For those seeking clear suggestions on how the pharma industry can engage in social media channels, reading the FDA's recent and quietly issued Guidance for Industry Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices was like searching for a needle in a haystack. Still, this cautious approach may be the best thing in the long run because it stresses enforcing the message, not the medium.
Many hoped this would be the clear, step-by-step social media guidance for which the healthcare industry was waiting. However, the FDA's nonbinding recommendations are more general, somewhat subtle, and perhaps even (commendably) cautious.
Media coverage declared the guidelines missed the boat. In truth, nothing in the guidance was terribly social media-focused. But why should it be? The guidance effectively clarifies the FDA definition for both unsolicited and solicited requests for information, as well as ways to respond to unsolicited requests for off-label information.
Ultimately, this boils down to what most healthcare communicators are already trying to do: practice good judgment and be transparent when working with partners - be they clients, spokespeople, advocacy organizations, or media.
It's clear that providing social media guidance is moving up on the FDA's priority list and that the body is conversant in digital media strategies. As such, we can view this guidance as a potential blueprint for what's to come. We should expect a continued conservative approach from the FDA. But, when in doubt, we should exercise common sense and consider how our interactions might be interpreted. As PR pros, we should also consider some fundamentals.
Revisit organizational charts and protocols. We all know how often client contacts may relocate or assume new roles. Be ready for off-label requests for information by knowing who to call within your client's organization and when, as well as being clear on company protocols.
Training is also vital. Don't wait for the FDA to issue additional social media guidelines. There is a wealth of content available to help industry professionals provide sound social media counsel. For example, www.communicationcompliance.com offers resources focused on regulatory compliance for new and emerging media.
While some might debate the "like" I've given the FDA for this guidance, it was a step in the right direction. Of course, there is still a lot to learn about the ever-evolving social media landscape.
Judi Kennedy is VP and group manager for Ketchum's healthcare practice in Washington, DC.