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Stanford Medicine

FDA, Technology

FDA accepting public comments on social media rules for drug companies

Two years ago, the U.S. Food and Drug Administration held hearings on regulating how drugs and medical devices under its oversight are promoted through social media and on the web. The agency recently released social-media marketing guidelines (.pdf) for pharmaceutical companies and is currently taking public comments on the proposal.

American Medical News reports:

The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format.

The agency calls on companies to respond to public requests, such as those sent through Facebook or Twitter, by guiding the requestor to the appropriate personnel or department for private, one-on-one help. The agency said the private responses should be science-based and answer only the question or questions asked.

The guidance does not apply to information or requests received in response to a solicitation by the pharmaceutical or medical device company.

Comments are being accepted until March 26. They can be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852.

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