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PDUFA Needs More Than 300 Additional FTEs, New US FDA Capacity Planning Formula Says

 
• By Derrick Gingery

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.

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The FDA's new capacity planning adjustment predicted many more FTEs are needed for the PDUFA and BsUFA programs in FY 2021 than the agency actually funded. • Source: File photo

A new capacity planning adjustment formula developed by the US Food and Drug Administration could have required drug and biologics sponsors to pay nearly $98.7m in additional prescription drug user fees to hire the necessary employees projected to be needed in fiscal year 2021.

But the FDA chose to have sponsors pay less than 13% of the total, in part because of its historically low hiring success, highlighting once again

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