Over-the-Counter Monograph Drug User Fee Amendments

Over-the-Counter Monograph Drug User Fee Amendments

This 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 by

• revising 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, and
• requiring 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.)