US court overturns off-label drug promotion ruling, citing right to free speech

The US Court of Appeals in New York determined that a pharmaceutical sales representative's free speech rights under the First Amendment had been violated by an earlier ruling related to the off-label promotion of narcolepsy drug Xyrem (sodium oxybate).

Alfred Caronia, a sales representative for Jazz Pharmaceuticals' unit Orphan Medical, was convicted in 2008 of conspiracy to introduce a misbranded drug into commerce by promoting Xyrem for unapproved uses. The drug was authorised by the FDA in 2002 to treat patients with narcolepsy and in November 2005 for excessive daytime sleepiness linked to narcolepsy. Prosecutors claimed that prior to the second approval, Caronia promoted Xyrem for off-label uses including excessive daytime sleepiness, muscle disorders, chronic pain and fatigue. However, Caronia argued that it should not be a crime for drugmakers and sales representatives to truthfully promote FDA-approved medicines for legal, off-label uses when doctors are allowed to engage in such speech.

In a split decision, the federal appeals court ruled 2-1 that pharmaceutical companies and their sales staff can’t be prosecuted for promoting drugs for "lawful," unapproved uses. "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," circuit judge Denny Chin said. "The proscribed conduct for which Caronia was prosecuted was precisely his speech in aid of pharmaceutical marketing," Chin added.

The appellate court noted that the US has "repeatedly prosecuted" drug companies and sales representatives for off-label promotion, citing multiple cases including one that resulted in a $3-billion settlement by GlaxoSmithKline earlier this year. Circuit judge Debra Ann Livingston commented in her dissent that the decision may restrict such future prosecutions. "The majority calls into question the very foundations of our century-old system of drug regulation," Livingston wrote.

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