119th Congress · introduced in the House · Jul 2, 2025
Over-the-Counter Monograph Drug User Fee Amendments
Official title from Congress.gov
Latest action (Sep 17, 2025): Placed on the Union Calendar, Calendar No. 254.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in House (Jul 2, 2025)
Over-the-Counter Monograph Drug User Fee Amendments
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through FY2030 and revises certain aspects of the program, including total fees to be collected and fee due dates.
Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the Food and Drug Administration (FDA), rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective, and include ingredients, dosages, and other requirements. OMUFA permits the FDA to collect fees from OTC drug facilities and entities requesting changes to a monograph.
The bill makes certain changes to OMUFA, including by
• revising the total facility fee revenue amount to be collected for FY2026-FY2030,
• revising due dates for facility fees,
• permitting the FDA to implement a one-time adjustment to facility fees if certain conditions exist, and
• requiring the FDA to publish facility and order request fee amounts at least 60 days before the start of each fiscal year.
Finally, the bill adds as a Tier 2 OTC monograph order request a request for the addition or modification of a testing procedure applicable to a monograph drug, provided the testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality. (Requestors seeking certain kinds of changes to a monograph are awarded a period of market exclusivity if the FDA makes the requested changes; tier 2 requests are not eligible for market exclusivity.)
Show less of the summaryIncludes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Placed on the Union Calendar, Calendar No. 254.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
Committee Consideration and Mark-up Session Held
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Actions from Congress.gov, newest first.
Congressional oversight · Drug safety, medical device, and laboratory regulation · User charges and fees
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsCoverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 24, 2026.
27 citations; showing the 25 most recently posted.
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION · lobbying firm or registrant: AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 19, 2026 · issue area: Health Issues
$2,047,000
Spent on own lobbying
H.R. 3686, the SAFE Sunscreen Standards Act; H.R. 4273/S. 2292, Over-the-Counter Monograph Drug User Fee Amendments; H.R. 5509/S. 2903, the Safe Step Act; H.R. 4002, the Patient Access to Higher Quality Health Care…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 13, 2026 · issue area: Health Issues
$146,407
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standard…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION · lobbying firm or registrant: AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Health Issues
$580,000
Spent on own lobbying
H.R. 3686, the SAFE Sunscreen Standards Act; H.R. 4273/S. 2292, Over-the-Counter Monograph Drug User Fee Amendments; H.R. 5509/S. 2903, the Safe Step Act; H.R. 4002, the Patient Access to Higher Quality Health Care…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 14, 2026 · issue area: Health Issues
$199,750
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standard…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CHATTEM, INC. DBA OPELLA · lobbying firm or registrant: AKIN GUMP STRAUSS HAUER & FELD
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Health Issues
$70,000
Paid to lobbying firm
…mentation of the OTC Drug Monograph User Fee Program reauthorization and non-prescription drug status - The Over-the-Counter Monograph Drug User Fee Amendments H.R. 4273/S. 2292; S. 2529 - The SMART OTC Act; Division F, Title V of The Continuing Appropriations and Extensions Act, 2026 - H.R. 5371; Issues related to consumer hea…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION · lobbying firm or registrant: AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 16, 2026 · issue area: Health Issues
$620,000
Spent on own lobbying
H.R. 3686, the SAFE Sunscreen Standards Act; H.R. 4273/S. 2292, Over-the-Counter Monograph Drug User Fee Amendments; H.R. 5509/S. 2903, the Safe Step Act; H.R. 4002, the Patient Access to Higher Quality Health Care…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 14, 2026 · issue area: Health Issues
$159,409
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standard…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
THE PROCTER AND GAMBLE COMPANY · lobbying firm or registrant: THE PROCTER AND GAMBLE COMPANY
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 26, 2026 · issue area: Health Issues
$527,000
Spent on own lobbying
-H.R.4273 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, and for other purposes. -Is…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PERSONAL CARE PRODUCTS COUNCIL · lobbying firm or registrant: THE PERSONAL CARE PRODUCTS COUNCIL
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Health Issues
$120,000
Spent on own lobbying
H.R. 4273 / S.2292, Over-the-Counter Monograph User Fees Act (issues related to the OMUFA program); H.R. 3686, Supporting Accessible, Flexible, and Effective (SAFE) Suns…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
S.C. JOHNSON & SON, INC. · lobbying firm or registrant: S.C. JOHNSON & SON, INC.
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Health Issues
$79,373
Spent on own lobbying
Over-the-Counter Monograph User Fees Act (reauthorization of OMUFA program), H.R. 4273 / S.2292. Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act, H.R. 3686. Continuing Appropriations, Agriculture, Legislative Branch,…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
HALEON US HOLDINGS LLC · lobbying firm or registrant: HALEON US HOLDINGS LLC
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Health Issues
$210,000
Spent on own lobbying
…71 - Continuing Appropriations and Extensions Act, 2026, in particular provisions under Title V related to Over-the-Counter Monograph Drug User Fee Amendments. H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments; H.R.6868 - To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CHATTEM, INC. DBA OPELLA · lobbying firm or registrant: AKIN GUMP STRAUSS HAUER & FELD
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Health Issues
$60,000
Paid to lobbying firm
…ssues related to OTC Drug Monograph User Fee Program reauthorization and non-prescription drug status - The Over-the-Counter Monograph Drug User Fee Amendments H.R. 4273/S. 2292; S. 2529 - The SMART OTC Act; Division F, Title V of The Continuing Appropriations and Extensions Act, 2026 - H.R. 5371.
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION · lobbying firm or registrant: AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Health Issues
$450,000
Spent on own lobbying
H.R. 3686, the SAFE Sunscreen Standards Act; H.R. 4273/S. 2292, Over-the-Counter Monograph Drug User Fee Amendments; H.R. 5509/S. 2903, the Safe Step Act; H.R. 4002, the Patient Access to Higher Quality Health Care…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
HALEON US HOLDINGS LLC · lobbying firm or registrant: CROSSROADS STRATEGIES, LLC
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 19, 2026 · issue area: Health Issues
$50,000
Paid to lobbying firm
…of the Over-the-Counter Monograph Drug User Fee Act and policies impacting a Nonprescription Drug Product with an Additional Condition for Nonprescription Use; H.R.4273/S.2292, Over-the-Counter Monograph Drug User Fee Amendments; FY2026 Continuing Appropriations and Extensions Act (H.R.5371/P.L.119-37).
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 14, 2026 · issue area: Health Issues
$245,484
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standard…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
THE PROCTER AND GAMBLE COMPANY · lobbying firm or registrant: THE PROCTER AND GAMBLE COMPANY
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 22, 2025 · issue area: Health Issues
$751,000
Spent on own lobbying
-H.R.4273: Over-the-Counter Monograph Drug User Fee Amendments (Entire Bill)
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
HALEON US HOLDINGS LLC · lobbying firm or registrant: HALEON US HOLDINGS LLC
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Health Issues
$220,000
Spent on own lobbying
…71 - Continuing Appropriations and Extensions Act, 2026, in particular provisions under Title V related to Over-the-Counter Monograph Drug User Fee Amendments. H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments; S.2292 - Over-the-Counter Monograph Drug User Fee Amendments; S.2513 - OTC Monograph Drug User Fee Trans…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
NATIONAL ASSOCIATION OF MANUFACTURERS · lobbying firm or registrant: NATIONAL ASSOCIATION OF MANUFACTURERS
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Health Issues
$1,902,000
Spent on own lobbying
340B Reform ERISA - Employer Sponsored Health Insurance ERISA preemption H.R. 4273, Over-the-Counter Monograph Drug User Fee Amendments Interim Final Rule (RIN 0694-AJ95) on Cytometers and Mass Spectrometry Equipment Medicare Drug Price Negot…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CHATTEM, INC. DBA OPELLA · lobbying firm or registrant: AKIN GUMP STRAUSS HAUER & FELD
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Health Issues
$60,000
Paid to lobbying firm
…sues related to OTC Drug Monograph User Fee Program reauthorization and non-prescription drug status - The Over-the-Counter Monograph Drug User Fee Amendments (H.R. 4273/S. 2292); Issues related to S. 2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription sw…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PERSONAL CARE PRODUCTS COUNCIL · lobbying firm or registrant: THE PERSONAL CARE PRODUCTS COUNCIL
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 19, 2025 · issue area: Health Issues
$110,000
Spent on own lobbying
H.R. 4273 / S.2292, Over-the-Counter Monograph User Fees Act (reauthorization of OMUFA program); H.R. 3686, Supporting Accessible, Flexible, and Effective (SAFE) Sunscre…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
HALEON US HOLDINGS LLC · lobbying firm or registrant: CROSSROADS STRATEGIES, LLC
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 19, 2025 · issue area: Health Issues
$50,000
Paid to lobbying firm
…of the Over-the-Counter Monograph Drug User Fee Act and policies impacting a Nonprescription Drug Product with an Additional Condition for Nonprescription Use; H.R.4273/S.2292, Over-the-Counter Monograph Drug User Fee Amendments; H.R.5371, Continuing Appropriations and Extensions Act, 2026.
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION · lobbying firm or registrant: AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 16, 2025 · issue area: Health Issues
$1,100,000
Spent on own lobbying
H.R. 3686, the SAFE Sunscreen Standards Act; H.R. 4273/S. 2292, Over-the-Counter Monograph Drug User Fee Amendments; H.R. 5509/S. 2903, the Safe Step Act
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CHATTEM, INC D/B/A OPELLA · lobbying firm or registrant: CHATTEM, INC D/B/A OPELLA
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 15, 2025 · issue area: Health Issues
$160,000
Spent on own lobbying
H.R.4273 - Over-the-Counter Monograph User Fee Amendments; S.2292 - Over-the-counter Monograph User Fee Amendments; S.2529 - The Streamlining Market Access for Therapeu…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 15, 2025 · issue area: Health Issues
$254,122
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standard…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
THE PROCTER AND GAMBLE COMPANY · lobbying firm or registrant: THE PROCTER AND GAMBLE COMPANY
2025 Q2 report (Apr 1, 2025 – Jun 30, 2025) · posted Jul 21, 2025 · issue area: Health Issues
$1,320,000
Spent on own lobbying
…d to over the counter drug policy -Issues related to ingredient labeling -H.R. 3749(IH) Health and Endocrine Research on Personal Care Products for Women Act* -H.R.4273 To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, and for other purposes
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing