- North Carolina Attorney General Josh Stein filed a brief Thursday at the 4th US Circuit Court of Appeals opposing state restrictions on the abortion pill mifepristone.
- Both Stein and UNC Health Dr. Amy Bryant filed paperwork calling on appellate judges to throw out all state restrictions on the abortion drug.
- US Chief District Judge Catherine Eagles issued an injunction in June blocking state restrictions that the judge viewed as conflicting with federal rules set by the Food and Drug Administration. Eagles allowed other restrictions to stand.
- State legislative leaders are defending mifepristone restrictions. They are asking the 4th Circuit to uphold all restrictions spelled out in state law.
North Carolina Attorney General Josh Stein is making his case against North Carolina’s abortion pill restrictions at the 4th US Circuit Court of Appeals.
Stein is the Democratic nominee for governor in this fall’s election. In a brief filed Thursday at the Richmond, Virginia-based appellate court, Stein sided with the UNC Health doctor who filed a federal lawsuit challenging state restrictions on the drug mifepristone.
State legislative leaders are defending the restrictions at the Appeals Court.
US Chief District Judge Catherine Eagles issued an injunction on June 3 blocking state restrictions that the judge viewed as conflicting with rules set by the federal Food and Drug Administration. Eagles allowed other state restrictions on mifepristone to remain in place.
Republican lawmakers, Stein, and UNC Health Dr. Amy Bryant all appealed portions of Eagles’ ruling.
Stein’s brief notes that the FDA has regulated mifepristone for “more than two decades” under provisions of federal law.
“North Carolina law nonetheless imposes some of the very same restrictions on mifepristone that the FDA has implemented and then subsequently withdrawn,” according to Stein’s brief. “Under settled preemption principles that the Supreme Court has applied for decades, the Supremacy Clause does not permit States to frustrate the considered judgment of a federal agency in that manner.”
“To be sure, States ordinarily have wide latitude to protect the health and safety of their citizens in different ways, and state laws generally ‘offer[ ] an additional, and important, layer of consumer protection that complements FDA regulation.’ But when state law imposes the same restrictions that a federal agency tasked with ‘achiev[ing] a somewhat delicate balance of statutory objectives’ has deliberately rescinded, state law must yield,” Stein argued.
“The district court appropriately applied these preemption principles to enjoin some of the challenged North Carolina laws — but the court should have enjoined them all,” according to Stein’s brief. “Each one countermands the FDA’s expert judgment on how to balance regulatory burdens against patient access to a safe and effective drug that has been in use for decades. For that reason, each of the challenged laws frustrates Congress’s purposes and objectives and is, accordingly, preempted.”
Bryant, the plaintiff in the case, filed a separate brief Thursday. It offered similar arguments to those in Stein’s court filing.
“Although medication abortion is legal in North Carolina, the state has erected a series of barriers to patients’ ability to access mifepristone that FDA expressly considered and rejected,” Bryant’s lawyers wrote. “For example, it has dictated that only physicians may prescribe mifepristone, even though FDA concluded that mifepristone ‘is safe and effective when prescribed by … physician assistants and nurse practitioners.’ North Carolina has also frustrated FDA’s judgment that telemedicine is appropriate by requiring patients to have at least three in-person visits with a doctor in order to receive the drug: an in-person examination and consultation, a second in-person visit where the patient must take the drug in the doctor’s presence, and a third in-person follow-up visit.”
“North Carolina’s restrictions on mifepristone are preempted because they ‘upset the careful regulatory scheme established by federal law,’” Bryant’s lawyers 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.
The NC Values Institute, American Center for Law and Justice, Family Research Council, Concerned Women for America, Heartbeat International, and Advancing American Freedom filed briefs in August supporting state mifepristone restrictions.
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.
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.”
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.”
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.