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Court reverses conviction involving off-label promotion of drugs

A federal appeals court on Monday ruled to vacate the conviction of a pharmaceutical sales representative who promoted a drug for off-label use. In a 2-1 decision, the US Court of Appeals for the Second Circuit in Manhattan said the FDA’s ban on marketing misbranded drugs — part of the Food, Drug and Cosmetic Act — violated the sales representative’s freedom of speech.

In an 82-page decision, the court explained that “if the government’s objective is to shepherd physicians to prescribe drugs only on-label, criminalizing manufacturer promotion of off-label use while permitting others to promote such use to physicians is an indirect and questionably effective means to achieve that goal.”

Alfred Caronia, a former sales representative for Orphan Medical, which is now owned by Jazz Pharmaceuticals, was caught on audio tape promoting off-label use of Xyrem (sodium oxybate) — a drug approved by the FDA for narcolepsy — to a doctor who was a government informant. Caronia was convicted in 2008.

The decision to throw out the conviction may have lasting consequences in the prosecution of pharmaceutical companies for selling or promoting drugs for off-label use.

In July, GlaxoSmithKline agreed to pay $3 billion in fines in the largest health care fraud settlement in US history. The British drug company agreed to plead guilty to three criminal counts, including two counts of misbranding the drugs Paxil (paroxetine hydrochloride) and Wellbutrin (bupropion hydrochloride) and one count for failing to report safety information about the drug Avandia (rosiglitazone maleate) to the FDA.

In August, Johnson & Johnson agreed to pay $181 million to resolve claims that the company’s subsidiary, Janssen Pharmaceuticals Inc., improperly marketed the antipsychotic drug Risperdal (risperidone).

Pharmaceutical and Research Manufacturers of America (PhRMA), a trade group for the pharmaceutical industry, said in a statement it was pleased with the court’s decision.

"PhRMA believes that truthful and non-misleading 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," PhRMA spokesman Matthew Bennett said.

In her dissent, Judge Debra Ann Livingston said by vacating the conviction, “the majority calls into question the very foundations of our century-old system of drug regulation.”