This Article explores the constitutionality of the Food and Drug Administration’s (“FDA’s”) regulatory restrictions on so-called “off-label” pharmaceutical advertising and promotion—marketing efforts, typically by drug companies and their agents, that promote uses for drugs other than those approved by the FDA. This Article argues that the First Amendment has passed by the FDA’s long-standing and near-absolute restriction on such off-label advertising, and that off-label promotion of drugs, when accompanied in certain cases by appropriate disclaimers, should be deemed protected by the First Amendment.
