"How A Federal Appellate Court Diluted The FDA’s Power To Regulate Big Pharma"
A federal appellate court on Monday sided with pharmaceutical industry interests to overturn the conviction of Alfred Caronia, a pharmaceutical sales representative who sold and promoted drugs for off-label use, on First Amendment grounds. This decision sets the stage for a potential Supreme Court case that would have enormous consequences for the Food and Drug Administration (FDA), and potentially shift the contours of how the pharmaceutical industry is regulated in America.
The Second Circuit Court of Appeals in Manhattan found by 2-1 margin that Caronia was simply exercising his right to free speech while promoting a drug — which has been officially approved by the FDA to treat narcolepsy — as a suitable treatment for insomnia, along with several other medical conditions for which it was not intended. While doctors have the authority to prescribe medication for purposes other than a drug’s intended use, drug manufacturers are subject to a higher level of scrutiny in the way they promote their products’ uses, and firms such as Johnson&Johnson have had to dole out big settlements to the Justice Department in recent years for violating these standards and promoting off-label use.
While the appellate court ruled that Caronia was within his constitutional rights to discuss the alternative effects of the drug he was promoting, government officials and dissenting Judge Debra Livingston warned that the Second Circuit’s wide-ranging decision could open up a can of worms that leads to an asymmetric level of power and discretion for pharmaceuticals, while stripping the FDA of its ability to safeguard Americans’ health by effectively regulating drug makers:
“Most if not all of these cases have been based on a central premise: that it is unlawful for a company and one of its employees to be promoting a drug or a medical device off-label,” said John R. Fleder, a director at the law firm Hyman, Phelps & McNamara who represented the F.D.A. while working at the Justice Department. “And this decision hits at the heart of the government’s theory.” [...]
Under the Food, Drug and Cosmetic Act, which gives the F.D.A. the authority to regulate drugs, selling a “misbranded drug,” or one that is intended to be used for purposes not listed in the label, is illegal. Doctors, on the other hand, are free to prescribe a drug for any use. The agency has argued that off-label promotion of drugs is evidence that a sales representative or company intended to sell misbranded drugs. [...]
The lone dissenting judge [in the court's decision], Judge Debra Ann Livingston, vigorously disagreed, arguing that by throwing out Mr. Caronia’s conviction “the majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote F.D.A.-approved drugs for nonapproved uses, they would have little incentive to seek F.D.A. approval for those uses.”
If the decision is upheld in a review by the full Second Circuit bench or the Supreme Court, the FDA will have to significantly modify its approach to overseeing the drug industry. Former FDA chief counsel Gerald Masoudi says that the ruling will force the FDA to “focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing versus something that is not approved” in future dealings with pharmaceutical promotion and advertising.
This is not the only major drug industry case that may soon be headed to the Supreme Court. As ThinkProgress reported, the Supreme Court decided Monday to review a case asking whether bio-tech drug company Myriad Genetics can patent two human genes for a cancer-prevention screening procedure.