As I See It: FDA's social-media moves
James G. Dickinson
FDA's timid, long-awaited moves on social media reflect industry's nervousness, and the agency's statute-directed guidance on the issue, due in July, is unlikely to blaze new trails.
Why so much reluctance on the part of a regulator better known for power grabs in gray zones like stem cell clinics and emergency contraceptives?
Since at least 1996, FDA has been stolidly insisting that its antique regulations controlling what drug manufacturers can say about their products are adequate to address every new promotional challenge.
This is at once a comfortable and dangerous posture for FDA. It affords the agency flexibility in devising ad hoc interpretations and policies on a case-by case basis, but exposes it to high risk if its position is taken to court—as in the Plan B emergency contraceptive and the Caronia off-label promotion cases.
Now when FDA is directed by statute to formalize its attitude to social media statements by and for manufacturers of regulated products, it finds itself pushed into defining things it has avoided defining for decades—such as how advertising (which it is authorized to regulate) can be stretched to also cover other forms of speech (which it is not authorized to regulate).
This is a minefield best left to lawyers to navigate in court, an arena which FDA has been avoiding, because in First Amendment cases it always loses. Its next loss could clip its wings so badly it might be too crippled to venture into the non-advertising promotional arenas it is used to exploring—and exploiting.
That's why I expect FDA's guidance document on social media will be a lot less than many who are eager to read it are hoping for.
James G. Dickinson is editor of Dickinson's FDA Webview (fdaweb.com).