Legislative leaders defend mifepristone restrictions at 4th Circuit

State legislative leaders defended North Carolina’s restrictions on the abortion pill mifepristone as they filed an opening brief Monday at the 4th US Circuit Court of Appeals.

Republican lawmakers are challenging a June order from US Chief District Judge Catherine Eagles. It struck down portions of a state law that Eagles viewed as conflicting with rules from the federal Food and Drug Administration.

“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.

“That ruling squares with neither basic preemption principles nor the text of the Food, Drug, and Cosmetic Act (FDCA). And it puts in jeopardy not only North Carolina’s commonsense safety requirements for abortion drugs but also any state law that imposes a ‘safety-related’ protection on particularly high-risk drugs,” the brief continued.

“To start, the district court’s decision violates the presumption against preemption,” lawmakers’ lawyers argued. “Federal courts begin ‘with the assumption that the historic police powers of the States [are] not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’ Yet the FDCA does not express any intent — much less a ‘clear and manifest’ one — to preempt complementary state law.”

Lawmakers challenge arguments from the case’s plaintiff, UNC Health Dr. Amy Bryant. “According to Plaintiff, the 2007 Amendments to the FDCA, the Food and Drug Administration Amendments Act (FDAAA), radically altered the federal-state balance long struck by Congress with respect to drug regulation. Instead of setting the traditional federal floor, she argues, the FDAAA sets a federal ceiling, too, at least for the highest-risk drugs.”

“On this view, the FDA — and only the FDA — ‘is responsible for deciding what terms are required for safe access to’” drugs with a federal risk evaluation and mitigation strategy, or REMS. “But that gets Congress’s purpose backwards. The FDAAA is part of a long line of statutory enactments providing for more drug regulation — not less,” lawmakers’ lawyers wrote.

“Nothing in the text, structure, or history of that amendment suggests that Congress meant to reverse course and disallow complementary state regulation — much less with the clarity necessary to surmount the strong presumption against preemption,” the brief explained. “Under the district court’s counterintuitive logic, the riskier a drug, the less a State can do to protect its citizens.”

“Indeed, if the district court is right, States may regulate antibiotics but not opioids,” lawmakers’ lawyers argued. “That absurd result is contrary to the text of the FDAAA and conflicts with basic preemption principles. It could have devastating effects on real people.”

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.

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 named state Attorney General Josh Stein as lead defendant in her lawsuit. Stein, the Democratic nominee for governor, split with Republican legislative leaders over how to address Bryant’s complaints.

Stein and leading lawmakers offered Eagles opposing arguments in February court filings. Bryant also submitted her own brief.

“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.