Abortion Drug Ruling Unlikely to End Debate on State Oversight

A recent appellate decision that allowed West Virginia to block access to the abortion-inducing drug mifepristone is fueling uncertainty over the reach of states’ power to restrict FDA-approved medications.

Greer Donley, a University of Pittsburgh law professor who studies abortion law, said the July 15 decision from the US Court of Appeals for the Fourth Circuit “theoretically provides support for banning other FDA-approved drugs.”

Indeed, counsel for GenBioPro Inc.—which challenged the law—told the court at oral argument that such a ruling would make the court the first to hold that states can restrict medications the US Food and Drug Administration has deemed safe and effective.

But the court never reached that question, anti-abortion advocates said. Instead, it merely upheld West Virginia’s right to restrict abortions post-Dobbs v. Jackson Women’s Health Organization.

GenBioPro is expected to ask the full Fourth Circuit to rehear the case, and unless and until that happens, the full impact of the panel ruling remains unclear.

“This decision quashes any potential challenge to laws restricting the use of FDA-approved” drugs, said Catherine Short, Chief Legal Officer of Life Legal Defense Foundation, which filed an amicus brief supporting West Virginia.

Moreover, West Virginia’s law doesn’t ban a particular drug; it prohibits the drug’s use for a particular purpose, she said.

Another case proceeding in North Carolina—also in the Fourth Circuit—could give clarity.

Novel Argument

GenBioPro sued West Virginia over the law, which bans most abortions and specifically prohibits using a drug or medication to terminate a pregnancy.

Donley joined other law professors in a friend-of-the-court brief supporting GenBioPro’s argument that the Food and Drug Administration Amendments Act of 2007 preempted state laws banning FDA-approved drugs that are subject to the agency’s risk evaluation and mitigation strategy, especially those that impose “elements to assure safe use.”

Neither the Federal Food, Drug, and Cosmetic Act nor the FDAAA expressly override more stringent state laws governing prescription drugs—states can regulate such medications as long as there’s not “direct and positive conflict” with the statute—the brief said. But in passing the FDAAA, Congress intended to strike a balance between patient access and drug safety, it said.

A REMS drug is subject to patient access restrictions, but those restrictions can’t make access “impracticable,” they said.

Donley called that argument novel, but said it has merit.

She noted that a federal judge refused to dismiss a similar case in 2015 in which drugmaker Zogenix Inc. challenged Massachusetts regulations that the company said effectively banned its opioid product, Zohydro.

The judge allowed Zogenix to assert “obstacle preemption,” which applies when a state law “stands as an obstacle” to accomplishing congressional objectives. But Zogenix voluntarily dismissed the suit and the court never issued a final judgment on the issue.

Rachel Rebouché, dean and professor at Temple University’s Beasley School of Law, said just because that preemption theory hasn’t really been tested or applied doesn’t mean it isn’t worth making.

The argument raises a question about the FDA’s purpose, said Rebouché, who joined the brief along with Donley.

The US Supreme Court has been sympathetic to the FDA, looking at what the agency is meant to accomplish, she said. A court could say “the FDA’s job” is to decide a drug’s safety and effectiveness, and states shouldn’t second-guess those decisions, Rebouché said.

Other Uses

West Virginia said its law banned abortion, not mifepristone, but the effect for the drugmaker was “exactly the same,” Donley said: GenBioPro can’t sell its product in the state.

Marc Wheat, General Counsel for Advancing American Freedom, said West Virginia didn’t ban mifepristone—the law doesn’t call out the drug by name—it merely prohibited the use of any drug to end a pregnancy, with some narrow exceptions.

Wheat represented AAF, a group founded by former Vice President Mike Pence, in an amicus brief supporting the state.

Mifepristone is the most commonly used drug in medication abortions up to 10 weeks, but it’s also used for other purposes, such as treating hyperglycemia associated with Cushing syndrome in patients with Type 2 diabetes.

There’s no indication mifepristone won’t be available in West Virginia for purposes other than abortion, Wheat said. The court simply confirmed that states have “latitude to exercise their traditional police powers to regulate for the safety and health of their residents,” including when it involves drugs that may endanger their citizens, Wheat said.

But Rebouché said mifepristone is really only used for abortions—it’s “very rarely” used for other conditions.

Banning its use to end a pregnancy effectively takes it off the market, she said.

Further, although the court made the distinction between banning a drug and banning it for the purpose of abortion, it’s not clear where the lines are for other “politically unpopular drugs,” she said.

North Carolina Case

Court observers are now waiting to see what the Fourth Circuit does in a similar case that was stayed pending the outcome of the GenBioPro case.

There, physician Amy Bryant sued North Carolina seeking a declaration that the state’s post-Dobbs abortion laws restricting mifepristone are invalid.

A district court judge issued a split ruling, blocking enforcement of prescribing and distribution limits on the drug, an in-person follow-up provision, and an adverse event reporting measure, saying they stood “as obstacles to Congress’ purpose in creating” a REMS that regulated the same conduct.

But she refused to block informed consent and broader health and safety measures that “focus more on the practice of medicine,” which traditionally is subject to state regulation.

Bryant’s case is a better fit for deciding the preemption question anyway because North Carolina specifically regulated matters that fell within the REMS, Donley said.

The case is GenBioPro, Inc. v. Raynes, 4th Cir., No. 23-2194, 7/15/25.