In December, FDA released a draft document titled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” The guidance is geared to responding to unsolicited requests for off-label information in a social media context.

The agency’s plan is simple: If an off-label use query comes in via a public forum (e.g., blogs, chatrooms, Twitter, Facebook, or company-sponsored Web sites), medical device firms are advised to take the discussion to a private venue (via e-mail or phone).

This rule should be relatively easy to manage in an online setting, although FDA admits that in some cases, responding publicly to an off-label use query might actually be in patients’ best interests. “Because firms usually have robust and current information about their products, it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are made in public forums, especially since other responders may not provide or have access to the most accurate and up-to-date medical product information,” the document explains.

Nonetheless, the agency says that because the information may be posted indefinitely, detailed responses about off-label use could become outdated, and therefore could be misleading.

For the most part, these concerns are logical. “FDA is generally following longstanding off-label principles,” says Jennifer Henderson, counsel at law firm Hogan Lovells. She says FDA’s guidance should be relatively easy to comply with online once companies take a look at their practices and assess risk.

However, an example provided in the guidance presents a stickier wicket: “During a live presentation, an individual asks a question, directed to a firm’s representatives but heard by other attendees, regarding off-label use of a specific product. This request is a public request. Similarly, a response by the firm that is conveyed to the same audience as the original question would be considered a public response.”

This example raises a red flag. “The principles of this guidance are clearly limiting nonsocial media contexts,” Henderson explains. Based on FDA’s own logic, if there is nothing enduring about a verbal communication (e.g., no pamphlets or handouts), there is no reason to limit the communication to such an extent. Medical device companies should have something to say about that.

Would FDA really take action if a speaker at a conference responded to a comment about off-label use? Henderson says the likelihood is not high, unless the company is already on FDA’s radar for similar issues. “FDA is driven by a number of factors when they go after enforcement,” she says. “For a first-time offense or for an inadvertent transgression, I have a hard time believing FDA would issue a warning. But any time a product has a safety issue, all bets are off. And if a company has crossed the line in the past, that factor might come into play.”

Further, Henderson explains there may be free speech implications. “It raises questions about how the guidance fits into recent case law in first amendment speech issues,” she says. Henderson points to the Sorrell ruling, in which the Supreme Court held that a Vermont statute restricting the sale, disclosure, and use of records that revealed the prescribing practices of individual doctors violated the First Amendment.

What’s next? The comment period for this draft guidance ends in March, so it’s important to get recommendations in. Henderson expects some significant comments from industry. First Amendment concerns could stall the guidance from being finalized.

After that, firms should to look to assess their risk, Henderson advises. “Companies need to get a sense of their potential exposure. In some cases, it might be prudent to revise your SOPs.” One critical action is to get regulatory affairs involved in company-sponsored online and social media campaigns. “That was never part of FDA’s guidance, until now,” she says. Traditionally, marketing or sales manage these spaces, but “it makes sense to have your regulatory staff involved,” Henderson says.