HR4273Referred to Committee

Over-the-Counter Monograph Drug User Fee Amendments

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-07-02
Introduced
3
Cosponsors
HR
ⓘ
Type

Sponsor

Robert E. Latta
Robert E. Latta
Republican · OH · Representative
Votes with party: 98.4% (554 recorded votes)

Full profile: /officials/L000566

Source: Congress.gov · FEC

Cosponsors (3)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Placed on the Union Calendar, Calendar No. 254.

2025-09-17

Source: Congress.gov

Committee Activity

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Plain-English Summary

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.)

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health
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