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FDA - Legal Supervision Required

By James M. Beck and Mark Herrmann

Not too long ago, Bexis and Sean Wajert (along with Dechert associate Vince Gallo), wrote a backgrounder for the WLF about likely problems that could arise from the FDA's recent decision to allow its non-lawyer staff to send out warning letters without bothering to have them pre-reviewed by the FDA's internal lawyers.  Of these problems, they said that "most obvious risk relates to the First Amendment implications of regulatory letters."

More than ever, it looks like their analysis was spot on. Blog subscriber and frequent correspondent Arnie Friede recently sent us an article he published last month in the RPM Report about a recent FDA warning letter, that strikes us as taking the FDA's war against "promotion" of products for non-labeled (not technically "off-label") uses to a positively bizarre extreme.

This letter wasn't sent to a manufacturer, but only to a clinical investigator.  This investigator was also a well-known plastic surgeon in her own right.  In her own right, and not on behalf of the manufacturer that sponsored the study in question (this is uncontested), she also gave several interviews in the popular press about what she thought about this new product.  The problem was, product had not yet received FDA approval (that's why this doesn't technically involve "off-label" use - there wasn't any label yet).

Simply because this doctor had agreed to participate in a clinical trial, the FDA took the position that it could muzzle her personal expression of her personal views in the press on the basis that this constituted "pre-approval promotion."  Friede article at 2.

Also according to Freide, the FDA (DDMAC) "conceded, established that the statements in [the magazine articles] attributed to [the doctor] were made by her independently?without any involvement, influence, initiation, or direction whatsoever by. . .the company responsible for marketing [the new drug]."  Id. at 3.

Has the FDA gone crazy?  Since when does simply participating in a clinical trial work a forfeiture of a doctor's First Amendment rights?  It's UNCONTESTED that the doctor was not in any acting on behalf of the manufacturer that was sponsoring the trial.  Even moreso than with truthful promotion of off-label use, which we also support, the FDA is not Big Brother to the medical community.  How many doctors will be willing to participate in clinical trials if they think they're going to be subject to FDA gag orders?

We don't think the FDA's gone crazy.  We think that what happened is some lower level Agency bureaucrat got his/her nose out of joint at this celebrity doctor, and decided to take the initiative to "do something about it."  The problem is, with the FDA decision to do away with legal pre-clearance of warning letters, legally untrained front-line folks in the Agency are no longer subject to legal (we could say "adult") supervision before they can take action ostensibly in the name of the Agency.  Without legal pre-clearance, there's no longer anybody around to advise the bureaucracy to step back, count to ten, and think about what they're actually doing.

Anyway, we hope the good doctor fights this, because it looks like a slam dunk First Amendment winner to us.  We also think the FDA needs to reinstate legal preclearance - before it ends up looking really silly in court.

Full post as published by Drug and Device Law on April 09, 2010 (boomark / email).