Federal Preemption and the Post-Dobbs Reproductive Freedom Frontier

James M. Beck, Philip W. Danziger, Sarah B. Johansen & Andrew R. Hayes*

ABSTRACT

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 U.S. Food and Drug Administration (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 Federal Food, Drug, and Cosmetic Act (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 FDAapproved products. It also addresses implied preemption under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), of privately brought “stopselling” 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 actual or de facto state 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 FDA at greater risk of political and judicial interference with its science-based standards for approval of drugs and their intended uses.