GREENSBORO, N.C. — Legal arguments unfolded in federal court on Wednesday regarding North Carolina’s restrictions on medication abortion and the state’s authority to regulate beyond FDA guidelines.
In January 2023, Dr. Amy Bryant initiated a lawsuit against the North Carolina Medical Board, challenging restrictions on the abortion drug mifepristone. State law mandates patients to undergo state counseling, observe a 72-hour waiting period, and have the drug administered by a physician in a certified facility, with an ultrasound required in certain cases. Bryant contends that these state-specific restrictions, diverging from U.S. Food and Drug Administration (FDA) guidelines, impose undue burdens on both her and her patients. She argues that the state should defer to the FDA’s directives.
Mifepristone received FDA approval for medication abortion in 2000.
State Senate President pro tempore Phil Berger and Speaker of the House Timothy Moore, as intervenor-defendants, sought to dismiss Bryant’s lawsuit. The motion was heard in court on Wednesday, with U.S. District Judge Catherine Eagles indicating her intention to motion for summary judgment. While lawyers concurred on the facts, they disputed the applicability of federal preemption.
Erin Hawley, representing Berger and Moore, argued that the state has the right to enhance regulations on medications covered by the FDA’s Risk Evaluation and Mitigation Strategies provisions, designed to ensure safe use and access. Mifepristone falls under this category.
“The FDA sets a floor, states are allowed to add to those requirements,” stated Hawley. “Congress did not intend the FDA to be the exclusive authority over drug decisions.”
Bryant’s lawsuit contends that the 2023 FDA guidelines do not mandate in-person distribution of mifepristone. She argues that North Carolina should not act independently to restrict the drug, stating, “North Carolina’s restrictions conflict with federal law and upset the regulatory balance struck by FDA, creating an obstacle to the congressional objectives.”
The court session debated whether the state is obligated to strictly adhere to FDA guidelines or if it can impose additional restrictions on certain drugs.
Paul Mezzina, Bryant’s lawyer, asserted, “Congress charged the FDA in striking a balance in prioritizing patient safety that would not unreasonably burden patients.” He highlighted that the FDA had rejected requirements aligned with North Carolina’s restrictions.
Hawley argued that the state aims to protect women by enforcing guidelines in place for two decades, including the requirement for in-person prescription of mifepristone. She defended the 72-hour waiting period as “minimally burdensome” and justified the ultrasound requirement as scientifically supported to determine gestational age.
Mezzina countered that complications increase weekly in a pregnancy, emphasizing the significance of the 72-hour delay and questioning the necessity of the ultrasound, which the FDA has not recommended before medical abortion.
North Carolina also prohibits physicians from prescribing mifepristone via telemedicine, requiring in-person consultations. Mezzina argued that this requirement hinders access, particularly for rural and underserved residents.
Hawley countered that more information about complications would aid the FDA in assessing risk.
State Attorney General Joshua Stein, also named in the lawsuit, opposed lawmakers’ attempts to dismiss the suit. Stein emphasized that a state cannot impose laws conflicting with federal objectives.
Judge Eagles expressed her inclination toward summary judgment, noting the significance of Congress instructing states not to regulate a specific category of drugs. Parties were instructed to file briefs by Feb. 5.