In NEJM Editorial, FDA Commish Has Selective Memory
FDA Commissioner Margaret Hamburg's editorial in this week's NEJM is read with interest here, but not so much for Hamburg's recounting of the FDA's history and the historic legislation that enables the agency's activities. Rather, what's really interesting is that Hamburg, in an effort to sustain and justify the FDA's purview, cites 2 recent lawsuits that "have challenged the FDA's authority to review the safety and effectiveness of products before they are marketed."
Curiously enough, one of lawsuits that Hamburg cites is the much-blogged-about Allergan v. United States, in which the drug company (maker of Botox) contested, back in October of 2009, the FDA's prohibition of off-label speech. Hamburg argued that if Allergan's (now-dropped) lawsuit had been successful, it "could [have undermined] the premarket review system that has been in place for drugs since 1962 and for devices since 1976. Indeed, [lawsuits like Allergan's] place at risk efforts that are currently under way at the agency to ground FDA practices more solidly in public health practice." She continued,
Without question, such legal challenges, if successful, would turn back the proactive role of the FDA in American medicine, threaten current efforts to ground FDA practices in public health science, and jeopardize the safety of patients, as well as the future of innovation and medical progress. Quite simply, they would ignore the lessons of history.
For all her reproach, what Hamburg fails to acknowledge in her editorial is the confounding position that the FDA created for Allergan, when the agency demanded in April of 2009 that the drug company warn, in relatively comprehensive fashion, of the risks of Botox when used for the unapproved condition of limb spasticity. It was the FDA's demand that prompted Allergan's lawsuit. The company rightly and logically countered that the agency had placed the company in a double-bind—by simultaneously asking for and prohibiting Allergan's public dissemination of information about the off-label use of Botox.
Who can forget the government's ambiguous and ambivalent response to Allergan's free-speech complaint, when it failed to clearly distinguish promotional speech from nonpromotional speech and an unapproved use from an intended use? With waffling language (ie, "usually"), the government attempted (and failed, in my mind) to reassure the court and Allergan that it would not overstep its regulatory bounds:
In practice, FDA usually does not treat an unapproved use as an intended use solely because the manufacturer knows that the unapproved use is taking place [emphasis added].
It's also not lost on anyone (who's interested) that the FDA squirmed out of its illogical stance (at least partially) by approving Botox for the treatment of limb spasticity in March of this year—thereby making the condition an approved, on-label condition.
I'd stay tuned for the response letters.
