Abortion Constitutionality Medical abortion

Constitutionality of banning off-label use of drugs

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:

Teresa Collett

Teresa Stanton Collett is a professor at the University of St. Thomas School of Law in Minneapolis, Minnesota, where she teaches bioethics, property law, and constitutional law. A nationally prominent speaker and scholar, she is active in attempts to rebuild the Culture of Life and protect the institutions of marriage and family. She often represents groups of state legislators, the Catholic Medical Association, and the Christian Medical and Dental Association in appellate case related to medical-legal matters. She represented the governors of Minnesota and North Dakota before the U.S. Supreme Court as amici curiae regarding the effectiveness of those states’ parental involvement laws. She has served as special attorney general for Oklahoma and Kansas related to legislation designed to protect the well-being of minors and unborn children. She is an elected member of the American Law Institute and has testified before committees of the U.S. House of Representatives and U.S. Senate Committee on the Judiciary, Subcommittees on the Constitution, as well as numerous legislative committees in the states.