United StatesSenate Bill 2292S 2292

Over-the-Counter Monograph Drug User Fee Amendments

Health

48 pages

senate
house
president

Last progress July 15, 2025 (4 months ago)

Introduced on July 15, 2025 by James E. Banks

Sponsors (4)

House Votes

Vote Data Not Available

Senate Votes

Pending Committee

July 15, 2025 (4 months ago)

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Presidential Signature

Signature Data Not Available

Text Versions

Text as it was Reported in Senate

September 8, 2025•48 pages

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Text as it was Introduced in Senate

July 15, 2025•16 pages

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Amendments

No Amendments

This legislation would update and continue the user fee program for over-the-counter (OTC) medicines that follow FDA “monograph” rules. In plain terms, companies that make many common OTC drugs would keep paying fees to help the FDA review and manage these products. The goal is to maintain oversight and keep the program going, with some changes to how it works .

Here are the basics based on the text provided:

Affected: Companies that make OTC monograph drugs, and the FDA program that oversees them .
What changes: The user fee program is revised and extended (details of the changes are not listed in the provided text) .
Why it matters: Continuing fees help fund FDA’s work on these everyday medicines, supporting safety and access .
When: The provided document does not specify dates or timelines for the changes .

Key point	What it means
Who is affected	Makers of OTC monograph drugs; FDA oversight program
What changes	The fee program is revised and extended; exact details not provided here
When	Timeline not specified in the provided text