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North Carolina Abortion Pill Regulations Invalid, Suit Says (1)

Jan. 25, 2023, 2:55 PMUpdated: Jan. 25, 2023, 8:11 PM

North Carolina’s restrictions on the use of an abortion-inducing drug conflict with regulatory controls imposed on the drug by the US Food and Drug Administration and should be declared invalid, a state-licensed doctor says in a new complaint.

Amy Bryant’s lawsuit, filed Wednesday, asks the US District Court for the Middle District of North Carolina to declare that the state’s limits on using mifepristone are preempted to the extent that they’re inconsistent with regulations issued by the agency under the Food, Drug, and Cosmetic Act’s Risk Evaluation and Mitigation Strategies provisions.

The case comes at a time when anti-abortion activists have ramped up their attacks on medication abortion—an alternative available up to 10 weeks of pregnancy in which a patient self-ingests mifepristone and another drug, misoprostol to terminate a pregnancy. Several lawsuits challenging similar state regulations on constitutional grounds were filed before the US Supreme Court decided in Dobbs v. Jackson Women’s Health Org. that there’s no federal constitutional right to abortion, but it’s one of the first post-Dobbs suits and turns on a preemption question.

It’s also one of the first to follow a Texas-based federal lawsuit in which a Christian physicians group sued the FDA to force the agency to withdraw its 2000 approval of the drug.

FDA has used its authority “to impose a precise set of controls on an FDA-approved drug,” Bryant’s complaint says. “A State may not impose additional controls—including restrictions that FDA has specifically rejected—that upset the carefully balanced regulatory scheme established by federal law,” it says.

North Carolina requires doctors to provide mifepristone in person at a particular type of facility after a 72-hour waiting period and, in some cases, an ultrasound examination. FDA has considered and specifically rejected these restrictions, which impose substantial costs on physicians and patients, the complaint says. The waiting period also may prevent people from having medication abortions, because timing is crucial—FDA approved the drug for use in ending pregnancies up to 10 weeks, it says.

FDA first approved mifepristone for this use in 2000 and issued the first REMS for the drug in 2011 that imposed a physician-only requirement and distribution restrictions. In 2016, FDA lifted the physician-only restrictions. In 2021, it opened a new review and removed the in-person dispensing requirement. Most recently, the agency lifted the clinic-only rule and added a certification scheme for pharmacies to be able to distribute the drug.

Susan B. Anthony Pro-Life America spoke out against FDA’s “progressive removal” of restrictions on the drug regimen used to end pregnancies.

“Mail-order abortion drugs have become a leading health risk to mothers and babies, with the chemical abortion pill regimen posing a 53% greater risk of an ER visit due to abortion complications compared to surgical abortions,” SBA President Marjorie Dannenfelser said in a statement provided to Bloomberg Law Wednesday. The FDA has “ignored science, which points to the great need for oversight of dangerous abortion drugs,” she said in response to the filing and a similar one in a West Virginia federal court.

“The FDA must do its job and safeguard Americans from this dire public health threat,” Dannenfelser said.

Causes of Action: Supremacy clause.

Relief: Declaration that North Carolina regulations are in conflict with and preempted by federal law; order blocking state and its officials from enforcing the restrictions; attorneys’ fees and costs.

Response: Nazneen Ahmed, a spokeswoman for North Carolina Attorney General Josh Stein (D), told Bloomberg Law that Stein’s office is reviewing the complaint.

Attorneys: King & Spalding LLP represents Bryant.

The case is Bryant v. Stein, M.D.N.C., No. 23-cv-77, complaint filed 1/25/23.

(Updates end of story to add comments from an anti-abortion group.)

To contact the reporter on this story: Mary Anne Pazanowski in Washington at mpazanowski@bloomberglaw.com

To contact the editors responsible for this story: Rob Tricchinelli at rtricchinelli@bloomberglaw.com; Carmen Castro-Pagán at ccastro-pagan@bloomberglaw.com