Some NC restrictions on abortion drug are unlawful and undermine FDA, judge says

In a lawsuit by an OB-GYN challenging North Carolina regulations on dispensing medication abortion, a federal judge struck down some of the laws on the grounds that they undermine the national regulatory system.

Dr. Amy Bryant of UNC Health sued the state last year challenging its regulations on mifepristone, which is the first part of a two-pill regimen for termination of a pregnancy within the first 10 weeks of gestation. Bryant challenged state laws in place around prescribing the pill, such as requiring doctors to provide the pill in-person at certified facilities, and after a 72-hour waiting period.

She argued that the U.S. Food and Drug Administration usage requirements, which are more lenient than state laws, preempt North Carolina’s restrictions.

On Tuesday in Greensboro, U.S. District Judge Catherine Eagles granted a partial victory to Bryant.

She ruled that several of North Carolina’s laws go against a congressional mandate that the FDA create the regulatory framework for safe drug distribution and use. Among those are state laws requiring:

• That mifepristone must be prescribed, dispensed, and administered in-person.

• That only physicians prescribe and provide the drug, not other medical providers.

• That an in-person follow-up appointment be scheduled.

• That complications caused by the drug be reported to the FDA.

“These state safety rules must yield to the safety decisions made by the federal agency in whose hands Congress placed decision making authority about safety,” Eagles wrote.

But state laws can stand if they do not impose requirements reviewed by the FDA or if they focus more on the practice of medicine and a patient’s informed consent — such as the state’s requirements for an in-person, 72-hour advance consultation and blood type testing.

The ruling could be appealed to higher courts.

Parties in the case

Eagles, an appointee of Democratic President Barack Obama, was not persuaded by arguments made by defendants in the case around the the major questions doctrine, which centers on whether agencies have taken power beyond what Congress grants.

“The FDA acts in accordance with Congress’ command ... imposing requirements to reduce risks to patients while declining to impose requirements which in the agency’s judgment do not effectively reduce risks and ensure safe access,” Eagles wrote.

On Wednesday, Bryant wrote in an email to The N&O she was reviewing the ruling and was “pleased that Chief Judge Eagles recognized that North Carolina cannot impose restrictions on an FDA-approved medication that second-guess or interfere with the FDA’s expert judgment, and that many of North Carolina’s restrictions on mifepristone are preempted.”

Bryant filed her lawsuit in January 2023, the same month that the the FDA removed in-person dispensing requirements, allowing the medication to also be mailed. The agency also enabled certified pharmacies to dispense mifepristone directly to patients with a prescription from a certified prescriber.

The state’s top lawyer, Attorney General Josh Stein, a Democrat, would typically defend the state in such a case and was in fact named in the original lawsuit as a defendant. But he has recused himself in several abortion lawsuits and in this case, argued against the state in a legal brief.

On Tuesday, “the court held that parts of North Carolina’s anti-abortion law that make it harder for women, especially in rural North Carolina, to get medication abortion are unconstitutional. Republican legislators enacted the law to control, not protect, women. I’ll keep fighting to protect women’s freedoms,” Stein said in a statement sent by spokesperson Nazneen Ahmed.

Also named as defendants in the case are the top two Republican legislative leaders, state Senate leader Phil Berger and House Speaker Tim Moore. The N&O wasn’t immediately able to reach Berger and Moore by email for comment.

In a court filing, attorneys for Berger and Moore said that the lawsuit “seeks to eradicate important state-law protections for unborn children and their mothers’ health and welfare,” and that the FDA does not have the final say over “one of the most divisive and consequential social and political issues of our day and the past fifty years.”

Eagles called on the parties in the case to meet to narrow areas of disagreements.

Legal battle across the nation

Medication abortion has been the topic of lawsuits across the nation.

Since the U.S. Supreme Court’s Dobbs ruling in 2022, which overturned the constitutional right to abortion, at least four new cases have been filed in federal court regarding the FDA’s regulation of medication abortion, according to KFF. This includes North Carolina’s lawsuit.

One major case involves a group of doctors who filed a federal lawsuit in Texas, months after the Supreme Court ruling, challenging the approval of mifepristone, as previously reported by The N&O.

The judge in that case revoked approval of the medication last year, but following a series of appeals, the Supreme Court agreed to review this ruling. A decision is expected by the end of June, according to the Associated Press. The Texas Tribune in March reported following arguments that the majority of justices seem willing to preserve access to mifepristone.

NC’s abortion legal landscape

Since the Dobbs ruling, North Carolina’s abortion legal landscape has changed significantly. Previously, abortions were permitted in the state up until fetal viability, generally considered to be around 23 or 24 weeks of pregnancy.

But once states got to determine their laws, North Carolina began enforcing a 20-week abortion ban that had been on the books in some form since 1973.

Last year, lawmakers also introduced and passed a new law that prohibited abortions after 12 weeks, starting last July. It included exceptions: up to 20 weeks for rape and incest, up to 24 weeks for “life-limiting” fetal anomalies, and without limit if a physician determines that the mother’s life is in danger due to a medical emergency. Medication abortions are also legal through 12 weeks.

But there were new requirements that physicians providing abortion-inducing drugs determine the woman’s blood type and schedule two new in-person appointments, one 72 hours before taking the pill and another appointment one to two weeks afterward. This was in addition to the in-person appointment already required when taking the pill.