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US FDA User Fee Conundrum: Collections Increase After 25% PDUFA Rate Hike

 
• By Derrick Gingery

With likely more fee-paying applications arriving at the agency, sponsors may be wondering whether user fees should have been increased as much as they were at the start of FY 2024.

revenue growth
The FDA raised its PDUFA revenue estimate $30m based on the pace of collections so far. • Source: Shutterstock

Despite efforts to make them predictable, user fee revenues continue to prove the opposite: sponsors may have been given an increase based on an expected downturn in submissions that is not materializing.

More than mid-way through fiscal year 2024, the US Food and Drug Administration increased its net collections estimate for the prescription drug user fee program by $30m, or about 2%, “because of the rate of collections thus far this fiscal year,” Funmi Ariyo, director of the user fees support staff in the FDA Office of Finance, Budget,

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