U.S. Court in West Virginia Allows Generic Drug Maker’s Challenge to State’s Abortion Ban to Proceed
- May 05, 2023
GenBioPro Inc., which is the sole U.S. manufacturer of the generic abortion pill, mifepristone, can proceed with its challenge to West Virginia’s near-total ban on abortions after a federal court in the state refused to dismiss its lawsuit on standing grounds.
The Food and Drug administration (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.
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 approval of the drug.
State officials disputed GenBioPro’s standing to bring the challenge. After hearing oral arguments April 24, the U.S. District Court for the Southern District of West Virginia found GenBioPro sufficiently demonstrated Article III standing.
According to the court, GenBioPro plausibly alleged an injury in fact based on economic harms—i.e., that it would be selling mifepristone, which the FDA has approved nationwide, to a wider market in West Virginia if not for the state’s restrictions. This injury was likely to be addressed by a decision that the restrictions were unconstitutional, the court added.
In so holding, the court rejected the defendants’ argument that invalidating the statutory restrictions would not redress the alleged injury because the sale of generic mifepristone depended on third parties—i.e., medical professionals—to prescribe the drug. The court said it was “reasonable to assume pharmacies and doctors will continue to prescribe and purchase abortion medication,” particularly given that medication abortion is the most common form of abortion in the United States.
The court also found “without merit” the state’s contention that, regardless of the statutory restrictions, GenBioPro’s business was illegal under the Comstock Act, which negated redressability.
The Comstock Act of 1873 provides that “[e]very article or thing designed, adapted, or intended for producing abortion,” as well as “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion,” may not be sent through the mail.
“While the plain language of the statute arguably encompasses GenBioPro's business model, the Comstock Act is currently understood to apply only to use of the mails in an illegal manner,” the court said. Importantly, the entity with authority to enforce the Comstock Act—i.e., the Department of Justice—has indicated that it would not take action against legal vendors of mifepristone, the court noted.
The court in an April 21 decision refused to stay the instant action after a federal judge in Texas granted an injunction upending the FDA’s approval of mifepristone. The U.S. Supreme Court stayed the injunction granted while the challenge to the abortion pill's approval plays out. The Fifth Circuit is expected to hear oral arguments in that case on May 17.
GenBioPro, Inc. v. Sorsaia, No. 3:23-cv-00058 (S.D. W. Va. May 3, 2023).