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Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By Sue Sutter

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

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The FDA's accelerated approval draft guidance describes an "uncertain standard" for identifying acceptable endpoints, PhRMA said. (Shutterstock)
Key Takeaways
  • Stakeholders said the FDA’s draft guidance on accelerated approval does not provide a clear path for developing acceptable, reasonably likely endpoints, and should be clarified.
  • Commenters also requested more flexibility in the expedited withdrawal process, including longer timelines for submitting an appeal and public comment, and greater flexibility on the timing of an advisory committee meeting.
  • The generic drug industry said special provisions need to be implemented for generic drugs and biosimilars when a reference product is withdrawn.

The US Food and Drug Administration’s accelerated approval draft guidance has left stakeholders wanting more clarity on the process for determining a surrogate marker or intermediate clinical endpoint is “reasonably...

Commenters also seek more flexibility in the expedited withdrawal process, including longer timelines for submitting an appeal and greater flexibility for convening advisory committee meetings.

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