1. Pink Sheet

PDUFA VIII: Continuous Fee Increases May Be Wearing On Sponsors

 
• By Derrick Gingery

A Pfizer exec says that the old prescription drug user fee formulas that usually increase funding and staffing for many FDA programs no longer deliver the same return on investment.

Rolling money uphill
The traditional idea of fixing FDA problems with more staff may be losing efficacy, Emmett said. • Source: Shutterstock

SAN DIEGO – Industry may no longer be willing to accept user fee increases and more hiring as the key to US Food and Drug Administration improvements, a potential change of strategy for handling the prescription drug user fee program.

Key Takeaways

  • Emmett said increasing spending and employees may not continue to fix FDA problems.

  • He suggested traditional metrics like acting on 90% of applications by their goal date also may be out of date

Negotiations likely will begin in about a year on potential updates to the PDUFA program and an agreement to extend it another five years

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