FDA’s social media marketing draft guidance: a roundup

The regulatory dos and don’ts of healthcare social media marketing has been a big question mark for pharmaceutical companies and medical devices who have been patiently waiting for the U.S. Food and Drug Administration to shed some insight.

On Dec. 30, the FDA released a draft guidancethat was fairlylimited in scope because all it addressed was off-label usage of pharmaceuticals. By all estimates, the draft guidance, the first of its kind, leaves a lot to be desired.

Ad Age’s headline — FDA’s Social-Media ‘Guidelines’ Befuddle Big Pharma — said it all. The story quoted a former associate FDA commissioner, Peter Pitts, who said “What everybody was looking for was never going to happen. If you’re waiting for divine guidance, you’re still waiting.”

A pharma-marketing expert said:”What everybody was expecting was actual guidelines around social media. I still think it’s monumental. The FDA finally addressed the digital channel in a specific way by mentioning Twitter and YouTube in the document, and those have never been mentioned before. But this is an industry that wants specific instructions and rules, and that didn’t happen here.”

Wall Street Journal’s Health Blog — FDA Has (Some) Social Media Advice For Pharma — was a bit more tempered, with another healthcare marketing executive commenting that the guidance shows that the agency “is starting to incorporate social media into its thinking.” But he declared that the multitude of platforms essentially means that the agency cannot ever say exactly what should be done on Facebook or while text messaging, for instance.

Pharmalot carped FDA Issues Social Media Guidance…Well, Sort Of, before adding that “the new guidance falls short of articulating any highly specific guidelines, although Twitter and YouTube are mentioned.”

This was just FDA’s first foray into developing guidelines for the industry after conducting hearings on the topic two years ago. And this won’t be the last. An FDA spokeswoman told Ad Age that the multiple guidances would address diverse topics such as how to fulfill regulatory requirements when there are space constraints (i.e. the 140-character limit of Twitter), how to use links online and how to correct misinformation.

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