According to the Food, Drug and Cosmetic Act it’s illegal to sell prescription drugs for any other purpose than what’s written on the label. Consequently, Orphan Medical sales rep Alfred Caronia was criminally prosecuted for making “off-label” promotional comments about his pharmaceutical companies’ drug Xyrem, a drug specified as a treatment for Cataplexy (weak and/or paralyzed muscles found in narcolepsy patients.)
Caronia, in a conversation taped by undercover government agents, told a doctor that the drug could also be used to treat other muscle conditions such as Restless Leg Syndrome and Parkinson’s. In addition, he told the doctor that the drug could be used in patients under 16, notwithstanding the black box warning on the drug that highlighted that FDA standard safety has not been established for the drug in under patients under 16.
The information provided by Caronia was truthful. Despite this, he was prosecuted for breaking the law. Mr. Caronia successfully appealed the conviction this week arguing that his First Amendment right to free speech was wrongfully and illegally restricted by the drug law.
Some observers are outraged by the appeal as they believe it endangers pharmaceutical regulation at-large. Dr. Andrew Kolodny, a New York psychiatrist, claims the decision is terrible for public health. “Off-label promotion is not about free speech, it is the medical equivalent of yelling fire in a crowded auditorium.” Judge Debra Ann Livingston, the only dissenter on the appeal panel, agreed that such an overturning would be dangerous, suggesting “the majority calls into question the very foundations of our century-old system of drug regulation.”
The Pharmaceutical industry, however, has embraced the decision arguing that off-label promotion can play an innovative role in health care provision. The Pharmaceutical and Research Manufacturers of America (PhRMA) issued a statement saying that they believe that “truthful and nonmisleading communication between biopharmaceutical companies and healthcare professionals is good for patients because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments.”
The scope of the rulings effect ultimately remains in the hands of the Supreme Court, should they take up the appeal issue, and the government is expected to challenge the repeal in order to bolster the FDA’s powers of regulation over the pharmaceutical industry.