FDA Is Really Going to Issue Rules for Social Media

FDA Is Really Going to Issue Rules for Social Media

January 4th, 2013 // 4:18 pm @

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Remember how the FDA, more than once, insisted that social media guidelines were on the way? This has become akin to Waiting For Godot. The agency, however, may yet get its act together. But when? And how might this play out? Brian Reid, a director at WCG, an integrated communications firm, and a social media maven, offers some possibilities

Two years ago, FDA watchers were atwitter: the agency had announced it would, in less than four months’ time, issue long-awaited guidelines (read here) on how companies could use social media to promote their products and educate the public. Speculation was rampant about how the FDA would deal with a world of “likes” and 140-character Twitter missives.

The deadline came and went (see this), though the agency told reporters that the new rules were among its “highest priorities.” But that high priority didn’t get tackled in 2011, and – with a new year looming – it looks like won’t be tackled in 2012, either. As a consequence, marketers have largely given up on the FDA. Companies have either decided to forgo social media altogether or move ahead with a play-it-safe strategy unlikely to raise the hackles of the agency.

But the wait for guidance may be coming to an end, thanks to a little-noticed provision in the FDA reform bill passed last summer (look here). In the legislation, the agency is directed to come up with social media rules by the summer of 2014 or face congressional scorn. The date you can circle on your calendar is July 9, 2014.

This opens up three possibilities, any of which would bring some clarity to those wishing to use Twitter, Facebook or any one of the dozens of other platforms available.

The first possibility is that the FDA develops a giant, comprehensive guidance document that drops sometime before the deadline, capturing the agency’s thinking on everything from online video to how you shoehorn risk information into a tweet. It won’t be a Rosetta Stone, but an effort to create a comprehensive site of rules would provide the green light to many companies nervous about operating without explicit guidelines.

The second possibility is that the agency simply blows the deadline and gets hauled before Congress. And then we’ll all get to watch as the FDA’s thinking gets probed — successfully or otherwise — by our elected representatives. And that will be illuminating, one way or another.

But it’s the third possibility that is the most likely and the most interesting: the FDA spends the next 18 months rolling out small rule changes that fold in new communication methods into all manner of FDA rules, integrating rather than segregating social media. This may have already begun; the FDA published guidelines on off-label promotion almost a year ago that explicitly speaks about social media (read here and here). But that document, rather than the first of many, remains the only FDA guidance to use the words “Twitter” or “YouTube.” That’s likely to change.

That doesn’t mean that current practices will change radically. New guidance documents may only codify existing rules, impairing companies from providing much in the way of branded information. But having rules will only encourage more experimentation.

And that change will be welcome. In the next month, Google estimates that Americans will type “cholesterol” into the search bar more than a million times. A quarter-million searches for “statin” will be served. And 165,000 searches will explicitly ask “how to lower cholesterol.” And few of those searches will bring consumers to the social properties of the companies that have invested billions in understanding heart disease.

That’s not to say that the pharma industry should be the only voice trying to provide information on social media. But it probably makes sense to make sure they’re not the only voice excluded from doing so.


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