Long before the Supreme Court decided Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228 (2022), Bexis was concerned that FDCA preemption would be dragged into the country’s culture wars by the abortion issue. He hoped the Supreme Court would adhere to long-established precedent and thus keep FDCA preemption out of politics and in product liability litigation where it belonged. Dobbs extinguished that hope (and many others), so Bexis decided that he might as well embrace the inevitable.
He proposed writing his own law review article on this subject – about which he knows as much as anyone – to the Food & Drug Law Institute. FDLI accepted the proposal, and now, over a year later, the article is now published: Beck, Danziger, Johansen & Hayes, “Federal Preemption & the Post-Dobbs Reproductive Freedom Frontier,” 78(2) Food & Drug L.J. 109 (2023). The article is available to the public at the journal’s website, here. Bexis hardly did this alone, being ably assisted by three (then) Reed Smith colleagues, Philip W. Danziger, Sarah B. Johansen, and Andrew R. Hayes.
Bexis concluded that three forms of preemption, (1) obstacle preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (2) impossibility preemption barring “stop selling” claims under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), and (3) express OTC drug preemption under 21 U.S.C. §379r, should preclude some (but hardly all) state abortion-related bans – particularly when states purport to target the availability of FDA-approved drugs for their FDA-approved indications. Here’s the article’s 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 FDA-approved products. It also addresses implied preemption under [Bartlett], 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 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.
Post-Dobbs Federal Preemption, 78 Food & Drug L.J. at 109.
The bottom line – FDCA-related federal preemption is strongly pro-choice. With that in mind, the multi-faceted attack directly against the FDA’s regulatory authority in the Alliance for Hippocratic Medicine litigation, that the Blog has discussed here, here, and here, is entirely understandable. The anti-choice side also understands that preemption is likely to preclude states from preventing access to FDA-approved products for their FDA-approved indications. Hence their drive to overturn FDA approval of mifepristone and other abortifacient drugs, or at least to turn back the FDA clock to prevent their use in telemedicine. Telemedicine is the key, since it allows residents of even the most anti-choice jurisdictions to access mifepristone through interstate commerce. That also explains why the Alliance plaintiffs sought to resurrect the 19th century Comstock Act – because it provides an (albeit archaic) federal ground to attack interstate commerce in FDA-approved abortifacient drugs.
Bexis’ article addresses preemption, off-label use, and related issues with typical Bexis thoroughness. If you interested in this area, check it out.