FDA preemption of conflicting state drug regulation and the looming battle over abortion medications.

Abstract

Over the past 25 years, Congress and the FDA have determined the safest and most beneficial way to regulate the use of mifepristone (Mifeprex), the medication that accounts for the majority of abortions in the United States. The Dobbs decision has renewed the importance of those scientific determinations, especially FDA's decisions implementing the Risk Evaluation and Mitigation Strategy (REMS) provisions of the Federal Food Drug and Cosmetic Act (FDCA), that mifepristone may be taken by patients outside the presence of any healthcare provider (often through telemedicine prescription and shipment across state lines). Now that Dobbs has been decided, state officials have indicated that they will seek to enforce state statutes which conflict with FDA's regimen for the proper use of mifepristone, by banning its use entirely, prohibiting telemedicine prescription, or imposing other requirements which FDA has specifically considered and now rejected as contrary to the congressional mandate that FDA-approved drugs be as accessible as safety considerations allow. Litigation has already been filed to invalidate such statutes on the grounds that they are preempted by the doctrine that state law which conflicts with, or undermines the purposes of, FDA actions with respect to approved drugs are preempted under the Supremacy Clause of the Constitution. This article examines the Supreme Court caselaw and FDA actions which will dictate the outcome of that litigation. Part I details the statutory basis for FDA preemption of conflicting state law and the four decisions by the Supreme Court over the last 13 years (Levine, Mensing, Bartlett and Albrecht) which enunciate the governing legal standards for FDA preemption. We pay particular attention to the opinions of Justice Alito and the other conservative justices, which hold that such FDA preemption should be robust to ensure that there is one consistent, national policy for the distribution and regulation of drugs, under the science-based decisions of the FDA, rather than the 'parochialism' of differing state standards. Part II details FDA's comprehensive program for the balanced, though appropriately restricted, use of mifepristone, and the 22 years of FDA actions that brought that about. It then catalogs the state statutes limiting the use of the drug which, in material ways, conflict with those FDA determinations. Part III outlines the arguments made in one early lawsuit seeking preemption of the statutes of one state (Mississippi)-a law suit which previews the wider litigation to come. It then sets forth the strong arguments for FDA preemption of each type of state restriction and responses to the 'defenses' of those statutes that have been offered in an effort to avoid FDA preemption under the Supremacy Clause. That review shows that a straight-forward application of the FDCA and the Supreme Court caselaw should result in the preemption of the state restrictions that squarely conflict with the relatively free access to abortion medications which FDA has mandated.