119th Congress · introduced in the Senate · Jul 15, 2025
Over-the-Counter Monograph Drug User Fee Amendments
Official title from Congress.gov
Latest action (Sep 8, 2025): Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Reported to Senate (Sep 8, 2025)
Over-the-Counter Monograph Drug User Fee Amendments
This bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA); revises procedures used by the Food and Drug Administration (FDA) to evaluate topical, nonprescription drugs (e.g., sunscreens); and requires the FDA to clarify the process through which a prescription drug may be switched to nonprescription status.
Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the FDA, rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective. The bill reauthorizes the collection of OMUFA fees from OTC drug facilities through FY2030 and revises methods for calculating such fees.
Separately, the bill requires the FDA to allow for the use of real-world evidence to demonstrate the safety and effectiveness of active ingredients in topical, nonprescription drugs. The FDA must consider nonclinical tests and other alternatives to animal testing in evaluating such drugs.
The FDA must also issue guidance to clarify the application process for nonprescription drugs, including applications to switch a prescription drug to nonprescription status. The FDA must plan to engage stakeholders in identifying drugs that are promising candidates for a switch. Moreover, applicants seeking a switch may request to meet with the FDA to develop a plan for the requisite application.
Finally, the Government Accountability Office must report on (1) the OTC monograph drug supply chain, and (2) the FDA’s handling of applications to switch a prescription drug to nonprescription status.
Includes 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 Senate Legislative Calendar under General Orders. Calendar No. 152.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Actions from Congress.gov, newest first.
Congressional oversight · Drug safety, medical device, and laboratory regulation · Supply chain · 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.
17 citations.
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 Act of…
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 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 Act of…
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
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 20, 2026 · issue area: Health Issues
$70,000
Paid to lobbying firm
…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 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
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 Act of…
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 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) Sunscreen Sta…
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, Military…
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
…ast burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes. S.2292 - Over-the-Counter Monograph Drug User Fee Amendments; S.2513 - OTC Monograph Drug User Fee Transparency Act; S.3122 - Better FDA Act of 2025 General monitorin…
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
…ted 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 Act of…
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
…er-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
AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY ASSOCIATION · lobbying firm or registrant: AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY ASSOCIATION
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Nov 6, 2025 · issue area: Health Issues
Amount not reported
…Coalition Letter to House Subcommittee on Health: RE: Support H.R. 3686, the SAFE Sunscreen Standards Act - US Congress: SUNucate Coalition Letter RE: Support S.2292, the Over-the-Counter Monograph Drug User Fee Amendments
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. 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
…icular 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 Transparency Act; General monitoring of legislative and administrat…
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
…ed 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 switches;…
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) Sunscreen Standa…
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
…er-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 Therapeutics OTC 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