Lengthy earlier than the Supreme Court docket determined Dobbs v. Jackson Girls’s Well being Org., 142 S. Ct. 2228 (2022), Bexis was involved that FDCA preemption could be dragged into the nation’s tradition wars by the abortion concern. He hoped the Supreme Court docket would adhere to long-established precedent and thus hold FDCA preemption out of politics and in product legal responsibility litigation the place it belonged. Dobbs extinguished that hope (and plenty of others), so Bexis determined that he may as nicely embrace the inevitable.
He proposed writing his personal legislation evaluate article on this topic – about which he is aware of as a lot as anybody – to the Meals & Drug Legislation Institute. FDLI accepted the proposal, and now, over a yr later, the article is now revealed: Beck, Danziger, Johansen & Hayes, “Federal Preemption & the Put up-Dobbs Reproductive Freedom Frontier,” 78(2) Meals & Drug L.J. 109 (2023). The article is out there to the general public on the journal’s web site, right 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 types of preemption, (1) impediment preemption beneath Buckman Co. v. Plaintiffs Authorized Committee, 531 U.S. 341 (2001), (2) impossibility preemption barring “cease promoting” claims beneath Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), and (3) specific OTC drug preemption beneath 21 U.S.C. §379r, ought to preclude some (however hardly all) state abortion-related bans – notably when states purport to focus on the provision of FDA-approved medication for his or her FDA-approved indications. Right here’s the article’s summary:
Within the wake of the Dobbs determination abolishing the constitutional proper to reproductive freedom, some states have enacted measures that will prohibit the importation, sale, and use of U.S. Meals and Drug Administration (FDA)-approved medication (each prescription and OTC) which are a part of treatment abortion and emergency contraception medical therapies. Opponents of such measures have raised the prospect of federal preemption beneath the Federal Meals, Drug, and Beauty Act (FDCA) in opposition to these enactments.
This paper discusses the 2 kinds of implied preemption that will be raised in opposition to state bans and different restrictions of FDA-approved abortion-related pharmaceuticals, in addition to attainable specific preemption within the context of OTC medication. It examines prior preemption litigation involving affirmative state bans imposed in opposition to FDA-approved merchandise. It additionally addresses implied preemption beneath [Bartlett], of privately introduced “stop-selling” claims introduced in opposition to varied FDA-approved pharmaceuticals within the product legal responsibility context. The paper additionally discusses state management over medical follow within the context of off-label use of FDA-approved medication to terminate being pregnant or to supply post-coitus contraception.
The paper concludes that these preemption arguments seem meritorious within the context of precise or de facto state bans on abortion-related medication, at the least within the context of on-label use, with state management over off-label use being a weaker case. It factors out that these preemption arguments additionally place FDA at larger threat of political and judicial interference with its science-based requirements for approval of medicine and their supposed makes use of.
Put up-Dobbs Federal Preemption, 78 Meals & Drug L.J. at 109.
The underside line – FDCA-related federal preemption is strongly pro-choice. With that in thoughts, the multi-faceted assault immediately in opposition to the FDA’s regulatory authority within the Alliance for Hippocratic Drugs litigation, that the Weblog has mentioned right here, right here, and right here, is totally comprehensible. The anti-choice aspect additionally understands that preemption is prone to preclude states from stopping entry to FDA-approved merchandise for his or her FDA-approved indications. Therefore their drive to overturn FDA approval of mifepristone and different abortifacient medication, or at the least to show again the FDA clock to forestall their use in telemedicine. Telemedicine is the important thing, because it permits residents of even essentially the most anti-choice jurisdictions to entry mifepristone by way of interstate commerce. That additionally explains why the Alliance plaintiffs sought to resurrect the nineteenth century Comstock Act – as a result of it supplies an (albeit archaic) federal floor to assault interstate commerce in FDA-approved abortifacient medication.
Bexis’ article addresses preemption, off-label use, and associated points with typical Bexis thoroughness. If you curious about this space, test it out.
