title: Snake oil salesmen or purveyors of knowledge: off-label promotions and the commercial speech doctrine.
abstract: The Second Circuit's December 2012 decision in United States v. Caronia striking down the prohibition on off-label marketing of pharmaceutical drugs has profound implications for economic regulation in general, calling into question the constitutionality of restrictions on the offer and sale of securities under the Securities Act of 1933, the solicitation of shareholder proxies and periodic reporting under the Securities Exchange Act of 1934, mandatory labels on food, tobacco, and pesticides, and a wide range of privacy protections. In this Article we suggest that Caronia misconstrues the Supreme Court's holding in Sorrell v. IMS Health, which was motivated by concerns of favoring one industry participant over another rather than a desire to return to the anti-regulator fervor of the Lochner era. Reexamining the theoretical justification for limiting truthful commercial speech shows that a more nuanced approach to regulating off-label marketing with the purpose of promoting public health and safety would pass constitutional muster. We argue that as long as the government both has a rational basis for subjecting a particular industry to limits on commercial speech intended to further a legitimate public interest, rather than unfounded paternalism, and does not discriminate against disfavored industry participants, those limits should be subject to intermediate scrutiny under the Central Hudson standard. We believe that our articulation of the commercial speech doctrine post-Sorrell will help resolve the current split in the Circuits on the appropriate standard of review in cases involving both restrictions on commercial speech and mandated speech. Finally, we critique the FDA's 2011 Guidance for Responding to Unsolicited Requests for Off- Label Information (draft) and present a proposal for new rules for regulating the off-label marketing of pharmaceutical drugs based on transparency, the sophistication of the listener and the type of information offered, and the requirement that the pharmaceutical company comply with ongoing duties of training, monitoring, reporting, and auditing.
authors.affiliation: Yale School of Management, and Yale Law School, United Sates.
authors.forename: Constance E
authors.initials: CE
authors.lastname: Bagley
authors.forename: Joshua
authors.initials: J
authors.lastname: Mitts
authors.affiliation: Delta Health Strategy Group, LLC.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Tinsley
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence*; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration