North Carolina medication abortion law challenged in court

GREENSBORO, N.C. (CN) — Lawyers took to federal court Wednesday to argue for and against North Carolina’s restrictions on medication abortion, and if the state is able to restrict access beyond FDA guidelines.

In January 2023, Dr. Amy Bryant sued the North Carolina Medical Board over restrictions on the abortion drug mifepristone. North Carolina law requires patients to receive state counseling, undergo a 72-hour waiting period, and have the drug administered by a physician in a “specially certified facility.” In some circumstances, an ultrasound is also required. Bryant argues that these restrictions — which go against U.S. Food and Drug Administration guidelines — burden her and her patients, and that the state should defer to FDA guidelines. 

The FDA approved mifepristone for medication abortion in 2000. 

State Senate President pro tempore Phil Berger and Timothy Moore, speaker of the House are intervenor-defendants who filed a motion to have Bryant’s lawsuit dismissed. The motion was heard in court Wednesday, where U.S. District Judge Catherine Eagles indicated she'd make a motion for summary judgment. Lawyers agreed on the facts of the suit, but disagreed on if federal preemption applied. 

Erin Hawley, lawyer for Berger and Moore, argued the state has the right to further regulate medications the FDA has written Risk Evaluation and Mitigation Strategies provisions to help support safe use and access. Mifepristone is one of these drugs. 

“The FDA sets a floor, states are allowed to add to those requirements,” said Hawley. “Congress did not intend the FDA to be the exclusive authority over drug decisions.” 

In the lawsuit, Bryant says that the 2023 FDA guidelines do not require mifepristone to be distributed in person and that the “FDA specifically considered and rejected the idea that mifepristone must be provided in person by a physician in a particular type of facility." She says North Carolina can’t “stand in the shoes of FDA” by taking it upon themselves to restrict medicine.

“North Carolina’s restrictions conflict with federal law and upset the regulatory balance struck by FDA, creating an obstacle to the congressional objectives,” Bryant says in her complaint. Lawyers argued over whether the state is required to strictly follow FDA guidelines or if they could add restrictions to certain drugs. 

“Congress charged the FDA in striking a balance in prioritizing patient safety that would not unreasonably burden patients,” said Bryant's lawyer Paul Mezzina. “The goal of Congress is to provide safe access to these drugs.”

He added: “The courts said when a federal agency has evaluated requirements a state cannot come in and oppose those requirements. The FDA has specially rejected the requirements that North Carolina is confirming.” 

Hawley said the state is trying to protect women by enforcing guidelines that were in place for 20 years, including the requirement that patients had to be prescribed mifepristone in person.

“If the FDA thought something was crucial for 20 years, the state under preemption has the right to enforce it. It makes complete sense that North Carolina still thinks these things are important. The FDA doesn't take away from the state’s ability to regulate,” she said.

Hawley argued the 72-hour waiting period for patients is “minimally burdensome” and that North Carolina can “build on” the FDA’s recommendations. 

She also called the ultrasound requirement "plainly supported by science” to determine gestational age, as complications increase week by week in a pregnancy. Preventing complications is their goal, and Hawley argued these restrictions are meant to protect women. 

Mezzina pounced on this and noted the risk of complications increase every week, which is why the 72-hour delay between being prescribed and being able to take mifepristone is notable. 

“If the informed consent has to happen 72 hours in advance, that would shorten the 70-day gestation period to 67 days,” he said. The FDA has never recommended an ultrasound prior to having a medical abortion. 

North Carolina also bars physicians from prescribing mifepristone through telemedicine, and instead requires patients to be seen in person.  

“That in-person requirement would frustrate the FDA’s attempt to create access through telemedicine,” Mezzina said, adding rural and under-provided residents are harmed by the restriction. 

Mezzina also urged the judge to dump the state's requirement that prescribing physicians inform the FDA of any side effects their patients report, which he said is inconvenient for both doctors and the FDA. "There are hundreds of pages of FDA documents” on mifepristone which the FDA has analyzed at length, he said.

Hawley countered: “The more information we get about complications with any drug will help the FDA assess risk."

State Attorney General Joshua Stein was also a named defendant in the lawsuit, but countered the lawmakers' attempt to dismiss the suit in an answer. 

“Under well-settled principles of preemption that preserve American federalism, a state cannot impose laws that conflict with and frustrate the objectives of federal law,” he wrote. “A state may not impose additional controls — including restrictions that FDA has specifically rejected — that upset the carefully balanced regulatory scheme established by federal law.”

Sarah Boyce, Stein’s lawyer, urged the court to take a cautious approach, as doctrine continues to evolve, but that "it could not be clearer that Congress intended for the FDA to have precisely the authority that it has exercised here."

Eagles said she'd push for summary judgment. “It seems like a pretty big deal for Congress to say to the states there is a category of drugs you cannot regulate,” she said, and asked the parties to file briefs by Feb. 5. 

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