GDUFA III Calculation Faces Rising Staff Costs
Generic Drug User Fee Projections Complicated By Shifting Personnel Costs
After dialing back the inflation adjustment in GDUFA II, FDA’s ANDA review program now faces rising personnel costs, in contrast to the agency overall, suggesting that GDUFA III might need a more tailored formula.
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The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.
Both issues have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.
The agency sees its personnel compensation and benefits costs decrease for the first time in at least 16 years, while the overall FTE count continues to rise.