A divided federal appeals court in West Virginia ruled Tuesday to uphold the state’s ability to prohibit the abortion drug mifepristone, rejecting a pharmaceutical company’s bid to federalize the issue.
“Big win out of the 4th Circuit today,” said Governor Patrick James Morrisey, who was attorney general at the time of the initial lawsuit. “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.”
Mifepristone is the first in a two-drug regimen for medical abortion. GenBioPro, a producer of generic mifepristone, sued the state of West Virginia in January 2023, claiming the Food and Drug Administration’s (FDA) approval of the abortion drug supersedes the state’s right to regulate the drug. The district court partially dismissed the challenge to the law in August 2023, and GenBioPro appealed the case to the Fourth Circuit Court of Appeals.
The 2007 Food and Drug Administration Amendments Act (FDAAA) enhanced the FDA’s postmarket authority over high-risk drugs, allowing the FDA to require a drug manufacturer to develop and implement a risk evaluation and mitigation strategy for risky drugs. Mifepristone has been subjected to this standard since 2011.
West Virginia enacted a law prohibiting abortion in most circumstances shortly following the Dobbs v. Jackson Women’s Health Organization decision in 2022, which returned the authority to regulate abortion to the states. The law, the Unborn Child Protection Act, extends to medical abortion by mifepristone and misoprostol.
GenBioPro argued that the 2007 FDAAA established a comprehensive scheme for regulating high-risk drugs through risk evaluation and mitigation that left no room for state regulation. The Fourth Circuit disagreed.
“Preemption in this instance would upend the federal-state balance by supplanting every state law tangentially touching a federal domain,” the court wrote in its opinion on GenBioPro v. Raynes.
The FDAAA creates a regulatory floor, they said, not a ceiling. States are not free to dilute congressional safety measures, but they are free to strengthen them as West Virginia has done.
“The 4th Circuit Court of Appeals rightly refused GenBioPro’s invitation to federalize the issue of abortion,” said Alliance Defending Freedom senior counsel Erin Hawley. “We’re pleased the 4th Circuit agreed that the 2007 amendments to the Federal Food and Drug Cosmetic Act do not forbid the states from setting minimum safety standards for high-risk drugs or enacting legislation that protects life.”
The decision comes amid increased scrutiny on the safety and proper regulation of the abortion medication, which now accounts for the majority of abortions in the country. Six medical professional organizations signed a letter last week urging the heads of the U.S. Department of Health and Human Services and the FDA to address the dangers posed by unregulated abortion drugs, citing studies from the conservative think tank the Ethics and Public Policy Center and the Foundation for the Restoration of America that showed the drug is much less safe than previously thought. The FDA, under the direction of FDA commissioner Martin Makary, has promised to conduct a review of the safety of mifepristone.
In the states, a legal battle between Texas and New York drags on over New York’s shield law, which protects abortion pill prescribers who send the drug into states with abortion bans. New York has refused the state’s attempts to fine a New York-based doctor who prescribed the drug to a woman in Texas, and the case is likely headed to the Supreme Court.
States should follow the example of West Virginia and be proactive in protecting women and children from the threat of abortion drugs, director of Legal Affairs and Policy Counsel for the pro-life organization Susan B. Anthony Pro-Life America Katie Glenn Daniel told National Review.
“The Fourth Circuit’s decision energizes pro-life Americans to continue to fight against the dangerous mail-order abortion industry,” Daniel said.