S 2292 119th Congress
Over-the-Counter Monograph Drug User Fee Amendments
A bill 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.
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Bill journey
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Introduction Congress.gov
Introduced
Introduced in the Senate.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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Introduced in Senate
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Introduced in Senate
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Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
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Reported to Senate
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View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Health, Education, Labor, and Pensions. | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionPlaced on Senate Legislative Calendar under General Orders. Calendar No. 152. | No additional detail supplied.Calendars · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Library of Congress · Code 14000 | Congress.gov | |
| Text versionReported to Senate | A dated text-version record is available. | Congress.gov |
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Congressional Research Service
CRS summary
Over-the-Counter Monograph Drug User Fee AmendmentsThis 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.
Official documents
Text versions
- Reported to SenateSep 8, 2025
- Introduced in SenateJul 15, 2025