A federal lawsuit over the abortion drug mifepristone has been filed in West Virginia, pitting the ability of states to regulate abortion under last summer’s Dobbs ruling in the U.S. Supreme Court versus the federal government’s broad role in regulating both drugs and interstate commerce.
The lawsuit has received national focus, including a New York Times story headlined “New lawsuit challenges state bans on abortion pills.”
“This case is about a federally approved medication that Congress subjected to a substantial and detailed federal regulatory program with which West Virginia law interferes,” according to the lawsuit filed by Charleston attorney Anthony Majestro.
“That state law must give way to the comprehensive federal regime Congress enacted and the Food and Drug Administration implemented.”
The lawsuit was filed on behalf of GenBioPro Inc., developer of a generic version of mifepristone “to give patients a safe, effective, non-invasive medication option for terminating a pregnancy.
The company contends that the abortion ban passed in West Virginia last fall interferes with its ability to market the drug even though it is subject to extensive federal regulation.
“Federal law preempts West Virginia’s ban and restrictions. These laws impermissibly restrict patients’ access to mifepristone and GenBioPro’s opportunity and ability to market, promote, and sell the medication in the state,” according to the lawsuit.
The lawsuit names West Virginia Attorney General Patrick Morrisey as well as Putnam County Prosecutor Mark Sorsaia.
“We are prepared to defend West Virginia’s new abortion law to the fullest,” Morrisey stated.
“While it may not sit well with manufacturers of abortion drugs, the U.S. Supreme Court has made it clear that regulating abortion is a state issue. I will stand strong for the life of the unborn and will not relent in our defense of this clearly constitutional law.”
Prior to the state Legislature’s passage of an updated abortion law in West Virginia, Morrisey’s office had spotlighted a possible battle over mifepristone.
The Food and Drug Administration has approved mifepristone and misoprostol to be used in the first 10 weeks of pregnancy. Both drugs have received federal approval for doctors to prescribe online to be sent to patients by mail.
Mifeprestone and misoprostol are used together to induce a physical reaction like an early miscarriage. Mifepristone interrupts early pregnancy by blocking the effect of progesterone, a hormone necessary to maintain a pregnancy, and misoprostol causes uterine contractions, leading to the contents of the uterus being expelled.
Medication abortion accounts for more than half of all abortions in the United States, according to the Guttmacher Institute, research organization focused on advancing reproductive health policy.
In West Virginia, medication has been a common method for abortion.
In 2021, the Women’s Health Clinic of West Virginia performed 1,304 abortions, according to supporting documentation in an earlier state-level lawsuit challenging West Virginia’s abortion statutes.
Of those, 693 were medication abortions and 611 were procedural abortions.
FDA approved branded mifepristone for sale in 2000 and, in doing so, imposed specific restrictions it determined were necessary to assure the drug’s safe use.
In deeming mifepristone to be one of the few drugs subject to heightened FDA regulation, the lawsuit contends, Congress solely authorized FDA to impose restrictions on access to the drug.
“The ban and restrictions frustrate and conflict with that congressional mandate,” according to the lawsuit. “West Virginia cannot override FDA’s determinations about the appropriate restrictions on a medication that FDA approved for use and Congress subjected to this enhanced regulatory regime.”