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.

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FDA 对相互冲突的州药物监管的先发制人以及迫在眉睫的堕胎药物之争

在过去的 25 年里，国会和 FDA 已经确定了最安全和最有益的方式来规范米非司酮 (Mifeprex) 的使用，这种药物在美国造成了大多数流产。Dobbs 的决定重申了这些科学决定的重要性，尤其是 FDA 实施联邦食品药品和化妆品法案 (FDCA) 的风险评估和缓解策略 (REMS) 条款的决定，即米非司酮可以由患者在没有任何药物存在的情况下服用医疗保健提供者（通常通过远程医疗处方和跨州运输）。既然 Dobbs 已经被决定，州政府官员已经表示他们将通过完全禁止使用米非司酮来寻求执行与 FDA 正确使用米非司酮的方案相冲突的州法规，禁止远程医疗处方，或强加 FDA 已经特别考虑但现在拒绝的其他要求，因为这违反了 FDA 批准的药物在安全考虑允许的情况下尽可能容易获得的国会授权。已经提起诉讼以使此类法规无效，理由是它们被以下学说所取代，即根据宪法至高无上的条款，与 FDA 就批准的药物采取行动相冲突或破坏其目的的州法律将被取代。本文审查了最高法院的判例法和 FDA 的行动，这些行动将决定该诉讼的结果。第一部分详细介绍了 FDA 优先考虑冲突州法律的法定依据以及最高法院在过去 13 年中做出的四项决定（Levine、Mensing、Bartlett 和 Albrecht）阐明了 FDA 优先购买权的管理法律标准。我们特别关注 Alito 法官和其他保守派法官的意见，他们认为 FDA 的这种先发制人应该是强有力的，以确保在基于科学的决策下，有一个一致的国家药品分配和监管政策FDA，而不是不同州标准的“狭隘主义”。第二部分详细介绍了 FDA 为平衡但适当限制使用米非司酮而制定的综合计划，以及 FDA 为实现这一目标而采取的 22 年行动。然后，它对限制药物使用的州法规进行了分类，这些法规在实质上与 FDA 的决定相冲突。第三部分概述了一个早期诉讼中提出的论点，该诉讼寻求先发制人地取代一个州（密西西比州）的法规——该诉讼预示了将要发生的更广泛的诉讼。然后，它提出了 FDA 对每种类型的州限制的优先权的有力论据，以及对那些为避免 FDA 在至高无上条款下的优先权而提供的法规的“辩护”的回应。该审查表明，直接适用 FDCA 和最高法院判例法应该会导致州限制的先发制人，这与 FDA 规定的相对自由地获得堕胎药物直接冲突。然后，它提出了 FDA 对每种类型的州限制的优先权的有力论据，以及对那些为避免 FDA 在至高无上条款下的优先权而提供的法规的“辩护”的回应。该审查表明，直接适用 FDCA 和最高法院判例法应该会导致州限制的先发制人，这与 FDA 规定的相对自由地获得堕胎药物直接冲突。然后，它提出了 FDA 对每种类型的州限制的优先权的有力论据，以及对那些为避免 FDA 在至高无上条款下的优先权而提供的法规的“辩护”的回应。该审查表明，直接适用 FDCA 和最高法院判例法应该会导致州限制的先发制人，这与 FDA 规定的相对自由地获得堕胎药物直接冲突。