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Bending PDUFA’s Cost Curve: PhRMA Looking For Sustainable Program Growth

 
• By Derrick Gingery

Industry feels that sufficient program management tools are in place, but a PDUFA VII negotiator says they need more time to mature.

revenue growth
PDUFA VII likely will continue the current trend of regular program revenue growth. • Source: Alamy

The pharma industry is signaling acceptance of ongoing prescription drug user fee revenue increases, so long as they are paired with systems to manage the growth and measure the performance of the US Food and Drug Administration program.

PDUFA is expected to generate about $1.2bn in fiscal year 2022, a more than $481m (67%) increase from the target...

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Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
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FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

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