The FDA and Social Media: What the Headlines Got Wrong

Posted by: in Healthcare Insights, Social Media Insights & Trends on January 5, 2012

The Food and Drug Administration, last week, pushed out guidance on how companies may respond to inquiries about off-label use of marketing drugs and devices, reaffirming a policy that’s been in place for at least a quarter-century. The document includes a discussion of a number of different arenas in which information in shared, including online outlets. **

As a result — in a fitting reflection of how starved people are for rules governing the use of new media technology – the document has been widely referred to as the FDA’s “social media guidance.” AdAge’s headline called them “Social-Media ‘Guidelines” in a widely cited piece. Slate’s headline used “Draft Guidance on Social Media.” FiercePharma’s headline talked about “sharing in social media.”

Though the excitement is forgivable, the headlines are not quite right. None of the larger philosophical questions about social media were addressed. None of the impacts of FDA inaction I wrote about last month have been ameliorated. It’s hard to imagine any large-scale changes in approach based on this document. Indeed, to the extent that the new guidance is helpful, it is in codifying a set of policies that are already in place.

What the FDA published last week is not social media guidance. It is merely guidance that mentions social media, or — in FDA’s parlance — “emerging electronic media.” It uses the words “YouTube” (once) and “Twitter” (once) and “blog” (once). The lack of ambition was skewered by former Merck policy guru Ian Spatz, who called the document “a belated lump of coal” on Twitter.

But even if the guidance doesn’t change the rules on social media, there is reason for optimism. The FDA is clearly conversant in digital media strategies and the new rules suggest an understanding of the way that companies are operating in the online space. When it comes to the narrow topic of unsolicited off-label communication, the agency did a thoughtful job of including a broad range of potential communication scenarios, from YouTube contests to public medical meetings. If all future guidance is as inclusive, we’ll begin to see the outlines of a coherent communications framework. Eventually.

Of course, the alternative is that the FDA could pull back the curtain on that framework even faster. Now that would be headline-worthy.

** WCG clients: We’ve done a brief analysis of the implications of the new guidance for both real-world and on-line communications. Please talk to your client partner if you’d like to learn more.

By: Brian Reid

Brian Reid is a director at WCG in the product group, where he specializes in media. He is a former journalist who believes content really is king.

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4 Responses

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  1. Mark Senak said

    Brian – this is spot on. The real issues here don’t have much to do with social media at all. While mentioning social media, it is not about social media. Big difference.

  2. Hi Brian,

    It’s good to see that the FDA believes Pharma brands can be trusted to jump into social media conversations and take on the role of educators. In a public online forum, wouldn’t it be best for a manufacturer to respond to questions rather than a member of the public who, even with good intentions, may not have the most accurate information?

    It’s progress. :)

    Jason Boies
    Radian6 Community Team
    http://www.radian6.com/

  3. @Jason: Thanks for weighing in. You bring up what I think is one of the most compelling arguments for a liberal FDA communications policy. Sadly, it’s not one that has had much traction. We live with hope.

    @Mark: And *your* post today points out today why social media might be the red herring in all of this. Let’s hope we get clarity sooner, rather than later.

Continuing the Discussion

  1. Draft Guidance on Unsolicited Requests for Off-Label Information | Eye on FDA linked to this post on March 13, 2014

    […] commentary regarding its issuance stated that it was an FDA social media guidance.  (See “The FDA and Social Media:  What the Headlines Got Wrong“).  It is actually a guidance that mentions social media, which is welcomed, but not a […]

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