Ruling Jeopardizes Women’s Access to FDA-Approved Medication

WEST VIRGINIA – Today, a panel of the U.S. Court of Appeals for the Fourth Circuit dismissed GenBioPro’s effort to strike down West Virginia’s post-Dobbs abortion ban in a 2-1 decision. Judge Benjamin’s dissent laid out clearly the adverse impacts the ruling will have on West Virginians’ access to lifesaving care, noting 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.”

“The court is allowing the state to continue putting those seeking medication abortion care in harm’s way,” said GenBioPro CEO Evan Masingill. “The panel’s 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. As we have always made clear, GenBioPro will not stop fighting to ensure all people can access safe, evidence-based healthcare.”

Last October, the U.S. Court of Appeals for the Fourth Circuit heard arguments in the legal challenge to reverse West Virginia’s “Unborn Child Protection Act,” which bans abortion in almost all cases, at any stage of pregnancy and makes it a felony for anyone other than physicians to sell, prescribe, or dispense mifepristone, outside of the UCPA’s narrow exceptions. The suit argued that West Virginia’s ban and restrictions on mifepristone are preempted by federal law and cannot stand.

“Despite the overwhelming majority of Americans supporting the legal right to abortion, far-right politicians remain determined to severely restrict access to a critical drug that women across America depend on. West Virginia’s near-total abortion ban is unlawful and is a dubious effort by extremists to substitute political ideology for medicine and science,” said Skye Perryman, President and CEO of Democracy Forward. “This ban harms people who seek medication abortion in West Virginia – and sets a dangerous precedent regarding access to other evidence-based health care that FDA has deemed safe and effective. Access to federally approved medication should not depend on one’s zip code but unfortunately today’s decision creates that reality for many.”

“The majority has misunderstood the Supremacy Clause and misread Dobbs to permit States to criminalize a woman’s access to a federally approved medication,” said David Frederick of Kellogg Hansen. “The Court’s error consigns women in West Virginia to medical risks and a lack of freedom.”

“The majority decision ignores FDA’s essential national role in regulating drugs, and the expert scientific and medical judgments it makes in that role, which leave no room for states to impose their own conflicting regimes of drug regulation, especially those that deprive Americans of access to the care they need,” said Daphne O’Connor of Arnold & Porter.

GenBioPro, which produces a majority of the mifepristone sold in the United States, has held FDA approval for generic mifepristone since 2019. Medication abortion using the two-drug regimen involving mifepristone early in pregnancy is the most common and preferred form of abortion care in the United States, accounting for more than half of all pregnancy terminations.

GenBioPro is represented in this case by Democracy Forward; Kellogg, Hansen, Todd, Figel & Frederick; and Arnold & Porter Kaye Scholer.

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Democracy Forward Foundation is a national legal organization that advances democracy and social progress through litigation, policy, public education, and regulatory engagement. For more information, please visit www.democracyforward.org.