The manufacturer of one of two drugs used in a medication abortion filed a federal lawsuit on Wednesday against the state of West Virginia over its new abortion ban that prohibits the procedure at all stages of pregnancy, arguing that federal law supersedes the state’s ability to restrict access to the medication.
GenBioPro, which manufactures a generic version of mifepristone that is used with misoprostol to induce an abortion, is arguing that the Food and Drug Administration’s approval of the medication takes precedence over restrictive abortion laws and that such laws violate the supremacy and commerce clause in the Constitution.
The lawsuit is the first of its kind to come after the Supreme Court overturned Roe v. Wade. If the court rules in favor of the manufacturer, it could pave the way for legal challenges to other restrictive abortion laws. While, if the court sides with the state, it could propel states to restrict access to other FDA-approved drugs.
“Our case makes clear that nothing in the court’s decision last year in Dobbs displaced Congress and FDA’s role in deciding whether medications are safe and effective and determining which regulations should be imposed on mifepristone,” said Skye Perryman, president and CEO of Democracy Forward, who is also serving as counsel for GenBioPro. “States cannot substitute their medical and scientific judgments for judgments FDA has made, and doing so undermines not only access to medication but the country’s entire drug regulation system.”
The lawsuit alleges that West Virginia’s abortion ban that passed last year restricts the company’s ability to market, promote, and sell mifepristone.
“Congress authorized FDA, and only FDA, to impose restrictions on access to mifepristone. Before FDA may impose any restrictions, Congress requires the agency to determine that they are necessary for patient safety and will not unduly burden patient access. The Ban and Restrictions frustrate and conflict with that congressional mandate,” according to the lawsuit.
West Virginia Attorney General Patrick Morrisey said the state will defend its abortion law.
“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,” Morrisey said in a statement.
The lawsuit follows a rule change from the FDA earlier this month that allowed certified retail pharmacies to dispense mifepristone to women who have a prescription from a qualified health provider, expanding access to the drugs. Previously, the FDA had only allowed abortion medication to be prescribed and dispensed by clinics, medical offices, hospitals, or under the supervision of a certified health provider.
It is one of several lawsuits concerning the legal landscape for abortion medication post-Roe. A North Carolina doctor filed a lawsuit against the state’s regulations on mifepristone, arguing that North Carolina’s requirement that the drug be prescribed in a specially certified surgical facility undermines the FDA’s authority to determine access to the drug and its safety.
A separate federal lawsuit in Texas by anti-abortion groups is seeking to reverse the FDA’s decades-old approval of mifepristone, which the HHS said would “upend the status quo.” Abortion medication accounted for roughly half of all abortions in the United States in 2021.
GenBioPro received approval in 2019 to market the first generic version of mifepristone.