First Amendment - Commercial Speech - Second Circuit Holds That Prohibiting Truthful Off-Label Promotion of FDA-Approved Drugs by Pharmaceutical Representatives Violates First Amendment

Harvard Law Review, December 2013 | Go to article overview

First Amendment - Commercial Speech - Second Circuit Holds That Prohibiting Truthful Off-Label Promotion of FDA-Approved Drugs by Pharmaceutical Representatives Violates First Amendment


FIRST AMENDMENT--COMMERCIAL SPEECH--SECOND CIRCUIT HOLDS THAT PROHIBITING TRUTHFUL OFF-LABEL PROMOTION OF FDA-APPROVED DRUGS BY PHARMACEUTICAL REPRESENTATIVES VIOLATES FIRST AMENDMENT.--United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).

Government regulation of pharmaceutical marketing has recently emerged as an important First Amendment issue. The Food and Drug Administration (FDA), pursuant to the Federal Food, Drug, and Cosmetic Act (1) (FDCA), approves all new drugs and drug labeling before commercial distribution. The labeling must set forth approved uses, and any unapproved use is considered "off-label." (2) Despite the fact that physicians can prescribe, and patients can use, drugs for off-label purposes, the government has construed the FDCA to prohibit off-label promotion (3) and frequently prosecutes pharmaceutical companies and their representatives for such activity. (5) Recently, in United States v. Caronia, (5) the Second Circuit held that the prohibition and criminalization of truthful off-label promotional speech by pharmaceutical companies and their representatives violates the First Amendment. (6) The Caronia ruling is consistent with the evolution of the commercial speech doctrine; however, the holding is undesirable from a policy perspective because it undermines substantial regulatory and public health interests.

In July 2002, Orphan Medical, Inc. received FDA approval to market Xyrem, a central nervous system depressant, to treat cataplexy in narcolepsy patients. (7) Xyrem has severe side effects and, if abused, can cause depression, seizures, coma, and death. (8) To protect against these safety risks, the FDA mandated "black box" labeling--the most serious warning on prescription medication--and national distribution from a single pharmacy. (9) In March 2005, Orphan hired Alfred Caronia as a sales consultant to promote Xyrem. (10) Shortly thereafter, the federal government began a criminal investigation into alleged off-label promotion of Xyrem by Orphan, Caronia, and Dr. Peter Gleason, a physician hired by the company to promote Xyrem through its "speaker programs." (11) In audio-recorded conversations with prospective physician customers, Caronia promoted Xyrem for unapproved uses, including unapproved indications (such as fibromyalgia, insomnia, and chronic pain) and unapproved populations (namely, patients under sixteen). (12) The government charged Caronia with two misdemeanor offenses under the FDCA: conspiracy to misbrand a drug and introduction of a misbranded drug into interstate commerce. (13) Caronia filed a motion to dismiss, arguing, inter alia, that the government's construction of the FDCA misbranding provisions violated his right to free speech under the First Amendment. (14)

The federal district court denied Caronia's motion. (15) The court first determined that off-label promotion constitutes commercial speech. (16) The court then applied the four-prong analysis set forth in Central Hudson Gas & Electric Corp. v. Public Service Commission (17) to determine whether the commercial speech regulation was consistent with the First Amendment. (18) First, as a threshold matter, to qualify for First Amendment protection, the speech must concern lawful activity and not be misleading. (19) Second, the asserted government interest must be substantial. (20) Third, the regulation must directly advance that interest. (21) Fourth, the regulation must be narrowly drawn and not more extensive than necessary. (22) Applying Central Hudson, the court upheld the constitutionality of the FDA regime. (23) A federal jury ultimately convicted Caronia for conspiracy to introduce a misbranded drug into interstate commerce. (24)

The Second Circuit vacated the conviction and remanded. (25) Writing for a divided panel, Judge Chin (26) first determined that Caronia was prosecuted for his speech, not for his conduct: off-label promotion did not merely serve as "evidence of intent" to introduce a misbranded drug into interstate commerce but, instead, constituted the actus reus of the crime. …

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