Judge blocks some North Carolina restrictions on abortion pill

A state cannot enact restrictions to a drug if the Federal Food and Drug Administration had already “expressly considered and rejected” them, the judge wrote. 

A federal judge has struck down several North Carolina restrictions on the abortion medication mifepristone, ruling that state lawmakers could not add any barriers to the drug that federal health officials had already removed. 

US District Judge Catherine Eagles ruled in the case last week that since Congress gave the US Food and Drug Administration final say over specific drug regulations, it was unlawful for a state to enact any restrictions the FDA had “expressly considered and rejected.” But the judge wrote that the state could add new restrictions to mifepristone, or any other federally-approved drug, as long as the FDA had never weighed in on them.

The case sprung from a lawsuit filed last year by Dr. Amy Bryant, an UNC obstetrician, who said that the state’s mifepristone restrictions were medically unnecessary, conflicted with federal policies, and prevented her giving her patients the best possible care. 

Mifepristone is a safe and effective method of abortion care, has undergone several extensive safety studies, and is the most common method of abortion in the United States. While there are several federal restrictions on the drug, North Carolina has many more in place that the FDA has either rejected outright or never considered.

Which means Judge Eagles’ ruling blocks some of them and leaves others in place.

What restrictions are blocked?

North Carolina says that only doctors can prescribe mifepristone and that they have to administer the drug in person. The FDA had similar rules in effect, but after new safety studies in 2021, the FDA loosened those requirements, saying that pharmacists could also prescribe mifepristone and that the drugs could be sent directly to the patient by mail. 

Since the FDA had “expressly considered” and discontinued these policies, Eagles wrote, North Carolina’s restrictions violated federal laws meant to establish a national standard for establishing a drug’s safety without imposing unreasonable barriers to access.

Other state provisions mandating an in-person follow-up appointment, which the FDA likewise rejected, were also unlawful, she wrote.

The case hinged on specific decisions on this one drug, but carried larger resonance, Eagles wrote. If North Carolina got to overrule federal officials on this drug, what is to stop them from disrupting federal standards on cancer drugs, HIV drugs, or other important medication?

“While this case concerns the distribution of a drug used to terminate a pregnancy, a similar case could arise over any drug, from FDA-approved thyroid or diabetes medications, drugs for cancer treatment, vaccinations, contraceptives, or opioids for pain management,” she wrote. 

Which restrictions remain?

North Carolina’s Republican-controlled General Assembly included mifepristone restrictions in its 12-week abortion ban, a law passed and enacted several months after Bryant filed her suit. She amended the suit to include them.

The new law requires patients seeking a medication abortion to first have an in-person consultation with their doctor, during which they will be shown an ultrasound whether they want to see one or not. Then they have to wait at least 72 hours before doctors can prescribe the medication. 

Since the FDA had never considered these specific rules, they can stay in place, Eagles wrote. 

In a statement emailed through her lawyer last week, Bryant said she welcomed the judge’s decision.

“I am 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,” Bryant said. 

“We are carefully reviewing the ruling and the implications it has for providing care to patients in North Carolina.”

What’s next?

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.

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 to 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. 

Judge Eagles rejected this defense. But an appeal is likely. And the US Supreme Court is expected to rule in a separate but similar case regarding mifepristone this summer. So for now, there is no definitive answer.

‘Unnecessary costs’

North Carolina’s mifepristone restrictions are not only medically nonsensical, Bryant’s lawsuit said, 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).”