A divided federal court panel confirmed West Virginia’s prohibition on drug-induced abortions, determining that the law aligned with the FDA’s regulation of pharmaceuticals.
The U.S. Court of Appeals for the Fourth Circuit rejected the appeal from Genbiopro, the primary manufacturer of Mifepristone, which sought to challenge the state’s near-total abortion ban. In a 2-1 decision, the court clarified that the FDA’s approval of Mifepristone did not override West Virginia’s legislative restrictions.
Genbiopro, which has held FDA approval for generic Mifepristone since 2019, contended that the FDA’s jurisdiction over prescription regulations supersedes state-level constraints on drug access. However, the lower court ruled against them, prompting this appeal.
Circuit Judge J. Harvey Wilkinson noted that the federal law from 2007 allows states the discretion to enact their own regulations, suggesting that the federal stance does not aim to eliminate state sovereignty regarding public health and safety.
This ruling marks a first for a federal appeals court allowing a state to limit Mifepristone’s availability. According to the Guttmacher Institute, which focuses on reproductive health, 28 states have implemented restrictions on medication abortions.
The Supreme Court had previously upheld access to Mifepristone, even as the FDA dismissed lawsuits in 2016 and 2021 that sought to reverse previous access expansions.
Wilkinson acknowledged the arguments made by Genbiopro and others advocating for Mifepristone access as crucial for women’s health and reproductive rights but clarified that the contention lay with the jurisdiction of the case.
Wilkinson, appointed by President Reagan, was joined by District Judge Rossy Alston, appointed by President Trump.
In a statement, Genbiopro CEO Evan Masingill criticized the ruling, asserting it permits the state to limit access to critical medications, potentially leading to harmful consequences for healthcare availability. He reiterated the company’s commitment to advocate for access to safe medical care.
West Virginia Governor Patrick Morrissey expressed pride in the ruling, stating that it allows the state to uphold laws designed to protect life.
In contrast, Circuit Judge Deandrea Gist Benjamin, appointed by President Biden, expressed concern that the state law creates obstacles to essential healthcare for many residents, indicating that such barriers weren’t anticipated by Congress.
Judge Benjamin emphasized that limiting abortion access cannot undermine the FDA’s recognized authority over drug regulation, arguing that West Virginia’s restrictions overstep the federal mandate established in the Dobbs decision.
