Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says
FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.
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The FDA's revised draft guidance on scientific communications to health care providers about unapproved uses of products describes the studies that are likely to be scientifically sound and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.
US FDA proposes studies to look at the impact of disclosure of a product’s secondary claims and biosimilar designation; disclosure about unapproved uses; and the impact of citing a drug’s multiple indications in TV ads.
FDA’s social media guidance on interactive promotional materials should require companies to submit only content that they have control over, PhRMA and BIO tell FDA; industry asks for clarification on a firm’s responsibility for user-generated content, such as comments on off-label use.