In a lawsuit that could affect access to abortion across the country, a North Carolina physician on Wednesday asked a federal district court to lift 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 violate rules set by the Food and Drug Administration, the federal agency charged by law with governing drug access and safety.
“North Carolina can’t be in the shoes of [the] FDA to impose restrictions on access to medications that the FDA has determined are not appropriate and that distort the careful balance that the FDA was ordered to strike by Congress,” according to the complaint filed on behalf of Bryant by the law firm King & Spalding in the U.S. District Court for the Middle District of North Carolina.
Since the Supreme Court rejected Roe v. Wade in June, at least 14 states have banned nearly all abortions, including access to drug-induced abortion, either because of laws passed by state legislatures or because of confusion over the laws.
The limited access has led to a rising demand for mifepristone, a single pill that terminates 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 ectopic pregnancy, which require immediate medical attention. But the FDA also says mifepristone is safe enough to be dispensed through telehealth appointments and emailed to a patient without evaluating them in person.
Earlier this month, the FDA expanded the rules to allow retail pharmacies to dispense the drug for the first time, as long as they adhere to certain rules. Some pharmacy chains like Walgreens and CVS say they plan to join the program, but are still figuring out 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 accordance with FDA rules. But the state also requires the patient to receive the drug through a doctor in a specially certified surgical facility. The state also requires state-mandated counseling 72 hours prior to an abortion.
In a statement to ABC News, Bryant said she filed her lawsuit because there is “no medical justification for politicians to interfere with or restrict access to the drug.”
“These inconvenient restrictions on medication abortion force physicians to deal with unnecessary restrictions on patient care and on the health care system,” she said.
Bryant’s attorney, Eva Temkin, argued for federal rules over state drug prevention regulations when the two are in conflict.
“Congress has made it clear that the FDA has a duty to establish regulatory controls on this drug to ensure safety and patient access in the least burdensome manner,” she said.
Abortion rights advocates hope that cases like this of “federal preemption” 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 headed by Democratic Governor Roy Cooper. The lawsuit names North Carolina Attorney General Josh Stein as the defendant; Stein, a Democrat, announced his candidacy for governor in 2024 last week.
“No state has ever blocked access to an FDA-approved drug before, and that shouldn’t start now,” said Kirsten Moore, director of the Expanding Medication Abortion Access Project. “We can’t have swiss cheese of whatever drugs you can get” in different parts of the country.
Anti-abortion groups await a ruling in 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 ban on distribution of the pill before it eventually makes its way to the Supreme Court.
“We are urging the court to deny the marketing and distribution of… chemical abortion drugs so that the health, safety and welfare of women are protected,” an ADF lawyer said in November.