When the FDA approved the sale of RU-486 in this country, the agency used a little known process historically reserved for life-saving drugs. Lars Noah described the process in his article, A Miscarriage in the Drug Approval Process?: Mifepristone Embroils the FDA in Abortion Politics. Since the approval of the drug, abortion providers have continued to experiment with the dosage and means of delivery, as well as use of the drug for aborting pregnancies beyond the 49 days LMP approved by the FDA. Various states have attempted to require abortion providers to adhere to the protocol used to obtain FDA approval of the drug. For example in Planned Parenthood of Cincinnati v. Strickland, the federal court upheld an Ohio law that required use of the FDA protocol. A similar case is currently pending in South Dakota.
A new law review article explores the constitutionality of prohibiting use of federally controlled drugs for non-approved purposes. The author describes her thesis as:
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.
Greenwood, Kate, The Ban on ‘Off-Label’ Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis Against False or Misleading Commercial Speech? (July, 13 2011). American Journal of Law and Medicine, Vol. 37, p. 278, 2011. Available at SSRN: http://ssrn.com/abstract=1885076