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Last year Bexis was lead author on a law review article in the Food and Drug Law Journal titled Federal Preemption and the Post-Dobbs Reproductive Freedom Frontier.  The article expands on themes previously raised in this blog, including here, here and here.  It discusses the application of federal preemption under the Food Drug and Cosmetic Act (FDCA) to state-law medication abortion restrictions after Dobbs. The article recognized that, following Dobbs, it was inevitable that FDCA preemption would become embroiled in the abortion controversy. That prediction was accurate.  Today’s decision addresses the impact of preemption on a North Carolina law that imposed significant restrictions on an FDA approved medication taken to terminate a pregnancy.

Bryant v. Stein, 2024 WL 1886907 (M.D.N.C. Apr. 30, 2024) is another decision addressing the abortifacient drug mifepristone.  We’ve blogged about mifepristone litigation in Texas and West Virginia, and the Supreme Court heard argument earlier this year on the Fifth Circuit’s decision that, while overturning the Texas district court decision nullifying the FDA’s approval of mifepristone, voided both the 2016 risk evaluation and mitigation strategy (REMS) for mifepristone and the FDA’s decision allowing prescription by telemedicine.  The bizarre Texas decision doesn’t involve a preemption analysis, and the Fifth Circuit’s decision did not even mention preemption.  Bryant, however, puts FDCA preemption squarely in the cross hairs, and it largely lands where Bexis predicted in his law review article.

Bryant involves 2023 amendments to North Carolina’s “Abortion Laws.” In those amendments North Carolina imposed restrictions on the use and distribution of abortion-inducing drugs, including mifepristone.  The plaintiff in Bryant challenged the provisions in the North Carolina statute that: (1) only physicians can prescribe mifepristone; (2) physicians prescribing mifepristone must administer the drug in-person; (3) the drug can only be prescribed after an in-person examination including a determination of the patient’s blood type, gestational age by ultrasound, and an in-person consultation; (4) a provider must schedule a follow up appointment with the patient and document all efforts to get the patient to attend the appointment; and (5) providers must report all adverse events and complications to the FDA.  The statute provides that violations by medical providers could subject them to professional, civil and criminal penalties.

The court began its preemption analysis with a detailed examination of the regulatory history of mifepristone.  The FDA approved Mifeprex (brand name of mifepristone) in 2000 under the Subpart H regulation – pursuant to which the FDA could limit distribution to certain facilities or physicians with special training or experience, or condition distribution on the performance of specified medical procedures.  Upon initial approval, Mifeprex could only be provided by a physician who had to (1) be able to accurately assess the duration of the pregnancy and diagnose ectopic pregnancies, (2) provide surgical intervention or have plans to provide surgical intervention through the use of others if needed, (3) give patients a medication guide and obtain a signed patient agreement, (4) fully explain the procedure, and (5) report any hospitalizations or serious adverse events.  Patients had to sign an agreement in which they agreed to take the medication in their doctor’s office and agree to return for a follow up appointment in 14 days.  Id. at *6.  These requirements were later memorialized in the REMS for mifepristone following the 2007 amendments to the FDCA (those amendments required that, for certain categories of drugs—including any drugs previously approved under Subpart H—REMS are necessary to ensure that the benefits of a drug outweigh the risks).

In 2016 the FDA modified the REMS for mifepristone to eliminate the requirements that only a physician could prescribe the drug, that patients agree to return for an in person appointment, and that providers had to report any hospitalizations or serious adverse events.  In 2021 and in connection with the COVID-19 pandemic, the FDA announced that it would not enforce the in-person dispensing requirement (e.g., in a doctor’s office, clinics or hospitals) so long as the other REMS elements were followed.  Later the same year the FDA removed the in-person requirement entirely from the REMS – so mifepristone can be prescribed by telemedicine.

Turning from the regulatory history to the interplay between the FDA’s regulation of mifepristone and the North Carolina statute, the court flagged what it called the “obvious tension and overlap between state and federal regulation of prescription drugs and the providers who prescribe and distribute them.”  Id. at *9.  But it recognized that:

Given Congress’ explicit permission and requirement that the FDA regulate aspects of the practice of medicine as to REMS drugs, the mere fact that a state law regulates the practice of medicine as to that drug does not give the law an automatic free pass to avoid a preemption challenge.

Id.  The court then turned to the 2007 amendments to the FDCA and the REMS requirements. It highlighted the FDA’s role under those amendments for determining what restrictions should be imposed on the distribution of drugs with serious risks of harm and on the providers who prescribe those drugs. The court concluded that Congress’ “clear and manifest purpose” was to create a “comprehensive federal strategy under which the FDA is responsible for deciding what safety restrictions on higher-risk drugs are necessary to make use of those drugs less risky.” Id. at *11.  Any state law that creates an obstacle to this “clear and manifest purpose” would be preempted.

The court then broke down its approach to the preemption analysis based on state laws that regulate the use and administration of a drug versus laws that focus on the protection of prenatal life, general patient health or safety, or broad regulation of the medical profession:

A state law regulating the use and administration of an inherently toxic or potentially harmful drug like mifepristone based solely on its health and safety risks stands as an obstacle to Congress’ goal of creating a comprehensive regulatory framework under which the FDA is responsible for deciding what terms are required for safe access to and use of these drugs while considering patient access and burdens on the health care system.  State laws which disagree or interfere with the FDA’s judgement are preempted.  But nothing in the REMS statute or the [2007 amendments to the FDCA] suggests that Congress intended to preempt all informed consent laws concerning health conditions treated by prescription medications or to restrict state rules that otherwise are directed to regulating medical care generally.

Id. at *12.

Applying this rationale, the court held that the provisions of the North Carolina statute requiring in-person administration by a physician, in person follow up appointments, and reporting any adverse events to the FDA were all preempted.  The court’s decision was driven by the facts that (1) these limitations had already been considered and explicitly rejected by the FDA (as reflected in the modified REMS), and (2) the provisions related solely to the safe administration of the drug – rather than to the regulation of the practice of medicine in general. The court summarized its holding as follows:

Based on a disagreement with the FDA over what safety restrictions on the use of mifepristone are necessary, North Carolina has enacted laws requiring physician-only prescribing . . ., in-person prescribing, dispensing and administering of the drug, scheduling of an in-person follow up appointment, and non-fatal adverse event reporting to the FDA; these parts of the Abortion Laws conflict with the decisions made by the FDA explicitly finding such requirements to be unnecessary for safe use. Because these provisions are obstacles to congressional purpose, they are preempted. These state safety rules must yield to the safety decisions made by the federal agency in whose hands Congress placed decision-making authority about safety.

Id. at *20.

Conversely, the court held that the requirements for in person advance consultation, use of an ultrasound, in person examination and blood type determination were not preempted. The court viewed these restrictions as regulating the medical profession generally – rather than regulating the safe use of mifepristone.  The fact that these restrictions tracked the North Carolina limitations on surgical abortions (as well as the Dobbs decision in general) appear to have impacted the court’s analysis, as the court noted that “the presumption against preemption is especially strong as to these state law provisions because they broadly address pregnancy-related health matters.” Id. at *13 (citing Dobbs).  The court also noted that the health and safety of a state’s citizens are generally a matter of state concern, and informed consent laws have generally been the primary responsibility of the state.

Two defendant intervenors in the case (two state legislative leaders) also contended that the major questions doctrine precluded implied preemption of the FDA’s actions related to mifepristone. The major questions doctrine addresses “agencies asserting highly consequential power beyond what Congress could reasonably be understood to have granted.” Id. at *20, quoting West Virginia v. EPA, 597 U.S. 697, 724 (2022).  The court rejected this, underscoring that the FDA acted within its express authority:

No one disputes that in 2007, Congress specifically granted the FDA authority to adopt a REMS program for higher-risk drugs or that mifepristone was one of a number of prescription drugs requiring a REMS because the FDA approved it under Subpart H of the FDA’s regulations. Nor does anyone dispute that the 2007 amendments authorize and indeed require the FDA to review, modify and update a REMS program periodically. . . . Here, the FDA acts in accordance with Congress’ command: it has implemented a REMS for a variety of drugs, including mifepristone, imposing requirements to reduce risks to patients while declining to impose requirements which in the agency’s judgment do not effectively reduce risks and ensure safe access.

Id. The court was unmoved by the defendant-intervenor’s argument that “nothing in the text of the FDCA suggests that Congress accorded the FDA any power, much less exclusive power, to set national abortion policy.” Id. The statutory mandate authorizing the FDA to implement REMS applies to drugs without regard to their purpose, and nothing indicated the FDA was applying or interpreting the FDCA to give it greater authority over mifepristone than it has over any other REMS medication.  As a result the major questions doctrine had no application.

It is unfortunate that FDCA preemption is becoming tangled in litigation involving abortion medication. Although Bryant largely adhered to existing precedent, results driven decisions could have a dramatically different outcome and impact if they depart from the established preemption analysis applicable to prescription drugs.