West Virginia — GenBioPro, the manufacturer of generic mifepristone, which is approved by the U.S. Food and Drug Administration (FDA) as part of a two-drug regimen for the termination of early pregnancy, sued to block West Virginia’s ban on abortion and associated restrictions that limit access to the medication. The suit, filed in federal court, alleges that a state abortion ban passed in the aftermath of Dobbs and other restrictions on medication abortion violate the Supremacy Clause and the Commerce Clause of the US Constitution.

“Congress subjected [mifepristone] to a substantial and detailed federal regulatory program with which West Virginia law interferes. That state law must give way to the comprehensive federal regime Congress enacted and the Food and Drug Administration implemented,” the Complaint states. West Virginia’s ban and restrictions “impermissibly restrict patients’ access to mifepristone and GenBioPro’s opportunity and ability to market, promote, and sell the medication in the State,” the Complaint alleges. 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 was founded out of a deep conviction that all people, regardless of income level, race, sex, or geography are entitled to the benefits of evidence-based medicine and state-of-the-art medication,” said GenBioPro CEO Evan Masingill. “We have sought to make mifepristone more accessible through commercializing the first FDA-approved generic version of the medication. And, consistent with our commitment, we are challenging laws in the state of West Virginia that in effect ban mifepristone, a drug that is safe and effective and which Congress and FDA have subjected to a specific regulatory regime,” he continued.

GenBioPro’s suit, which is the first of its kind to be filed since Dobbs, comes on the heels of FDA’s announcement earlier this year that enabled mifepristone to be accessed through certified pharmacies.

GenBioPro is represented in the suit by a team of lawyers from Kellogg, Hansen, Todd, Figel & Frederick, Democracy Forward Foundation, Arnold & Porter, and Powell & Majestro.

“West Virginia cannot override the FDA’s safety and efficacy determinations, nor can it disrupt the national market for this medication,” said veteran United States Supreme Court advocate and GenBioPro counsel David Frederick of Kellogg Hansen.

“Laws like the ones in effect in West Virginia are harmful and unlawful,” said Skye Perryman, President and CEO of Democracy Forward, who is also serving as counsel for the company. “Our case makes clear that nothing in the Court’s decision last year in Dobbs displaced Congress and FDA’s role in deciding whether medications are safe and effective and determining which regulations should be imposed on mifepristone. States cannot substitute their medical and scientific judgments for judgments FDA has made, and doing so undermines not only access to medication, but the country’s entire drug regulation system.”

“We are honored to represent GenBioPro in its effort to invalidate West Virginia’s unlawful overreach,” said Daphne O’Connor of Arnold & Porter.

“West Virginia’s decision to step in where Congress has granted FDA the authority to regulate mifepristone is harmful and unlawful,” said Anthony Majestro of Powell & Majestro, a West Virginia-based firm. “We look forward to representing the company in enforcing protections afforded by the US Constitution,” he added.

GenBioPro received FDA approval to market the first generic version of mifepristone in 2019. Last year, it appeared on Fortune magazine’s list of Companies Changing the World for its commitment to making reproductive healthcare accessible.


Press Contact: Feldman Strategies, team@feldmanstrategies.com