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Federal judge strikes down part of NC law restricting abortion pill

Carolina Journal


A federal judge has thrown out part of North Carolina’s state law restricting access to an abortion pill called mifepristone. The judge ruled that state lawmakers cannot overrule the federal Food and Drug Administration’s previous decisions about the pill.


Yet US District Judge Catherine Eagles’ 49-page order Tuesday also upheld portions of the law that the FDA has not addressed.


Plaintiff Dr. Amy Bryant, a UNC Health doctor, filed a lawsuit challenging the state’s restrictions. Bryant argued 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. “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.”


Eagles’ ruling calls on the parties in the case to discuss “proposed judgments and injunctions” and submit them to the court by May 21.


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 supported Bryant’s arguments in his latest brief.


“[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 safetyand 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.

During a January hearing, Eagles converted legislators’ motion to dismiss Bryant’s suit into a cross motion for summary judgment. That means both the plaintiff and legislative leaders sought a favorable ruling from Eagles without a trial.


Eagles is also presiding over a separate lawsuit challenging portions of North Carolina’s 2023 abortion law. She granted an injunction in September blocking two pieces of that law from taking effect. A trial in that case is scheduled for July. Defenders and critics of the updated abortion law have asked Eagles to rule without holding a trial.


Earlier court filings from legislative leaders defended existing state law related to mifepristone.


“North Carolina has the authority to enact laws for the general welfare that respect unborn life, promote maternal health, and uphold the integrity of the medical profession,” wrote attorneys representing Berger and Moore. “While always true, the Supreme Court reaffirmed the proper allocation of regulatory power last summer in Dobbs v. Jackson Women’s Health Organization.”


“Plaintiff, a North Carolina physician who performs abortions, seeks to eradicate important state-law protections for unborn children and their mothers’ health and welfare,” lawmakers’ lawyers wrote. “She makes the novel claim that the Food and Drug Administration’s (“FDA”) approval of chemical abortion drugs for certain uses preempts North Carolina’s police power and, as a result, the FDA’s regulations bind and limit the state’s laws on abortion.”


“Supreme Court precedent requires that an agency must identify clear congressional authorization to justify the agency’s attempt to control actions related to a significant political issue under the major questions doctrine,” the motion continued. “Plaintiff’s claim requires a finding that when Congress passed the Federal Food, Drug, and Cosmetic Act (“FDCA”) in 2007, it gave the FDA sole power to regulate chemical abortions in all fifty states.”


“Yet, the FDCA merely required the FDA to implement safety measures over the use of dangerous drugs, including the chemical abortion drug Mifeprex. Nothing in the text of the FDCA suggests that Congress authorized the FDA to exercise exclusive, preemptive power over one of the most divisive and consequential social and political issues of our day and the past fifty years,” legislative leaders’ lawyers argued. “The Supreme Court’s decision in Dobbs directly controls the matter.”


“The FDA sets a floor to declare whether drugs are safe enough to market,” the motion continued. “FDA approval under the FDCA does not preempt state regulation of the use or prescription of drugs by state-licensed physicians to patients in the state. Nor does it trump compelling state interests in protecting unborn life, promoting maternal welfare, and regulating the medical profession. This Court should grant this motion and dismiss this lawsuit against all Defendants.”


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.

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