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PDUFA Spending Trends: Fee Revenue Jumps As Percentage Of Funding As Staffing Grows

 
• By Derrick Gingery

FY 2018 is first year that US FDA's device center got PDUFA funding for staffers; our infographic shows how CDER is getting an increasing proportion of user fee staff even as other sections of the agency have seen growth over the last five years.

Money Wave
The FDA now has staff from the Center for Devices and Radiological Health supporting the prescription drug user fee program. • Source: Shutterstock

Stakeholders have more evidence to fuel worries that the US Food and Drug Administration's new drugs program is too dependent on prescription drug user fee revenue. The Fiscal Year 2018 PDUFA Financial Report indicates user fee revenue gained an increasingly dominant position in PDUFA program spending, compared to what were termed "non-user fee appropriations." Fee revenue was 68% of spending in FY 2014 and had increased to 77% of spending by FY 2018. (See chart below.)

The law requires a minimum amount of non-user fee appropriations in order to collect fees, but concerns rise when that total compared to the trigger amount decreases. More recent data may signal a reversal of the trend, as the FY 2020 FDA appropriations bill proposed by US House of Representatives would increase the non-user fee appropriated dollars for the agency significantly

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