US FDA Advisory Committee Meetings In Jeopardy After Layoffs, But Some Employees Called Back

Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."

Broken glass
FDA layoffs have fractured the usual process for putting together an advisory committee meeting. (Shutterstock)
Key Takeaways
  • CDER is considering cancelling advisory committee meetings that were scheduled, but not formally announced, because support staff based in the drug and biologic centers have been laid off.
  • The staff were responsible for meeting-specific tasks, including conflict-of-interest screening and travel arrangements, which raises questions about the agency's ability to conduct any adcomms in the near term.
  • Numerous former FDA employees in other areas are getting requests to return temporarily to help ensure continuity of operations.

The US Food and Drug Administration is considering cancelling some advisory committee meetings in the wake of recent layoffs that have gutted the staff who plan and organize them.

Review staff and product sponsors are planning for advisory committee meetings, but the likelihood of most of those meetings actually happening given recent layoffs is increasingly unlikely.

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