• by Erik Sass , Staff Writer @eriksass1, January 4, 2012

Pharmaceutical marketing is one of the most heavily-regulated areas of media, so it’s no surprise that the FDA has some thoughts about how pharma companies should be able to use social media to communicate with consumers. Some of the most recent regulations are interesting in that they allow pharma companies to use social media to communicate about off-label uses of prescription drugs.  Sort of.

Off-label information covers the range of possible uses for a drug which haven’t been recognized as official indications for the drug by the FDA. For example, the anti-depression drug known commercially as Wellbutrin is also sold under another name, Zyban, for smoking cessation. Up to one-fifth of all prescriptions in the U.S. are off-label uses, rising to almost a third in some branches of medicine like psychiatry.

Because off-label uses aren’t officially sanctioned by the FDA, and because there often isn’t rigorous scientific backing for them, some consumer advocates have alleged that they are ineffective and simply exist as a way for pharma companies to sell more drugs. In any event, off-label uses have a number of legal and regulatory issues associated with them, ranging from professional liability for doctors who prescribe them, to advertising and customer service.

Which may explain the FDA’s Solomon-esque, “split the difference” approach to social media communications about off-label drug uses. According to guidelines issued in the FDA’s snappily-titled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” pharmaceutical companies may give information about off-label uses to patients -- but only if the question wasn’t solicited, for example through marketing materials or advertising.

What’s more, pharma companies can respond to public questions about off-label uses received via social media sites like Twitter, Facebook, or online discussion boards -- but the response itself can’t be public. According to the FDA, all communication about off-label drug uses must be private, meaning if someone posts a question in a public forum, the pharma reps’ only availabel course of action is to advise the consumer to contact them again, separately, via a private channel.

Oh, also, the responses shouldn’t come from pharma sales or marketing personnel, because the information is supposed to be fair and non-promotional. It will be interesting to see how pharma companies handle this (if they don’t just give up).