Jazz Pharmaceuticals neurology news

The U.S. Court of Appeals for the Second Circuit said in a 2-1 ruling in United States v. Caronia that the "government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of an FDA-approved drug." In the ruling, Judge Denny Chin wrote that so long as the off-label use of the FDA-approved drug is legal, the government's interpretation of FDCA's misbranding provisions to prohibit and criminalize the promotion of off-label use "unconstitutionally restrict[s] speech." FDCA prohibits misbranding, but does not expressly prohibit the promotion or marketing of drugs for off-label use.

The appeals court vacated and remanded a lower court decision which convicted Alfred Caronia, a specialty sales consultant at Orphan Medical, of conspiring to misbrand a drug. The government prosecuted Caronia based on his audiotaped conversations promoting narcolepsy drug Xyrem sodium oxybate to physicians for unapproved indications, including chronic pain, fibromyalgia and chronic fatigue. In 2008, a jury for the lower court held that Caronia's off-label promotion constituted criminal misbranding, which FDCA defines as labeling that fails to bear adequate directions for the safe and intended use of a drug. Caronia was sentenced to one-year probation and 100 hours of community service. Caronia appealed the decision, arguing that his conviction was based solely on his speech and therefore was a violation of his First Amendment rights. Jazz acquired Orphan Medical in 2005 (see BioCentury, July 4, 2005). ...