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Over-the-Counter Monograph Drug User Fee Amendments
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
88pct
55d open
vs 5,674 other S bills in the 119th — cohort avg 32d
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.
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Filing registrants (10)
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. 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
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2026 · third_quarter · Health Issues
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 2025 Clinical Laboratory Improvement Amendment
Client expense: $2,047,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2026 · third_quarter · Health Issues
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 Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act H.R.6868 - ACCESS Through OTC Innovation Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) H.R.6868 - To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes. S.3122 - Better FDA Act of 2025 H.R.7366 - Dietary Supplement Regulatory Uniformity Act S.3788 - CLEAR LABELS Act - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule H.R. 10336 - Dietary Supplement Innovation Act
Client expense: Not reported · Firm income: $146,407
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2026 · second_quarter · Health Issues
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 2025
Client expense: $580,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · second_quarter · Health Issues
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 Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) H.R.6868 - To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes. S.3122 - Better FDA Act of 2025 H.R.7366 - Dietary Supplement Regulatory Uniformity Act S.3788 - CLEAR LABELS Act - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule - Dietary Supplement Drug Preclusion - legislation intended to clarify ingredients that can be used in dietary supplements.
Client expense: Not reported · Firm income: $199,750
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2026 · first_quarter · Health Issues
Issues related to implementation 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 products supply chain; Issues related to FY2027 appropriations report language.
Client expense: Not reported · Firm income: $70,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
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 2025
Client expense: $620,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2026 · first_quarter · Health Issues
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 Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) H.R.6868 - To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes. S.3122 - Better FDA Act of 2025 H.R.7366 - Dietary Supplement Regulatory Uniformity Act - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule - Dietary Supplement Drug Preclusion - legislation intended to clarify ingredients that can be used in dietary supplements.
Client expense: Not reported · Firm income: $159,409
2025 · fourth_quarter · Health Issues
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 Standards Act
Client expense: $120,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
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 Construction and Veterans Affairs, and Extensions Act, 2026, H.R.5371 (Sec. 6506).
Client expense: $79,373 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
General monitoring of legislative and administrative action related to health care policy; including the reauthorization of the OTC Monograph Drug User Fee Program (OMUFA); H R.5371 - 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 Services to apply the least 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 monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of coverage for medically necessary services in Medicare and Medicare Advantage, Review of legislation impacting the Dietary Supplement Health and Education Act of 1994; General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options; and General monitoring and review of Executive Order 14273, particularly section 9(b) as related to improvements to the process through which prescription drugs can be reclassified as over-the-counter medications, including recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter. Monitoring and review of federal rulemaking processes on Increasing Access to Nonprescription Drugs.
2025 · fourth_quarter · Health Issues
Issues 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.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
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 2025
Client expense: $450,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
Issues related to healthcare and payment for over-the-counter drugs; General education of over-the-counter switches, including reauthorization 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).
Client expense: Not reported · Firm income: $50,000
2025 · fourth_quarter · Consumer Issues/Safety/Products
Issues related to regulation of cosmetics, including sunscreen regulation and the implementation of the Modernization of Cosmetics Regulation Act as enacted as part of the Consolidated Appropriations Act (PL 117-328). Issues related to the regulation of over-the-counter products, including H.R.4273/S.2292, Over-the-Counter Monograph Drug User Fee Amendments, and H.R.5371, Continuing Appropriations and Extensions Act, 2026.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · fourth_quarter · Health Issues
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 Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) H.R.6868 - To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to apply the least burdensome appropriate means for supporting certain administrative order requests with respect to over-the-counter monograph drugs, and for other purposes. S.3122 - Better FDA Act of 2025 - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule - The Dietary Supplement Regulatory Uniformity Act - legislation that would restore a national standard for dietary supplements. - Dietary Supplement Drug Preclusion - legislation intended to clarify ingredients that can be used in dietary supplements.
Client expense: Not reported · Firm income: $245,484
2025 · third_quarter · Health Issues
- US House of Representatives: SUNucate 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
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Health Issues
General monitoring of legislative and administrative action related to health care policy; including the reauthorization of the OTC Monograph Drug User Fee Program (OMUFA); H R.5371 - 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 Transparency Act; General monitoring of legislative and administrative action related to womens health issues; General monitoring of legislative and administrative action related to over-the-counter consumer healthcare products; General monitoring of legislative and administrative action related to dietary supplements, multivitamin, and hunger issues; General monitoring of legislative and administrative action related to FDA monograph reform and user fees; General monitoring of legislative and administrative action related to the switch of prescription medications to over-the-counter medications; Review of coverage for medically necessary services in Medicare and Medicare Advantage, Review of legislation impacting the Dietary Supplement Health and Education Act of 1994; General review of legislation and amendments focusing on non-addictive, non-opioid pain management medications, with a focus on over-the-counter (OTC) options; and General monitoring and review of Executive Order 14273, particularly section 9(b) as related to improvements to the process through which prescription drugs can be reclassified as over-the-counter medications, including recommendations to optimally identify prescription drugs that can be safely provided to patients over the counter.
Client expense: $220,000 · Firm income: Not reported
2025 · third_quarter · Consumer Issues/Safety/Products
Issues related to regulation of cosmetics, including sunscreen regulation and the implementation of the Modernization of Cosmetics Regulation Act as enacted as part of the Consolidated Appropriations Act (PL 117-328). Issues related to the regulation over-the-counter products, including H.R.4273/S.2292, Over-the-Counter Monograph Drug User Fee Amendments, and H.R.5371, Continuing Appropriations and Extensions Act, 2026.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Health Issues
Issues 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 switches; Issues related to the Continuing Appropriations and Extensions Act, 2026 (H.R. 5371).
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Health Issues
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 Standards Act
Client expense: $110,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Health Issues
Issues related to healthcare and payment for over-the-counter drugs; General education of over-the-counter switches, including reauthorization 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.
Client expense: Not reported · Firm income: $50,000
2025 · third_quarter · Health Issues
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
Client expense: $1,100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Health Issues
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.
Client expense: $160,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2025 · third_quarter · Health Issues
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 Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act, 2026 S.2491 - SAFE Sunscreen Standards Act S.2529 - A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches (SMART OTC Act) - Activity related to Acetaminophen use - Nonprescription Drug Product with an Additional Condition for Nonprescription Use Rule - Legislative language on General Recognition of Safety and Effectiveness
Client expense: Not reported · Firm income: $254,122
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
Client expense: $210,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of
Government targets: HOUSE OF REPRESENTATIVES, SENATE