H.R. 4273Heading to a voteHealth care
Bill extends FDA fees on over-the-counter drugmakers through 2030
Data as of July 12, 2026
The bill renews FDA fees on OTC drugmakers through 2030 to fund safety and quality reviews.50-second read · 5 questions answered below
Decoded
What does this do?
This bill renews and updates the FDA's OTC drug fee program, extending it through 2030. It updates fee schedules, adjusts inflation and cost formulas, sets specific funding amounts for certain years, and lets the FDA recognize modern voluntary industry testing standards without a lengthy formal process. It also extends FDA reporting requirements to Congress on fee use and pushes back deadlines to match the 2026–2030 timeframe.
Who does it affect?
Pharmaceutical and consumer health companies that make OTC drugs pay these fees. Consumers who buy OTC medicines are indirectly affected, since the fees fund FDA safety and quality oversight.
Why does it matter?
Without renewal, the fee program was set to expire, which would have affected FDA funding for reviewing OTC drug ingredients and manufacturing facilities. The changes adjust how much companies pay and when, and how the FDA verifies drug quality standards.
What does it cost, and who pays?
- Industry pays facility and manufacturing fees
- Set dollar amounts added in certain years
- No direct cost to consumers
Where does it stand?
- Introduced
- House committee
- House vote — You are here
- Senate
- President's desk
Right now: it's headed for a House floor vote. If the Senate changes it, it goes back to the House before reaching the President.
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Official title
Over-the-Counter Monograph Drug User Fee Amendments
- Introduced:
- July 2, 2025
- Latest action:
- September 17, 2025
Placed on the Union Calendar, Calendar No. 254.
Read the official bill on Congress.govMake the call
Three steps: where you stand, your script, the call.