Under state law, any physician prescribing the abortion pill mifepristone to patients must be in the same room with them at a certified surgical facility when they take the pills, despite FDA rules to the contrary.
A North Carolina physician has filed a lawsuit against the state seeking to overturn its restrictions on the abortion pill mifepristone.
Dr. Amy Bryant, an OB/GYN who also teaches at the UNC School of Medicine, prescribes the pill to patients and argues that the US Food and Drug Administration’s (FDA) approval of the drug should override state-level restrictions on the pills.
Abortion is legal up to 20 weeks in North Carolina, but under state law, any physician prescribing mifepristone to patients must be in the same room with them at a certified surgical facility when they take the pills, despite FDA rules to the contrary. The state also mandates counseling 72 hours in advance of any abortion.
“North Carolina cannot stand in the shoes of [the] FDA to impose restrictions on medication access that FDA determined are not appropriate and that upset the careful balance FDA was directed by Congress to strike,” according to Bryant’s complaint, which was filed in the U.S. District Court for the Middle District of North Carolina.
The FDA approved mifepristone in 2000 as a safe way to end a pregnancy, when used in combination with a second medication, misoprostol. The combination is approved for use up to the 10th week of pregnancy. During the Covid-19 pandemic, the agency eased restrictions on mifepristone, and in 2021, eliminated the in-person requirement for the pill, citing a review showing no change in risk if the drug was taken at home. Under that change, doctors can now prescribe the medication via telehealth appointments and ship it to patients via mail-order pharmacies.
Most recently, the FDA introduced new rules this month allowing pharmacies like CVS and Walgreens to dispense the drugs to patients with a prescription, as long as they follow certain rules.
Bryant’s lawsuit argues that the federal agency’s regulations should preempt the state restrictions, which obstruct her ability to treat patients.
“These burdensome restrictions on medication abortion force physicians to deal with unnecessary restrictions on patient care and on the healthcare system,” she told ABC News. There’s “no medical reason for politicians to interfere or restrict access” to the drug,” she added.
North Carolina Attorney General Josh Stein’s office, which is named in the filing, has yet to comment on the matter, telling reporters they’re reviewing the lawsuit.
Bryant’s case could have national implications. Since the US Supreme Court overturned Roe v. Wade last summer, abortions are now banned in at least 13 states, including via medication abortion.
But if Bryant’s argument that federal regulations preempt state-level restrictions succeeds, it could provide reproductive freedom advocates with a new strategy to use to fight for abortion access in other states.
“No state has ever blocked access to an FDA approved drug before and that should not start now,” Kirsten Moore, director of the Expanding Medication Abortion Access Project, told ABC News. “We can’t have a Swiss cheese of what drugs you can get” in different parts of the country.
The Associated Press contributed to this report.
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