GenBioPro – the manufacturer of generic mifepristone for pregnancy termination – filed a suit in federal court Wednesday to block laws in West Virginia that limit access to the medication.
According to a press release from Democracy Forward, a group that is providing legal counsel for GenBioPro, mifepristone is approved by the U.S. Food and Drug Administration. It is administered as part of a two-dose regimen during early pregnancy.
Democracy Forward said that it is the most common form of abortion in the country, accounting for more than half of all pregnancy terminations.
The suit “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 U.S. Constitution,” said the press release. This summer, the Dobbs v. Jackson Women’s Health Supreme Court case overturned decades of abortion protections in the U.S. established by the landmark Roe v. Wade case.
“Congress subjected [mifepristone] to a substantial and detailed federal regulatory program with which West Virginia law interferes,” said the complaint. “That state law must give way to the comprehensive federal regime Congress enacted and the Food and Drug Administration implemented.”
Per the Guttmacher Institute, the following abortion restrictions were in place as of June 28, 2022 in West Virginia:
· A requirement that patients receive state-directed counseling that includes information designed to discourage the patient from having an abortion, and then wait 24 hours before the procedure is provided
· A prohibition on the use of telemedicine to administer medication abortion; a requirement that a parent of a minor must be notified before an abortion is provided
· A requirement that public funding only be made available for abortion only in cases of life endangerment, rape, incest, or fetal impairment and when the procedure is necessary to prevent long-lasting damage to the patient’s physical health
· A ban on abortion at 20 or more weeks postfertilization (22 weeks after the last menstrual period) except “in cases of life endangerment or severely compromised health,” as well as a ban on abortions using dilation except “in cases of life endangerment or severely compromised physical health”
Data from the Guttmacher Institute showed that, in 2017, 1,430 abortions were provided in West Virginia, a 26% decline from 2014. It said that abortions in West Virginia represent 0.2% of all abortions in the U.S.
“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 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.”
According to Democracy Forward, GenBioPro’s suit is the first of its kind to be filed since Dobbs. It comes after the FDA’s announcement that allowed mifepristone to be accessed through certified pharmacies.
“West Virginia cannot override the FDA’s safety and efficacy determinations, nor can it disrupt the national market for this medication,” said veteran U.S. Supreme Court advocate and GenBioPro counsel David Frederick of Kellogg Hansen, who is also representing the company in the suit.
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