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Off-Label Drug Marketing, the First Amendment, and Federalism

Author: David Orentlicher (Indiana University Robert H. McKinney School of Law)

  • Off-Label Drug Marketing, the First Amendment, and Federalism

    Article

    Off-Label Drug Marketing, the First Amendment, and Federalism

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Abstract

This article focuses on the unique nature of prohibited disclosures within the health care field. Specifically, this article details the relationship between restrictions on off-label drug use advertising and constitutionally protected free speech. Orentlicher explores the conflict between regulation of off-label drug use through direct prohibition versus regulation through indirect advertising restrictions. Ultimately, Orentlicher argues that pharmaceutical companies should not be able to invoke first amendment arguments against off-label advertising restrictions due to the potential for harm to the consumer.

Keywords: First Amendment, Federalism, Free speech, Off-label drug marketing, Advertising, Regulation, FDA

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Published on
2016-01-01