U.S. Court in North Carolina Finds Federal Law Preempts Certain State Restrictions on Abortion Pill
- May 10, 2024
Several restrictions that North Carolina has in place on the use of the abortion pill mifepristone impose requirements the Food and Drug Administration (FDA) has affirmatively rejected and therefore are preempted by federal law, the U.S. District Court for the Middle District of North Carolina held April 30.
However, other restrictions that the FDA has not expressly considered or that focus more on the practice of medicine and informed consent are not preempted, the court found.
The FDA approved the brand-name version of mifepristone in 2000 for medical termination of pregnancy up to seven weeks. Mifepristone currently is subject to a Risk Evaluation and Mitigation Strategy (REMS), which the FDA has updated several times since 2016 to expand access to the drug, including increasing the indicated gestational age limit to ten weeks, approving a generic version, removing in-person dispensing requirements, and allowing the drug to be delivered by mail.
The U.S. Supreme Court recently heard oral arguments in a challenge to the FDA’s decision to lift restrictions on the use of the abortion pill. A decision in that case—brought by several emergency room doctors and the Alliance for Hippocratic Medicine—is expected before the end of the Court’s term in June. Mifepristone and a second drug misoprostol account for about half of abortions nationwide.
The instant action, brought by a medical doctor who prescribes the abortion pill, challenges requirements that North Carolina imposes on the use of the abortion pill that go beyond what the FDA now requires.
At the outset, the court noted the question of whether a state can impose additional requirements on the distribution of an FDA-approved drug has broad application beyond the instant challenge concerning the abortion pill.
The court found state provisions prohibiting health care providers other than physicians from prescribing the drug, requiring in-person prescribing and dispensing, mandating in-person follow-up appointments, and requiring non-fatal adverse event reporting are preempted because they “frustrate the congressional goal of establishing a comprehensive regulatory framework under which the FDA determines conditions for safe drug distribution.”
However, requirements for an-person advance consultation, use of an ultrasound, an in-person examination, blood type testing, and adverse event reporting to state health authorities “do not interfere with Congress’ purpose and are not preempted,” the court concluded. The FDA either did not expressly consider and reject these requirements, or they hewed more closely to the state’s traditional role in regulating the practice of medicine and a patient’s informed consent, the court explained.
Bryant v. Stein, No. 1:23-CV-77 (M.D.N.C. Apr. 30, 2024).
In an August 2023 decision raising similar issues, another federal district court largely rejected an action brought by GenBioPro Inc., which is the sole U.S. manufacturer of generic mifepristone, challenging West Virginia’s near-total ban on abortions.
The court agreed with state officials who argued West Virginia's Unborn Child Protection Act banning abortions, including those that are induced via a drug or medicine, except in limited circumstances was not preempted by the Food and Drug Administration Amendments Act (FDAAA), which added the REMS provisions to the Federal Food, Drug, and Cosmetics Act (FDCA).
The FDCA does not include an express preemption provision, the court in that case noted. Nor was there any evidence of congressional intent in the FDCA or FDAAA to preempt state regulations related to health and safety, the court said. In the court’s view, the UCPA is a restriction on the incidence of abortion that did not directly conflict with the REMS, which specifies the methods by which mifepristone may be prescribed. GenBioPro, Inc. v. Sorsaia, No. 3:23-0058 (S.D. W. Va. Aug. 24, 2023). That case currently is on appeal to the Fourth Circuit.