In lawsuits that could affect access to abortion across the country, drug maker GenBioPro and a North Carolina physician on Wednesday filed separate federal complaints seeking to overturn state restrictions on the abortion drug mifepristone.
GenBioPro, which makes the pill, filed its complaint in West Virginia, naming as defendants a county prosecutor and state attorney general Patrick Morrisey, who said in a statement that his state’s law was “clearly constitutional.”
Both GenBioPro and the North Carolina lawsuit filed by Dr. Amy Bryant argue that her state’s restrictions on the abortion pill are at odds with rules set by the Food and Drug Administration, the federal agency charged by law with determining access to and safety of medications.
“North Carolina cannot stand in the place of [the] FDA to impose restrictions on access to drugs that the FDA has determined are not appropriate and that upset the careful balance that the FDA was instructed by Congress to strike,” according to the complaint filed on Bryant’s behalf by the law firm King & Spalding in the US District Court for the Middle District of North Carolina.
GenBioPro’s lawsuit argues similarly: “Federal law prevails over West Virginia’s prohibition and restrictions. These laws impermissibly restrict patients’ access to mifepristone and GenBioPro’s opportunity and ability to market, promote, and sell the drug in the state”.
Since the Supreme Court overturned Roe v. Wade in June, at least 14 states have stopped nearly all abortions, including access to medical abortion, either because of laws passed by state legislators or because of confusion in the laws.
Limited access has resulted in increased demand for mifepristone, a single pill that terminates an early pregnancy by blocking the hormone progesterone.
Under FDA rules, mifepristone can only be prescribed by certified providers who understand how the drug works and agree to look for potential complications or medical conditions, such as ectopic pregnancy, that require immediate medical attention. But the FDA also says mifepristone is safe enough to be given through telehealth appointments and sent to a patient without evaluating them in person.
Earlier this month, the FDA expanded rules to allow retail pharmacies to dispense the drug for the first time, as long as they follow certain rules. Some drugstore chains, such as Walgreens and CVS, say they plan to join the program but continue to work out the details.
But many states, including North Carolina and West Virginia, have their own rules when it comes to dispensing the drug.
In North Carolina, for example, mifepristone is allowed in early pregnancy under FDA rules. But the state also requires the patient to obtain the drug through a physician at a specially certified surgical facility. The state also requires state-mandated counseling 72 hours before any abortion.
In a statement to ABC News, Bryant said he filed the lawsuit because “there is no medical reason for politicians to interfere or restrict access” to the drug.
“These heavy restrictions on medication abortion force clinicians to deal with unnecessary restrictions on patient care and the healthcare system,” she said.
Bryant’s attorney, Eva Temkin, argued that federal drug rules trump state regulations when the two conflict.
“Congress has made it clear that the FDA is tasked with establishing regulatory controls for this drug to ensure safety and patient access in the least onerous way,” she said.
Abortion rights advocates hope this type of “federal preemption” case will test a new legal strategy that could be applied in other states.
They also see North Carolina as a promising place to experiment. While Republicans control both chambers of the state legislature, the government is headed by Democratic Governor Roy Cooper. The suit names North Carolina Attorney General Josh Stein as a defendant; Stein, a Democrat, last week announced his candidacy for governor in 2024.
A spokesperson for Stein told ABC News that they were looking into the complaint.
Morrisey, the West Virginia Attorney General, said in his statement that we are prepared to defend West Virginia’s new abortion law to the fullest extent. While it may not please the manufacturers of abortive drugs, the US Supreme Court has made it clear that regulating abortion is a matter of state. I will stay strong for the life of the unborn child and I will not give in.”
“No state has ever blocked access to an FDA-approved drug before and this shouldn’t start now,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project. “We can’t have a swiss cheese from all the drugs you can get” in different parts of the country.
Anti-abortion groups are awaiting a ruling on their own case in Texas. The Alliance Defending Freedom (ADF) filed a lawsuit last fall on behalf of other anti-abortion rights organizations, arguing that the FDA erred in approving mifepristone decades ago. That case could lead to a national injunction on the pill’s distribution before it finally reaches the Supreme Court.
“We ask the court to reject the marketing and distribution of … chemical abortive drugs so that the health, safety and well-being of women are protected,” an ADF lawyer said in November.
Mary Kekatos of ABC News contributed to this report.
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