The Truth Hurts?: FDA Regulation of Truthful Speech

Abstract

One of the more frightening pictures in our society is one of a speaker being silenced, simply by virtue of who the speaker is; yet, the FDA engages in that type of censorship on a regular basis. The FDA censors manufacturer dissemination of truthful information concerning unapproved ("off-label") uses of prescription drugs, and does so at the expense of the First Amendment. Nor does the FDA further its mission of protecting the health and safety of the American public through its censorship. In fact, the FDA's rigid policy creates more harm than good. Although off-label drug use can present serious harms, there are more efficient and less constitutionally offensive means to minimize such harms than through the FDA's current regulations. Parts I and II of this essay will set forth the relevant regulatory scheme and the current rubric for commercial speech jurisprudence. Part III examines the FDA's asserted justifications and rationales for regulating information pertaining to off-label drug-use. Parts IV and V include a policy analysis of the regulations, and set forth a few alternative solutions. This essay concludes that not only do the FDA regulations violate the First Amendment, they do not make good policy sense. The freedom agencies enjoy in the face of the First Amendment is a serious problem in our society, one exemplified by FDA regulation of manufacturer dissemination of truthful speech concerning off-label uses.