On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12...08 December 2016
Hogan Lovells Comments on the FDA's "Draft Guidance on Responding to Unsolicited Requests"
As our FDA group follows these issues closely on behalf of the industry, we filed a Comment on this draft guidance encouraging the agency to reconsider and clarify certain elements of the Draft Guidance, specifically with respect to: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.