A federal appeals court has agreed to hear oral arguments about whether the First Amendment protects a sales rep’s ability to share information about off-label uses of a drug.
A date for oral arguments, which will be heard by the 2nd Circuit Court of Appeals (located in New York City), has not yet been set, according to Richard Samp, chief counsel at the Washington Legal Foundation (WLF). The WLF filed a brief with the court last April, and filed a motion in November to present oral arguments on behalf of the sales rep, which the court granted. Soon afterward, the Justice Department requested that the court allow Douglas Letter, a top DOJ appellate attorney, to also present oral arguments, Samp told MM&M. Letter did not immediately respond for comment.
The case stems from a sting operation in 2005 wherein Alfred Caronia, a sales rep for Orphan Medical, a wholly owned subsidiary of Jazz Pharmaceuticals, was asked by an internal medicine doctor (and government informer) to give a presentation on Xyrem (sodium oxybate). At the time, Xyrem was indicated only for cataplexy, and has since been approved for the treatment of narcolepsy, to reduce too much daytime sleepiness.
For the Xyrem presentation, Caronia and Peter Gleason, a physician whom Caronia had used in promotional efforts with physicians, met with the informer, and Gleason answered questions about off-label uses of Xyrem. After the meeting, both Caronia and Gleason were indicted on felony charges related to misbranding Xyrem, according to a report in the New York Law Journal.
Samp said the WLF believes that the First Amendment protects the right of individuals to speak truthfully about off-label uses, adding that in this case, FDA has never claimed that what Caronia said was untrue. The government claims that that it does not punish speech in off-label cases; it punishes conduct. “But then they point to speech,” said Samp. “Part of the problem for FDA is they never attempted to put [drug] labeling into evidence or demonstrate why someone would know not to use [Xyrem]” outside of its indication, he said.
The 2nd Circuit court initially said it would not hear oral arguments in the appeal, but the WLF brief made the court change its mind, according to Samp. Jazz Pharmaceuticals plead guilty and paid $20 million in 2007 to settle criminal and civil investigations into illegal Xyrem marketing, and entered into a five year Corporate Integrity Agreement.
Allergan filed a similar First Amendment suit over illegal Botox off-label promotion, but dropped the suit as a mandatory component of its $600 million settlement with the DOJ in September. The WLF filed briefs in that case as well, before it was withdrawn.
