Mr. Friede is Principal of Arnold I. Friede & Associates. The firm specializes in FDA-related legal and regulatory matters.

Among other things, Mr. Friede is a former FDA Associate Chief Counsel. He can be reached at Arnie@FriedeFDALaw.com.

Arnold Friede
There has been a lot of debate about the recent 2011 FDA Guidance Unsolicited Requests for Off-Label Information. Although not specific to social media, what does it say or not say about their view of the use of social media by pharma? While the Draft Guidance includes examples and issues related to the use of social media, it does not represent or reflect any sort of comprehensive guidance on the subject that industry has generally been seeking. Should we be happy with what we received or do you see this as complicating the situation? No. Industry should not be happy. In fact, based on the specifics of the Draft Guidance as it now stands, industry should probably be happy that FDA has not yet etched in stone its overall policy on social media. For if the truth be told, the Draft Guidance represents a potent reaffirmation by FDA that anything that remotely resembles a meaningful on-line dialogue about uses not yet approved by FDA will continue to be regarded by the agency as promotional and thus subject to the agencys stringent approach to off-label promotion. For example, the Draft Guidance discourages any meaningful exchange of information on-line in response to what it calls a public request for information about off-label uses. That sounds like a pharmaceutical company is very limited in a world that is defined by interactivity and engagement. What does that mean for individual companies and brands today? About the only thing a company can do in this context (off-label request) is to provide information so that the requester can contact the company privately and receive a narrowly circumscribed compilation of information about the off-label use. Given the reality of the on-line medium, and the need for relatively contemporaneous responses to requests for information that health information seekers wish to obtain, it seems quite likely that a private dialogue between a public requester and a company is likely to ensue only rarely and, if it does, is unlikely to provide the kind of immediate response that health information seekers, both physicians and layman, wish to engage in today.

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Ok, so is it a lost cause for the millions of patients seeking to engage really engage with pharmaceutical companies? As a practical matter, FDAs Draft Guidance provides little comfort that the agency is prepared to open up social media as a meaningful forum for communications between regulated entities and health information seekers, at least when it comes to off-label information. In the Draft Guidance, FDA is telling us in no uncertain terms that it continues to view such on-line engagement as promotional and thus subject to all the rules respecting offlabel promotion that FDA has historically applied. I leave it to the reader whether FDAs approach is correct as a matter of law and social policy. At the same time, FDAs ongoing categorical prohibition on any meaningful on-line communications between the public and companies about off-label uses suggests that the agency continues to view these exchanges as a form of traditional advertising. There are compelling arguments, however, that at least in a social media context, and at least where a company has not unilaterally initiated the dialogue, and at least in a forum where the dialogue is occurring, whether or not company sponsored or supported, that is educational and non-promotional, this kind of communication might not be advertising or promotion of the kind that FDA has historically regulated. It is not traditional push advertising of the kind we see on TV or in print. In an appropriate educational context, this kind of

communication might be regarded as not proposing a commercial transaction and, at least arguably therefore, would not be the kind of speech that FDA should regulate as advertising and promotion. What can we do next as patients, physicians, and pharmaceutical companies seeking a world where social health aligns with the needs of the digital customer? All of these arguments can and should be developed further if industry wishes to persuade FDA to adopt a more liberal approach to off-label communications in social media channels. As it stands now, however, the Draft Guidance on Responding to Unsolicited Requests should provide little if any comfort to industry that FDAs ultimate approach to social media will meaningfully liberalize current rules. Again, I leave it to the reader to decide if adherence to FDAs traditional approaches is or is not correct from a policy or legal standpoint. What technology companies do you most admire? Apple, Google. What technology device do you most admire? iPhone When is the last time you went off the grid for at least 24 hours? A very long time ago.

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