Lawsuits Challenge West Virginia, North Carolina Restrictions on Abortion Pill
- January 27, 2023
A pair of lawsuits filed this week are taking aim at state laws in West Virginia and North Carolina banning or restricting access to the abortion pill, mifepristone, which is approved by the Food and Drug Administration (FDA).
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 (70 days or less since the first day of the last menstrual period). Medication abortions now account for about half of abortions nationwide.
GenBioPro, which manufactures the generic version of the drug, filed its lawsuit January 25 in the U.S. District Court for the Southern District of West Virginia, arguing the state’s near-total ban on abortions enacted in the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, 142 S. Ct. 2228 (2022), has “severely constricted the market for mifepristone statewide.”
According to the complaint, federal law—i.e., the FDA’s approval of the medication with a risk evaluation and mitigation strategy (REMS)—preempts West Virginia’s conflicting ban and other restrictions.
The lawsuit alleges the West Virginia ban on mifepristone violates the Supremacy and Commerce Clauses of the U.S. Constitution.
“Individual state regulation of mifepristone destroys the national common market and conflicts with the strong national interest in ensuring access to a federally approved medication to end a pregnancy,” the complaint says.
In early January, the FDA moved to expand access to mifepristone with a regulatory change that allows certified retail pharmacies to sell mifepristone directly to patients.
Under the drug’s original REMS, only a physician could dispense mifepristone to patients. In 2021, during the COVID-19 pandemic, the Biden administration temporarily lifted the in-person requirement to allow mifepristone to be prescribed via telemedicine and delivered by mail. The updated REMS that FDA approved makes that change permanent and also allows retail pharmacies to apply for certification from the drug’s manufacturer to dispense mifepristone directly to patients who have a prescription from a certified prescriber.
A second lawsuit, filed by an obstetrician/gynecologist, also argues that federal law preempts additional restrictions on the use of the drug in North Carolina.
Specifically, North Carolina requires that abortion medications must be provided in-person by a physician at specially certified facilities following state-mandated counseling and a 72-hour waiting period.
“A State may not impose additional controls—including restrictions that FDA has specifically rejected—that upset the carefully balanced regulatory scheme established by federal law,” the complaint argues.
Dr. Amy Bryant, a North Carolina physician, filed the lawsuit January 25 in the U.S. District Court for the Middle District of North Carolina.
In still another lawsuit, abortion opponents are challenging the FDA’s approval of mifepristone as unlawful. That lawsuit, which was filed in November 2022 in the U.S. District Court for the Northern District of Texas, argues the FDA exceeded its regulatory authority in approving mifepristone by characterizing pregnancy as an “illness.”