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FDA guidance on social media: a draft is not enough!

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(But it is a good start!)

At last, the agency has issued a draft including social tools (see below an extract), but it is far from satisfying.

Unfortunately, the draft guidelines finally released last week by the Food and Drug Administration won’t clear up too much of the confusion. The 15-page document (PDF)—and it’s important to emphasize that this is still only a draft—focuses  exclusively on social media discussion of off-label medication use“.

What everybody was looking for was never going to happen. If you’re waiting for divine guidance, you’re still waiting.” Indeed, one unnamed pharmaceutical marketer tells Ad Age that the guidelines are “ambiguous.” But this isn’t the FDA’s only bite at the cherry; other guidelines may come down in the future as the terrain becomes clearer.

Guidance on that subject might not be divine, but it will be crucial, says Torie Bosch in Slate.

Bosch, Torie. FDA Releases Draft Guidelines on Social Media and the Pharmaceutical Industry. Slate, Posted on January 3, 2012.
http://www.slate.com/blogs/future_tense/2012/01/03/big_pharma_and_social_media_fda_releases_draft_guidelines_.html

Leigh Householder, of IQ, is more positive: “The FDA’s perspective on what brands can and should do online is really progressive – and, it sounds a lot like some of the conversations that happened on the floor of those hearings. The challenge they’re facing, of course, is how to adequately act on it.”
http://www.whatsyourdigitaliq.com/inside-the-fdas-first-ever-social-media-guidance-is-a-really-productive-perspective/

Other comments:

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Example 8: A firm asks or otherwise encourages users to post videos about their own uses of its  product on third-party video-sharing sites (e.g., YouTube), which may result in video postings about an off-label use of its product. If the firm’s initial request for posting of videos results in any questions about off-label uses, or if any off-label video posting made in response to the firm’s encouragement of video postings results in questions about the product’s off-label use, these questions would be considered solicited requests.

Example 9: If a firm sends out packets of information to known bloggers or online consumer reviewers and encourages them to write about an off-label use of its product on third-party sites and this then provokes a discussion about that off-label use, any requests inquiring about the product’s off-label use as a result of these blogs, whether posted as comments to the third-party site or directed to the firm, would be considered solicited requests.

Example 10: If a firm announces results of a study via a microblogging service (e.g., Twitter) and suggests that an off-label use of its product is safe and effective, any comments and requests received as a result of the original message about the off-label use would be considered solicited  requests.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf

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Written by hbasset

January 5, 2012 at 6:30 pm

Posted in Pharmaceutical Industry

Tagged with ,

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