Bills · S 2292
REPORTED· 119TH CONGRESS
Senate BillS 2292Drug safety, medical device, and laboratory regulationSupply chain
Over-the-Counter Monograph Drug User Fee Amendments
INTRO JUL 15· LAST ACTION SEP 8
READING
34MIN
COSPONSORS
3BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Reported, not passed
LEGISLATIVE PROGRESS
STEP 3 / 8Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenVoters should care about this bill because it directly impacts the funding for the FDA's oversight of over-the-counter drugs, which are used by millions of Americans daily. If this bill passes, the FDA will have a stable and dedicated source of funding until 2030 to continue its work in reviewing, setting standards for, and ensuring the quality of common medicines like allergy pills, pain relievers, and antacids.
If this bill does not become law, the existing user fee program for OTC monograph drugs would eventually expire. This could lead to a significant funding gap for the FDA's OTC drug activities, potentially slowing down the agency's ability to address new safety concerns, update quality guidelines, or introduce new over-the-counter treatment options, which could ultimately affect public health and consumer access to essential medicines.
KEY PROVISIONS
5AI-extractedPROVISION 01
Extends the user fee program for over-the-counter monograph drugs, allowing the FDA to continue collecting fees through fiscal year 2030.
Provides a consistent funding source for the FDA's regulatory activities related to over-the-counter medicines for several more years.
PROVISION 02
Expands the types of activities covered by these fees to include adding or changing testing procedures for OTC drugs that meet voluntary quality standards.
Ensures that funding supports ongoing efforts to improve and update quality control and testing for over-the-counter medications.
PROVISION 03
Changes the time period used to determine which drug manufacturing facilities owe fees, shifting it to better align with federal fiscal years.
Adjusts the criteria for fee assessment, potentially impacting which facilities are subject to fees in a given year and streamlining administrative processes.
PROVISION 04
Revises the due dates for facility fees, including a two-installment payment system for fiscal year 2027 and setting earlier deadlines for subsequent years.
Alters the financial planning and payment obligations for over-the-counter drug manufacturers, requiring them to adapt to new schedules.
PROVISION 05
Establishes how total facility fee revenue will be calculated for each fiscal year from 2026 through 2030, including base revenue, inflation, and an operating reserve adjustment.
Provides a clear framework for how the FDA will determine the amount of fees collected, ensuring funding levels are appropriate and predictable.
SPONSORSHIP
1 + 3
R· Indiana
YRS IN OFFICE
9
BILLS LED
99
COSPONSOR BREAKDOWNBIPARTISAN · 66%
DEM 2 REP 1 IND 0
ACTION TIMELINE
5 EVENTSSEP 8
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
SEP 8
Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
JUL 30
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
JUL 15
Introduced in Senate
BILL INFO
TypeSenate Bill
NumberS 2292
Congress119th
StatusReported
IntroducedJul 15, 2025
Last actionSep 8, 2025
READER REACTIONS
OVERALL SENTIMENT
No reactions yet. Be the first to weigh in.
Discussion
Loading comments...
REPORTED· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED JUL 15, 2025
Senate BillS 2292Drug safety, medical device, and laboratory regulationSupply chain
Over-the-Counter Monograph Drug User Fee Amendments
INTRODUCED JUL 15, 2025· LAST ACTION SEP 8, 2025
PASSAGE CHANCES
—%
READING
34 min
COSPONSORS
3
COMPLEXITY
Moderate
