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 Slate’s headline used “Draft Guidance on Social Media.”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.