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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, Florida, Gottlieb told the audience of generic industry executives that “my recommendation to industry leaders when they’ve asked...

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More from AAM

After A Decade Of US Biosimilars, ‘The Challenges Are Becoming More Clear’

 
• By Dave Wallace

As the US marks 10 years since the first biosimilar approval and launch, AAM Biosimilars Council executive director Craig Burton talks to Generics Bulletin about the lessons learned so far and the path ahead, including how to move on from market models that have proved to be “not appropriate” for biosimilars.

‘You’re Going To See A Much More Aggressive Approach’ – AAM Chief Murphy Sets Out Plans To Engage On Tariffs, Shortages And The IRA

 
• By Dave Wallace

In a wide-ranging conversation, the AAM’s president and CEO John Murphy talks to Generics Bulletin about how the US industry association is planning to gain traction with the new Trump administration by adopting “a much more aggressive communications approach” on topics including medicines shortages, trade tariffs, PBM reform, the IRA and biosimilar interchangeability.

‘I’m Focused On The Opportunities Rather Than The Challenges’ – AAM Chair Haruvi Examines The New US Landscape

 
• By Dave Wallace

A new US presidential administration brings both challenges and opportunities for the off-patent industry. Speaking to Generics Bulletin on the sidelines of the AAM’s annual conference earlier this month, the association’s chair and Sandoz North America president Keren Haruvi discusses how the group plans to make its voice heard on key priorities including tariffs, PBM reform, and regulatory streamlining.

AAM Stares Into The Biosimilar Void

 
• By Dave Wallace

Discussing a new report highlighting the lack of US biosimilar competition on the cards for the majority of biologics losing exclusivity in the next ten years, the AAM’s Access! 2025 conference heard that the “sobering” findings should act as a “wake-up call for stakeholders.”

More from Policy & Regulation

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

UK-India FTA Could Offer ‘Significant Benefits’ For Generics And Biosimilars

 
• By Dave Wallace

A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.