As we reported last month, a recent federal appeals court decision may have a dramatic impact on the Food and Drug Administration's complex drug approval process. The Court of Appeals for the Second Circuit in Manhattan ruled (by a 2-to-1 vote) that pharmaceutical companies have a free-speech right to promote approved drugs for uses that are "off-label," such as using an anti-epilepsy drug to control appetite and weight.
ACSH's Dr. Josh Bloom wrote in Medical Progress Today that the appeal's court's reasoning was "dead on," but ACSH's Dr. Gilbert Ross is convinced otherwise, based on years of clinical practice and by a discussion by Mina Kimes in an article in Fortune.
The Fortune article posits that the appeals court's ruling would "eviscerate" the FDA's regulatory system, because the ban on off-label marketing is crucial to the drug-approval process.
"If companies did not have to conduct clinical trials in order to procure the right to market products for new uses, why would they run trials at all? Convincing patients to undergo experimental treatment is time-consuming and expensive," writes Ms. Kimes. "There's no reason to believe that businesses would conduct meaningful trials in the absence of any incentive."
Lifting the ban on off-label marketing would also greatly increase the FDA's regulatory burden, forcing them to scan a much greater range of communications for "demonstrably false and misleading" claims. Right now drug companies need to conform their marketing to the language on the drugs' labels.
Dr. Ross says it "gives me chills" to think that drug makers, mainly through drug marketing representatives called detail reps, would have such "unfettered communications" with doctors. While "truthful communications" should always be unfettered, he says, this raises the whole issue of "what is truth" when it comes to promotion of even approved drugs for unapproved uses.
Dr. Bloom believes that responsible communication meaning the dissemination of information backed by publication in a peer-reviewed journal will do far more good than harm. He says, The drugs in question have already undergone safety studies during the approval process, so at an appropriate dose the safety profile of the drug should be the same whether it is taken as approved or off-label. Several valuable drugs are now being used off-label. I see nothing wrong with a discussion between a rep and a doctor provided that it is done in a responsible manner.
Anyway, we are as always interested in what our readers have to say about this. Please leave a comment on our blog and let us know what you think or email your thoughts to morning@acsh.org.