Bills · HR 4273
REPORTED· 119TH CONGRESS
House BillHR 4273Drug safety, medical device, and laboratory regulationUser charges and fees
Over-the-Counter Monograph Drug User Fee Amendments
INTRO JUL 2· LAST ACTION SEP 17
READING
12MIN
COSPONSORS
3BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Reported, not passed
LEGISLATIVE PROGRESS
STEP 3 / 8Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenThis bill matters because it ensures that the FDA continues to have dedicated funding to oversee the safety, quality, and effectiveness of over-the-counter drugs, which are used by millions of Americans daily. Without this program, the FDA's ability to perform these essential regulatory functions, such as reviewing drug standards and ensuring manufacturers meet quality requirements, could be significantly weakened. By extending the user fee program and updating its provisions, the bill aims to provide a stable financial foundation for the FDA's work, which is crucial for public health.
If this bill becomes law, consumers can expect the FDA to maintain its oversight of OTC medications, potentially incorporating more modern testing standards. If it does not pass, the existing user fee program for OTC monograph drugs would expire, creating uncertainty for both the FDA's regulatory capacity and the industry's ability to bring new or improved non-prescription drugs to market under a consistent framework.
KEY PROVISIONS
4AI-extractedPROVISION 01
Extends the Over-the-Counter Monograph Drug User Fee program through fiscal year 2030.
This ensures the continued dedicated funding for FDA's oversight of common non-prescription drugs for several more years.
PROVISION 02
Changes the time period used to determine which drug manufacturing facilities are assessed user fees and revises the due dates for these annual fees.
This adjusts the financial obligations and payment schedules for companies making OTC drugs.
PROVISION 03
Clarifies that activities related to adding or modifying testing procedures for OTC drugs, especially those based on recognized national or international standards, are covered by the user fee program.
This updates the regulatory framework to better incorporate modern testing standards and improve drug quality.
PROVISION 04
Sets the total annual revenue amounts to be collected from these fees for fiscal years 2026 through 2030, including specific additional amounts for the first three years.
This determines the overall funding level for the FDA's OTC drug activities for the next several years.
SPONSORSHIP
1 + 3
R· Ohio
YRS IN OFFICE
18
BILLS LED
19
COSPONSOR BREAKDOWNBIPARTISAN · 66%
DEM 2 REP 1 IND 0
ACTION TIMELINE
6 EVENTSSEP 17
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-300.
SEP 17
Placed on the Union Calendar, Calendar No. 254.
JUL 23
Committee Consideration and Mark-up Session Held
JUL 23
Ordered to be Reported (Amended) by the Yeas and Nays: 51 - 0.
BILL INFO
TypeHouse Bill
NumberHR 4273
Congress119th
StatusReported
IntroducedJul 2, 2025
Last actionSep 17, 2025
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REPORTED· 119TH CONGRESS · ENERGY AND COMMERCE COMMITTEE · INTRODUCED JUL 2, 2025
House BillHR 4273Drug safety, medical device, and laboratory regulationUser charges and fees
Over-the-Counter Monograph Drug User Fee Amendments
INTRODUCED JUL 2, 2025· LAST ACTION SEP 17, 2025
PASSAGE CHANCES
—%
READING
12 min
COSPONSORS
3
COMPLEXITY
Moderate
