

    FDA also published a proposed order on sunscreens, proposing new 
monograph conditions under which nonprescription sunscreen drug 
products would be determined to be generally recognized as safe and 
effective (GRASE) under the FD&C Act. Notably, in September 2024, FDA 
received the first OMOR submitted by industry, requesting to add a new 
ingredient to the sunscreen monograph, potentially increasing choice 
for American consumers. FDA is actively reviewing that submission 
according to the timelines established in the user fee goals document, 
---------------------------------------------------------------------------
and has a current goal date of late February 2026.

    Overall, these accomplishments during the first 5 years of the 
OMUFA program demonstrate that OMUFA I fee resources not only helped 
make the OTC monograph system more efficient, but supported the 
development of the infrastructure needed for continued success.
                        OMUFA II Reauthorization
    Reauthorization of OMUFA is instrumental to build upon the 
successes of OMUFA I to create a transparent, modernized regulatory 
system for safe and effective OTC monograph drugs.

    OMUFA resources are key to supporting the safety of the OTC drug 
products consumers use every day. For example, in 2023, there was a 
worldwide safety alert regarding over-the-counter medicines, primarily 
children's cold medicines, contaminated with diethylene glycol (DEG) 
and ethylene glycol, the main ingredient in antifreeze, resulting in 
more than 300 deaths in children in multiple countries. Because of 
quick work by FDA to issue guidance for testing, request for records 
from manufacturers, and issue import alerts for affected products, 
American consumers were spared this tragedy. FDA continues to conduct 
quality surveillance for this contaminant--with multiple import alerts 
issued so far this year for toothpaste products potentially 
contaminated with DEG. Although a disaster prevented often goes 
unnoticed, having a robust system for ensuring drug safety, efficacy, 
and quality is why American consumers can confidently choose OTC drugs 
in the United States. The resources and commitments related to improved 
quality surveillance and transparency included in the OMUFA II proposal 
are needed to help ensure this consumer confidence is both maintained 
and enhanced.

    Similarly, without the resources from OMUFA, FDA will not have 
sufficient capacity to help ensure the safety and efficacy of OTC 
monograph products. If OMUFA were not reauthorized, some of the actions 
FDA has planned could take a decade or longer to implement. These are 
actions that impact our most vulnerable Americans--including pregnant 
women and children. For example, FDA will be working to address:

          pediatric weight-based dosing for acetaminophen,

          pregnancy labeling for non-steroidal anti-
        inflammatory drugs,

          risks associated for codeine-containing cough 
        medicine in adults and children,

          the safety and efficacy of oral anesthetics 
        containing benzocaine, including for infants,

          greater availability of child-friendly options of 
        certain oral medications for children.
            Process to Development OMUFA II Recommendations
    Many stakeholders including consumer groups, medical societies, 
pharmacy associations, academics, and regulated industry recognize 
OMUFA's critical role in establishing and maintaining an efficient and 
transparent OTC monograph system. To ensure the OMUFA II 
reauthorization recommendations reflect shared priorities, FDA held two 
public meetings and gathered additional feedback via a public docket. 
In addition, we held 25 extensive negotiation sessions with industry 
stakeholders. \3\
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    \3\  https://www.fda.gov/industry/fda-user-fee-programs/omufa-
reauthorization-fiscal-years-2026-2030.

    Because OMUFA I was authorized from fiscal years 2021-2025, this 
was the first negotiation with industry to develop reauthorization 
recommendations, for fiscal years 2026-2030. Throughout the 
negotiation, FDA and industry remained aligned on the common goal of 
advancing public health while maintaining scientific standards and 
promoting innovation. Given the relative newness of the OTC monograph 
reform program, recommendations for OMUFA II focus on ensuring stable 
funding for the program, enhanced transparency of the OMOR process, and 
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enhanced regulatory efficiency and predictability.

    With Congress' support and a timely OMUFA reauthorization, we are 
excited to begin realizing the full potential of OMUFA--to meaningfully 
advance our efforts to help American families have access to safe and 
effective drugs regulated through the OTC monograph system, including 
by reviewing OMORs and developing and issuing proposed and final 
administrative orders, facilitating innovation and up-to-date safety 
information about these important products. The commitments FDA can 
achieve with timely reauthorization thematically fall into the 
following categories, discussed below:

          Funding Stability

          Monograph Drug Product Quality Enhancement

          Financial efficiency and transparency

          Information transparency

          Meetings with industry and notice of Advisory 
        Committee meetings

          Education for industry

          Updating testing methods in monographs

    The reauthorization proposals for OMUFA that are described below 
were submitted to Congress in January, under the previous 
Administration. The Trump administration looks forward to working with 
Congress toward reauthorization of the important OMUFA program to build 
upon the successes of OMUFA I and facilitate a transparent, modernized 
regulatory system for safe and effective OTC monograph drugs.
                           Funding Stability
    OMUFA II recommendations reflect the goal of ensuring stable 
funding for the program, including avoiding large fee increases. Under 
OMUFA, FDA sets annual facility fees to generate the total facility fee 
revenues for each fiscal year established by section 744M(b) of the 
FD&C Act. The yearly base revenue amount is the starting point for 
setting annual facility fee rates. The OMUFA II proposal resets the 
starting base revenue under the statute for OMUFA II to include the 
additional direct cost adjustment of $3 million from the final year of 
OMUFA I, which is approximately 8 percent of the total revenue in 
fiscal year 2025. This adjustment helps ensure that the OTC monograph 
drug program is adequately resourced to meet increasing demands. The 
proposed base revenue for fiscal year 2026 will be approximately $36.5 
million, and the additional proposed funding will increase fee revenue 
by 12 percent over the course of the 5-year authorization period, in 
addition to inflationary increases. Overall, total target revenue for 
OMUFA II is proposed to be an estimated $206.8 million, including 
estimated inflation. These increases will continue to support increased 
efficiency of the OTC program in FDA, creating value for the American 
consumer.

    The OMUFA II reauthorization recommendations support an addition of 
11 new full-time equivalents (FTEs), added over the first 3 years of 
the reauthorization period. These new hires will support the growing 
responsibilities and commitments associated with conducting FDA's OTC 
monograph drug activities, and will bring total OMUFA funded FTEs to 
116. In addition to personnel, the proposal supports a modest 
allocation for contract expenses tied to the proposed new OMUFA II 
commitments.
               Monograph Drug Product Quality Enhancement
    The OMUFA II recommendations include commitments to enhance 
monograph product quality surveillance and transparency. The commitment 
letter agreement includes a new commitment from FDA to more quickly vet 
new registrants to confirm whether they should be included in CDER's 
catalog of OTC monograph drugs and establishments. Today, when a new 
facility registers with FDA and lists the drugs that they make for the 
U.S. market, FDA commonly needs to correspond with the registrant to 
obtain further information to confirm, for example, that the registrant 
is making a drug and not a cosmetic, or that a foreign registrant is 
actively shipping to the U.S. The proposed OMUFA II funding will 
provide additional resources to enable FDA to more quickly gain 
accurate information from registrants about the drugs they are 
producing as well to request and review information about the 
registrant's compliance with applicable current good manufacturing 
practice (CGMP) requirements to inform FDA's risk-based manufacturing 
facility inspections.

    Additionally, FDA agreed to hold a workshop aimed at helping 
industry stakeholders enhance quality and ensure compliance with CGMP 
requirements. FDA also committed to updating the risk-based inspection 
site selection model, which is used to prioritize surveillance 
inspections, and the associated Manual of Policies and Procedures 
(MAPP), to include risk factors specific to OTC monograph drugs. For 
example, given an initial observed association between failure to pay 
OMUFA fees and violative surveillance inspection outcomes, FDA will 
evaluate the failure to pay OMUFA fees as an important risk factor to 
be included. These commitments from both FDA and industry to enhance 
product quality will help ensure American consumers continue to have 
access to safe and effective OTC drugs.
                 Financial Efficiency and Transparency
    The OMUFA II recommendations address industry concerns about 
financial transparency and management through several key initiatives. 
The proposed statutory amendments aim to enhance financial efficiency 
by aligning the annual OMUFA facility fee due date with the October 1 
fiscal year-start due date for annual fees under other drug user fee 
programs, helping streamline the assessment and collection process for 
both FDA and industry. This common-sense reform benefits both the 
Agency and industry (who may pay other annual drug user fees), 
enhancing efficiency and predictability.

    Additionally, to improve unpaid fee recovery and transparency, 
OMUFA II commitments will increase visibility of facilities that have 
not paid fees, including breakdowns of foreign and domestic firms in 
arrears. This will promote accountability in the industry and help 
level the playing field for American manufacturers. FDA will also use 
information obtained from records requests to focus recovery efforts on 
outstanding OMUFA user fee delinquencies. Additionally, the proposed 
OMUFA II amendments to statutory fee setting introduce a new contingent 
adjustment to annual target revenue, allowing for a one-time upward 
adjustment if the number of fee-liable OMUFA facilities increases over 
a specified level. If necessary, this would help ensure that FDA can 
accommodate the additional work required to oversee a growing number of 
facilities, both foreign and domestic, without compromising quality or 
efficiency. These financial enhancements demonstrate FDA's commitment 
to responsible fiscal management while maintaining robust oversight.
                        Information Transparency
    FDA commitments under OMUFA II would take significant strides in 
terms of information transparency, including through agreeing to post 
information on FDA's Web site about monograph-related exclusivity, 
updating and maintaining monograph-related Web site links, and ensuring 
Web site accessibility of historic monograph-related materials and 
regulatory information. These measures address industry demands for 
clear, more consistent information about the OTC monograph process, 
including FDA's review of OMORs and development and issuance of 
proposed and final orders addressing safe and effective conditions of 
use for OTC monograph drugs. In particular, the information regarding 
monograph-related exclusivity will ensure uniform access to such 
information for all OTC manufacturers and stakeholders. FDA will post a 
page on its Web site addressing monograph-related exclusivity afforded 
by final administrative orders, including a table of relevant monograph 
change(s), requestor(s), the final order date, and relevant listing 
updates for drugs subject to the final order.

    FDA will also report annually on its Web site aggregate information 
about records requests issued to OTC monograph drug manufacturers under 
section 704(a)(4) of the FD&C Act. This reporting provides industry 
with more transparency regarding the information FDA is requesting 
related to compliance with CGMP requirements and how often the 
information provided leads to FDA action. Reporting will begin in 
fiscal year 2027 if the aggregate number of requests issued exceeds 20; 
otherwise, reporting will begin in fiscal year 2028. Similarly, FDA 
will enhance the Agency's warning letter Web page to improve its search 
capability for warning letters issued to OTC monograph drug 
manufacturers. Both of these actions will not only improve 
transparency, but also will contribute to efforts aimed at ensuring 
product quality and safety--key pillars of the OTC monograph reform 
program supported by OMUFA.
               Meeting and Advisory Committee Refinement
    OMUFA II commitments significantly enhance the utility of FDA-
industry meetings, including by providing for advance notice of certain 
Advisory Committee meetings, which directly addresses industry's 
requests for more productive and transparent communication with FDA. 
OMUFA II commitments also include a new follow-up opportunity which 
allows OMOR requestors to confirm or clarify with FDA something in 
meeting minutes or written response, similar to a PDUFA VII 
enhancement. It also includes the potential for extended meeting 
options for complex topics, allowing more meaningful engagement for 
sponsors. Similarly, OMUFA II will facilitate the ability of requestors 
to seek feedback on protocol synopses, improving both regulatory 
efficiency and predictability.

    Regarding Advisory Committee meetings specifically, FDA has agreed 
to provide at least 100 business days' advance notice for a specific 
subset of OTC monograph-related Advisory Committee meetings. FDA 
recognizes that this advance notice can help provide stakeholders time 
to coordinate and prepare for meaningful Advisory Committee discussion. 
This commitment will not apply to situations where the Advisory 
Committee is planning to discuss an emerging safety issue or if 
existing policy on advanced notice for certain Advisory Committee 
meetings applies.
                         Education for Industry
    The OMUFA II proposal also demonstrates FDA's commitment to 
transparency and predictability through ongoing education and outreach 
efforts for industry to facilitate innovation and safe and effective 
OTC monograph drug products for Americans. In addition to the CGMP 
webinar mentioned above, FDA has agreed to host a webinar on OMOR 
submission through the Next Gen Portal, as well as a crowd sourced 
session on OMOR submissions and GRASE determinations. Finally, FDA has 
committed to introducing draft guidance on filing eligibility for OMORs 
proposing new monograph active ingredients and another on the handling 
of confidential information submitted to the Agency in connection with 
proceedings on an OTC monograph order. Taken together, the 
recommendations for OMUFA II demonstrate a significant commitment to 
addressing the priorities of the public, the regulated industry, FDA, 
and public health.
                               Conclusion
    OTC monograph reform, supported by OMUFA I, has been transformative 
for OTC drug regulation and has created a faster, more transparent, and 
more predictable system that benefits American consumers. Through 
additional resources provided under OMUFA I, FDA built the necessary 
infrastructure for implementing OTC monograph reform, hired and trained 
staff, launched a modern IT system to facilitate efficiency, and issued 
important guidance for industry. In just a few years, we met OMUFA 
performance goals, issued five key guidances, and provided a forward-
looking monograph forecast. We also posted 33 final administrative 
orders defining baseline monograph conditions for various therapeutic 
categories of OTC drugs, as established upon enactment of section 505G 
of the FD&C Act, and issued two FDA-initiated proposed orders to update 
the monograph conditions for safety and efficacy of certain OTC drugs. 
These achievements would have been impossible under the previous 
regulatory framework.

    This progress cannot continue without OMUFA reauthorization. OMUFA 
II resources are critical to maintaining efficiency, ensuring safety, 
and fostering innovation in the OTC market. Without it, we risk losing 
the gains we have made and returning to slower responses to safety and 
fewer innovative choices for American consumers. I look forward to 
working with you to authorize OMUFA II and secure the future of a 
modern, responsive OTC monograph system.
                                 ______
                                 
    The Chairman. Thank you, doctor. So, I have a question 
here, but it kind of goes against the flavor of your testimony. 
And your testimony was very positive about the positive things 
that OMUFA has done.

    But my question is, it seems like the Rx to OTC switch, 
which is from prescription to non-prescription, that FDA has 
struggled to make that happen. So, is that a misperception of 
my part, or is there a--has it been more successful than I have 
understood?

    Dr. Corrigan-Curay. Thank you for that question. In the 
past few years, we have brought certain prescription drugs to 
over-the-counter, and that would include the Naloxone that 
became over-the-counter and was very critical, I believe, in 
helping us address the opioid crisis.

    We have brought the--[technical problems]--contraceptive 
over-the-counter as well, and we have bought some of the nasal 
allergy sprays over-the-counter. And as you also may be aware, 
we have a rule that should be finalized, and that would be to 
bring additional medications over-the-counter with a condition 
of use.

    To have a new way of bringing medications over-the-counter 
and we hope that would greatly expand.

    The Chairman. Explain the condition of use.

    Dr. Corrigan-Curay. Yes. So, under this rule, if we 
determine that you could not bring a drug over-the-counter with 
just the drug facts label, because with that label alone, a 
person could not appropriately self-select for that drug and 
use it, then a company could propose an additional condition.

    It might be a mobile app or something with some questions. 
And then if we can show that with use of that additional 
condition or those questions before they access the product, 
they can access it safely, that would open the door to products 
that we currently do not have over-the-counter.

    The Chairman. Now, can you give an example of that, or is 
it--?

    Dr. Corrigan-Curay. They are still in development. There 
are things in development, but we could think potentially about 
drugs that might be more for chronic conditions where we could 
select a population for which that drug was safe to take over-
the-counter.

    The Chairman. Now, let me go back to, you listed some that 
have become over-the-counter, but you listed like five or six. 
And there is a heck of a lot of drugs out there that could be 
over-the-counter.

    Is it that you are just giving me a sample, that there is--
you are giving me sample, for example, five or six drugs I am 
going to mention, or is it, no, that is the universe of those 
that have been approved? Because, let me ask you that.

    Dr. Corrigan-Curay. Thank you. In the recent timeframe, 
those were the ones I highlighted. We certainly work hard to 
look for opportunities to bring drugs over-the-counter that 
patients can safely self-select and use. And then, as I said, I 
think our----

    The Chairman. No, let me understand the process. Don't mean 
to interrupt, but I have limited time.

    Dr. Corrigan-Curay. No, please. Sorry.

    The Chairman. Does the drug company have to apply, or can 
you--for example, Benadryl, I think, used to be like a 
prescription drug. And so--and Claritin used to be a 
prescription drugs.

    Dr. Corrigan-Curay. Right.

    The Chairman. But really, you could have looked at those 
and said, this doesn't have to be a prescription drug, I mean, 
this could be over-the-counter. So do the drug companies have 
to apply, or can the agency say, this drug can safely be given 
OTC?

    Dr. Corrigan-Curay. Thank you for that question. It does--
the application does need to come in. However, in the case of 
Naloxone, if I recall, we put out an FR notice saying that we 
were open to working to bring Naloxone over-the-counter.

    I think we have opportunities to signal where we think 
there might be opportunity. We also do speak to companies, and 
we can suggest that we might be open to a development program. 
It does require a development program to show that they----

    The Chairman. And what do you mean by development program?

    Dr. Corrigan-Curay. Yes. So a company would need to show 
that consumers can self-select appropriately and use it with 
the information that is on the drug facts label.

    The Chairman. Now, let's go back to something like Tagamet, 
which again at one point was a prescription drug, or Prozac, 
which was a prescriptions drug. You could have looked at that 
initial--I am saying you, rhetorically you, could have looked 
at that and said this is a pretty safe drug, and people could 
take it for heartburn.

    I guess I am asking, since that would save lots of money 
for patients, lots of money for patients if they could buy 
those drugs--OTC as opposed to having to see a physician. Is 
there something Congress can do to expedite that, or do you 
have all the tools that you need to actually generate a kind of 
more aggressive approach to the Rx to OTC method?

    Dr. Corrigan-Curay. Thank you. So, in the case of that 
drug, we certainly would say first, yes. Does it look like it 
has a safety profile that we time--we have enough experience? 
But then we do have to have the information saying that the 
consumers can self-select. We are always happy if you have 
ideas to work with you on those.

    The Chairman. Senator Kaine.

    Senator Kaine. I am such an OMUFA nerd that I am going to 
stay for the whole hearing. So I am going to yield to Senator 
Kim and take my questions later.

    Senator Kim. Okay. Thank you. Thank you for coming on out. 
I wanted to ask you, it was raised in the opening remarks about 
some of the reduction in force. So I guess I just wanted to ask 
you, are you able to tell us if any of the staff in the Office 
of Non-Prescription Drugs were terminated under the reduction 
in force efforts?

    Dr. Corrigan-Curay. Yes, thank you for that question. 
Unfortunately, and consistent with our policy, when there is 
something that is a subject of litigation, we don't comment on 
the specifics. And as you know, there is a preliminary 
injunction around the reduction in force, so I can't go into 
any details at this point.

    Senator Kim. When you are able to provide answers----

    Dr. Corrigan-Curay. Yes, we would be happy.

    Senator Kim. Yes, I would like to know how many staff have 
been let go or resigned from the Office of Non-Prescription 
Drugs and how many of those were funded by user fees.

    Also I want to talk about the commitments that the FDA made 
with the OTC industry as part of the OMUFA commitment letter, 
specifically the agreement that FDA would hire 11 new full-time 
employees over the length of the reauthorization.

    I understand that there is currently a hiring freeze at the 
FDA. First, is that the case? And second, if so, will the FDA 
be able to stand by this commitment of hiring 11 additional 
full-time staff?

    Dr. Corrigan-Curay. Yes, thank you for that question. Yes, 
there is a hiring freeze, but I know as Dr. Makary has 
indicated, he is working to allow us to hire the reviewers that 
we need for all aspects, and so I am confident that he will be 
working with us to give us the resources we need to be 
successful under OMUFA II.

    Senator Kim. Okay. I want to just kind of hone in on a 
particular example to try to get a sense of how OMUFA is moving 
forward and how it is performing. So, for instance, sunscreen.

    This is something where we understand that the United 
States has continued to lag behind other countries in terms of 
UV filters that are approved for use in sunscreens. And the FDA 
has not approved a new filter, a UV filter, since 1999. Is that 
correct?

    Dr. Corrigan-Curay. That is correct. Although we do have a 
new OTC monograph order under review for a new sunscreen 
ingredient.

    Senator Kim. Well, I guess I would just like to hear a 
little bit more from you because despite Congress creating this 
new pathway and then several years overhauling the entire OTC 
monograph order process so, yet we still have no new sunscreen 
ingredients formally approved. You said there's something in 
the works?

    Dr. Corrigan-Curay. Yes.

    Senator Kim. But I guess I just want to kind of ask you 
like how do we try to address this? How do we try to make sure 
that we are moving forward and addressing these main challenges 
of approving new ingredients?

    Dr. Corrigan-Curay. Yes. So I would like to explain a 
little bit about the sunscreen market. Sunscreens for us, they 
are considered drugs because they are used to protect against 
the damages of sun and skin cancer. And any drug that we 
approve that is topical but that has systemic absorption, we 
need to make sure that the systemic absorption has no untoward 
effects.

    Those could include things like disrupting the endocrine 
system or even abnormal growth of cells or tumors. And we do 
know that certain ingredients in the literature have been 
highlighted for potential endocrine disruption. So to do that 
we would ask a company to do those tests, just like for any 
other drug that we approve.

    We have laid out the data that we think would be necessary 
for us to do an assessment. And we are waiting for more 
companies to come to us with that data, and then we would be 
happy to review it and work on that. I would also like to note 
that I know that there are additional sunscreens in different 
countries.

    Not all of them are under--treated as a drug. But I would 
also like to say that there is no data that those are more 
effective or that we don't have effective sunscreens on the 
market here in the United States.

    Senator Kim. I want to just switch gears a little bit, just 
sort of another angle. I am a father of a 7-year-old and a 9-
year old. A lot of parents in the bleary early mornings of a 
sick child try to wander off, try to figure out what we can do 
for our kids.

    I understand that the FDA has stated its intention to 
develop pediatric weight-based for acetaminophen during the 
next user fee authorization. I guess I want to know for myself 
if I am giving my kids the right dosage here.

    Could you explain to the Committee what staff resources are 
needed to make that change happen? How do we ensure that we are 
able to move that forward promptly?

    Dr. Corrigan-Curay. Yes, thank you. We will be asking for 
new staff in OMUFA II to continue to put out our orders and 
guidance. But this is a priority for us. We do know that there 
have been improvements in the way the acetaminophen--
concentrations on the shelf, but we need to address this 
weight-based, and we will put that as a priority. It is on our 
agenda.

    Senator Kim. Well, I just raise this as another example of 
just the importance that we have staff. That the experts there 
are able to process this. And when we see so much slashing of 
employees and staff, I worry that these types of direct 
benefits to people will be cast to the side. And with that, I 
will yield back.

    The Chairman. Senator Marshall.

    Senator Marshall. All right. Thank you, Mr. Chairman. And 
welcome to our guest today. Let's talk about measuring success. 
My question is, how do you measure success? I assume that from 
a safety standpoint, every month you are reviewing things that 
will--did we get anything wrong and how come?

    But beyond that, how do measure success from the standpoint 
of the ones that are coming into the system? Is there a set 
amount of time you would like to have them out by? What 
percentage of those made it through the process in that amount 
of time? How do you measure success?

    Dr. Corrigan-Curay. Thank you. I think in OMUFA I, we have 
measured success in that we have stood up the program. We have 
provided those foundational guidance. We have created an 
electronic, efficient way for companies to communicate with us.

    Then we have the first new proposed order in that we are 
reviewing. We are also making all of our commitments on 
meetings. So we are meeting with companies. And so, our success 
will be to continue to move those development programs----

    Senator Marshall. All those are you trying to improve 
success, but I don't hear you measuring success. In the 
standpoint of you run a hospital, you run a bank. Every month 
you look to these key metrics to say, are we hitting these 
measures.

    Dr. Corrigan-Curay. Yes. For us, we will be putting out our 
agenda, and that is the plan 3-year agenda, and that will tell 
you the successes of getting these orders out. So, for example, 
the new order that we just put out, which will allow for 
changes in the dosage forms, and we think that is very 
innovative and will help----

    Senator Marshall. You don't have a monthly dashboard of 
metrics that you are looking at to see if we are meeting them?

    Dr. Corrigan-Curay. We are tracking all of the things that 
we are doing in terms of proposed orders, that we are meeting 
our timelines on reviews. And when there is an----

    Senator Marshall. Can you share your dashboard with us?

    Dr. Corrigan-Curay. I don't know if it is an electronic 
dashboard, but we are tracking what we are doing and our 
commitments.

    Senator Marshall. Okay. I would love to see how you are 
measuring success, so if it is not a dashboard----

    Dr. Corrigan-Curay. Sure. We should get back to you.

    Senator Marshall [continuing]. I would encourage you to get 
one. Let's talk about inactive ingredients. As you know, the 
OTC monographs only list active ingredients. A lot of Omaha 
moms out there are concerned about inactive ingredients, 
artificial flavors, sweeteners, etcetera.

    What is going on in the world of over-the-counters as far 
as identifying those inactive ingredients, and is there an 
effort to get the ones that are not safe out of these over-the-
counters?

    Dr. Corrigan-Curay. Thank you for that question. We 
certainly, anytime we identify that there is an issue with an 
inactive ingredient, we would review it, and we would look to 
make changes in that inactive ingredients.

    We do have ways and guidance. We just did one on color 
additives to allow firms to--a pathway if they want to change 
their inactive ingredients or their color additives. And we can 
get back to you with more information on that.

    Senator Marshall. Is there a way--isn't it going to be 
pretty simple for your monographs to include the inactive 
ingredients?

    Dr. Corrigan-Curay. I think I might have to get back to you 
on that question about could we just do that, if you don't 
mind. Thank you.

    Senator Marshall. All right. Let's talk, about studies. 
More and more, it would seem that AI can replace animal 
studies, and probably be even more accurate. So often, you read 
what works--what happens in monkeys and dogs has nothing at all 
to do with the biology of human beings. Is there any effort in 
your department to convert over to AI and doing less animal 
studies?

    Dr. Corrigan-Curay. Thank you. We are engaged on the new 
initiative to reduce animal studies in the monoclonal 
antibodies. And we had--previously, we have been working on 
looking for alternatives to animal studies.

    We already do--we no longer use animal studies for eye 
irritation or skin irritation, and we certainly will--are 
looking at both AI as we are looking at these non-animal 
approaches.

    There are still challenges in coming out with validated 
studies when you are looking--you are looking for an effect 
that would affect multi-organ systems. That doesn't mean that 
we won't get there, and we will continue to work on that.

    Senator Marshall. Okay. Again, if there is a way that you 
could measure that and show us. We were doing so many animal 
studies 5 years ago. This is how many we had last year. This is 
how many we are doing this year. Prove to me that you are 
making progress in that. That would be very helpful.

    Dr. Corrigan-Curay. We can get back to you. Thank you.

    Senator Marshall. Thank you so much, Chairman. I yield 
back.

    The Chairman. Senator Kaine.

    Senator Kaine. Senator Hickenlooper.

    Senator Hickenlooper. Thank you, Mr. Chairman. Thank you, 
doctor, for being with us and for your service and hard work 
over there. And I know there are hard times. Several of us are 
working on a bill we call Skinny Labels, Big Savings--the 
Skinny Labels, Big Savings Act.

    Senators Collins, and Cotton, and Welch, and I are trying 
to address the endless procession of lawsuits against generic 
drug manufacturers who obtain the skinny label FDA approvals. I 
think if we can encourage more generic drugs to come to market 
through this legislation, we are going to lower costs widely 
for the American consumers.

    Dr. Corrigan-Curay, are you willing to commit to work with 
us to advance this legislation so that we can lower drug costs? 
And as the Acting Director of the Center for Drug Evaluation 
and Research, what else are you working on to try and create 
more competition, more generic competition?

    Dr. Corrigan-Curay. Thank you for that question. 
Absolutely, we support additional generic competition. We know 
that generics make up 90 percent of the prescriptions in the 
United States. We think the skinny labeling, we are happy to 
work with you on that legislation.

    Other things that we are doing. We are continuing to put 
out our guidance, our product specific guidance which are a 
roadmap for developers. In addition, it is very important as we 
see more opportunities in complex generics that we work with 
industry and academia to develop the science to allow those to 
come forward. So we have a very robust regulatory science 
program.

    In fact, our science meeting on generics is ongoing today, 
and then we put guidance. We also seek to meet all of our 
goals. And I would just note, I believe in 2024, we approved 
about 59 first generics. So those are generics drugs for which 
there was no generic competition before we approved.

    Senator Hickenlooper. That is great. I appreciate that. I 
will come back also to AI, because you are touching on AI there 
as well. This week you launched ELSA, this new AI tool. And 
Commissioner Makary stated that ELSA was designed to expedite, 
to review processes at the agency with the goal of making them 
shorter, and yet more successful, better.

    He stated, ``all information stays within the agency and 
the AI models are not being trained on data submitted by the 
industry.'' And so, can you share with us a little bit, Dr. 
Corrigan-Curay, some of the additional details about how 
exactly the FDA is going to ensure that the data within ELSA 
remains secure? I mean, I view ELSA as a tool, but like any 
tool, we have got to make sure we handle it safely.

    Dr. Corrigan-Curay. Yes, thank you. We are very excited 
about the initiative that Dr. Makary is leading on AI, because 
we do see there is utility to this tool in our work. And we are 
not training it on the data.

    What we are doing in AI, this type of AI could be very 
helpful when we have got a number of documents and we want to 
summarize them, and we have to summarize for one of our 
reviews. We still have to check it, and we have to make sure it 
is right.

    But the confidentiality and privacy of data within the FDA 
is one of our top priorities. I mean people--we are trusted to 
keep that, and we will continue to work on that, even as we 
incorporate new tools into our review processes.

    Senator Hickenlooper. Well, I appreciate that, and I 
support that 100 percent. Let's talk a little bit about 
transparency at the FDA. Secretary Kennedy, Commissioner Makary 
both sat in your seat and committed during their confirmation 
that transparency would be a priority for them and for the 
entire agency.

    Yet, FDA appears to have attempted to gut the team that 
responds to the freedom of information requests. In other 
words, those requests for the transparency, everyone 
disappeared--everyone was let go or encouraged to retire. Also, 
the FDA bypassed the Advisory Committee on Immunization 
Practices, ACIP, in the recent COVID vaccine guidance, taking 
one of the few forums we have for clear and open debate on 
vaccines, and they kind of skipped right over it.

    Does any of this promote transparency? How do we reconcile 
the public commitments to transparency with some of these 
opaque actions. At least they appear to me and to many of us. 
And how can we course correct and make sure that Americans feel 
confident that they are getting transparency, they are seeing 
what is coming, and that they can believe in these actions?

    Dr. Corrigan-Curay. Thank you for that. At CDER, we are 
very committed to being transparent. We held an Advisory 
Committee, I believe, about a month ago on our opioid PMRs. We 
continue to communicate. And we will continue to keep that 
transparency and communication open with the public.

    In OMUFA, we have several initiatives that we will be doing 
in terms of webinars, posting not only the firms that didn't 
pay, but the firms that did pay to provide transparency around 
that, transparency around exclusivity. So we will continue to 
do that.

    Senator Hickenlooper. Appreciate that. Thank you, Mr. 
Chairman. I yield back.

    The Chairman. Senator Tuberville.

    Senator Tuberville. Thank you. Thank you, doctor, for being 
here. We know Secretary Kennedy is all into modernization. 
While we are waiting for these user fees to be reauthorized, 
what are we doing in the meantime of getting ready for dealing 
with the atmosphere that we are in today? What are you doing?

    Dr. Corrigan-Curay. Thank you. Are you asking me how we are 
preparing for the user fee negotiations?

    Senator Tuberville. Yes. Right.

    Dr. Corrigan-Curay. Yes, thank you. So as we do every cycle 
for the user fees--obviously for OMUFA we are here to talk 
about the reauthorization. For the other user fees, we do have 
internal processes that we undertake to think about the next 
agreements and what we would like to propose.

    Of course, those would be discussed with Dr. Makary. I 
believe the notices of our public meetings for July are already 
out, and so we will have those public meetings and engage the 
public on those user fees.

    Senator Tuberville. Thank you. We have already talked a 
little bit about dyes, some things like sweeteners that go into 
a lot of our over-the-counter drugs. You go into these places 
and the drug stores look like a candy store, and they are 
enticed to be marketed in certain ways because of the color.

    Do we have--what kind of priorities do we have on labeling 
of, No. 1, what goes into some of the over-the-counter drugs? 
Where they are made. I have looked at a lot of bottles and 
things inside our stores, and you can't find out whether they 
are made in Korea, whether they are made in China, or whether 
they were made in the United States. Shouldn't that be a 
priority?

    Dr. Corrigan-Curay. Thank you for that question. One thing 
when we think about where a drug is made, we are committed to 
making sure that wherever the drug is made and if it is being 
marketed that it's safe, that we apply the same standards, 
whether it is made domestically or it is made internationally.

    We certainly are very supportive. I know the Administration 
is looking to onshore pharmaceutical manufacturing, and that 
would be for prescriptions or for OTC. And we are very 
supportive of that, and we will work with them in terms of our 
regulatory frameworks to help make that happen.

    But right now we don't have a labeling on the drug for 
where it is made. We are happy to work with you, if that is a 
priority.

    Senator Tuberville. Well, I think in the future, with the 
problems we are having worldwide, I think it will probably be a 
good suggestion that people, when they go in and they find out 
where it is made--we found out during COVID, we don't make much 
anymore. Most of it comes from China, and we really don't know 
what is in it.

    We are just finding out now a lot of metals and things are 
in a lot of the drugs and even the foods that we have. Another 
question I had about sunscreen. Most of us use sunscreen. I 
don't know how it is evaluated, but over the years, last 50 
years, melanoma and skin cancers have almost quadrupled.

    I don't know whether people don't use it, or it is not 
working, or we get some kind of skin cancer from ingredients 
that are in sunscreen. All of us used it at some point. It 
doesn't really feel safe every time I put it on, but I put in 
on because sometimes you look at the worst case scenario. So 
what are your thoughts on that?

    Dr. Corrigan-Curay. Yes, thank you for that. First of all, 
we are very aware that skin cancer risk is a very serious 
problem. And the sunscreens we have, the testing does say they 
are effective if used properly. And some of our tests, when we 
are testing for systemic absorption, is how you use them.

    We do have two sunscreens that are mineral sunscreen, that 
are grass. They are not absorbed. For those that are absorbed 
we have asked for additional tests just to assure their safety. 
That any systemic absorption has no untoward effects.

    Senator Tuberville. Are we looking into the ingredients 
that are so-called cancer causers? I would hope we would be--
and read it all the time.

    Dr. Corrigan-Curay. Yes--sorry to interrupt. Yes, and part 
of the testing that we want to do whenever a drug is absorbed, 
and it reaches systemic levels is a test for tumor formation.

    Senator Tuberville. Thank you. I yield back.

    The Chairman. Senator Kaine.

    Senator Kaine. Senator Markey.

    Senator Markey. Thank you, Mr. Chairman. The Trump 
administration has fired 3,500 Federal employees at the Food 
and Drug Administration out of 20,000, and 800 out of the 7,500 
people at your Center for Drug Evaluation and Research.

    Despite assurances from Commissioner Makary that slowdowns 
would not happen, I have heard from researchers and companies 
that the drug review process has slowed down to a crawl and 
many have been stuck in limbo for months waiting on reviews and 
approvals to be completed.

    Up in Massachusetts in a survey released by MassBio, in 
May, 67 percent of biopharma firms surveyed were highly 
concerned that workforce reductions will delay drug approvals, 
and at least 50 percent were already feeling the impacts from 
the FDA layoffs. So this is not a good situation for all these 
biotechs up in my state and across the country.

    The Trump administration's actions have guaranteed that 
every stage of developing life-saving drugs, from research, to 
clinical trials, to approvals is slowed down or stopped. We are 
witnessing in real time a giveaway of our global leadership in 
drug research, in development, in biomedical innovation, and 
firing FDA officials responsible for drug approvals and 
evaluation is part of the problem.

    My question is, obviously there have been many essential 
employees who have left as part of this reduction in workforce. 
And the goal has to be to increase, obviously, the timeliness 
of the review processes. So what is your plan, doctor, to 
replace the institutional knowledge that was lost from long-
time FDA employees being fired or resigning?

    Dr. Corrigan-Curay. Thank you for that question. I know we 
can't really discuss details around the RIF about the 
litigation, but our reviewers are----

    Senator Markey. Can you pull over the microphone a little 
bit, please?

    Dr. Corrigan-Curay. Sorry. Our reviewers are in place. And 
I would say that we are meeting our timelines. I know that 
occasionally----

    Senator Markey. The timelines to do what?

    Dr. Corrigan-Curay. The timelines for approval and for 
our--approval of our drugs. We do occasionally miss timelines. 
If you look at our----

    Senator Markey. I have 50 percent of my companies who are 
already saying they are feeling the impacts of the FDA layoffs. 
So they are already feeling it.

    Dr. Corrigan-Curay. We certainly will look into that. I 
would note that, we are approving drugs and making our 
timelines.

    There are certain times all of our agreements, we have 90 
percent, not 100 percent because sometimes there are issues 
that come up that are complex and scientific issues that we 
would rather take a little bit more time if we need to, to make 
sure we get them right.

    But we are also going to work with Dr. Makary. We have 
turnover in our review staff on a routine basis every year and 
Dr. Makary----

    Senator Markey. I appreciate that, but you are down 800, 
which is a lot, in the real time that these companies have to 
get some answers. So what was your role in the firing of the 
800 employees at the Center for Drug Evaluation and Research?

    Dr. Corrigan-Curay. Again, I apologize, but because of the 
ongoing litigation, I can't comment a lot about the RIF and the 
employees, and the reduction of employees.

    Senator Markey. Was DOGE involved in the firings at the 
FDA?

    Dr. Corrigan-Curay. Again, because of the ongoing 
litigation, I am not able to comment on that.

    Senator Markey. In a lawsuit that was filed by Federal 
workers yesterday, a Federal worker stated that on March 31st, 
2025, just 2 months ago, a group of DOGE employees visited the 
FDA's office. And that day, someone dressed in a business 
attire yelled, this is DOGE, and this is your last supper as an 
FDA employee.

    Doctor, can you walk me through what happens when someone 
at the Center for Drug Evaluation and Research is fired, in 
terms of who signs off on the termination paperwork, and how 
the notification is sent to employees?

    Dr. Corrigan-Curay. Again because the RIF is involved in 
litigation, I can't comment further on the process, and I am 
not aware of that incident.

    Senator Markey. Yes, well, obviously, you are in a 
difficult position, which I appreciate--I appreciate that. But 
whether it is Makary, or Kennedy, or DOGE who are calling the 
shots, it is obviously going to ripple down into very negative 
consequences for the bio-pharma industry, but for people across 
our Country and nation who are waiting for these drugs to be 
available to help their families.

    It is really--it is a crisis. And combined with all of the 
cuts in NIH research funding, we might as well gift wrap the 
biotech sector as a gift to the Chinese government because this 
is just an absolute tragedy in real time that is unfolding in 
our Nation, and it is just completely unnecessary. So, I thank 
you so much.

    The Chairman. Senator Moody. Husted, I am sorry.

    Senator Husted.

    Senator Husted. Thank you. Appreciate you joining us today. 
The realm of my question is really around the idea that health 
care costs are the most inflationary costs in the 21st century 
in the American economy. And that time is money.

    The faster we can do things, we can lower costs and improve 
access to consumers. And whether it is moving from prescription 
to over-the-counter, whether it is approval of generics, 
whether it is decreasing the time development and approval 
process, parallel approval tracks, all of those things, give me 
your thoughts on how we can go faster, maintain quality, but 
also in everything that FDA touches to reduce the cost of 
delivery ultimately within the economy to our consumers, our 
patients.

    Dr. Corrigan-Curay. Yes, thank you for that. I think there 
is a number of different things we do. For example, on the 
innovative drug side, when we approve a new molecular entity, a 
new drug, a novel drug that has an unmet need, it often 
undergoes priority review. So, we speed up that review.

    In 2024, we approved 50 new drugs. 52 percent were for rare 
diseases. And of those, 56 percent we did priority review. So, 
shaving off the time. We also realize that our role in this is 
really to increase competition. So as I spoke, our generic 
program is very robust and we seek to get generic drugs on the 
market by working to provide clarity on the pathway, by working 
on regulatory science that can make a difference.

    Then the other younger program is a biosimilar, but we are 
seeing that accelerate with the number of approvals we have. 
And again, we have been working on thinking about this--the 
biosimilar to interchangeable that in most cases you don't need 
any additional study.

    We also have convened a meeting with the public and our 
international regulators to think more on how we can rely on 
analytic rather than clinical studies because we know those 
take the longest and are the most expensive. So those are some 
of the areas that we are working on.

    Senator Husted. I know that the issue of AI has been 
discussed in terms of process refinement, but what quantum 
computing and other tools are being used in the health care 
sector to speed development. Do you have any comments or 
thoughts on that and how that can enhance the time?

    Dr. Corrigan-Curay. Yes, we have--yes, thank you. We do 
have a program called Model and Foreign Development in which we 
do modeling, and we use machine learning to look at how we can 
accelerate a review program, maybe looking at different doses 
through modeling.

    Our biostatisticians also do a lot of modeling if they are 
doing complex statistical modeling to see how we work on the 
development program. So we are very committed to using AI. Some 
of our research, I believe, in the generic industry is also--in 
the generic science program also focuses on some AI approaches. 
We can give you more information if you would like.

    Senator Husted. Yes, that would be great. And again, I 
didn't hear you really touch on generic approval and generics--
approval of generics and timeframe around that. Is there any 
thoughts on that?

    Dr. Corrigan-Curay. Again we do have two different tiers in 
the generic. So if it is a first generic or there is not a lot 
of competition, again, we speed up those timelines to really 
try and meet the need.

    We have been meeting the timelines that we have agreed with 
industry, and we will be looking for efficiencies. I think the 
AI, in terms of summarizing some of the paper and 
administrative tasks that are involved, we will try and work on 
that.

    Senator Husted. I am going to give you an opportunity to 
give us some advice. What laws exist that are inhibiting you 
from going faster, and what should we change?

    Dr. Corrigan-Curay. Well, in the generic industry, I think 
one thing would be to make the ingredients transparent so that 
they wouldn't have to ask us the ingredient and the amount. 
That is what we call the Q1, Q2. I think we have put forth 
legislation because we often have to go back and forth on that 
topic. So that would be very helpful. I think what was spoken 
about with the skinny labeling is very helpful to give 
certainty in that area and bring generics. And I think in the 
biosimilar area we have talked about not having this biosimilar 
interchangeable classification and have everything that is a 
biosimilar be interchangeable. I think that would also be quite 
helpful.

    Senator Husted. Great. Thank you.

    The Chairman. We did have a drug bill last December before 
you came in, John, that addressed the Q1, Q2, and so we do hope 
to get that back up.

    Senator Husted. Great. Thank you, Mr. Chairman.

    The Chairman. Senator Kaine.

    Senator Kaine. Senator Hassan.

    Senator Hassan. Thank you, Senator Kaine and Chairman 
Cassidy. And Senator Husted, Senator Paul and I have the Q1, Q2 
bill that the witness was just talking about, and we would love 
it if you would take a look at it too. Dr. Corrigan-Curay, 
thank you for being here today, and thank you for your work at 
the FDA from one Administration to the next. It is really 
important work.

    Before 2015, FDA used a labeling system that made it hard 
for pregnant women to understand the health risks of different 
medications. For example, the old system labeled two very 
different kinds of medications under a single category, 
medications where animal studies suggested risks for pregnant 
women and medications where the risk for pregnant women hadn't 
been studied at all.

    The FDA replaced this system back in 2015, but as of 
earlier this year, there were still several drugs on the market 
using the old, including common medications like antibiotics. 
Senator Budd and I wrote to the FDA in January urging the 
agency to address this issue. Doctor, has the Center for Drug 
Evaluation and Research brought all prescription drug 
manufacturers into compliance with pregnancy labeling 
standards?

    Dr. Corrigan-Curay. Yes, thank you. We now have submissions 
from all of the drugs that were outstanding to put into the 
PLLR labeling.

    Senator Hassan. Thank you. That is really good progress, 
and I appreciate it very much. Now, I understand that over-the-
counter drugs sometimes have pregnancy warnings on the label, 
but the FDA does not have a specific standard for pregnancy 
safety labeling for over-the-counter drugs. Is the FDA working 
to improve the labeling process for over-the-counter drugs as 
well?

    Dr. Corrigan-Curay. I know we do have--in our proposed 
order, we are going to be looking at some labeling for 
pregnancy. I believe it is around the NSAIDs, but we can take 
that under advisement.

    Senator Hassan. I think that would be a really important 
thing to look at, and I would look forward to working with you 
on that. At Commissioner Makary's confirmation hearing, he and 
I discussed lowering drug prices by increasing generic drug 
competition, something we were just talking about.

    Pharmaceutical companies currently use loopholes in the 
patent system to build so-called patent walls around their 
products. The patent walls can block low-cost generic versions 
of medications for decades.

    What steps is the FDA taking--you talked about this a 
little bit with Senator Husted. What steps is FDA taking to 
improve its coordination with patent regulators in the United 
States to facilitate more access to low-cost generics?

    Dr. Corrigan-Curay. Thank you. We have started meeting with 
the Patent and Trade Office and sharing our expertise with 
them. As well as we are cooperating. As you know, the FTC has 
sent some letters about certain products in the Orange Book. We 
are not the experts in this, but we certainly will work with 
the other agencies on these issues.

    Senator Hassan. Well, thank you. I appreciate that. I have 
a bipartisan bill that would improve access to generic drugs by 
closing a loophole through which drug makers currently exploit 
a lack of coordination between the FDA and the Patent Office. 
The bill would allow patients to access lower cost medication 
sooner and would save taxpayers $100 million over a decade.

    I am hopeful that the Chairman and my colleagues on this 
Committee will work with me to advance the legislation. 
Families across the country rely on over-the-counter 
medications to stay healthy, especially during bad cold and flu 
seasons like the one we just had. Unfortunately, in recent 
years, we have seen vulnerabilities in our supply of common 
medications such as children's cold and flu medications.

    In the winter of 2023, many families, including my own, 
could not find children's Tylenol or Motrin on the shelf due to 
extreme increased demand and strain on the supply chain. How 
can Congress help the FDA identify and address vulnerabilities 
in our over-the-counter drug supply chains so we can ultimately 
stop these shortages from happening?

    Dr. Corrigan-Curay. Yes, thank you. And that was a very 
unfortunate time where we had a very rapid increase in demand 
for those medications, and our shortage staff have really 
worked and worked very hard to resolve it like they do with 
other shortages.

    I think one thing that we do have a lot of--we do 
reporting, and you gave us this authority, when there is an 
interruption supply, for example, for manufacturing or a lack 
of API, but we don't have the same required reporting for 
increased demand. So in that case whether we could get--if we 
can get an earlier signal that increased demand could lead to a 
shortage, that is when we can take action.

    Each year--last year in 2024, there were 11 new shortages. 
That is unfortunate. We would like that to be zero. But we 
prevented over 250 shortages. And it is that early action that 
allows us to start doing things quickly in terms of getting new 
suppliers, getting new API. So, demand would be great.

    Senator Hassan. No, that would be something I would be 
really interested in working on. There is nothing like watching 
a child's temperature go up and up and up and not have the 
medication you need to not only get that child comfortable but 
prevent further risks and complications. So, thank you so much. 
Thank you, Mr. Chairman.

    The Chairman. Senator Moody.

    Senator Moody. Thank you, Mr. Chairman. Thank you for being 
here and thank you for your service. We are grateful to you. I 
am from the Sunshine State. I am Ashley Moody. I am the newest 
Senator in the Sunshine State. Sunscreens are really important 
to our almost 24 million citizens.

    This is a topic that I want to get into, and I know that 
speed and delay has been addressed with you. That is an issue 
across Federal agencies. What I am really loving about this new 
Administration, they are focusing on efficiency and getting 
back to the mission of these agencies.

    I am hopeful that we are going to see that on some of these 
issues. I know in your testimony you talked about sunscreen and 
how we can move forward. I think we are basing--trying to get 
new products on the market that may be more effective, and it 
is adding some ingredients.

    Do you expect that to be addressed quickly? Because I 
cannot tell you how important it is to all the golfers, and all 
the beach goers, and all of the Florida folks, and all of the 
tourists by the way--we broke another record in tourism in 
Florida this year--to have that looked at. We want people to be 
safe obviously but is that going to be expeditiously approved?

    Dr. Corrigan-Curay. Yes, so we are very excited to be 
reviewing the first new sunscreen, and we will review that on 
time. We will get the order out and get the public comment. And 
we will meet our goals on that hopefully. It will be a 
special----

    Senator Moody. What is that--what is that timeline? What is 
your goal?

    Dr. Corrigan-Curay. When something--I would have to look at 
exactly when it was submitted. Our timeline for a new 
ingredient is 17 months, which seems long, but it is quite 
different than our other UFAs. So it would have--because it has 
a public comment period, because the public is so involved in 
this process. And so, we have a 45-day comment period, and then 
we get those comments.

    Often the public wants to provide us a lot of comment. We 
have to make sure that we take that comment into respect when 
we then move forward with the final order. And I think what is 
different in the OMUFA and why the timelines look a little bit 
longer is when we are in the PDUFA or GDUFA, it is one company, 
one drug. When we are the OTC monograph, it is one monograph 
that could be many and thousands of drugs.

    We have to make sure that we really get that right when we 
issue that final order. And again we are committed to working 
with companies. They get us that data, as you said, so we make 
sure any of those ingredients that were absorbed are safe. We 
are also looking at alternative test methods to see if they are 
validated and we can use them.

    Senator Moody. I think that is one of the key things. And 
one of the key issues you have been addressing today, I think, 
is speed. We want to make sure we are protecting the health, 
safety, and welfare of Americans, obviously, but we need to 
also make sure bureaucracy is not weighing down what is meant 
to be a protection mechanism.

    It would be my preference, as not just a United States 
Senator but as an American, that Government stay out of our 
business as much as possible. In fact, I think that--if that 
can be achieved, that is what promotes a thriving, successful 
populist country. Only when it is necessary to protect rights 
or safety of our citizens.

    Even there, at the bare minimum. As Attorney General in 
Florida, I once had to fight the Biden administration because 
they wanted to put masks on 2-year-olds while they were 
outside. I mean, it made absolutely no sense. They wanted to 
involve themselves in every facet of American life.

    I, for one, believe that the first thing that should cross 
a bureaucrat's mind when they are going to act is, do we really 
need to be involving ourselves in this issue or in Americans' 
lives? The majority of the time it should be no. But when they 
do, it should be minimized, and we should deliver and act as 
efficiently as possible. And one of the things that I am happy 
about is how quickly we were able to get Naloxone to the 
market. I know that you have been happy about that.

    You used both the monograph drug user fee program and other 
things to make sure that was done. And I believe that is 
significantly contributing to the decrease in deaths as it 
relates to the opioid crisis. In fact, I think nationally we 
saw over a 12 month period a 27 percent decline nationwide.

    In Florida, we exceeded that number, a 30 percent decline. 
But it was not just about interdiction efforts or getting 
people to seek treatment, it was also about access to Naloxone 
and people being able to get that over-the-counter.

    Thank you for that. Was there anything that you can learn 
from working with the drug sponsor, getting information 
quickly, getting that through the process, that we can apply to 
how we are moving forward to making sure we are streamlining 
this program? Because the deadline to reauthorize it is coming 
up quickly, I know.

    If we are going to have a program that is supposed to push 
things forward quicker, if Government is going to involve 
itself in the lives of Americans to protect them, how do we do 
that quicker? Is there something you learned from that in the 
FDA approval of the Naloxone drug to over-the-counter that we 
can apply to this program?

    Dr. Corrigan-Curay. Yes, thank you. And just to clarify, 
the OTC--Naloxone was not under the monograph program because 
they are not monographs, but yes. One of the things that we are 
introducing in OMUFA II is we need to make sure, when we are 
working with a company and they are meeting with us, that we 
are maximizing that time and getting them on the right path.

    One of things that we will do, we will expand those 
meetings if it is complex. We will make sure that we give them 
advice on their protocol synopsis if they need it. And if we 
give them advice and they are still not sure what to do, they 
have the opportunity to ask us to clarify that advice.

    I think making sure that when we interact, it is very clear 
to the company what our expectations are. And I 100 percent 
agree with you, we want to streamline. We want to take a risk-
benefit approach to every action that we do and to try and get 
products to the market that are--to meet an unmet need as 
quickly as possible.

    The Chairman. Thank you.

    Senator Kaine.

    Senator Kaine. Senator Alsobrooks.

    Senator Alsobrooks. Thank you so much. Good morning, Dr. 
Corrigan-Curay. And thank you so for being here today. And I 
also want to just thank you for your service. It is really--it 
is unfortunate, because I know you have been thrust in the 
position today, to answer for many of the very reckless 
decisions of political leadership at the Federal Drug 
Administration.

    But the reality is that this Administration really has been 
unable to answer basic questions about their so-called 
Reduction In Force. Just this week, Commissioner Makary 
canceled a meeting with the Maryland delegation.

    We were just simply asking about the impact of the 
Administration's cuts to my state. I have been waiting, for 
example, for 7 weeks now for specific answers from the 
department, and we just need to know how many staff at FDA have 
received a RIF notice.

    We would like to know how many participated in the Deferred 
Resignation Program, were terminated on the basis of their 
probationary status, or are concurrently on administrative 
leave pending termination. I don't like the term Reduction In 
Force because it softens, I believe, the reality of what has 
happened.

    It is the very heartless and cruel firing of thousands of 
very critical civil servants without cause and without an ounce 
of thought about the potential consequences to public health 
and safety.

    Public health and safety is what brings us here today. I 
know that we are here to talk about reauthorizing the over-the-
counter monograph drug user fee program to keep Americans safe, 
and we also know that the Administration has terminated 3,500 
staffers from the FDA, including at the Center for Drug 
Evaluation and Research, which undermines its ability to do--to 
really operate.

    I want to just make very clear to the public, because these 
staffing cuts have really been--they have been framed as 
duplicative or administrative staff that have no bearing on 
public health, but the truth of the matter is that these staff 
members really contribute to the core functions of the FDA to 
keep humans safe.

    Each of them makes sure that, for example, pharmaceutical 
advertising is accurate, that the public is aware of potential 
risks, that drug shortages are mitigated, and that approvals 
are conducted in a timely manner.

    I understand that you are not able to answer specific 
questions about the so-called Reduction In Force. But instead, 
I hope that you can demonstrate today the importance of the 
work that the civil servants do every day and to talk generally 
about the implications of it.

    Just quickly, can you briefly share what the Center, for 
example, for Drug Evaluation and Research does every day?

    Dr. Corrigan-Curay. Yes, thank you. So, in the Center for 
Drug Evaluation and Research, we oversee several different 
programs, including obviously the OMUFA program and the OTC.

    Our Office of Non-Prescription Drugs, I can tell you, we 
have had very little loss in that office. That is the office 
that is primarily. We review new drugs that are coming through. 
We work with the sponsors.

    We have meetings on development programs. We review safety 
data in the post-marketing and make sure that the labels were 
up to date. We do review direct-to-consumer advertising and 
make sure promotion.

    As I said, we work on generic drugs. That is a big priority 
to get additional generic drugs in competition. In the 
biosimilar space, we are reviewing biosimilars and we have a 
regulatory science program under that to develop the science to 
bring those drugs to the forefront sooner.

    Then we need to--we always communicate what we are doing. 
We are putting out. We have Advisory Committees when needed to 
bring further transparency and get additional expertise to 
inform our decisions.

    Senator Alsobrooks. These are critical staff. The Center's 
Office of Pharmaceutical Quality, can you just talk to us about 
what those staff members--I know you said there have been very 
few cuts, but cuts in any of these areas I think really do 
impact public health. So can you just tell us what the Center--
the Center's Office for Pharmaceutical Quality does?

    Dr. Corrigan-Curay. Yes, and I am sorry. I should have 
mentioned that because they are really core to all our 
programs. They are responsible for looking at the manufacturing 
of--and the quality of the drug manufacturing.

    Under--for example, under OMUFA II, we are going to put 
more resources so that when a facility comes and starts to 
market an OTC monograph, that we quickly evaluate that 
facility. That we get those records requests out there. That we 
are going to update our risk model to make sure we are taking 
appropriate--and selecting the facilities that we need to do an 
inspection on.

    They do carry that out for our biosimilars and for our 
generics and our new drugs as well. And they are also working--
just sort of be very forward-working. So when we--there is a 
priority by the Administration to try and bring our 
manufacturing back and for supply chain reasons, and we have 
been thinking about that and understand that companies would 
probably want to use advanced manufacturing to be more 
competitive.

    Several years ago we started a special program to work with 
manufacturers. So when they want these new technologies, they 
can come talk to us early and we can give them advice and get 
them on the right path.

    Senator Alsobrooks. Thank you so much. So the work you do 
is critical. All of these staff are critical as well. Just 
making the point that they are not wasteful. These are critical 
to our public health and safety. Thank you so much. I yield.

    The Chairman. Senator Banks.

    Senator Banks. Thank you, Mr. Chairman. Doctor, what 
improvements will the public see in the products on their drug 
store shelves if Congress reauthorizes OMUFA for another 5 
years?

    Dr. Corrigan-Curay. Yes, thank you for that question. I 
think the first thing I would mention, the order that we just 
did, which would allow certain drugs to be changed from just a 
tablet or a capsule into an oral dissolving or a chewable 
capsule or a film. And I think that will be a lot of innovation 
that will make these drugs more accessible to children and for 
those who have trouble swallowing.

    As I said, the more that we innovate with the industry by 
providing them further guidance, by meeting with them and 
making sure they have clarity on our expectations. We are going 
to do some webinars on the GRAS standard and talk to them about 
confidentiality guidance when they are doing a new ingredient.

    All those things we think are going to speed up innovation, 
and we hope to see additional OTC orders come out on new 
products.

    Senator Banks. On that point, the monographs and user fees 
are supposed to streamline the FDA's process to approve over-
the-counter drugs so better products come to market faster. But 
that only happens when the FDA uses that authority. How are you 
going to make better use of the OMUFA authority over the next 5 
years to encourage that type of innovation?

    Dr. Corrigan-Curay. Again, the commitments that we have 
agreed to is really to make the meetings with our companies, 
make them as productive as possible, extend them if we need to, 
give them advice on their protocol synopsis so they get their 
products.

    We are also going to ask to create a new tier two so they 
can update their test methods, and that may be more efficient. 
We are going to continue to give them education on the GRAS 
standards, on how to submit their orders and what should be in 
there, and their eligibility for that.

    We are going to also make sure that we are being very 
transparent in all of this, including all the historical 
documents that will be up on the web so everyone can learn from 
those. They can learn all the issues that we identify in the 
quality, and we will do some work on good manufacturing 
practices so that the expectations are clear. And when the 
expectations are clear, I think that allows for innovation.

    Senator Banks. On another point, I am curious, why doesn't 
the FDA inspect more overseas facilities that export over-the-
counter drugs to the U.S.?

    Dr. Corrigan-Curay. Right now we do use a risk-based model 
to determine where our inspections, and we do inspections 
overseas and domestically. And we can get you those exact 
numbers. I don't have them off the top of my head.

    One of the things we will do is we are going to update our 
risk-based model and make sure it is taking into account any 
factors that may be specific to OTC monograph facilities, and 
that would determine inspections. We are also going to more 
rapidly do those record requests to assess the facilities that 
might need an inspection that are coming.

    Senator Banks. Do you think, are there loopholes there that 
allow for some overseas facilities not to be as inspected as 
much?

    Dr. Corrigan-Curay. In terms of if we can do the 
inspection, what is different in the OTC monograph space is in 
the other UFAs, there is a time point in which we can do the 
inspection before the product comes to the market.

    Whereas in this, in the OMUFA, there isn't that one time 
point. They can come into and register with us and start to 
distribute, and then we start the assessment of that facility.

    Senator Banks. Mr. Chairman, contaminated, non-sterile eye 
drops coming from China and other countries have been a problem 
for years. I would like to enter three different letters, FDA 
warning letters to these companies into the record.

    The Chairman. Without objection.

    [The following information can be found on page 35 in 
Additional Material:]

    Senator Banks. Doctor, how do you determine whether these 
over-the-counter drugs actually follow the monographs and are 
safe or whether they are safe, or whether they are fraudulent 
and dangerous?

    Dr. Corrigan-Curay. Again, we looked for reports with the 
eye drops. We did do--we had adverse events, and we followed up 
on them. We issued the warning letters.

    We do inspections to see. So we do monitor the safety of 
the products on the market, and that is how we do a risk-based 
approach to that.

    Senator Banks. Okay. I would like to dig into that further 
at another time. Thank you, Mr. Chairman. I yield back.

    The Chairman. Thank you. Senator Kaine.

    Senator Kaine. Thank you, Dr. Corrigan-Curay. I am going to 
focus my 5 minutes on transparency, which has been mentioned by 
many of my colleagues and you have mentioned it in your 
testimony.

    I think it needs to be a hallmark of this particular 
program, and it also matches up with the values that Secretary 
Kennedy talked about when he has been here before us. And I 
have been troubled that while transparency is a goal, there is 
this one area where we just can't get answers.

    I asked Secretary Kennedy about people, the number of 
people who have been RIF or took the Fork in the Road 
Initiative and he could not answer. At the time, he didn't have 
the number at his fingertips. But when I did a follow-up 
letter, I still have not gotten a response.

    That was kind of an interesting contrast to how customer-
focused Secretary Kennedy was in my questioning of him when he 
was recently before us. I raised the issue of his response to 
some of my constituents who were writing in about concerns and 
they were getting response from HHS--it was actually a CMS 
response saying because of the change in Administration, we can 
no longer entertain these kinds of questions.

    When I showed that, Secretary Kennedy went back and he 
found that was an improper response, and he told me that it 
was, and he said he was going to correct it, and this wasn't 
authorized. So he actually responded to my concern about that. 
And I think Senator Murray had a particular constituent concern 
that she raised, and he was very solicitous, we want to respond 
to that.

    It seems like there is this sort of gag order on talking 
about the number of people that are employed or the number of 
people that are RIF. And for an Oversight Committee that is 
trying to exercise oversight over these programs, or even 
trying to decide what is the right way to reauthorize a program 
so that it can be effective, more effective, if we can't get an 
answer about kind of this basic issue, it hobbles us in our 
ability to do our job.

    I know that policy decisions of this kind are probably not 
yours, but let me just ask if you could answer this question, 
within the Center for Drug Evaluation and Research, how many 
people were subject to the RIF issued by Secretary Kennedy?

    Dr. Corrigan-Curay. Again, because it is under litigation, 
I am not allowed to, or I can't discuss specifics, but we would 
be very happy when that litigation is resolved to come back and 
provide you those numbers.

    Senator Kaine. I am assuming you would answer the same way 
if I ask you the question about how many of these folks who 
were RIF were veterans.

    Dr. Corrigan-Curay. Um----

    Senator Kaine. You would answer the same way?

    Dr. Corrigan-Curay. I would answer the same way.

    Senator Kaine. You and I both went to law school. And I 
have had to give a lot of advice to witnesses about not talking 
about pending litigation. And so, I didn't ask you who was 
involved in the discussion, who was involved the decision, what 
was the rationale for the decision. Were there different 
rationales.

    I haven't asked you any of that. All I have asked you is 
the factual question, which is public--it should be public 
information because the public is paying for all of this, about 
the numbers of people.

    The fact that I can't get that answer from you, from 
Secretary Kennedy. We have similar questions of folks who have 
been here from the Department of Labor. Nobody wants to answer 
the question, how many people have been laid off and what 
percentage of veterans.

    Now, the veterans issue matters to me as a Virginian 
because we are such a veteran heavy state. I have asserted, 
based on what I have been able to cobble together, that this 
Administration has fired more veterans than any Administration 
in the history of the United States. That is based on what I 
have been able to cobble together. I would like to be proven 
wrong.

    Maybe if I got the answers to my questions, I am making an 
assertion that is incorrect. But I think I am entitled to the 
information. I know you have been instructed not to answer it. 
It is not that you can't, and it is not that you won't. It is 
that you have been instructed not to. But I will say, pending 
litigation is not really an excuse for not answering a basic 
factual question the knowledge of which is within the ambit of 
the Administration.

    On transparency, I do have some proposals about the 
reauthorization. You did a good job in your testimony of kind 
of laying out, if this program is not reauthorized, here are 
some bad things that can happen.

    But also, I know the Chairman is very much into this idea, 
if you are going to reauthorize, we don't just reauthorize as 
is. We should reauthorize and improve. There have been 
obviously longer-standing, more established user fee programs 
where there is lessons learned about how we can improve.

    I have been getting feedback from groups about how this 
particular OMUFA program can be improved. With the updates that 
I am proposing that are in the transparency space, we would be 
able to have question answers to questions like how many OTC 
monographs were filed and approved during a fiscal year.

    Which drug facility and contract manufacturing 
organizations have actually paid their user fees instead of 
only having visibility into those who haven't paid their users 
fees. How is the FDA addressing post-market safety for OTC 
products.

    I think a lot of the questions today have kind of wrapped 
around that important topic, including how the agency responds 
to individual reports of adverse events. My hope is that we 
will do this bill. I think it is going to be bipartisan. I 
think we cannot only reauthorize but improve by taking some of 
the lessons from the other similar programs.

    Pro-transparency initiatives are things that I think are 
going to get pretty nice support on both sides of the dais 
here. With that, I yield back.

    The Chairman. I have a couple of follow-ups. How many Rx to 
OTC drugs in the last 1 year, 2 year, 3 years, how many have 
actually made that transition from being a prescription only to 
be an OTC?

    Dr. Corrigan-Curay. Thank you for that question. I know 
that the Naloxone would have been in 2023. And I think the Opil 
was also around that time. I would have to go back further and 
get you the details on the rest of the drugs.

    The Chairman. Marshall asked about a dashboard, but that 
seems to be rubber hits the road. We have only had three drugs 
in the last two and a half years that have gone from Rx to OTC.

    Dr. Corrigan-Curay. I believe that is correct. For some 
reason, I think I am forgetting one, but I will get back to 
you.

    The Chairman. That just seems like a not very productive 
record.

    Dr. Corrigan-Curay. Again, I think the issue is we do need 
to find drugs--drugs are safe--that are safe for a population, 
for anyone to walk in, and look at that drug facts label, and 
appropriately self-select and use that drug.

    We need to look at the drugs that we have and think if that 
is appropriate and look at the development programs. And I 
think that is why the new rule that we have coming out is 
really meant to try and open up that space more.

    Because for any drug, it may be relatively safe in this 
population, and it may, but we are--sometimes a drug fact label 
is not sufficient for just those folks to understand that is a 
drug for them, and it is not for others.

    The Chairman. That is true of everything. Non-steroidals, 
you shouldn't take if you have a history of active peptic ulcer 
disease.

    Dr. Corrigan-Curay. Right.

    The Chairman. Yet we have approved non-stereoidals all over 
the place. And so, we are willing to accept that somewhat of a 
risk. And so, for the greater good. And turns out we have--it 
worked out. Not that many people are taking non-steroidals and 
exacerbating their peptic ulcer disease.

    Dr. Corrigan-Curay. Right, that is true. We did----

    The Chairman. I just want to lean into this because, I 
mean, this costs consumers a heck of a lot of money to go to a 
doctor to get a prescription for something which they could 
safely take OTC.

    Dr. Corrigan-Curay. Yes, I agree. And we are going to look 
for opportunities. And as I said, I think the new rule in which 
we can sort of just--it is adding something in the self-
selection to the drug facts label has the real potential to 
open up for other conditions that could be for chronic 
conditions and open up consumer choice. And so we are going to 
work with--to finalize that rule and work on development 
programs that could come under that rule.

    The Chairman. I asked this earlier, but I didn't quite 
follow the answer, so I will finish with this. Do you feel as 
if this final rule--that you have the tools, particularly with 
this final rule, to expedite the transition from Rx to OTC, or 
does Congress need to do something to kind of light a fire?

    Dr. Corrigan-Curay. I think with this rule, that we have a 
new tool that is going to be very powerful and effective for us 
to move things from Rx to OTC.

    The Chairman. Would you expect the new rule to be 
implemented?

    Dr. Corrigan-Curay. The rule was--the implementation was 
delayed. I think it should be the end of May, but I need to 
check. There was a delay after we had the transition.

    The Chairman. Okay. Yes?

    Senator Kaine. I have a follow-up just based upon the 
Chairman's questions.

    To what degree was the fact that there have only been three 
or four Rx to OTC in the relevant time period he was 
discussing, to what degree is that a function of just sheer 
personnel or resources within CDER versus the regulatory 
structure that shapes what can be approved?

    Dr. Corrigan-Curay. I would say in the last 5 years, it is 
more about the regulatory structure and what can be 
appropriately put over-the-counter and selected.

    Senator Kaine. Hopefully this new rule, when it becomes 
effective, will help you accelerate.

    Dr. Corrigan-Curay. Yes.

    Senator Kaine. Thank you.

    The Chairman. Okay. For any Senator wishing to ask 
additional questions, questions for the record will be due on 
10 business days on June 18th at 5.00 p.m.. Thank you very 
much, Dr. Corrigan-Curay.

    Dr. Corrigan-Curay. Thank you.

    The Chairman. The Committee stands adjourned.

                          ADDITIONAL MATERIAL
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 

    [Whereupon, at 11:22 a.m., the hearing was adjourned.]

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