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The Court of Appeals for the Second Circuit in Manhattan has decided to overturn the conviction of a sales rep who promoted off-label uses for a prescription drug, in a ruling which has the potential to change the future of how drugs are marketed.

By Ben Steele on Dec 4, 2012

The court decided with a 2-1 majority to throw out the conviction of Alfred Caronia, a sales rep for Orphan Medical (now owned by Jazz Pharmaceutical) who was charged with promoting off-label uses for the narcolepsy drug Xyrem. Mr. Caronia argued his right to free speech was protected by the First Amendment, pointing out that off-label uses for drugs are legal for physicians to discuss with and prescribe to their patients.

Under the Food, Drug and Cosmetic Act the FDA has the authority to prosecute companies accused of selling a “misbranded drug” – however, in this case the court agreed with Caronia and opted to “decline the government’s invitation to construe the FDCA’s misbranding provisions to criminalize the simple promotion of a drug’s off-label use by pharmaceutical manufacturers and their representatives because such a construction – and a conviction obtained under the government’s application of the FDCA – would run afoul of the First Amendment”. Such a ruling questions the FDAs longstanding assertion that off-label promotion by sales reps is illegal.

Circuit Judge Denny Chin, who voted in favour of overturning the conviction, wrote that “In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed”. She also made clear that First Amendment protection does not apply to false or misleading off-label promotion. 

The trade group for the pharmaceutical industry, Pharmaceutical Research and Manufacturers of America, showed satisfaction with the ruling, stating that “PhRMA believes that truthful and nonmisleading communication between biopharmaceutical companies and health care professionals is good for patients, because it facilitates the exchange of up-to-date and scientifically accurate information about new treatments”. On the other hand, the Circuit Court judge who cast the dissenting vote, Judge Debra Ann Livingston, wrote that “the majority calls into question the very foundations of our century-old system of drug regulation”. She warned that if drug firms “were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses”.

This may not be the end of the road for what promises to be a contentious issue for years to come. The government is likely to ask the court to hear the case again with a full panel of judges, and it could even go as far as the Supreme Court. Until then, drug companies will be unlikely to modify their marketing behaviour as the ruling only applies to the three states in the Second Circuit’s jurisdiction – but they with no doubt be watching avidly from the sidelines.