Wednesday, June 18, 2014

FDA Releases Long-Awaited Social Media Guidances

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This post was contributed by @MikeMadarasz 

The pharmaceutical industry has a reputation of moving at a deliberate pace when it comes to social media.  Fittingly, the FDA proceeded at the same cautious rate in releasing a draft of their social media guidance which was published on Tuesday.  The guidelines were organized into two distinct guidances and on the surface, it appears that they’ll limit the amount of advertising companies can do on social sites with character limitations such as Twitter. 

The proposal requires companies to warn about associated risks as well as the benefits that go along with their products.  This could potentially consume valuable characters in mediums where space is limited.  But don’t expect the full laundry list of side-effects that you generally hear at the end of a TV commercial.  As part of posting these warnings, companies should also include a link to more detailed information about the risks. 

The second guidance posted by the FDA outlined direction for dealing with third party postings on sites such as Wikipedia.  The guidance states that companies should attempt to correct any misinformation by reaching out to bloggers and other authors, but are not held responsible if information remains unchanged.  In cases where a company or employee is contributing this information, they should follow normal guidelines as promoting a product. 

Tom Abrams, head of the FDA’s Office of Prescription Drug Promotion, explained in a WSJ article, “The information should not be promotional and should be factually correct. This is not an opportunity for a company to tout its drugs.”  He added, “The information [being added or revised] should be consistent with the FDA-approved [product] labeling and for it to be effective, you want it posted right by the misinformation.”

With a lack of formal guidelines on social, many large drug companies have remained “gun shy” in engaging with customers and patients through these mediums.  These guidelines, once finalized, will be a first step in establishing a blue-print of how companies should leverage social.  The IMS Institute for Health Informatics reports that half of the 50 largest drug companies are not currently using social media.  If there’s something that can move the needle there, this may be it.

Want to hear more on the FDA’s social media guidance?  Hear from the FDA’s own Mark Roh as he walks through some of the new guidelines at this year’s ePharma West.  Join us September 22-24 in San Francisco. Download the agenda to see what’s on tap.

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