Wrinkle, Wrinkle Little Star

Much brouhaha about the DDMAC letter sent to Dr. Leslie Bauman about her, um, enthusiastic comments about a yet-to-be-approved anti-wrinkle injectable.

At first blush this seems like regulatory creep and cause for First Amendment agita. But it isn’t.  This is not a case of the FDA trying to stifle unregulated speech by an individual without “interest.” Dr. Bauman is a clinical investigator for the product she’s been touting. That’s “interest” whether the trial sponsor paid her to do so or not. (In this instance, there was no “pay for play.”) In any case, it’s an unambiguous regulatory no-no.

According to FDA regulation (at 21 CFR 312.7(a)), "A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug."

No ambiguity there.  No regulatory creep.  Just good enforcement in an area of medicine that is all too frequently prone to hyperbole.  This is not (IMHO) about the free and fair dissemination of scientific data -- or even an "interested" discussion thereof.

Alas, just as too many medical marketers misinterpreted the agency’s April 2009 letters on sponsored Google links to mean “we can’t use social media,” so too will many pharmaceutical MLR departments ( the “nabobs of no”) point to the Bauman letter as a reason to question the appropriate use of medical spokespeople. And the New York Times certainly does stoke the flames of such paranoia in its reportage. (See New York Times story here.)

My advice, read the letter before you get your panties in a twist about “doctors are being muzzled” or overly agitated that the FDA is getting ready to launch a full-frontal assault on physicians-as-spokespeople. Just read the regs – and stay away from the gray zone.

Good catch DDMAC.