Regulatory updates: First Glimmer of Guidance?
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While the FDA's recent draft guidance is hardly a social media roadmap, it does offer some useful pointers. Peter Pitts and John Kamp read between the lines
On December 27, 2011, the FDA issued draft guidance on “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” While its focus is not social media per se, it still offers pharma a snapshot of what to expect.
Peter Pitts, president, CMPI, and former FDA deputy, believes the onus will be on industry to self-regulate. “If you wouldn't say it offline, don't say it online,” he says. “The FDA is asking industry to use its best judgment. That's the good news. The bad news is many folks in pharma find that frightening.”
John Kamp, executive director of the Coalition for Healthcare Communication is not one of those, but casts some aspersions on the magisterial force of the docket. “It is anything but permissive,” he says.
Pitts, meanwhile, continues to extract lessons from the FDA's message: In creating social-media procedures, pharma should draw parallels to existing channels; Using social media to advance public health takes precedence over marketing; It is the responsibility of every company to correct product misinformation; and Companies that respond to posts on third-party sites should monitor those sites for future legitimate interventions. Pitts also credits FDA with acknowledging that social media means “sharing knowledge with those who want it, when they want it, where they want it.” All of which sounds reasonable.
Then, not so reasonable. “Without stating why,” says Kamp, “the guidance instructs companies to respond only to unsolicited questions, and then only in private to the individual making the request. In effect, it would ban all company responses to off-label questions in traditional and Internet-based public media.”
In fact, the guidance specifically deems brand.com sites to be an inappropriate channel for addressing such questions. “Why shouldn't a product website—assuming that every word on the site is appropriately compliant—be used?” asks Pitts. “Isn't this where the most comprehensive, up-to-date, and accurate product information resides?”
Kamp believes the challenge for industry will be to use this guidance aggressively and responsibly while working with the FDA to advance the public health through improved communications. And he is optimistic. “An active FDA combined with aggressive leadership by regulated companies, agencies and media,” says Kamp, “could mark 2012 as the year patients and doctors have better access to information that improves patient care.”
But Pitts is less convinced pharma will grasp the initiative. “We'll see if these promised multiples [of FDA guidance] will reinvigorate the denizens of inertia who believe regulated industry needs to wait for further agency instruction before embracing a more holistic approach to social media.”