Bill extends FDA fees on over-the-counter drugmakers through 2030
Placed on the calendarH.R. 4273Latest action
Sponsor: Robert E. Latta · Representative · OH
AIDecoded by AI · checked against the recordRead the official text
Official title: Over-the-Counter Monograph Drug User Fee Amendments
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
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The bill renews FDA fees on OTC drugmakers through 2030 to fund safety and quality reviews.
50-second read · 5 questions answered below
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
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Where does it stand?
- IntroducedJul 2, 2025
- House committee
- House voteYou are here · Sep 17, 2025
- Senate
- The president's desk
Right now: it was placed on the , and the official record shows no floor action on it since. If the Senate changes it, it goes back to the House before reaching the president.
Latest action: — Placed on the Union Calendar, Calendar No. 254.