NC Republicans can’t overrule FDA on abortion pill, judge affirms

abortion pill

Demonstrators in Raleigh protested the Supreme Court's decision striking down Roe v. Wade in 2022. (Photo by Peter Zay/Anadolu Agency via Getty Images)

By Michael McElroy

June 4, 2024

The ruling, the final word on a decision the judge rendered in April, blocks several state restrictions on abortion medication, but leaves others in place.

[7:55 p.m. This post has been updated to add comments from doctors responding to the ruling.]

A federal judge issued a final ruling Monday blocking North Carolina lawmakers from overruling federal drug regulations on the abortion medication mifepristone.

The ruling, which enforces a decision the judge rendered in April, blocks several state restrictions on the abortion medication, but leaves others in place.

US District Judge Catherine Eagles wrote in her in-depth ruling in April that a state cannot enact restrictions to a drug if the US Food and Drug Administration (FDA) has previously “expressly considered and rejected” them.

The state could, however, 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.

“Today’s ruling is a welcome relief that once again affirms that the FDA holds the authority to regulate medications on the market,” Bryant said in an emailed statement on Monday.

“Politicians in North Carolina cannot interfere with the FDA’s authority and impose medically unnecessary restrictions on medication abortion care,” she wrote.

“While the ruling still leaves in place some inappropriate restrictions that are not evidence-based or medically warranted, it will allow for increased access to safe and effective medication abortion care throughout North Carolina.”

What goes and what stays?

Mifepristone 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.

Medical providers applauded the ruling on Tuesday.

“Mifepristone and misoprostol are exceedingly safe, backed by decades of of high quality research,” Dr. Robin Wallace, a family physician in Orange County who provides abortion care, said late Tuesday afternoon.

“It is critical that North Carolinians can access these medications when needed and without necessary barriers.”

Barring an appeal, the rulings strike down state restrictions that:

  • Say only doctors can prescribe mifepristone.

 

  • Require doctors to administer the medication in-person.

 

  • Require an in-person follow up visit after taking the medication.

All of these clashed with federal regulations. That means that, pharmacists can now prescribe the medication, mifepristone can be taken at home, and no follow-up is necessary.

Here are the restrictions that remain in place:

  • A mandated in-person consultation 72 hours before the medication can be administered.

 

  • Requirements that doctors also conduct a physical examination before prescribing mifepristone and show the patients an ultrasound.

While doctors say these are also often medically unnecessary, the FDA has never weighed in on them, so they are not unlawful, the judge wrote.

Avoiding a dangerous precedent

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.

North Carolina’s Republican-controlled General Assembly included the mifepristone restrictions in its 12-week abortion ban, a law passed last year.

Dr. Erica Pettigrew, a family physician who was among more than 1,400 doctors who wrote an opening letter to Republicans before the vote on the abortion bill vote warning them of the consequences, called the ruling “fantastic news.”

“While it’s certainly a victory for abortion access, it goes far beyond to ensure that all medical science vetted by the FDA cannot be circumvented by the whims of politicians,” she said.

RELATED: ‘Complete disregard for human life’: Doctors reflect on NC’s abortion ban

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. Stein, a Democrat who is running for governor this year, has long supported abortion rights and criticized efforts to restrict access.

When Stein declined to defend the case, 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 while this is the final word on this case, the overall issue remains unresolved.

 

Author

  • Michael McElroy

    Michael McElroy is Cardinal & Pine's political correspondent. He is an adjunct instructor at UNC-Chapel Hill's Hussman School of Journalism and Media, and a former editor at The New York Times.

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