FDA Prescription Drug User Fee Rates: Fiscal Year 2019

FDA Releases Prescription Drug User Fees (PDUFA) for FY 2019

On Wednesday, August 1st, FDA released a notice with updated prescription drug user fee rates for fiscal year 2019.

Prescription Drug Application Fees

According to the Food, Drug, & Cosmetic (FD&C) Act, application fees should provide 20% of the total revenue, while program fees should provide the other 80%. Application fees are set at $202,064,400 for FY 2019. The application fees were determined by estimating the total number of expected fee-paying full application equivalents (FAEs) for the year. The updated fees are as follows:

  • Full application (with clinical data): $2,588,478
  • Application (without clinical data): $1,294,239

This is a 6.9% increase from FY 2018 fees, which were $2,421,495 per full application requiring clinical data, and $1,210,748 per application not requiring clinical data.

Prescription Drug Program Fees

FY 2019 program fees were calculated by dividing the adjusted total revenue from program fees ($808,257,600) by the estimated number of program fees (2,608). The FY 2019 program fee is $309,915. This is a 1.9 percent increase from the FY 2018 program fee of $304,162.

Fee Category FY 2019 Fee Rates FY 2018 Fee Rates
Application Requiring Clinical Data $2,588,478 $2,421,495
Application Not Requiring Clinical Data $1,294,239 $1,210,748
Program $309,915 $304,162
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