A free-speech challenge to off-label marketing rules has gained some traction in federal court. It's the case of Alfred Caronia, a former Orphan Medical sales rep for the narcolepsy drug Xyrem. Criminally charged under the Food, Drug and Cosmetic Act, Caronia was convicted in district court after a judge rejected his argument for First Amendment protections.
Caronia appealed, and according to Forbes, the case appeared set for an affirmation of the lower court's decision, without any oral arguments whatsoever. But the Washington Legal Foundation stepped in, filing a brief in support of the free-speech defense, saying that the prosecution doesn't dispute the truth of Caronia's sales pitches on Xyrem, and those off-label uses he promoted are now FDA-approved. So, the Second Circuit has decided to hear oral arguments, an indication that it actually might consider overturning Caronia's conviction.
The Department of Justice is concerned enough that it has asked to bring in the big guns to help argue the prosecution's side. Specifically, the DoJ wants to add Douglas Letter, a First Amendment expert and top appellate lawyer, to its legal team on the case. Meanwhile, the WLF has joined in to help persuade the court that the FDA violated Caronia's First Amendment rights.
A victory for Caronia could mean (provided it survived subsequent appeals) could seriously interfere with FDA's push to prosecute individuals for off-label marketing violations. After all, if pushing a drug for off-label use is a free-speech right, then how could FDA crack down on it?
- read the Forbes story