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Off-Label Guidance Creates ‘Safe Harbor’ For Dissemination of Certain Info To HCPs

 
• By Brenda Sandburg

The FDA's revised draft guidance on scientific communications to health care providers about unapproved uses of products describes the studies that are likely to be scientifically sound and clinically relevant. The agency also gives recommendations on presenting off-label information on web pages and in exhibit halls.

Safe harbor
FDA guidance provides a safe harbor for manufacturer communications about unapproved uses of medical products. • Source: Shutterstock

After nearly a decade, the US Food and Drug Administration updated a draft guidance on off-label communications to convey what scientifically sound and clinically relevant information sponsors may share with healthcare providers and how best to present the information.

The guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers,” was posted on 23 October. A Federal Register

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