“Podium policy” (when regulators give speeches or media interviews that announce new regulatory expectations), is never a good idea. And least of all when the policy implicates First Amendment values and involves potential criminal enforcement.
The issue at hand is pharma and social media – an issue where there is already significant confusion. And now, unfortunately, there’s more.
Consider the comments of Jean-Ah Kang (special assistant to DDMAC director Tom Abrams) in her recent 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.”
Dr. Kang then defines what she meant by “the public health”:
“Meaning, is this prescription drug promotion truthful? Is it balanced? Is it accurate? Is it false or misleading? That’s the big picture at the end of the day.”
And 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.”
And 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.” Talk about "net impressions." The implications of her remarks are chilling. Chilling, frustrating and disappointing – but not necessarily surprising. After all, it’s all about ambiguity.
Ambiguity is power. That’s why interpretation of FDA regulations (on social media and a host of other issues) is such a vibrant cottage industry. Regulated industry, on the other hand, seeks clarity. Industry wants bright lines. They want to know the rules. They want predictability. This may sound simple, but it has proven to be a fractious bureaucratic kulturkampf within the FDA. “Change is not required,” as management guru W. Edwards Deming once said. “Survival is not mandatory.” And nowhere is this truer or more dangerous than at DDMAC.
Regulators change industry behavior by changing the rules of the game. But changing the minds of regulators, having them embrace bright lines rather than vague, ever-changing expectations based on undefined notions of what serves “the public health,” is a distinctly more challenging proposition.
If the FDA wants to remain relevant (and out of court), they should develop clear rules that safeguard the important First Amendment values at stake. And this is about more than just the speech rights of companies. It’s about the rights of the Internet user (yes, you) to obtain information from a full range of sources – not just the government and plaintiffs lawyers and snake oil salesmen.
Dr. Kang is a smart person and a real believer in the potential of social media to advance the public health and she does her best to portray the FDA process as thoughtful and deliberative. It is. But, at a bare minimum, we are entitled to something more (or perhaps it would be better to say something less) than Jean-Ah’s remarks. After all, the FDA doesn’t have the authority to regulate or even define what is “bad” for the public health writ large. That’s regulatory creep of the first order. (Her complete interview can be found here.)
When I served at the FDA, we struggled with how to both regulate and advance the new field of pharmacogenomics. As Commissioner McClellan said at the time, “pharmacogenomics is a new field, but we intend to do all we can to use it to promote the development of medicines. By providing practical guidance on how to turn the explosion of pharmacogenomic information into real evidence on new drugs, we are taking an important step toward that goal.” The same philosophy of “regulator as colleague” should also be true for the new dynamic of social media. It’s like a game of chutes and ladders. FDA should act as a guide to the ladders and a sentry against the chutes – rather than an as the ogre at the foot of the bridge.
“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.
Predictability is the result of creative, forward-thinking leadership that rises above bureaucratic ambiguity. And it’s never easy, because swimming against the tide of an entrenched bureaucracy never is. But as Commissioner Hamburg and other agency change agents (Drs. Sharfstein, Woodcock and Goodman to name three) demonstrate, it is possible.
As Winston Churchill said, “Ease is relative to the experience of the doer.”
