Drug company and doctor sue over abortion pill access, in test cases of federal power

The lawsuits argue that state rules on abortion drugs conflict with federal law.

January 25, 2023, 1:12 PM

In lawsuits that could impact abortion access nationwide, the drug manufacturer GenBioPro and a doctor in North Carolina on Wednesday filed separate federal complaints seeking to strike down state restrictions on the abortion drug mifepristone.

GenBioPro, which manufactures the pill, filed its complaint in West Virginia, naming as defendants a county prosecutor and the state attorney general, Patrick Morrisey, who said in a statement that his state's law was "clearly constitutional."

Both GenBioPro and the suit filed in North Carolina by Dr. Amy Bryant argue that their state'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.

GenBioPro's suit argues much the same: "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."

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 and West Virginia, have their own rules when it comes to dispensing the drug.

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., on March 16, 2022.
Allen G. Breed/AP, FILE

In North Carolina, for example, 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.

A spokesperson for Stein told ABC News that they were reviewing 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. 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."

"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.

ABC News' Mary Kekatos contributed to this report.