Fourth Circuit Hears North Carolina Mifepristone Preemption Appeal

• Dr. Amy Bryant is appealing a district court ruling to the Fourth Circuit, challenging North Carolina's additional restrictions on mifepristone.
• The lawsuit, filed in January 2023, argues state requirements conflict with federal preemption principles and burden patient access.
• A district judge in 2024 preempted state requirements for in-person prescribing, dispensing, administering, and follow-up appointments for mifepristone, but upheld others like a 72-hour consultation and ultrasound.
• North Carolina's Solicitor General argues states cannot reimpose regulations on REMS drugs that the FDA previously withdrew after balancing access and safety.
• The appeal will determine the extent to which states can regulate FDA-approved drugs, particularly those with REMS programs, beyond federal requirements.

States are prohibited from reimposing regulations on REMS drugs that the FDA had once implemented and then deliberately decided to withdraw.

A legal challenge currently before the Fourth Circuit Court of Appeals seeks to clarify the extent of North Carolina's authority to impose additional regulations on the abortion-inducing drug mifepristone, beyond those established by the Food and Drug Administration. Dr. Amy Bryant initiated a lawsuit in January 2023, contending that the state's requirements for patients accessing mifepristone exceed the FDA's risk assessment framework and unduly burden patient access. Her complaint asserts that established principles of federal preemption prevent states from enacting laws that conflict with or undermine the objectives of federal statutes.

In response, legislative defendants U.S. Representative Tim Moore and state Senator Phil Berger argue that restricting states from implementing supplementary regulations, such as mandatory in-person prescribing and administration, would severely limit their capacity to enhance safeguards for high-risk medications. They also suggest that such limitations could potentially eliminate state-level tort remedies for drug-related issues. Erin Hawley, representing Moore and Berger, stated during the recent hearing that the plaintiffs' evidence primarily points to FDA statements deeming certain provisions "not necessary," which she distinguished from an outright prohibition on state regulation.

U.S. District Judge Catherine Eagles issued a partial ruling in 2024, siding with Dr. Bryant on several key points. Judge Eagles determined that North Carolina could not enforce safety restrictions that the FDA had specifically rejected, concluding that such state laws "frustrate the congressional goal of establishing a comprehensive regulatory framework" and are thus preempted by federal law. Consequently, the state was permanently enjoined from enforcing requirements for in-person prescribing, dispensing, administering, and follow-up appointments. However, the district court upheld other state requirements, including an in-person 72-hour advance consultation, the use of ultrasound, an in-person examination, blood testing, and reporting adverse side effects, deeming these to be related to informed consent and broader health and safety matters not subject to preemption. Dr. Bryant is now appealing this decision, urging the appeals court to declare all of North Carolina's restrictions preempted by federal law.

The central legal question revolves around the doctrine of federal preemption, specifically how it applies to state regulation of drugs, particularly those subject to Risk Evaluation and Mitigation Strategies (REMS) like mifepristone. Nicholas Brod, North Carolina's solicitor general, representing Democratic Attorney General Jeff Jackson, argued before the Fourth Circuit that the FDA has dedicated 25 years to meticulously balancing patient access, the burdens on healthcare delivery systems, and safety concerns related to mifepristone. Brod characterized the state's actions as an attempt to revert to an earlier version of regulations that the FDA itself had previously imposed but subsequently withdrew, describing this as an "unusual situation" that supports a "quite narrow" preemption theory.

Brod emphasized that the state cannot enforce legislative regulations that undermine the carefully calibrated balance achieved by the FDA to ensure patient access to mifepristone, echoing arguments made in a previous brief by former Attorney General Josh Stein. When questioned by U.S. Circuit Judge Julius Richardson about whether the FDA dictates abortion policy, Brod clarified the scope of state authority. He affirmed that states possess broad power to regulate FDA-approved drugs, allowing them to enact laws that complement federal regulations, fill regulatory gaps, or even exceed FDA standards when those standards are set as minimums. However, Brod drew a critical distinction: states are prohibited from reimposing regulations on REMS drugs that the FDA had once implemented and then deliberately decided to withdraw.

The Fourth Circuit's forthcoming decision in this case carries significant implications for the broader landscape of drug regulation across the United States. It will serve to clarify the precise boundaries of state authority in regulating FDA-approved medications, particularly those designated as high-risk or subject to REMS programs. The outcome will help define the extent to which states can impose requirements that either go beyond or directly contradict federal regulatory decisions concerning drug access and safety.

This appeal will provide crucial guidance on whether states can implement additional safeguards without being deemed to be in conflict with federal law, or if such actions risk being preempted. The arguments presented highlight a fundamental tension between states' desires to enhance public health and safety through additional regulations and the federal government's role in establishing a comprehensive and uniform regulatory framework for pharmaceuticals. The resolution of this case will therefore be a critical benchmark for future disputes concerning state drug regulation and federal preemption.

This Fourth Circuit appeal will clarify the extent to which states can impose regulations on FDA-approved drugs, particularly those with REMS programs, beyond federal requirements. Lawyers advising pharmaceutical companies, healthcare providers, or state agencies should monitor the decision to understand the boundaries of state regulatory authority over drug access and safety, and potential preemption challenges to similar state laws.

Source: Original reporting via Courthouse News Service