1. Medtech Insight

US Could Lose Its First Approver Advantage After FDA Layoffs

 
• By Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Dominoes falling in the dark
• Source: Shutterstock
Key Takeaways
  • Medical product reviewers were spared during the 1 April layoffs at FDA, but cuts to support and policy staff likely will slow drug development and approval, experts said.
  • The result could be that the US loses its status as the first region companies turn to for product approval.
  • The nature of the 3,500-person reduction-in-force also is expected to increase voluntary departures in application review-related positions.

The speed of US medical product reviews likely will be slowed by the approximately 3,500 US Food and Drug Administration job cuts made 1 April, which experts expect will propel...

Ultimately “US patients and the US economy will suffer,” said Howard Sklamberg, a partner at Arnold and Porter and a former FDA deputy commissioner for global regulatory operations and policy....

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