Just as the FDA dips its toes into the world of social media with via a new partnership with WebMD (details here), some pharmaceutical and medical device companies are stepping into something else -- abuse of social media.
Here's the dénouement -- social media must play by the same regulatory rules as, well, pre-social media.
After all, if the medium is the message – and the message is regulated – than the same rules apply. Specifically FDA rules, guidances – and draft guidances. This is not rocket science and pharmaceutical and medical device companies should know this without having to be told.
Alas, that does not seem to be the case with some.
In September, the FDA sent a letter to Shire Pharmaceuticals, asking it to pull a YouTube video for Adderall XR that the agency said overstated the hyperactivity drug's effectiveness and omitted risk information. The company said it didn't intend to post the video on the site and, upon learning of the posting in May 2007, promptly removed it.
The newest culprits in this space are YouTube videos for medical devices sold by Abbott Labs, Medtronic and Stryker. The Prescription Project (with whom we share almost no common ground) points out that these videos violate federal rules because they don't contain required warnings and disclosures. And they’re right.
Stryker said it wouldn't comment because the issue was before the FDA. Medtronic said it is committed to adhering to FDA guidelines for direct-to-consumer advertising. The company said the video in question had been taken down. An Abbott spokesman said the company posted a link to safety and risk information next to its YouTube video, but will from now on embed safety and risk information in such videos.
Social media is the wave of the present and presents powerful new ways to both market to and educate the public. Mistakes such as these are not acceptable and will only lead to more Congressional fist pounding. The good news is that they are easy to avoid. Just follow the rules. Social media – indeed all media – must be used responsibly, in compliance, and for the benefit of the public health.
