What percentage of FDA’s human drug review budget comes from PDUFA fees?
PDUFA (Prescription Drug User Fee Act) fees are used to fund FDA’s drug review work, but the exact “percentage of the human drug review budget” attributable to PDUFA fees depends on the specific fiscal year and the FDA’s budgeting/allocation tables for that year. The figure can’t be stated accurately from the information provided here.
Where to find the exact PDUFA share in FDA budget documents
To get the exact percentage for the fiscal year you care about, check FDA’s Human Drugs budget presentation and the accompanying user fee/expenditure documents for that year (often shown as total resources and the portion coming from user fees vs. appropriations). These are typically reported in FDA budget materials rather than in a single static “percentage” that stays constant year to year.
Why the percentage can change year to year
Even when the overall PDUFA program continues, the share can shift because FDA budget totals and fee revenue can change due to:
- changes in the number/type of submissions subject to fees,
- fee rates set for the year under the PDUFA program,
- carryover balances and adjustments in FDA spending plans,
- how FDA categorizes “human drug review” activity across budget lines.
Can you specify the year (and which budget line)?
If you tell me the fiscal year (for example, FY 2024 or FY 2025) and whether you mean:
- total “human drug review” resources, or
- specifically “CDER human drug review” (Center for Drug Evaluation and Research),
I can help you pinpoint the correct percentage from the relevant FDA budget materials.
Sources
No sources were provided in your prompt, and I don’t have the specific FDA budget-year figures needed to compute or verify the exact percentage.