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Focus on Regulation

Hogan Lovells Comments on the FDA’s “Draft Guidance on Responding to Unsolicited Requests”

The FDA issued its Draft “Guidance for Industry: Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices” in December 2011. 

As our FDA group follows these issues closely on behalf of the industry, we filed a Comment on this draft guidance encouraging the agency to reconsider and clarify certain elements of the Draft Guidance, specifically with respect to:

  1. “Public” responses at meetings held between manufacturers and health care practioners,
  2. The materials that should accompany a response, and
  3. The role of toll-free customer service numbers in prompting requests for off-label information.

FDA’s final position on these issues may have a significant impact on how the industry engages in non-promotional exchange of scientific and medical information in response to unsolicited questions from healthcare professionals.  We will provide an update when FDA finalizes its guidance.