Food & Drug Law Journal

In the wake of the Dobbs decision abolishing the constitutional right to reproductive freedom, some states have enacted measures that would prohibit the importation, sale, and use of FDA-approved drugs (both prescription and OTC) that are part of medication abortion and emergency contraception medical treatments. Opponents of such measures have raised the prospect of federal preemption under the FDCA in opposition to those enactments.

This paper discusses the two types of implied preemption that would be raised against state bans and other restrictions of FDA-approved abortion-related prescription drugs, as well as possible express preemption in the context of OTC drugs. It examines prior preemption litigation involving affirmative state bans imposed against FDA-approved products. It also addresses implied preemption under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), of privately brought “stop selling” claims brought against various FDA-approved prescription drugs in the product liability context. The paper also discusses state control over medical practice in the context of off-label use of FDA-approved drugs to terminate pregnancy or to provide post-coitus contraception.

The paper concludes that these preemption arguments appear meritorious in the context of state actual or de facto bans on abortion-related drugs, at least in the context of on-label use, with state control over off-label use being a weaker case. It points out that these preemption arguments also place the FDA at greater risk of political and judicial interference with its science-based standards for approval of drugs and their intended uses.

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