US FDA's FY 2023 User Fees Finally Revealed
Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.
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Fiscal year 2024 prescription drug user fees skyrocket in part because of a low application volume in FY 2022, while biosimilar user fees continue to drop due to the program’s healthy operating reserve.
In past years, sponsors have pulled ANDAs at the beginning of a fiscal year in part to control their GDUFA program fee payments, but no approved ANDAs were withdrawn during the first two months of FY 2023.
The revenue is expected to sustain the prescription drug user fee program moving forward after reserves were tapped at the start of fiscal year 2023.