A federal appeals court must weigh how far FDA abortion pill regulations go in preempting state laws regulating the practice of medicine—a largely untested area that legal analysts say will shape abortion access.
Judge
Eagles determined some North Carolina laws—including one requiring an in-person 72-hour advance consultation and ultrasound use—deal with broader health and safety matters that are under the state’s jurisdiction, and are therefore not preempted by federal law.
Legal analysts predict both sides of the case are likely to appeal the ruling to the US Court of Appeals for the Fourth Circuit, which is already considering a West Virginia case from
Both cases center largely on the question of whether state laws that impact the availability of an FDA-approved medication, but don’t directly address FDA determinations, are still preempted by federal law. Abortion access supporters and officials defending state-level restrictions disagree on how much of medical practice FDA regulations should cover.
Federal judges are now left to balance the authority Congress granted to the FDA to regulate the safety and efficacy of medications, with the traditional role given to states to regulate how medicine is practiced within their borders. The issue is especially elaborate for mifepristone, reproductive and constitutional legal analysts say, after the US Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization that effectively left the issue of abortion access up to states.
“The relationship between the FDA’s regulatory power and the state’s power to regulate the practice of medicine is a complicated one” and “the FDA’s involvement in mifepristone is much more complex than with most medications,” said Wendy Parmet, a health law professor at Northeastern University.
Unique Situation
The FDA’s safety program for mifepristone, known as a risk evaluation and mitigation strategy (REMS), was updated in 2016 and 2021 to in part expand the use of the pill from seven to 10 weeks into pregnancy and remove the previous requirement that a patient visit a provider in-person to obtain the drug. These decisions are currently under review at the US Supreme Court in a separate challenge brought by anti-abortion physicians.
Some states, including North Carolina and West Virginia, place more stringent requirements on mifepristone access, including allowing only physicians to dispense the medication after an in-person visit.
Greer Donley, a professor at the University of Pittsburgh Law School focused on abortion and reproductive health, said in an interview that Eagles defended the FDA’s decisionmaking on mifepristone by determining “if there’s a direct conflict with what the FDA is doing, the supremacy clause should reign and it’s going to be hard for the state to regulate in a way that the FDA particularly said you shouldn’t be regulating.”
Amy Bryant, a doctor and lead plaintiff in the North Carolina case, said in an emailed statement that she was “pleased” Eagles “recognized that North Carolina cannot impose restrictions on an FDA-approved medication that second-guess or interfere with the FDA’s expert judgment.”
Bryant added, though, that she is still “reviewing the ruling and the implications it has for providing care to patients in North Carolina.”
Eagles upheld North Carolina abortion pill laws that addressed medical practices the FDA didn’t wade into, reaching a similar conclusion of a federal judge for the US District Court for the Southern District of West Virginia. Judge
“In general, the FDA approves a drug and then the practice of medicine is left to the states,” Parmet said, adding that for mifepristone, “it’s a much more complicated, nuanced decision by the FDA than just let it be sold.”
In both cases, Judges Eagles and Chambers declined to uphold the arguments from state defendants that FDA preemption in these cases was limited by the major questions doctrine—a principle in administrative law instructing courts to presume Congress would not leave policy decisions of major political or economic significance up to agencies. Both judges cited the law enacted by Congress in 2007 granting the FDA the authority to develop REMS programs for some medications to help prevent or reduce the impacts of serious risks or adverse events.
The North Carolina court is “the second federal court that has made clear that the major questions doctrine should not and does not bar claims like what you see in the North Carolina case and in other cases that are based on FDA’s regulation of mifepristone,” said Skye Perryman, president and CEO of Democracy Forward and legal counsel for GenBioPro in the West Virginia case.
“This is a situation where Congress clearly considered how it wanted to regulate the class of drugs mifepristone belongs to and to the extent that state laws are an obstacle to or conflict with what Congress intended, under our Constitution they’re preempted,” Perryman said.
Federal Preemption
GenBioPro’s ongoing appeal and the expected appeal of the North Carolina ruling will leave it to the Fourth Circuit to consider whether FDA preemption can apply to abortion laws in general, rather than just ones that directly conflict with REMS requirements.
“The challenge on appeal is for the doctor in North Carolina, the company in West Virginia, to show that the general abortion laws have an impact on the pills that have been approved by the FDA,” said David S. Cohen, a professor at the Drexel University Thomas R. Kline School of Law.
GenBioPro argued in its opening appeal brief at the Fourth Circuit that West Virginia’s Unborn Child Protection Act, under which doctors risk losing their license for prescribing mifepristone, and other state abortion restrictions “make it impossible for GenBioPro to provide mifepristone in West Virginia in accordance with the REMS.”
The ruling out of North Carolina didn’t consider the “ultimate question” of, in a situation where a state “tries to regulate abortion such that it still frustrates the purpose of the FDA regulation, is there going to be preemption?” Donley said.
Cohen says there should be, arguing any abortion laws that limit the availability and use of an FDA-approved medication “should be thought of in the same way as the pill-specific requirements.”
“The general abortion provisions that the court did not strike down still make it difficult for people to access the pills that the federal government has approved,” Cohen said.
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