“Podium policy” (when regulators give speeches or interviews that announce new regulatory expectations) is never a good idea. Consider the comments of Jean-Ah Kang, special assistant to DDMAC director Tom Abrams, about social media regulation in her interview with Ignite Health: “The bottom line is this is a regulated industry, and if you choose to do promotion in that area just make sure that at the end of the day what we're looking at is in the best interest of public health.”
Then she offers some qualifications: “Several things come to mind with use of intent. We have regulations and again, they're not black and white per se, but they exist…Even though someone may not have intended something, if the end result is that the public is misled then it's a problem.” Finally: “I mean people have gone to jail over these serious public health issues. So just be aware of the regulatory environment.”
“Intent” to promote against the “best interest of the public health” via regulations that are “not black and white” and over which “people have gone to jail.” The implications of her remarks are chilling. Chilling, frustrating and disappointing—but not surprising. After all, it's all about ambiguity. Ambiguity is power. That's why interpretation of FDA regulations is such a vibrant cottage industry. Regulated industry, on the other hand, seeks clarity. Industry wants predictability.
“I know it when I see it” as an approach to social media regulation doesn't cut it. Predictability is power in pursuit of the public health. And social media is as powerful tool for advancing the public health today as any medical breakthrough you care to name. In 2010, healthcare begins at search.Peter J. Pitts is partner/director of global health at Porter Novelli and a former FDA associate commissioner