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The Fourth Circuit Court of Appeals upheld a 2023 district court ruling that West Virginia can restrict the sale of abortion medication.
GenBioPro sells mifepristone, the first drug in a Food and Drug Administration (FDA)-approved two-drug medication abortion regimen. The company’s lawsuit claims West Virginia, and then-Attorney General Patrick Morrisey, violated federal law by prohibiting the sale of the drug.
Sean Tu is a nationally recognized expert on patent and drug law, and a professor at the University of Alabama School of Law. He was previously a professor of law at West Virginia University College of Law for many years.
Tu said Tuesday’s decision upholds states’ rights to restrict access to medication beyond the FDA’s restrictions.
“The Fourth Circuit says that this is really a separation of states rights and federal rights, and typically you can have more restrictive laws,” he said.
The FDA has a regulatory scheme that has deemed mifepristone to be safe and effective, but also imposed a Risk Evaluation and Mitigation Strategy (REMS) for what they consider high-risk drugs.
“For those drugs, you have to jump through extra hoops to make sure that the drug is being used in a safe and effective manner,” Tu said. “The state has argued that’s the floor. And if we want to have more restrictive laws and say that you have to jump through extra hoops to use this drug safely, then we’re going to make you jump through these extra hoops.”
Tu, who also has a masters in pharmacology, said he struggled to understand why mifepristone has a REMS in the first place. He believes it to be a safe and effective drug, but also one that has been heavily politicized.
“If it can happen to mifepristone, it can happen to any drug,” he said. “Because unlike other drugs that have real bad side effects and they don’t work efficaciously for what it is that they say they’re supposed to work for, this is not that case, this is not that drug.”
As attorney general, Morrisey defended the state’s abortion ban against the suit and said he was proud to see a victory in the case.
“Big win out of the 4th Circuit today,” Morrisey said in an emailed statement. “I defended this law as Attorney General and am proud to see a victory in this case. West Virginia can continue to enforce our pro-life laws and lead the nation in our efforts to protect life. We will always be a pro-life state!”
Passed during a special session of the West Virginia Legislature in September 2022, House Bill 302 defines abortion to include the use of any medicine, drug, or other substance “with intent to terminate the pregnancy of a patient known to be pregnant and with intent to cause the death and expulsion or removal of an embryo or a fetus.”
In January 2023, GenBioPro brought suit in the United States District Court for the Southern District of West Virginia, arguing that West Virginia’s law overrode Congressional authorization for the Food and Drug Administration (FDA) to exclusively impose restrictions on access to mifepristone via the Food and Drug Administration Amendments Act (FDAAA) of 2007.
In a published opinion, Judge Harvie Wilkinson – joined by Judge Rossie D. Alston – ruled that the FDAAA leaves states free to regulate access to medication in their jurisdiction.
“Because the Act 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, we affirm,” Wilkinson said.
Wilkinson said that the Supreme Court restored the states’ traditional authority to regulate abortion in the 2022 Dobbs v. Jackson Women’s Health Organization decision. He said that for the court “to once again federalize the issue of abortion without a clear directive from Congress, right on the heels of Dobbs, would leave us one small step short of defiance.”
Wilkinson called his panel’s decision “a narrow one” that takes no position on West Virginia’s abortion law and said the judgment of the law belongs with the people and their elected representatives. He said disagreeing with Dobbs is not the point.
“At a time when the rule of law is under blunt assault, disregarding the Supreme Court is not an option,” Wilkinson said.
He clarified that states are certainly not free to dilute federal safety standards where they have been clearly established, or that Congress could not preempt state abortion laws if it chooses to do so.
“We simply hold that (Congress) must express that intention with the clarity befitting such a significant alteration to our system of dual sovereignty,” Wilkinson said. “Because the FDAAA does not do so, we decline to overturn the West Virginia law.”
Judge DeAndrea G. Benjamin concurred with Wilkinson’s finding that GenBioPro had standing to bring suit against West Virginia. But she dissented from his main finding, arguing that “the twin sensitivities of abortion access and states’ rights cannot influence our willingness to recognize the Food and Drug Administration’s (FDA) clear authority in this area.”
Benjamin argues that HB 302 oversteps the federal government’s regulatory authority by criminalizing medical professionals for prescribing a medication that they are otherwise federally certified to prescribe.
“In doing so, (HB 302) ventures far beyond ‘tangentially touching the federal domain,’ as the majority claims,” she said. “It invades the very space occupied by the federal government and reserved for federal oversight—the regulation of medication.”
Wilkinson replied to the dissent, and said that regardless of how ill-advised the law may be, it is not the place of the courts to substitute their own policy preferences.
“We simply lack authority as a federal court to substitute our policy preferences for those of the West Virginia Legislature,” he said. “Litigation was never meant to displace the hard democratic work of persuading the people’s representatives. The arguments must be matched to the forum, and the mismatch is glaring in this case.”
Margaret Chapman Pomponio is the executive director of West Virginia Free, a reproductive health advocacy organization. She said the ruling won’t immediately change what is happening in West Virginia for the average person, but it does contribute to a set of policies stacked against everyday West Virginians who need to terminate a pregnancy.
“West Virginia Free is disappointed by this decision, but not surprised,” Pomponio said.
“The fact is, West Virginians have been living in a very difficult landscape with regard to reproductive health ever since the legislature banned abortion and even before then,” she continued. “We have maternity deserts in our state, we have abortion deserts. Our work as advocates and educators is to try to get West Virginians the information and the resources they need to make the best decisions for their own reproductive lives and bodies.”
Pomponio said mifepristone is the most common form of pregnancy termination, and bans across the country have not stopped people from seeking out treatment.
“People are safely managing at home with pills or going out of state to get the care that they need,” she said. “We always knew that banning abortion would not stop abortion. It just makes it much harder to get. These bans are really cruel, not just on women and people who can become pregnant, but their families, friends and their employers, and this ruling just makes it that much harder.”