Yesterday’s pre-publication Federal Register Notice (here) announced the Prescription Drug User Fees Act (PDUFA) program fees to be charged to fee-paying new drug applications for FY 2025. As you will note from the chart below, the application fees increased, but the program fee decreased. It is interesting that the magnitude of the application fee increases were much less for FY 2024 to 2025 than for FY 2023 to FY 2024, when the application fee requiring clinical data increased by $806,669 (see previous post here) while applications not requiring clinical data were assessed at one-half of that fee increase.
For FY 2025, the program fee actually fell, likely because of the number of newly approved NDAs containing multiple strengths. Remember, a program fee is assessed yearly for each strength of a product, up to five, approved in a single NDA application. With more NDAs being approved and more strengths available for fees, the denominator of required derived fees for program activity increases, and the program fee decreases as a result.
There does not appear to be any relief for NDA fee increases unless the number of new NDAs submitted substantially increase and the applications gain approval. Please see the FR Notice itself for details of the FDA’s explanation of how it arrived at the FY 2025 PDUFA fees.
Comparison of FY 2024 and FY 2025 PDUFA Fees
