Bill · H.R. 4273· House(119-HR-4273)
Over-the-Counter Monograph Drug User Fee Amendments
- Introduced
- 7/2/2025
- Last activity
- 9/17/2025 — Placed on the Union Calendar, Calendar No. 254.
- Sponsored by
- Robert Latta
- Cosponsors
- - 1 - 2
- Introduced
- On Calendar
What this bill would do
This bill, titled the "Over-the-Counter Monograph Drug User Fee Amendments," aims to amend the Federal Food, Drug, and Cosmetic Act. It revises and extends the user fee program specifically for over-the-counter (OTC) monograph drugs. The legislation adjusts how fees are assessed, how much revenue is generated, and the timing of fee due dates. It also includes provisions for technical corrections regarding development advice and reporting requirements. Ultimately, the bill extends the authority of these programs through fiscal year 2030.
Yes· 3 of 4
Does this give the federal government more power?+1
The bill expands the authority and revenue collection mechanisms of the FDA.
Does this make what the government does easier for the public to see?+1
The bill maintains transparency by requiring the publication of fee revenue amounts in the Federal Register.
Does this give people more protection from unfair business practices?+1
The bill enhances pharmaceutical quality standards which indirectly protects consumers.
The opposite
Would business owners be better off under this?-2
The bill imposes higher and more complex fee structures on drug manufacturers and facilities.
Who it would affect, and how
Potential Positive Impacts for People
-
Standardized Testing Procedures: The bill allows for the addition or modification of testing procedures if they reflect a voluntary consensus standard established by a national or international standards development organization (Section 3). This could provide more consistency in pharmaceutical quality.
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Extended Program Authority: By extending the expiration of certain sections to October 1, 2030, the bill provides long-term stability for the OTC monograph drug user fee program (Section 7).
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Increased Representation in Development Advice: The bill expands the ability for sponsors or requestors to have organizations nominated to represent their interests during development advice proceedings (Section 6(a)).
Potential Negative Impacts for People
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Increased Fee Revenue Requirements: The bill establishes specific additional dollar amounts that must be added to the annual base revenue for fiscal years 2026, 2027, and 2028 (Section 4(b)(1)(E)).
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Potential for One-Time Fee Increases: The Secretary is granted the authority to implement a one-time facility fee workload adjustment for fiscal years 2028, 2029, or 2030 (Section 4(c)(4)).
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New Payment Schedules for Facilities: The bill modifies when facility fees are due, creating specific installment requirements for fiscal year 2027 (Section 4(a)(1)(B)).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Business Owners-2
- Governance And Ideology
- Improves Government Transparency+1Increases Federal Power+1
- Economy And Finance
- Improves Consumer Protection+1
- Healthcare
- Improves Healthcare Access+1
- 9/17/2025
- Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
- Placed on the Union Calendar, Calendar No. 254.
- 7/23/2025
- Committee Consideration and Mark-up Session Held
- Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
- 7/2/2025
- Referred to the House Committee on Energy and Commerce.
- 3 Cosponsors added.
- Introduced in House
2 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Dan CrenshawRepublican · Texas
Diana DeGetteDemocrat · Colorado
Debbie DingellDemocrat · Michigan