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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