FDA Issues Social Media Guidance… Well, Sort Of

FDA Issues Social Media Guidance… Well, Sort Of

January 5th, 2012 // 1:35 pm @ marquee

Two years after first pondering social media guidelines, the FDA has finally issued a draft guidance that addresses, to a limited extent, the sort of communications that drugmakers can have with consumers, physicians and other parties in certain online settings. But the new guidance falls short of articulating any highly specific guidelines, although Twitter and YouTube are mentioned.

Specifically, the 15-page draft guidance, which was issued late last month, suggests how drugmakers should respond to solicited and unsolicited requests for off-label information, but only off-label information. The draft addresses both private requests, such as one-on-one communications, and requests made in public forums – not only conferences attended by real people, as well as product websites, blogs, discussion boards and chatrooms.

Although falling short of what some may have hoped for from the FDA in the way of sweeping do’s and don’t’s, the draft guidance is the first time the agency has addressed the specific topic of off-label information and the Internet when it comes to unsolicited, public requests. And here’s a crucial take-away: if a drugmaker adheres to the draft guidance, the FDA will not use the response as evidence that there was intent to promote off-label.

First, the agency does address the use of Twitter in discussing solicited requests. For instance, if a drugmaker Tweets about a study and somehow suggests an off-label use is safe and effective, any comments and requests received thanks to the original Tweet about off-label use would be considered solicited.

Similarly, if a drugmaker encourages people to post videos about using one of its med on, say, YouTube, and the content includes off-label use that prompts questions, this also would be considered a solicited request. And the FDA tries to be quite clear that solicited requests “may be considered evidence of a (drugmaker’s) intent that a drug…be used for a use other than that specifically approved or cleared” by the agency.

As for unsolicited, public requests, the guidance is in keeping with existing FDA policy. Responses should be provided only to the person who makes a request and, not surprisingly, these should be scientific and non-promotional, and provided by medical or scientific liaisons. Responses must also be accompanied by the FDA labeling, and records should be kept.

But the juicy part concerns public, unsolicited requests. What are these? In the draft guidance parlance, such a request for info is not prompted by a drugmaker or its reps; rather, the request is strictly initiated by someone who is completely independent of the drugmaker. In a public setting, by the way, this would include queries directed to the drugmaker or in a forum at large.

Here’s an example: Someone posts a question about off-label use of a drug on a website run by a drugmaker or by a third party that can be seen by a ‘broad audience.’ The request could be directed to the drugmaker or others stopping by the site. And if a drugmaker responds in such a setting, this would be considered a public online response.

The FDA is concerned about a couple of things. By answering a question in public, a drugmaker may respond in such a way that an unapproved use may somehow be communicated to others who did not request information. And because material can reside on the Internet for a long time, the agency worries outdated information will remain. For instance, new risk information later becomes available.

And so, the FDA suggests that a drugmaker respond only to public, unsolicited requests for off-label information about its meds, including those encountered through “emerging electronic media.” And a public response about drugs should be limited to providing contact information for the drugmaker and should not include any off-label information.

“Any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question, should occur solely between the firm and the individual who made the request. Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum,” according to the draft.

A couple of other points: the draft states that representatives who provide public responses to unsolicited requests for off-label information should clearly disclose their involvement with a drugmaker or related entity. And public responses to public, unsolicited requests for off-label information “should not be promotional in nature or tone.”

The upshot? “If a firm responds to public unsolicited requests for off-label information, including those encountered through emerging electronic media, in the manner described above, FDA does not intend to use such responses as evidence of the firm’s intent that its product be used for an unapproved or uncleared use,” the draft concludes. “Such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising” (read the guidance here).

There will be more draft guidances, no doubt, as the agency navigates the online minefield.

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