Chapel Hill OB-GYN Dr. Amy Bryant filed a lawsuit in the federal district court for the Middle District of North Carolina last Wednesday that could impact abortion access across the country.
Bryant's complaint in the case, Bryant v. Stein et al., challenges North Carolina's restrictions on the abortion medication mifepristone, the first of a two-pill regimen that terminates pregnancy within 10 weeks of gestation.
She argues that North Carolina's restrictions on mifepristone contest regulations set by the U.S. Food and Drug Administration.
Earlier this month, the FDA expanded access to mifepristone to include pharmacies. The medication can be dispensed in person or by mail. The drug has been approved by the FDA since 2000.
According to the federal organization, the medication "must be dispensed by or under the supervision of a certified prescriber or by certified pharmacies for prescriptions issued by certified prescribers."
Despite the FDA's rules, North Carolina requires that abortion medications can only be provided in person by a physician and in a specially certified facility after mandatory counseling, a 72-hour waiting period and, occasionally, an ultrasound.
In the complaint, Bryant challenged the state's restrictions, claiming they impose "unnecessary costs" and "interfere" with her work as a physician.
She argues that N.C. law conflicts with federal law, specifically the Risk Evaluation and Mitigation Strategies provisions of the federal Food, Drug and Cosmetic Act, which was enacted by U.S. Congress in 2007.
This law gave the FDA additional authority to establish specific restrictions related to the prescription and distribution of certain medications.
Chelsea Corey, an attorney representing Bryant in the case, said this conflict is called "federal preemption," meaning federal law displaces state law because of the Supremacy Clause in the U.S. Constitution.
This isn't the first lawsuit Bryant has filed. She was also the named plaintiff in Bryant v. Woodall, a 2016 case filed challenging the constitutionality of the state's criminalization of pre-viability abortions.
"Medication abortion is safe and effective – there’s no medical reason for politicians to interfere or restrict access to it, or for states to force doctors to comply with mandates not supported by medicine or science," Bryant said in a press release.
The defendants in the case are Democrat N.C. Attorney General Josh Stein, District Attorney for Chatham and Orange counties Jeff Neiman, members of the North Carolina Medical Board and Secretary of the North Carolina Department of Health and Human Services Kody Kinsley.
Corey said the officials were chosen as the defendants because the threat of enforcement is a big concern in the case.
"The people who were sued as defendants are the people with authority to enforce regulations against the plaintiff in this case," she said.
Laura Brewer, deputy chief of staff for the N.C. Department of Justice, said Stein's office is reviewing the complaint.
The NCDHHS has not yet received the complaint but will review it once they receive it, a spokesperson said.
"Part of NCDHHS’ mission is ensuring that health care is accessible for all North Carolinians, and this includes reproductive health services. Access to these services is a public health issue," the spokesperson for the department said in a statement.
National impact and implications
Over fifteen states, including North Carolina, impose restrictions on medication abortion.
The same day that Bryant filed her case in North Carolina, GenBioPro Inc. filed a case in West Virginia, claiming the state cannot override FDA approval of mifepristone by banning the drug.
The two lawsuits are viewed by some as test cases in the aftermath of the U.S. Supreme Court ruling in Dobbs v. Jackson Women's Health Organization that eliminated the constitutional right to abortion. The "federal preemption" cases are some of the first post-Roe litigation related to abortion access and will test a new legal strategy regarding abortion access that could be applied in other states.
“The lawsuit is crafted to focus very much on the FDA side, and I think that's very much intentional," UNC law professor Joan Krause said regarding Bryant v. Stein et al.
In another case in Texas, anti-abortion organizations are asking a federal judge to undo FDA approval of mifepristone entirely, which could lead to a national injunction on the distribution of the pill.
The plaintiffs in the case argue that the FDA did not have the authority to approve mifepristone because it was granted “accelerated approval” under a process meant for “serious or life-threatening illnesses." They claim this shouldn’t apply to abortion pills.
Overall, the three cases highlight the unstable nature of abortion access in the U.S. as states wrestle with their recently-gained power to regulate it.
According to data from the Guttmacher Institute, medication abortion accounts for over 50 percent of all abortions in the United States.
"During the more than two decades since FDA’s approval of mifepristone as a safe and effective option for ending early pregnancy, medication abortion has been used by more than 5 million patients and now accounts for more than half of abortions nationwide," Bryant's complaint read.
Depending on the way the litigation proceeds in the North Carolina case, Krause said the court might decide the state can regulate mifepristone because it is allowed to regulate the practice of medicine, whereas the FDA cannot.
Krause said she will be watching the case to see what happens.
"You're gonna see a lot more cases like this where there's an option to try to avoid the Dobbs framework and try to focus on some other legal protection that isn't just the right to abortion," she said.
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