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05.29.13 | Blog Posts

Caronia And The First Amendment Defense To Off-Label Marketing: A Six Month Re-Assessment

The Insider: White Collar Defense and Securities Enforcement

When the Second Circuit issued its December 3, 2012 decision in United States v. Caronia, the opinion was proclaimed by many to signal a sea change in the prosecution of off-label promotion. Alfred Caronia, a former sales representative for the pharmaceutical company Orphan Medical, had been convicted at trial of conspiring to promote the drug Xyrem for uses not approved by the Food and Drug Administration ("FDA"). On appeal, Caronia advanced an argument that had been pursued by others for years, and had, in Caronia’s case, failed to persuade the district court: that the First Amendment protected his truthful promotion of a drug for indications not approved by the FDA. After over two years in which observers eagerly anticipated a ruling, the Second Circuit issued a two-to-one decision in which the majority vacated Caronia's conviction on the ground that it impermissibly criminalized protected speech and violated his First Amendment rights. [...]

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