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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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.
But the agency chose to fund only a small fraction of them, in part because of its hiring ability, and in part because all those employees would have cost an additional $98.7m in user fee revenue.