Federal Appeals Court places NC mifepristone case on hold to deal with WVa suit

The 4th US Circuit Court of Appeals will not resolve a dispute over North Carolina’s restrictions on the abortion drug mifepristone until it settles a similar dispute in a West Virginia case.

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 Tuesday.

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. Governor-elect Josh Stein and a UNC Health physician are fighting the restrictions.

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.

Stein filed a brief in the case in October in his role as North Carolina’s attorney general. He supported arguments from the plaintiff, Dr. Amy Bryant of UNC, against any state restrictions. Both Stein and Bryant relied on the 2007 Food and Drug Administration Amendments Act to bolster their case.

“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 aruged.

Stein’s Oct. 10 brief noted that the FDA had 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 on the same day. 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.

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 REMS 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. 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.

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