The U.S. Court of Appeals for the Fourth Circuit ruled against chemical abortion drug manufacturer GenBioPro Tuesday, upholding a West Virginia law banning most abortions, including those conducted with abortion pills.
The ruling by a panel of the Fourth Circuit in GenBioPro v. Raynes halted the abortion drug manufacturer’s attempt to place mifepristone under federal regulation. The ruling comes amid ongoing calls for the U.S. Food and Drug Administration (FDA) to reinstate previous safety regulations for chemical abortion drugs.
GenBioPro sought in the case to invalidate West Virginia's ban on chemical abortion by arguing that the state law is "preempted" by the FDA’s approval of mifepristone.
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West Virginia had replaced its earlier abortion regulation with the Unborn Child Protection Act in 2022 after the U.S. Supreme Court overturned Roe v. Wade in the Dobbs decision. The Supreme Court ruled in Dobbs that states may regulate abortion for “legitimate state interests” including, among others, “respect for and preservation of prenatal life at all stages of development,” and “the protection of maternal health and safety.”
“Preemption in this instance would upend the federal-state balance by supplanting every state law tangentially touching a federal domain,” the Fourth Circuit panel wrote in its opinion. The court concluded that the Food Drug and Cosmetic Act “create[s] a regulatory floor, not a ceiling,” and that there was no indication “Congress intended to guarantee nationwide access to mifepristone when it enacted the FDAAA.”
Then-West Virginia Attorney General Patrick Morrisey, now the state’s governor, along with attorneys from Alliance Defending Freedom (ADF), asked a federal district court in February 2023 to uphold the state’s Unborn Child Protection Act against a preemption challenge, ADF reports. The court partially dismissed the lawsuit challenging the law in August 2023 and GenBioPro appealed the case to the Fourth Circuit.
Heartbeat International, the largest network of pregnancy help organizations in the U.S., had submitted a friend-of-the-court brief with the court in April 2024 supporting the West Virginia law, and applauded the July 15 Fourth Circuit ruling.
“We celebrate the court’s conclusive pushback against Big Abortion’s totalitarian effort to use the judicial system for its own profits,” said Jor-El Godsey, president of Heartbeat International. “Gratefully, the court affirmed common-sense protections which everyone should celebrate. Every branch of government, at every level, should be more interested in protecting the public than preserving profits of Big Pharma and Big Abortion.”
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GenBioPro makes the generic version of mifepristone, the first of two drugs in the chemical abortion regimen. Mifepristone blocks progesterone in a pregnant woman’s system, depriving her unborn child of necessary nutrients. The second drug, misoprostol, taken a day or so later, causes her to go into labor and deliver her presumably deceased child.
While estimates vary, they all say chemical abortions account for a majority of abortions conducted in the U.S., and the percentage continues to grow with open access and scant regulation of the drugs. This access is fostered by illicit online sales and abortion drug providers circumventing state law to deliver the pills in states where they are illegal.
Abortion proponents have claimed throughout that mifepristone is safe and effective, even at times saying the drug is safer than Tylenol.
GenBioPro, along with abortion pill manufacturer Danco, has funded groups behind clinical trials and studies of the abortion pill that claim the drug is both safe and effective.
Pro-life and pregnancy help advocates continually note safety issues with chemical abortion drugs.
A study released in late April from the Ethics and Public Policy Center (EPPC) found that 10.93 percent of women experience sepsis, infection, hemorrhaging or another serious adverse event within 45 days of taking mifepristone -- a 22-fold increase over the 0.5 percent cited by the FDA and Danco, the manufacturer of the brand name chemical abortion pill Mifeprex.
Mifepristone was approved in 2000 in a process that some pro-life proponents argue was hurried, not in accord with science or law, and permeated by politics. The FDA then loosened its own safety standards on the drug in 2016 and 2021.
The safeguards for mifepristone removed by the FDA over the last nine years include an initial in-person doctor visit to screen for ectopic pregnancy and other serious conditions, and a follow-up visit to check for life-threatening complications such as internal bleeding and infection. The FDA then further lessened its Risk Evaluation and Mitigation Strategy (REMS) requirements for chemical abortion drugs, permitting them to be dispensed and mailed by pharmacies. The Biden administration made access to the drug without in-person dispensing permanent in 2023.
Part of the FDA’s reducing of its safety standards for mifepristone has included eliminating the requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System.
FDA data shows that at least 32 women have died following mifepristone use between the drug's approval in 2000 and 2022.
Aside from the physical risk to women pro-life concerns about mifepristone include the possibility that the drug would be used in human trafficking and other scenarios of abuse or coercion.
Along with pro-life advocates pro-life Members of Congress have urged the administration to take up the mifepristone safety issue.
Trump Cabinet officials HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have repeatedly indicated the administration would address safety concerns over mifepristone.
Godsey said the Fourth Circuit decision protects West Virginia’s authority to regulate abortion and protects women and children from the harms of the abortion drug.
“Heartbeat’s experience with women who have gone through abortion confirms the dangers these drugs present, and we support West Virginia’s efforts to protect women from these harms,” he said.
Editor's note: Heartbeat International manages Pregnancy Help News. The article has been updated.
