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US Monograph Facility Fees Due In Six Weeks While DOGE Subjects FDA To Rapid Changes

 
• By Malcolm Spicer

FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.

(Source: Shutterstock/Citeline)
Key Takeaways
  • First five-year authorization of the user fee program expires at the end of FY2025, 30 September; without reauthorization, the program would end and restarting it would require authorizing legislation.
  • FDA determined the number of OMUFA fee-paying organizations for FY2025 is 1,134; manufacturers account for 57% and CMOs for 43%.
  • Fees imposed for current fiscal year, but legislation authorizing OMUFA facility fees as part of an overhaul and modernization of the FDA’s OTC monograph drugs programs required the fees to be due in the third quarter (April-June) of each federal fiscal year.

The 2025 facility fees supporting a regulatory program crucial for expanding the US OTC drug market but potentially slowed by Trump administration cuts are due in six weeks.

A Food and Drug Administration notice published on 20 March shows that OTC monograph user fee program (OMUFA) facility fees for fiscal year 2025, due on 2 June, increase nearly...

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