- Governor-elect Josh Stein restated his opposition to North Carolina's restrictions on the abortion drug mifepristone in a new court filing this week.
- Both Stein and UNC Health Dr. Amy Bryant filed briefs Wednesday at the 4th US Circuit Court of Appeals.
- Bryant, Stein, and Republican state legislative leaders are all appealing a trial judge's June decision in the case. The judge threw out North Carolina restrictions that conflicted with federal mifepristone rules but allowed other restrictions to remain in place.
Governor-elect Josh Stein restated his case against North Carolina’s restrictions on the abortion drug mifepristone in a new court filing this week. Stein is the lead defendant in a UNC Health doctor’s lawsuit challenging state restrictions.
Stein, plaintiff Dr. Amy Bryant, and Republican state legislative leaders are all pursuing appeals at the 4th US Circuit Court of Appeals.
A trial judge threw out portions of state law that the judge determined to conflict with federal Food and Drug Administration rules tied to mifepristone. In a June decision, the judge allowed other restrictions to remain in place.
Bryant and Stein, as plaintiff and defendant, urge the 4th Circuit to overrule all state restrictions on the drug. GOP lawmakers, as intervenors in the case, want to see all state mifepristone restrictions upheld.
“Legislative Intervenors do not dispute that, in a limited set of circumstances, federal law may preempt state laws that stand as obstacles to the purposes and objectives of Congress,” lawyers wrote Wednesday in their latest brief for Stein, acting in his current role as North Carolina attorney general.
“Following Congress’s express instruction to balance safety with access and burden, the FDA has developed detailed regulations for the prescription, dispensation, and administration of a select subcategory of drugs, one of which is mifepristone. On multiple occasions since mifepristone’s initial approval in 2000, moreover, the FDA has revised, reevaluated, and rescinded certain of its restrictions to achieve the carefully calibrated scheme in place today. North Carolina law, however, reimposes some of the same restrictions that the FDA adopted and then subsequently withdrew,” Stein’s lawyers wrote.
“The Supreme Court has, time and again, affirmed that, in a narrow category of cases, States may not impose restrictions that a federal agency has ‘considered and rejected.’ At the same time, the Court has made clear that, in applying these preemption principles, courts must respect state sovereignty on matters of health and safety. The Attorney General’s position adheres to both principles,” the brief continued.
Bryant’s latest brief in the case Wednesday also rebutted arguments from GOP lawmakers.
“intervenors maintain that states should be free to impose restrictions specific to this … drug that FDA has considered and rejected and that obstruct FDA’s efforts to assure patient access to the drug,” Bryant’s lawyers wrote. “Remarkably, they even suggest … that the resulting 50-state ‘patchwork’ of conflicting, inconsistent ‘safety measures’ is something courts should celebrate rather than seek to avoid. That is not the law.”
The 4th US Circuit Court of Appeals announced earlier this month that it would not resolve the dispute over North Carolina’s mifepristone restrictions until it deals with a similar case from West Virginia.
The North Carolina case is “placed in abeyance” until the 4th Circuit resolves a case titled GenBioPro Inc. v. Raynes, according to a one-sentence order issued on Dec. 3.
In the GenBioPro case, plaintiffs allege that West Virginia’s abortion law effectively bans the sale of mifepristone in the state. The suit argues that West Virginia’s ban conflicts with the federal Food and Drug Administration’s approval of mifepristone.
The North Carolina case, Bryant v. Moore, involves state restrictions on mifepristone.
US Chief District Judge Catherine Eagles issued an injunction on June 3 blocking state restrictions that the judge viewed as conflicting with FDA rules. Eagles allowed other state restrictions on mifepristone to remain in place.
“As the Attorney General concedes, ‘States ordinarily have wide latitude to protect the health and safety of their citizens in different ways, including with respect to the regulation of FDA-approved drugs,’” lawyers for legislative leaders wrote in a brief filed on Nov. 27. “Given that ‘Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,’ Plaintiff must persuade this Court that the FDAAA radically altered the federal-state balance long struck by Congress. It did not. Indeed, the case for preemption is particularly weak here because Congress is well aware of state drug regulation in this historical area of state concern and yet declined to expressly preempt state law.”
Lawmakers rebutted arguments based on the legal concept of “obstacle preemption.” Bryant and Stein argued that North Carolina’s law interferes with federal law.
“Plaintiff distances herself from the decision below and says that obstacle preemption applies only to state requirements that the FDA has adopted and then rejected. That is nonsensical,” lawmakers’ lawyers wrote. “That the FDA once found a safety requirement necessary for the safe use of a drug is a point in favor of a state imposing the protection — not against it.”
“More fundamentally, obstacle preemption is based upon congressional purpose,” the brief continued. “Plaintiff never argues that Congress intended to regulate the minutiae of medical practice by eliminating follow-up visits or state reporting requirements. Instead, Plaintiff’s obstacle-preemption theory boils down to her claim that the FDAAA mandates access. To prevail, Plaintiff must establish that Congress intended the FDA to set a federal ceiling for high-risk drugs. But she cannot.”
“Even were this Court to apply Plaintiff’s novel initially-adopted-and-later-rejected test, the challenged provisions would pass,” lawmakers lawyers argued. “Several were never adopted by the FDA. Others were never rejected. Plaintiffs and the Attorney General thus invite this Court to displace state law based on ‘similar’ restrictions, ‘effective withdrawals,’ and vague ‘notions’ of agency intent. And while the Attorney General insists that States retain the power to protect their citizens from high-risk drugs like opioids, the FDA has rejected opioid dosage and duration limitations — protections enacted by many States. No FDAAA provision carves out abortion drugs for preemption.”
The FDA dealt with mifepristone through Risk Evaluation and Mitigation Strategies.
“Plaintiff objects to longstanding protections for women seeking abortions like modest waiting periods and informed consent,” lawmakers’ brief argued. “But such protections existed long before Congress enacted the FDAAA in 2007. And in the nearly twenty years since its passage, no one (until very recently) has suggested that REMS displace state laws that survived under Roe and Casey. This Court would be the first to so hold.”
“In short, North Carolina’s statutes regulating abortion drugs complement and reinforce Congress’s purpose: to protect consumers from dangerous drugs like mifepristone and opioids. While States may not reduce or eliminate REMS restrictions, they may supplement them,” lawmakers argued.
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.
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 restrictions conflicted with FDA’s mifepristone rules.
“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. Berger and Moore were not initially named as defendants. 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.