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User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says

 
• By Nielsen Hobbs

Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’

Could the user fee reauthorization schedule be stretched out to a more politically conducive time? (Shutterstock)
Key Takeaways
  • A former Trump-era FDA commissioner suggested that industry try to avoid conducting user fee negotiations during the beginning of the new Trump Administration.
  • Scott Gottlieb acknowledged that it is “always tempting” for political officials to insert themselves into negotiations between industry and the FDA, but “nothing good” would come out of it in the current environment.
  • Gottlieb has particular concerns about Trump’s nominee for HHS secretary, Robert F. Kennedy Jr.

Scott Gottlieb, who served as US Food and Drug Administration commissioner during the first half of President Trump’s first term, advised the pharmaceutical industry to seek a legislative extension of...

Speaking at the Association for Accessible Medicines’ annual meeting in Amelia Island, FL, Gottlieb told the audience of generic industry executives that “my recommendation to industry leaders when they’ve asked...

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