FDA announces 2022 user fees

Aug. 18, 2021

The U.S. FDA has announced the rates for prescription drug user fees for fiscal year 2022.

Each year, the agency adjusts its user fee amount based on factors such as inflation and resource capacity needs for the drug application review process. The FDA's fees are assessed as follows: (1) Application fees are assessed on certain types of applications for the review of human drug and biological products and (2) prescription drug program fees are assessed on certain approved products. Fee amounts are established each year so that revenues from application fees provide 20% of the total revenue, and prescription drug program fees provide 80% of the total revenue.

The 2022 fee rates for new drug applications (NDAs) and biologics license applications (BLAs) requiring clinical data will surpass $3 million for the first time ever — $3,117,218.  An application that doesn't require clinical data will cost $1,558,609 and the prescription drug program fee will be $369,413.

The FDA also forecasts workload volumes for CDER (based on predictive models and historical actuals). The agency estimates that CDER will review 161 NDA/BLAs, 9,548 active commercial investigational new drugs (INDs) and hold 4,534 PDUFA industry meetings

The agency announced the 2022 Generic Drug User Fee Amendments (GDUFA II) fees last month — the ANDA fee was set at $225,712.

All fees are effective on October 1, 2021, and will remain in effect through September 30, 2022.