State, national groups support NC mifepristone restrictions at 4th Circuit

As state legislative leaders appeal a federal judge’s ruling striking down some of North Carolina’s restrictions on an abortion pill, state and national groups are offering support in new court filings.

The NC Values Institute and American Center for Law and Justice have filed separate briefs in recent days with the 4th US Circuit Court of Appeals. Both briefs support Republican lawmakers’ efforts to have state restrictions on the drug mifepristone restored.

The Family Research Council, Concerned Women for America, Heartbeat International, and Advancing American Freedom filed additional briefs Monday.

Attorneys general from Iowa, Arkansas, and South Carolina led a coalition of 18 states filing a brief Monday supporting North Carolina’s law setting restrictions on mifepristone. Participating states “all prohibit, restrict, or otherwise regulate abortion,” according to their brief. “Each amicus State has a sovereign interest in protecting its citizens and in ensuring its laws are not preempted by an aggressive and expansive interpretation of the Food, Drug and Cosmetic Act.”

“North Carolina’s common-sense laws protecting unborn life, maternal healthcare, and the integrity of the medical profession do not conflict with the FDA’s regulation of mifepristone, and the judgment below should be vacated,” the state coalition argued.

US District Judge Catherine Eagles issued an order in June striking portions of state law that she viewed as conflicting with rules from the federal Food and Drug Administration.

“The Supreme Court has unequivocally returned abortion regulation to the elected representatives of the people,” wrote Deborah Dewart, the Onslow County-based attorney for the NC Values Institute.

Dewart’s friend-of-the-court brief referenced the North Carolina General Assembly’s response in 2023 to the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.  

“The Care Act requires that only physicians may prescribe mifepristone, a drug used to cause chemical abortions; requires in-person prescribing, dispensing, and administering; mandates in-person follow-up appointments; and requires non-fatal adverse event reporting to the FDA,” Dewart wrote. “These provisions, intended to protect pregnant women and their unborn children, were all enjoined by the district court.”

“The injunction is contrary to Dobbs and decades of precedent affirming state responsibility for health and safety laws,” Dewart wrote. “The relaxed regulations also threaten to place conscientious physicians in an untenable position when women inevitably suffer the consequences of chemical abortions and come to an emergency room seeking to complete their failed abortions.”

The NC Values Institute critiqued abortion supporters’ “brazen end-run around Dobbs by appealing to federal law to circumvent state restrictions on abortion.”

In a separate filing, the Washington, DC-based American Center for Law and Justice made two points. “First, that the FDA regulates a drug does not mean state law cannot restrict its use to commit a legal offense,” ACLJ lawyers wrote. “Homicide committed with fentanyl, for example, is still homicide, and states can legislate to restrict the conditions governing its use.”

“Second, mifepristone is by no means safe. By design, it aims to cause pregnancy loss, a serious adverse effect,” the brief added.

State legislative leaders defended North Carolina’s restrictions on mifepristone as they filed an opening brief on Aug. 12 at the 4th Circuit.

“North Carolina possesses the sovereign authority to protect the health and welfare of its citizens. Yet the district court issued a sweeping decision declaring that state ‘safety-related restrictions’ on high-risk abortion drugs are impliedly preempted because they pose an obstacle to a ‘comprehensive regulatory system’ set by the federal government,” wrote lawyers representing state lawmakers. The Washington, DC-based Alliance Defending Freedom makes up part of legislative leaders’ legal team.

Lawmakers filed their notice of appeal in the case on June 20, one week after the US Supreme Court rejected a separate challenge to mifepristone from abortion opponents working with the Alliance Defending Freedom.

The case’s plaintiff, UNC Health Dr. Amy Bryant, and state Attorney General Josh Stein also will file briefs with the 4th Circuit. Stein has supported Bryant’s legal arguments against the abortion pill restrictions.

Eagles issued a judgment and permanent injunction on June 3, confirming a ruling she initially announced in April.

The final three-page document blocked sections of state law “to the extent they prohibit any healthcare provider other than a licensed physician from providing mifepristone,” “to the extent they require mifepristone to be provided in person,” “to the extent they require scheduling an in-person follow-up visit after providing mifepristone or efforts to ensure such a follow-up appointment,” and “to the extent they require the reporting of non-fatal adverse events related to mifepristone to the FDA.”

Eagles dismissed “with prejudice” other elements of the challenge against state restrictions. That ruling means the plaintiff cannot challenge surviving elements of North Carolina’s mifepristone restrictions again.

The ruling followed a 49-page order Eagles issued on April 30. She determined that state lawmakers could not overrule the FDA’s previous decisions about mifepristone. Eagles’ order upheld portions of the law that the FDA had not addressed.

Bryant’s lawsuit alleged that state rules conflicted with FDA’s Risk Evaluation and Mitigation Strategy for mifepristone.

“This case thus raises the question of whether and when a state can impose additional requirements on the distribution of an FDA-approved drug,” Eagles wrote this spring. “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.”

“The Court finds and concludes that to the extent North Carolina law imposes safety restrictions on the distribution of the drug that the FDA has implemented and then later affirmatively rejected and removed, those laws frustrate the congressional goal of establishing a comprehensive regulatory framework under which the FDA determines conditions for safe drug distribution that do not create unnecessary burdens on the health care system or patient access,” Eagles continued.

“The provisions of the North Carolina law that prohibit health care providers other than physicians from prescribing the drug, require in-person prescribing, dispensing, and administering, mandate the scheduling of an in-person follow-up appointment, and require non-fatal adverse event reporting to the FDA stand as obstacles to Congress’ purpose and are preempted,” the judge wrote.

“But to the extent North Carolina law imposes requirements that have not been expressly considered and rejected by the FDA or that focus more on the practice of medicine and a patient’s informed consent, these provisions do not interfere with Congress’ purpose and are not preempted,” Eagles explained. “This includes the state’s requirements for an in-person advance consultation, use of an ultrasound, an in-person examination, blood type testing, and adverse event reporting to state health authorities.”

Bryant’s lawyers challenged the state’s restrictions in a February court filing with Eagles.

“As part of its meticulous, statutorily mandated review of the Mifepristone REMS, FDA has rejected the very restrictions North Carolina imposes,” Bryant’s lawyers wrote. “Consistent with its duty under the REMS statute, FDA has sought to reduce burdens on patient access and the healthcare system — particularly for ‘patients who have difficulty accessing health care (such as patients in rural or medically underserved areas)’ — by facilitating access to mifepristone through telemedicine, including by certifying pharmacies to dispense mifepristone and eliminating in-person visits under the REMS. North Carolina’s requirements frustrate those objectives and conflict with FDA’s considered judgments.”

Stein submitted a brief supporting Bryant’s arguments.

“[T]he Attorney General respectfully requests that this Court grant summary judgment to Plaintiff and enjoin the enforcement of the challenged state-law restrictions on the provision of mifepristone because they are in conflict with, and therefore preempted by, federal law,” wrote lawyers with Stein’s state Justice Department.

“When the FDA approved mifepristone in 2000, the FDA imposed a number of conditions it deemed necessary to ensure safe use. Since that time, the FDA has regularly modified the drug’s REMS based on evidence that has been compiled across two decades of use,” Stein’s brief added. “As part of these modifications, the agency has rescinded a number of conditions that, in its expert scientific judgment, are no longer necessary to ensure the drug’s safety and instead cause unnecessary burdens on access and delivery.”

“North Carolina law reimposes some of the very same restrictions on mifepristone that the FDA has withdrawn,” Stein argued. “Plaintiff challenges seven of those requirements. Under well-settled preemption principles, these requirements violate the Supremacy Clause because they frustrate the careful balance struck by the FDA pursuant to its express statutory authority. As a result, this Court should hold that the mifepristone REMS preempts the challenged North Carolina laws to the extent that those laws impose restrictions on mifepristone that the FDA previously required, but ultimately removed.”

Lawyers representing state Senate Leader Phil Berger, R-Rockingham, and House Speaker Tim Moore, R-Cleveland, intervened in the federal suit to defend North Carolina’s law.

“The States have long worked in tandem with the federal Food and Drug Administration to protect American consumers from dangerous drugs,” legislative lawyers wrote in February. “Mifepristone is a drug with known serious risks. For this reason, its FDA approval is subject to minimum safety requirements to ensure safe use.”

“North Carolina has chosen to protect the health and safety of its citizens by enacting additional safety measures above the federal floor set by the FDA,” lawmakers’ brief continued. “These requirements are consistent with Congress’s health and safety objectives.”

“Yet Plaintiff argues that North Carolina’s health and safety laws conflict with federal law. It is uncontested that no provision of federal law expressly preempts the challenged state laws and that nothing prevents Dr. Bryant from complying with both federal and state requirements,” legislators’ lawyers wrote. “She nevertheless argues that the state requirements somehow stand as an obstacle to Congress’s health and safety objective because the FDA has chosen not to adopt such requirements. Plaintiff can point to no federal statutory text supporting that argument and this Court should uphold the State’s health and safety requirements.”

Eagles took over the case on Dec. 21. It had been assigned to District Judge William Osteen.

Berger and Moore were not initially named as defendants in the lawsuit. Along with Stein, the list of defendants featured the state Health and Human Services secretary, Orange-Chatham district attorney, and members of the state Medical Board.

Eagles also presided over a separate lawsuit challenging North Carolina’s 2023 abortion law. She upheld most of that law’s provisions, including its ban on most abortions after 12 weeks of pregnancy. Eagles struck down a requirement for abortion providers to document the location of an intrauterine pregnancy before administering abortion drugs.

Editor’s note: This article has been updated to reflect the filing of additional friend-of-the-court briefs supporting North Carolina’s legislative leaders.