Off-Label Promotion Is Protected Speech: Second Circuit Sweeps Away Pharmaceutical Representative’s Misbranding Conviction Under the First Amendment – United States v. Caronia

Abstract

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 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.4Defendant 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 recorded8 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.11First, 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 alone, and speech in the aid of pharmaceutical marketing is . . . protected by . . . the First Amendment.13Second, 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. 15 By construing the misbranding provisions to prohibit and criminalize off-label drug promotion by pharmaceutical companies, the government was regulating based on content by prohibiting regarding the off-label use of FDA-approved drugs. 16 The government's interpretation of the provisions was also speaker-based because it prevented pharmaceutical companies from marketing off-label uses while allowing other speakers, such as physicians and academics, to discuss such uses.17Third, the Court applied the Central Hudson test 18 to determine whether the government's speech-restrictive interpretation could withstand heightened scrutiny and found that the government's construction did not survive heightened scrutiny. The construction did not directly advance the government's goals of preserving the . . . integrity of the FDA's drug approval process and reducing patient exposure to unsafe . . . drugs.19 Since only the promotion or marketing of a drug for off-label use-but not the off-label drug use itself-is prohibited, a ban on truthful promotion may interfere with the ability of physicians and patients to receive potentially relevant treatment information.20 The government was essentially legaliz[ing] the outcome of off-label use, but prohibit[ing] the free flow of information that would inform that outcome.21Furthermore, the construction was not narrowly drawn to achieve the government's interests in maintaining drug safety and public health.22 Prohibiting off-label promotion was more extensive than necessary because alternative schemes could be implemented to achieve the same goals without excessively constraining First Amendment free rights. Legitimate alternatives included: issuing guidance to help physicians and patients differentiate between misleading and truthful promotional information, developing safety tiers within the off-label market, and/or placing limits on off-label prescriptions. …