That's the title of this article by Constance Bagley, Joshua Mitts, and Richard Tinsley. The article deals with concerns about last year's Caronia decision, where the Second Circuit ditched the misdemeanor conviction of a drug company
prescription drug representative, saying that his promotion of one of
the company's products was protected by the First Amendment. (Go here for more info on Caronia.) Here's the 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 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 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. Finally, we critique the FDA’s 2011 Draft
Guidance for Responding to Unsolicited Requests for Off-Label
Information 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.
