Over-the-Counter Monograph Drug User Fee Amendments

Summary

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.

Summary from the Congressional Research Service. How we handle summaries

Where it stands

Out of committee and scheduled for a vote by the full chamber.

Senate Committee on Health, Education, Labor, and Pensions · U.S. Senate

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Cosponsors

Related bills

• H.R. 4273Over-the-Counter Monograph Drug User Fee AmendmentsRelated bill
• S. 2529A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.Related bill

As identified by Congress.gov.

Full history

1. Sep 8, 2025

   Reported out of committee

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

2. Sep 8, 2025

   Reported out of committee

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

3. Sep 8, 2025

   Reported out of committee

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

4. Sep 8, 2025

   Introduced

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.

   U.S. Senate

5. Sep 8, 2025

   Placed on Senate Legislative Calendar Under General Orders. Calendar No. 152.

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.

   U.S. Senate

Read the record

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