FDA Releases Draft Guidelines on Social Media and the Pharmaceutical Industry

Prescription pill bottles.

Photo by Mario Tama/Getty Images

Big Pharma spends big bucks on online marketing—more than $1 billion last year. But when it comes to playing in social media, pharmaceutical companies have been unclear on what is permissible and what is verboten. They have been waiting for guidance from the Food and Drug Administration, which held hearings into matter long ago, in November 2009.

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.

Former FDA associate commissioner Peter Pitts tells Ad Age, “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.

In November 2010, Jeremy A. Greene and Aaron S. Kesselheim laid out several of the social-media gray areas for Big Pharma in the New England Journal of Medicine. One of note:

Although most Internet users can often (but not always) find data on drugs’ risks and benefits within a few keystrokes, it is hard to determine whether the source is credible and disinterested. It is now recognized that the ghostwriting of medical research articles can have important public health implications; financial disclosures should be just as explicit for leading providers of social media content as for authors of articles in peer-reviewed journals.

Guidance on that subject might not be divine, but it will be crucial.

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