U.S. Court in West Virginia Largely Rejects Generic Drug Maker’s Challenge to State’s Abortion Ban
- September 01, 2023
A federal judge largely dismissed August 24 an action brought by GenBioPro Inc., which is the sole U.S. manufacturer of the generic abortion pill, mifepristone, challenging West Virginia’s near-total ban on abortions.
GenBioPro filed its lawsuit January 25, arguing the state’s near-total ban on abortion enacted in the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, 142 S. Ct. 2228 (2022), as well as prior restrictions on the sale of mifepristone, severely limited the market for the drug statewide. GenBioPro argued the state's restrictions violated the Supremacy and Commerce Clauses because they conflicted with the Food and Drug Administration’s (FDA’s) approval of the drug.
While the court ruled earlier that GenBioPro had standing to proceed with its claims, the latest decision dismissed the bulk of the company’s claims that the West Virginia restrictions were preempted by federal requirements and violated the dormant Commerce Clause.
The FDA approved the brand-name version of mifepristone in 2000 for medical termination of pregnancy. Mifepristone, taken in combination with a second drug misoprostol, is used to end a pregnancy through ten weeks gestation. Medication abortions now account for about half of abortions nationwide.
Mifepristone currently is subject to a Risk Evaluation and Mitigation Strategy (REMS), which the FDA updated in 2016, 2019, 2021, and 2023 to expand access to the drug, including increasing the indicated gestational age limit from 49 to 70 weeks, approving GenBioPro’s generic version, removing in-person dispensing requirements, and allowing the drug to be delivered by mail.
The court agreed with state officials who argued West Virginia's Unborn Child Protection Act (UCPA) banning abortions, including those that are induced via a drug or medicine, except in limited circumstances was not preempted by the Food and Drug Administration Amendments Act (FDAAA), which added the REMS provisions to the Federal Food, Drug, and Cosmetics Act (FDCA).
The FDCA does not include an express preemption provision, the court noted. Nor was there any evidence of congressional intent in the FDCA or FDAAA to preempt state regulations related to health and safety, the court said.
The UCPA regulates “licensed medical professionals,” not drug manufacturers like GenBioPro, the court added.
Moreover, the court said, the UCPA is a restriction on the incidence of abortion that does not directly conflict with the REMS, which specifies the methods by which mifepristone may be prescribed, such that licensed medical professionals could not lawfully comply with both.
“Here, West Virginia's UCPA has limited when an abortion may be performed, without touching how medication abortion is to be performed,” the court said.
The court also refused to invalidate the UCPA under the dormant Commerce Clause. According to the court, morality-based laws often curtail the sale of goods but have not been found to run afoul of the dormant Commerce Clause.
The court did find the 2023 REMS “unambiguously” preempted a prior restriction in West Virginia on prescribing mifepristone via telemedicine. “Rather than indicating what procedures are allowed in West Virginia, the telemedicine restriction dictates the manner in which mifepristone may be prescribed. This is a determination which Congress has allocated to the FDA.”
GenBioPro, Inc. v. Sorsaia, No. 3:23-0058 (S.D. W. Va. Aug. 24, 2023).