American Journal of Law & Medicine

Off-Label Promotion Is Protected Speech: Second Circuit Sweeps Away Pharmaceutical Representative's Misbranding Conviction under the First Amendment

Off-Label Promotion Is Protected Speech: Second Circuit Sweeps Away Pharmaceutical Representative's Misbranding Conviction Under the First Amendment--United States v. Caronia (1)--On December 3, 2012, the Second Circuit, in a two-to-one decision, vacated the conviction of a pharmaceutical sales representative for violating the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) (2) by promoting truthful off-label uses of a drug approved by the Food and Drug Administration (FDA). (3) The Second Circuit held that: (1) the government prosecuted defendant for his speech; (2) the government's interpretation of the misbranding provisions was content- and speaker-based, which warranted heightened scrutiny; and (3) off-label drug promotion was speech protected by the First Amendment, under the four-prong test set forth in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York. (4)

Defendant Alfred Caronia was a Specialty Sales Consultant employed by Orphan Medical, Inc., (5) to promote Xyrem, a drug approved by the FDA to treat a very specific subset of the population: narcoleptic patients with cataplexy and excessive daytime sleepiness. (6) The FDA required Xyrem to have a "black box" warning, the most serious warning placed on prescription medicine labels. (7) Caronia was recorded (8) promoting Xyrem for off-label uses, (9) which are uses not approved by the FDA, and he was convicted of misbranding by a jury. (10) Caronia appealed the decision, and the Second Circuit vacated his conviction. (11)

First, the Second Circuit found that the government prosecuted Caronia for the simple promotion of the off-label use of an FDA-approved drug. (12) The government therefore prosecuted Caronia not for his conduct but for his speech alone, and "speech in the aid of pharmaceutical marketing is ... protected by ... the First Amendment." (13)

Second, the Court, relying heavily on a recent Supreme Court decision, Sorrell v. IMS Health, Inc., (14) found the government's interpretation of the FDCA misbranding provisions warranted heightened scrutiny because the interpretation was both content-based and speaker-based. …

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