The FDA's oversight program for over-the-counter drugs — aspirin, antacids, sunscreen, cold medicines, and similar products — is funded largely by fees that manufacturers pay, and Congress has to reauthorize the program every few years. This bill extends the fee program through fiscal year 2030 and updates how fees are calculated, including inflation adjustments and a one-time workload bump if the number of regulated facilities grows past 1,625 on average. It also expands what counts as a qualifying product update to include voluntary pharmaceutical-quality testing standards developed by national or international standards bodies. Without reauthorization, FDA review of the thousands of products on U.S. pharmacy shelves would lose its primary funding source.
Congressional Summary
Over-the-Counter Monograph Drug User Fee AmendmentsThis bill reauthorizes the Over-the-Counter (OTC) Monograph Drug User Fee Program (OMUFA) through FY2030 and revises certain aspects of the program, including total fees to be collected and fee due dates.Under current law, many OTC drugs are marketed through compliance with an OTC monograph issued by the Food and Drug Administration (FDA), rather than through an approved new drug application. Monographs establish the conditions under which OTC drugs are generally recognized as safe and effective, and include ingredients, dosages, and other requirements. OMUFA permits the FDA to collect fees from OTC drug facilities and entities requesting changes to a monograph.The bill makes certain changes to OMUFA, including byrevising the total facility fee revenue amount to be collected for FY2026-FY2030,revising due dates for facility fees,permitting the FDA to implement a one-time adjustment to facility fees if certain conditions exist, andrequiring the FDA to publish facility and order request fee amounts at least 60 days before the start of each fiscal year.Finally, the bill adds as a Tier 2 OTC monograph order request a request for the addition or modification of a testing procedure applicable to a monograph drug, provided the testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality. (Requestors seeking certain kinds of changes to a monograph are awarded a period of market exclusivity if the FDA makes the requested changes; tier 2 requests are not eligible for market exclusivity.)
Legislative Subjects
Details
- Congress
- 119th
- Chamber
- House
- Status
- summarized
- Action
- Introduced in House
- Action Date
- 2025-07-02
- Date Added
- 2026-04-22
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