Reauthorizes the FDA's over-the-counter (OTC) monograph drug user fee program for fiscal years 2026 through 2030, extending the system that funds FDA review of common nonprescription drugs — things like pain relievers, antacids, and cold medicines — sold without a prescription. Manufacturers operating OTC drug facilities continue paying annual fees to the FDA, with the fee amount built from a base carried over from the 2025 level plus inflation adjustments, direct cost adjustments, and optional one-time workload adjustment if the number of paying facilities exceeds 1,625. Fee collection schedules are restructured for the FY2026 and FY2027 transition years: FY2026 fees are due by the first business day of June 2026 (or after an appropriations act is passed), while FY2027 fees split into two installments. The bill also expands what counts as a formal "order request" — which triggers a dedicated review track — to include modifications that align with voluntary pharmaceutical quality standards published by recognized standards bodies. New provisions direct FDA to use real-world evidence (data from health records and patient registries, rather than only controlled trials) when evaluating the safety and effectiveness of topical active ingredients like sunscreens, and to consider non-animal testing methods such as cell-based assays and computer modeling; FDA must issue draft guidance on those alternatives within one year. A streamlined framework is added for Rx-to-nonprescription switches, allowing manufacturers seeking to move a prescription drug to over-the-counter status to request pre-submission meetings with FDA and requiring the agency to publish guidance within 18 months on evidence standards and approval pathways. Starting with FY2026, FDA must report detailed annual metrics on Tier 1 and Tier 2 order request processing timelines, postmarket safety activities, and facility registration and fee-payment status; fee negotiation meeting minutes must be posted publicly within 30 days. A GAO report on OTC drug supply chain stability is due by September 30, 2027. The program sunsets on October 1, 2030.
Corporate Benefits
- Annual facility fees — reduced relative burden via structured two-installment payment schedule for transition years, easing cash-flow pressure on manufacturers
- OTC order request definition — expanded to cover voluntary consensus standards modifications, broadening the paid review track available to companies
Average Household Impact
- Real-world evidence standard — FDA can use health-record and registry data to evaluate topical OTC drug safety, potentially speeding access to sunscreens and topical treatments
- Rx-to-OTC switch pathway — structured FDA guidance and pre-submission meetings may increase the number of prescription drugs approved for nonprescription use, expanding consumer choice
- Non-animal testing alternatives — required guidance on cell-based assays and computer modeling for topical drugs may accelerate GRASE reviews for household products
Transparency & Accountability
- Annual FDA performance report — expanded to include Tier 1/2 processing timelines, postmarket safety activity counts, and facility fee-payment status starting FY2026
- Fee negotiation meeting minutes — required to be posted publicly within 30 days, with substantive proposals and significant disagreements documented
- GAO supply chain review — independent assessment of OTC drug supply chain stability due September 30, 2027
- Program sunset — authorization expires October 1, 2030, requiring Congressional reauthorization to continue
Congressional 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.
Legislative Subjects
Details
- Congress
- 119th
- Chamber
- Senate
- Status
- summarized
- Action
- Reported to Senate
- Action Date
- 2025-09-08
- Date Added
- 2026-06-04
- Source
- Congress.gov →
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