FDA's GDUFA War Chest Grows, And Industry May Look For Lower Fees
Executive Summary
Two years into collecting generic user fees, FDA has more than $277 million in unspent dollars.
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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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Thanks in part to budget authority bump, US FDA’s generic user fee revenue spending dropped in FY 2019, and hiring problems lead to an FTE decrease. The useable GDUFA carryover balance also increased in conjunction with the user fee revenue spending reduction, from $158.7m available at the end of FY 2018 to $199.2m at the end of FY 2019.