64 Pages Posted: 8 Jan 2014 Last revised: 9 Oct 2014
Date Written: January 7, 2014
The government has successfully prosecuted pharmaceutical companies for off-label promotion of drugs, maintaining that such promotion impermissibly undermines the FDA’s pre-market approval process and jeopardizes the public health. In several recent cases, however, pharmaceutical companies have alleged that regulations prohibiting such promotion are unconstitutional because off-label promotion is protected under the First Amendment. Two recent Supreme Court cases contain language that gives broad protection to advertising and marketing in the pharmaceutical field. This paper questions the reach of these cases as applied to the practice of off-label promotion through detailing.
Keywords: pharmaceutical, industry, marketing, authority, drug, ads, caputo, sorrell, western states, central hudson, guidance, regulatory, promotion, label, off-label, FDA, FDCA, pre-market, approval, regulations, First Amendment, Supreme Court
JEL Classification: I18, K10, K20, K23, K32, K40, M3, M30, M31, M37, M39
Suggested Citation: Suggested Citation
Greene, Stephanie M., After Caronia: First Amendment Concerns in Off-Label Promotion (January 7, 2014). 51 San Diego Law Review 645-708 (2014). Available at SSRN: https://ssrn.com/abstract=2375940