Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal-and beneficial-products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they "usually rest solely on the offensive assumption that the public will respond 'irrationally' to the truth." The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on "truthful speech to physicians" but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.
In 1962, a physician named Miles Robinson testified before the House Committee on Interstate and Foreign Commerce about the advertising and promotion of prescription drugs, including the tranquilizer Mellaril, the side effects of which include both the serious movement disorder tardive dyskinesia and sudden death. Mellaril's manufacturer was promoting the drug to general practitioners to treat, in the manufacturer's words, "tense, nervous patients seen in everyday practice ... for chronic fatigue, insomnia, anxiety, and apprehension, vague digestive disorders, etc."1 Dr. Robinson testified that he was "impressed with that 'etc' It just tapers off into the wide, blue yonder where tranquilizers are claimed to be good for everything."2
Promotional abuses like those Dr. Robinson described were part of the impetus for Congress to amend the Food and Drug Administration's (FDA) organic statute, the Federal Food, Drug, and Cosmetic Act (FDCA), to require that a manufacturer demonstrate to the FDA's satisfaction that, in addition to being safe, a drug is effective for a given use before marketing it for that use.3 The 1962 amendments to the FDCA (often termed the Harris -Kefauver Amendments after their congressional sponsors) require that manufacturers seeking agency approval of a new drug, or- importantly- of a new use for an already-approved drug, produce:
evidence consisting of adequate and well -controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.4
This statutory language underlies the FDA's requirement that a drug undergo preclinical testing followed by clinical trials in humans before an indication, method of administration, patient population, or, in some circumstances, dose, is enshrined on the product's agency-approved label.5 While physicians are free to prescribe a drug that has been approved for one use for any other use they deem appropriate, manufacturers may only promote it for its approved use or uses.6
The precise contours of the ban on off-label promotion derive from the Harris-Kefauver Amendments and the FDCA's misbranding provisions, as well as the FDCA's implementing regulations, court decisions, and various agency interpretations of the governing law. …