Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says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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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.
FDA has revised, but not loosened, its 2009 final guidance on good reprint practices for distribution of journal articles on unapproved uses of approved drugs and devices.
The draft guidance outlines substantial reporting requirements for websites that firms control and for content on third-party sites – as well as saying when FDA intends to use enforcement discretion.