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Will Off-Label Promotions Be Legal?

By now, you’ve probably heard of the case of Alfred Caronia, whose conviction of off-label promotion of Xyrem back in 2008 was overturned in early December by the Court of Appeals for the Second Circuit in Manhattan, which cited a violation of Caronia’s free speech rights. If you haven’t, here’s a quick recap:

Caronia was a sales rep for Jazz Pharmaceuticals, specifically the Orphan Medical unit. In 2008, he was convicted of conspiracy to introduce a mis-branded drug into commerce by promoting Xyrem for un-approved uses. Before the drug was approved in November 2005 for excessive daytime sleepiness linked to narcolepsy, but after it was approved only to treat patients with narcolepsy, Caronia promoted Xyrem for such uses as excessive daytime  sleepiness, muscle disorders, chronic pain, and fatigue. He argued that if physicians are legally allowed to truthfully promote FDA-approved drugs for legal, off-label uses, so too should drug makers and sales reps.

On December 3, the court ruled 2-1 that pharmaceutical companies and their staff cannot be prosecuted for promoting drugs for “lawful,” unapproved used. Circuit judge Denny Chin said, “The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. The proscribed conduct for which Caronia was prosecuted was precisely his speech in aid of pharmaceutical marketing.”

Judge Debra Ann Livingston couldn’t have disagreed more with Chin. “The majority calls into question the very foundations of our century-old system of drug regulation,” she argued. “[If pharmaceutical companies] were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses.” She brings up a good point, and it seems that the work of the FDA could drastically change with the ruling.

Former chief counsel of the FDA Gerald Masoudi certainly thinks so. The ruling is “very significant, because it’s going to make [the] FDA, in its promotion cases, 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,” he told the New York Times.

The Pharmaceutical Research and Manufacturers of America was expectedly pleased with the ruling, according to a statement from the group. “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,” the statement read.

So, now what? It looks like the government will likely ask for a rehearing before the circuit court’s full panel of judges. off-label promotions Should the ruling remain intact through these steps, it could mean the end of a long-running and costly issue for the industry. Off-label promotion cases like those in which GSK agreed to pay $3 billion back in July or in which J&J settled for $181 million in August may just go the way of the Dodo bird. In the meantime, the FDA may cut back, or even eliminate, pursuing cases similar to those of Caronia.

HealthBridge wants to know…

Will the ruling in the Caronia case change the way pharmaceutical companies promote their drugs? Why or why not?


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