GDUFA Sees First-Ever Fee Spending Decrease
Full-Time Equivalent Count Decreases As Revenue Spending Drops
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.
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Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.
Increases in the number of expected ANDA submissions, facilities and entities holding approved applications means lower user fees in most GDUFA II categories starting 1 October; program fee will see the largest percentage drop, amounting to savings of $200,000 for large companies.
Acting commissioner says greater flexibility in hiring has 'a real potential to solve some of our problems,' although only about 40-50 people have been added to date; recruitment and retention were very much on the minds of the FDA’s leadership at the recent BIO annual meeting, where center directors spoke of the long-term damage caused by the five-week partial government shutdown.