Life Sciences

First Amendment not enough to dismiss off-label prosecution

Pharma Compliance Alert, October 1, 2008

Eastern District of New York Judge Eric N. Vitaliano ruled the First Amendment’s free speech provisions were not enough to dismiss the prosecution of former pharmaceutical sales representative Alfred Caronia, according to a New York Law Journal article.

Caronia was hired in March 2005 to promote Orphan Medical’s Xyrem. He was charged with a felony related to a conspiracy to misbrand Xyrem after a meeting involving a confidential government informant and a physician who promoted Xyrem. Caronia claimed he only set up the meeting and attended it, but did not take part in the off-label discussion.

Caronia was later charged with a superseding two-count misdemeanor accusing him of intentionally conspiring to misbrand Xyrem. He asked for the charged to be dismissed because of the First Amendment right to free speech.

Vitaliano ruled Caronia’s prosecution was not an unconstitutional restriction on commercial speech and was not grounds for dismissal. Vitaliano said the FDA’s restriction on off-label promotion was necessary to ensure the integrity of the new drug application process.

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