As 2011 drew to a close, the FDA made a move destined to cause complaint: It issued a draft guidance for pharma communications online, via social media and otherwise. The guidance came more than a year after agency hearings addressed the subject, and many months later than professionals in the field had expected. And it tackled just one piece of the social-media puzzle—which means that more puzzle-piece guidance documents are on their way.
That's one down side of the FDA's "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices," the rather unwieldy title on a rather brief, common-sense document. The upshot? If someone asks a drugmaker for information about off-label use of a product, then the company can answer, so long as its answer is fair and nonpromotional. And that answer doesn't have to conform to the stringent disclosures required in, say, direct-to-consumer advertising.
There's just one big hitch: The FDA wants all actual off-label info to be communicated privately. People who contact the company directly for info should be given a comprehensive response, including such things as FDA-approved labeling. People who post online or tweet a question—those who pose a public request for information, in essence—should get a minimal public response. And we mean minimal: It's basically, "Contact us here for more." When and if the contact comes, then the company issues that same comprehensive, private response.
One key distinction the FDA draws in this document is between "solicited" requests for off-label information—including questions at dinner events, online posts responding to a company's presentations, Twitter-based questions prompted by a company-tweeted study—and "unsolicited" requests. The new rules apply only to the latter—and the latter only includes out-of-the-blue requests for info. Any sort of online bait for questions, including tweets and YouTube videos and so on, make those questions "solicited," and so different rules would apply.
A final, potentially problematic point: The FDA thinks sales and marketing folks shouldn't be in charge of responding to these off-label info requests. Those departments are "focused by training and experience on promoting a firm's products," and so they shouldn't have any input, the guidance states.