NEW YORK — In a lawsuit that could impact abortion access nationwide, a North Carolina doctor on Wednesday asked a federal district court to strike down the state's restrictions on the abortion drug mifepristone.
The complaint filed by Dr. Amy Bryant argues that North Carolina's restrictions on the abortion pill are at odds with rules set by the Food and Drug Administration, the federal agency tasked by law to determine drug access and safety.
"North Carolina cannot stand in the shoes of [the] FDA to impose restrictions on medication access that FDA determined are not appropriate and that upset the careful balance FDA was directed by Congress to strike," according to the complaint filed on Bryant's behalf by the law firm King & Spalding in the U.S. District Court for the Middle District of North Carolina.
Since the Supreme Court overruled Roe v. Wade in June, at least 14 states have ceased nearly all abortions, including access to medication abortion, either because of laws passed by state legislators or because of confusion over the laws.
The limited access has resulted in soaring 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 out for potential complications or medical conditions such as an ectopic pregnancy, which requires immediate medical attention. But the FDA also says mifepristone is safe enough to be provided via telehealth appointments and mailed to a patient without evaluating them in person.
Earlier this month, the FDA expanded the rules to allow for retail pharmacies to dispense the drug for the first time, so long as they follow certain rules. Some pharmacy chains like Walgreens and CVS say they plan to join the program but are continuing to sort through the details.
But many states, including North Carolina, have their own rules when it comes to dispensing the drug.
In North Carolina, mifepristone is allowed early in pregnancy in line with FDA rules. But the state also requires that the patient obtain the drug through a physician in a specially certified surgical facility. The state also requires state-mandated counseling 72 hours in advance of any abortion.
In a statement to ABC News, Bryant said she filed her lawsuit because there's "no medical reason for politicians to interfere or restrict access" to the drug.
"These burdensome restrictions on medication abortion force physicians to deal with unnecessary restrictions on patient care and on the healthcare system," she said.
Bryant's lawyer, Eva Temkin, argued federal rules for the drug preempt state regulations when the two conflict.
"Congress has made clear that FDA is tasked with establishing regulatory controls for this drug to ensure safety and patient access in the least burdensome way," she said.
Advocates in favor of abortion rights are hopeful that this kind of "federal preemption" case will test a new legal strategy that could be applied in other states.
They also see North Carolina as a hopeful place to try it out. While Republicans control both chambers of the state legislature, the administration is run by Democratic Gov. Roy Cooper. The lawsuit names North Carolina Attorney General Josh Stein as a defendant; Stein, a Democrat, last week announced his bid for governor in 2024.
"No state has ever blocked access to an FDA approved drug before and that should not start now," said Kirsten Moore, director of the Expanding Medication Abortion Access Project. "We can't have a Swiss cheese of what 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 was wrong to approve mifepristone decades ago. That case could lead to a nationwide injunction on distribution of the pill before eventually winding its way to the Supreme Court.
"We urge the court to reject the marketing and distribution of … chemical abortion drugs so that the health, safety, and welfare of women are protected," an attorney for ADF said in November.
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