West Virginia can block access to the abortion-inducing drug mifepristone, a federal appeals court said Tuesday in a landmark decision testing the reach of states’ power to restrict the medication despite its FDA approval.
The state’s criminal abortion provision doesn’t have to give way to the federal oversight system for mifepristone to the extent that the West Virginia law precludes using the drug to end pregnancies in the limited circumstances in which abortions are allowed, the US Court of Appeals for the Fourth Circuit ruled in a 2-1 decision.
The Fourth Circuit is the first federal appeals court to say mifepristone can be subject to state restrictions prohibiting its use. Congress didn’t clearly indicate an intent to give sole regulatory power over the drug to the federal Food and Drug Administration, it said.
The Food and Drug Administration Amendments Act of 2007 “falls well short of expressing a clear intention to displace the states’ historic and sovereign right to protect the health and safety of their citizens,” Judge
Judge DeAndrea Gist Benjamin concurred in part and dissented in part, calling the majority opinion “troubling,” as the state law is a “near outright ban on mifepristone.”
She concurred in the court’s finding that mifepristone’s manufacturer had standing to sue, but would hold that federal law preempts the West Virginia statute.
Mifepristone has been under attack by anti-abortion advocates since the US Supreme Court declared in 2022 that there’s no federal constitutional right to access abortion. The drug so far is available nationwide, but a suit contesting its FDA approval remains pending in Texas.
The question of whether a state can impose additional restrictions that essentially ban the use of an FDA-approved drug is new, especially where the medication is governed by a system Congress put in place for high-risk drugs, known as the federal risk evaluation and management strategy.
West Virginia has criminalized abortion at all gestational stages, except for when doctors determine that a pregnancy isn’t viable, is ectopic, a medical emergency exists, or the pregnancy resulted from a rape or incest reported to law enforcement within 48 hours of the abortion.
The state told the Fourth Circuit it has the authority to impose additional restrictions on mifepristone as part of its power to regulate health and safety. Mifepristone maker GenBioPro Inc. argued that states can’t prohibit use of an FDA-approved drug.
State Authority
Mifepristone is one of about 70 drugs subjected to federal safe use requirements meant to ensure that their benefits outweigh their risks. The FDA periodically reexamines the drugs, and most recently reissued the mifepristone REMS in January 2023.
The Fourth Circuit heard oral arguments last October Oct. 29 on a appeal from a district court decision finding the REMS didn’t preempt the state law.
GenBioPro sued state officials in January 2023.
Siding with West Virginia, Wilkinson said states traditionally have wide latitude to regulate health and safety, and there’s a presumption against preemption when an argument arises that a federal statute has supplanted state law in this area.
A court must presume Congress didn’t intend to override state law unless that intent was “clear and manifest,” he said.
Abortion regulations fall within a state’s prerogative, and West Virginia’s law “fits comfortably” within a tradition of state regulation, the judge added.
The FDAAA, moreover, doesn’t address a subject historically reserved to the federal government, Wilkinson said, rejecting GenBioPro’s argument that amendments to the law were intended to guarantee nationwide access to drugs like mifepristone.
The FDAAA didn’t “create a right” to use a particular drug, but rather established minimum safety requirements where it can be legally prescribed, Wilkinson said.
Judge
Restricts Access
“The court is allowing the state to continue putting those seeking medication abortion care in harm’s way,” GenBioPro CEO Evan Masingill said in a statement provided to Bloomberg Law.
The “ruling allows states to restrict access to medications that FDA has deemed safe and effective, threatening a dangerous ripple effect on the availability of essential medications in this country,” he said.
Skye Perryman, President and CEO of Democracy Forward, added that “West Virginia’s near-total abortion ban is unlawful and is a dubious effort by extremists to substitute political ideology for medicine and science.”
“Access to federally approved medication should not depend on one’s zip code,” she said.
West Virginia governor Patrick Morrisey (R), who previously defended the state law as attorney general, called the decision “a big win.”
“West Virginia can continue to enforce our pro-life laws and lead the nation in our efforts to protect life,” he said.
Alliance Defending Freedom, the West Virginia Attorney General’s Office, and the Putnam County Prosecuting Attorney’s Office represent the state defendants. Kellogg Hansen Todd Figel & Frederick PLLC, Democracy Forward Foundation and Arnold & Porter Kaye Scholer LLP represent GenBioPro.
The case is GenBioPro, Inc. v. Raynes, 4th Cir., No. 23-2194, 7/15/25.
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