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Could PDUFA VIII Align With Trump’s Efficiency Emphasis?

 
• By Sue Sutter

Given the Trump Administration’s intense focus on cutting costs and increasing efficiency, industry and the FDA should focus on what is and is not working in PDUFA VII when negotiating the next agreement, lobbyists said at the BIO CEO and Investor Conference.

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PDUFA VIII negotiations offer a chance to align the FDA's user fee program with the Trump Administration's focus on efficiency, lobbyists said. (Shutterstock)
Key Takeaways
  • The next prescription drug user fee negotiations are a chance to streamline the FDA’s drug review activities, aligning with the Trump Administration’s focus on efficiency and cutting costs, lobbyists said.
  • Lobbyists said industry and the agency should focus on successes and failures in the current user fee agreement.
  • PDUFA VII program expires in September 2027, and negotiations for a new agreement are expected to start later this year.

Upcoming negotiations to reauthorize the US Food and Drug Administration’s prescription drug user fee program should be viewed as a chance to make the program more efficient in the face...

“I think this is an opportunity for us to sit back and say what is working and what is not working,” Remy Brim, principal and healthcare practice head at BGR...

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