Hogan Lovells Comments on the FDA's "Draft Guidance on Responding to Unsolicited Requests"
As our FDA group follows these issues closely on behalf of the industry, we filed a Comment on this draft guidance encouraging the agency to reconsider and clarify certain elements of the Draft Guidance, specifically with respect to:
- “Public” responses at meetings held between manufacturers and health care practioners,
- The materials that should accompany a response, and
- 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.
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