- Legislative leaders filed a new legal brief Friday responding to criticism of their motion to dismiss a federal lawsuit against state abortion pill restrictions.
- Lawmakers' attorneys argue that plaintiffs believe a federal agency could "single-handedly invalidate every state pro-life law" or "impose a federal ceiling on prescription drug regulation."
- Democratic Attorney General Josh Stein has opposed lawmakers' motion to dismiss the suit. That's despite the fact that Stein is named as a defendant.
Top N.C. legislative leaders are renewing their plea for a federal judge to dismiss a lawsuit against the state’s abortion pill restrictions. Legislators’ attorneys responded Friday to arguments from lawsuit plaintiffs.
“Abortion is one of the most consequential and divisive social and political issues of the past fifty years. The Supreme Court has repeatedly found that abortion issues involve a ‘critical moral question,’ and there are ‘profound moral and spiritual implications of terminating a pregnancy, even in its earliest stage,’” according to legislators’ brief.
“Yet, according to Plaintiff, Congress impliedly gave the FDA — when it approved a REMS for Mifeprex — the authority to regulate chemical abortion nationwide and strip safety protections from state law,” the brief continued. “Plaintiff claims that it is not extraordinary for an agency to single-handedly invalidate every state pro-life law or to impose a federal ceiling on prescription drug regulation notwithstanding the states’ traditional and long-standing role in regulating for health and safety. Plaintiff is wrong.”
REMS refers to a risk evaluation and mitigation strategy. That’s a “drug safety program that the U.S. Food and Drug Administration can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks,” according to the FDA’s website.
“In fact, the FDA has never claimed authority to preempt state abortion regulations based on drug approval procedures,” lawmakers’ attorneys argued. “Such an assertion of agency power would be far ‘beyond what Congress could reasonably be understood to have granted.’ It would encroach on the long-exercised and historic power of states to regulate health and safety. For these reasons, the FDA has acknowledged that states may impose additional restrictions beyond the Mifeprex REMS, like limiting dispensing authority to only physicians as North Carolina law requires.”
Lawmakers’ new brief cited the 2022 U.S. Supreme Court decision in the Dobbs case, which overturned Roe v. Wade.
“Within the past year, the Supreme Court held that a state law ‘regulating abortion, like other health and welfare laws, is entitled to a “strong presumption of validity.” It must be sustained if there is a rational basis on which the legislature could have thought that it would serve legitimate state interests,’” the brief continued. “In so holding, the Supreme Court gave no indication that its decision was toothless because the FDA controlled state abortion laws and had already imposed a federal ceiling.”
“Currently, twenty-seven states have laws protecting unborn life that would — according to Plaintiff’s position — be preempted by the FDA’s Mifeprex REMS,” lawmakers’ attorneys wrote. “Plaintiff attempts to upend Dobbs and require every state to allow chemical abortion by mail without any physician oversight. The Supreme Court rejected that argument when it returned the power to legislate abortion policy to the states.”
“And Congress never gave to the FDA the power to overturn North Carolina’s duly enacted laws regulating abortion,” the brief added.
State Attorney General Josh Stein opposes legislators’ attempt to dismiss the suit. That’s despite the fact that Stein is a named defendant.
In paperwork filed in April, Stein formally rejected a motion to dismiss the case against him, the state Health and Human Services secretary, the Orange-Chatham County district attorney, and members of the N.C. Medical Board.
Health Secretary Kody Kinsley filed a separate document responding to lawmakers’ motion. The plaintiff, Dr. Amy Bryant, filed her own document opposing the motion as well.
“For more than two decades, the Food and Drug Administration has approved and regulated mifepristone, a drug used for the medical termination of early pregnancy,” wrote lawyers from Stein’s N.C. Department of Justice. “Based on extensive evidence, the agency has determined that mifepristone is safe and that serious complications are extremely rare.”
“The FDA regulates mifepristone pursuant to express statutory authority, which empowers the agency to weigh the benefits of the drug against its risks and to impose conditions on its administration,” Stein’s lawyers added.
“[T]he FDA has rescinded certain conditions that, in the agency’s expert scientific judgment, are no longer necessary to ensure the drug’s safety,” according to the N.C. Justice Department brief. “North Carolina law nonetheless imposes some of the very same restrictions on mifepristone that the FDA has implemented and then subsequently withdrawn. 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.”
Stein’s lawyers label state lawmakers’ arguments in the case “unpersuasive.”
Kinsley’s separate brief did not actively oppose state legislators’ motion. But the state health secretary warned of the dangers of “restrictions to reproductive health care.”
State legislative leaders filed a motion in March to dismiss the suit titled Bryant v. Stein. A federal judge had allowed them to intervene in the case. That was despite the fact no lawmaker was named as an original defendant.
“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 Republican lawmakers. “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,” according to legislators’ attorneys. They include representatives from the group Alliance for Defending Freedom. “She makes the novel claim that the Food and Drug Administration’s (“FDA”) approval of chemical-abortion drugs for certain uses pre-empts North Carolina’s police power and, as a result, the FDA’s regulations bind and limit the state’s laws on abortion.”