When the Food and Drug Administration (FDA) authorizes the marketing of a new drug or medical device, the license reflects the FDA’s review of data and information relating to uses specified by the manufacturer and set forth in agency-approved labeling. Authorized products are often used “off-label,” i.e., for purposes other than those for which they are labeled. However, such uses are legal. Indeed, “off-label” use can be standard medical practice. Despite this undisputed fact, in most instances the FDA prohibits manufacturers from promoting such off-label uses, even to members of the medical profession. In short, the FDA prohibits the speech, even though the activity promoted is perfectly legal and the speech is neither false nor misleading.
In this article, we seek to accomplish two goals: (1) to explore the political and administrative dynamics underlying the evolution of the FDA’s policy towards off-label promotion, and (2) to test that policy by reference to both controlling commercial speech jurisprudence and the underlying values of the First Amendment’s guarantee of free expression. We conclude that the FDA’s prohibition of off-label promotion is the product of a complex set of political factors. We further conclude that not only is the FDA’s policy towards manufacturers’ promotion of off-label use unambiguously inconsistent with well established Supreme Court doctrine on commercial speech, it also contravenes core precepts of democratic theory that provide the normative foundation for the constitutional protection of free expression.