NC Republicans to defend ‘unnecessary’ abortion pill restrictions in Court on Wednesday

A federal judge will hear arguments in a lawsuit accusing the state of overstepping its authority by imposing regulations to the drug mifepristone that surpass those set by the US Food and Drug Administration.

The next chapter in the national fight for reproductive rights moves to a federal courthouse in Greensboro on Wednesday, as a judge weighs whether to dismiss a lawsuit accusing North Carolina of implementing medically unnecessary restrictions on medication abortion. 

The plaintiff in the case, Dr. Amy Bryant, an obstetrician with UNC Health, filed the suit in January 2023 saying that the state had imposed barriers to getting the drug mifepristone that far surpassed the regulations set by the US Food and Drug Administration (FDA).  

Mifepristone is a safe and effective method of abortion care and has undergone several extensive safety studies. It was approved by the FDA in 2000 to be given in tandem with another drug, misoprostol. This two-drug tandem, given through the first 10 weeks of pregnancy, is now the most common method of abortion in the United States. 

Nothing in this case, or any other, seriously calls the drugs’ safety into question. 

Instead, this case revolves around a very specific legal question. 

Does the “supremacy clause” of the US Constitution – which says that federal law overrides state law in any direct conflict  –  extend to all federal agencies? 

Bryant and her lawyers say that at least in this case, it does.

Extra burdens

In the lawsuit, Bryant and her lawyers argue that the state does not have the authority to implement rules that “conflict with and frustrate the objectives of federal law.”

“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,” the suit says. 

The FDA still requires a prescription in order to get mifepristone, but patients can fill that prescription via telehealth and have it delivered through the mail. North Carolina law, however, requires the prescription be given after an in-person visit and only at certain facilities. The patient must also have a consultation first, then wait 72 hours to receive and take the medication, and must take the pill in the presence of the doctor. 

That equates to at least two doctor’s visits and three days of waiting, none of which has any basis in medicine, doctors, medical experts, and the FDA itself says.

North Carolina Attorney General Josh Stein, who by law is responsible for defending the state in any federal lawsuit against it, was originally among those the suit named as a defendant. But he declined to defend the case, arguing in court filings that he agreed with the suit’s premise. He has long supported abortion rights and criticized efforts to restrict access. 

“Based on extensive evidence, the [FDA] has determined that mifepristone is safe and that serious complications are extremely rare,” Stein wrote to the court. 

And though the FDA had once required some of the same restrictions at issue in the case, the agency had repealed them based on emerging evidence that they were no longer needed.

“North Carolina law nonetheless imposes some of the very same restrictions on mifepristone that the FDA has implemented and then subsequently withdrawn,” Stein wrote. 

“When, as here, state law imposes the same rules that a federal agency has deliberately rescinded, state law must yield.”

All about Dobbs

When Stein declined to defend the case, however, North Carolina’s Republican leaders in the General Assembly – Senate pro Temp Phil Berger and House speaker Tim Moore – successfully appealed the court to take up the reins of the defense. 

In March, they filed a motion to dismiss the case, arguing that the Constitution’s supremacy clause applies mostly to Congress, and does not trickle down through the federal agencies so that any order from any federal department head automatically wins out over state law. 

“Nothing in [existing law] suggests that Congress authorized the FDA to exercise exclusive, preemptive power over one of the most divisive and consequential social and political issues of our day and the past fifty years,” lawyers for the Republicans wrote in a brief. 

(This idea, called the “major questions doctrine,” is popular among far-right conservatives and has been at the center of other key disputes between federal agencies and the states over efforts to fight climate change, limit pollution, and require COVID vaccines.)

The Republicans also argued that the mifepristone case was moot anyway because of the US Supreme Court’s Dobbs ruling which invalidated federal abortion rights protections and left the issue up to the states. 

The extra mifepristone regulations in North Carolina, they say, are just examples of the state legislature doing what the Supreme Court said it could do.

“The Supreme Court’s decision in Dobbs directly controls the matter. States can pass these laws,” Berger and Moore’s attorneys wrote.

But Congress did give the FDA sole regulatory authority over medication, Bryant’s lawyers argue, and they gave it a clear directive: To assure the safety of any given drug without adding unnecessary burdens to healthcare. 

North Carolina’s mifepristone restrictions are not only medically nonsensical, Bryant’s lawsuit says, but also violate the FDA’s founding principles and make care more dangerous and expensive for her patients. 

“The challenged restrictions impose unnecessary costs on Plaintiff and her practice and interfere with her ability to provide medical care to her patients according to her best medical judgment and in accordance with federal law,” the lawsuit reads.

“Medication abortion is inherently time-critical, and delaying such care can unnecessarily increase risk or even push patients outside the window for use of mifepristone, potentially forcing patients to have more involved and more expensive procedures (which will present heightened risks for some patients).”