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Fight against abortion pill lawsuit cites federal ‘major questions doctrine’
Publisher's Note: This post appears here courtesy of the Carolina Journal. The author of this post is CJ Staff.
State legislative leaders' latest court filing in a legal battle over abortion pill restrictions cites the "major questions doctrine." That's a principle in federal legal arguments that Congress does not delegate issues of major political or economic significance to administrative agencies.
In a brief filed Monday in US District Court, Senate Leader Phil Berger, R-Rockingham, and House Speaker Tim Moore, R-Cleveland, argue that "Plaintiff's arguments fail" in the case, partly because "Congress has not given the FDA authority to mandate the major question of abortion policy in all states."
"Abortion is one of the most consequential and divisive social and political issues of the past fifty years," the document continued. "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.'"
"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," Berger and Moore's lawyers wrote. "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."
Republican legislative leaders' latest brief arrived on the same day that state Attorney General Josh Stein, a Democrat, filed his answer to the latest version of the abortion bill lawsuit. Stein opposes lawmakers' attempts to dismiss the suit, even though he is the lead named defendant.
"Under well-settled principles of preemption that preserve American federalism, a State cannot impose laws that conflict with and frustrate the objectives of federal law," Stein's lawyers wrote.
"When Congress enacted the Risk Evaluation and Mitigation Strategies ("REMS") provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), its clear objective was to ensure that REMS drugs are regulated in a way that is commensurate with their risks while not imposing undue burdens on the healthcare system or patient access."
"The U.S. Food and Drug Administration ("FDA" or the "Agency") has acted pursuant to this authority to impose a precise set of controls on an FDA-approved drug, mifepristone," Stein's brief continued. "A State may not impose additional controls - including restrictions that FDA has specifically rejected - that upset the carefully balanced regulatory scheme established by federal law."
Berger and Moore urge a federal judge to dismiss the suit. Lawmakers filed a motion for dismissal this month. They also continue to fight a separate suit challenging the state's latest abortion law.
"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."
Berger and Moore are fighting the abortion pill suit filed by Dr. Amy Bryant of UNC Health.
"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 entered the case to defend state law. Bryant named Stein as lead defendant in the lawsuit. The state Health and Human Services Secretary, Orange-Chatham district attorney, and members of the state Medical Board are also named defendants.
Stein opposes lawmakers' efforts to end the suit. The attorney general also stands against state legislators, and supports the plaintiffs' pursuit of a preliminary injunction, in a separate case challenging North Carolina's new abortion law. The law restricts most abortions after 12 weeks of pregnancy.
Berger and Moore filed paperwork on Aug. 7 opposing a preliminary injunction in that case. U.S. District Judge Catherine Eagles is scheduled to hold a Sept. 21 hearing in Greensboro to address the injunction.
Plaintiffs Planned Parenthood and Duke Health Dr. Beverly Gray seek to block two pieces of the law that otherwise took effect on July 1. One requires doctors using abortion drugs to document an intrauterine pregnancy. The other requires abortions performed after 12 weeks of pregnancy to take place in hospitals.
Eagles already has issued a temporary order blocking the "IUP requirement." The hospitalization requirement is scheduled to take effect on Oct. 1.
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State legislative leaders' latest court filing in a legal battle over abortion pill restrictions cites the "major questions doctrine." That's a principle in federal legal arguments that Congress does not delegate issues of major political or economic significance to administrative agencies.
In a brief filed Monday in US District Court, Senate Leader Phil Berger, R-Rockingham, and House Speaker Tim Moore, R-Cleveland, argue that "Plaintiff's arguments fail" in the case, partly because "Congress has not given the FDA authority to mandate the major question of abortion policy in all states."
"Abortion is one of the most consequential and divisive social and political issues of the past fifty years," the document continued. "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.'"
"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," Berger and Moore's lawyers wrote. "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."
Republican legislative leaders' latest brief arrived on the same day that state Attorney General Josh Stein, a Democrat, filed his answer to the latest version of the abortion bill lawsuit. Stein opposes lawmakers' attempts to dismiss the suit, even though he is the lead named defendant.
"Under well-settled principles of preemption that preserve American federalism, a State cannot impose laws that conflict with and frustrate the objectives of federal law," Stein's lawyers wrote.
"When Congress enacted the Risk Evaluation and Mitigation Strategies ("REMS") provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), its clear objective was to ensure that REMS drugs are regulated in a way that is commensurate with their risks while not imposing undue burdens on the healthcare system or patient access."
"The U.S. Food and Drug Administration ("FDA" or the "Agency") has acted pursuant to this authority to impose a precise set of controls on an FDA-approved drug, mifepristone," Stein's brief continued. "A State may not impose additional controls - including restrictions that FDA has specifically rejected - that upset the carefully balanced regulatory scheme established by federal law."
Berger and Moore urge a federal judge to dismiss the suit. Lawmakers filed a motion for dismissal this month. They also continue to fight a separate suit challenging the state's latest abortion law.
"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."
Berger and Moore are fighting the abortion pill suit filed by Dr. Amy Bryant of UNC Health.
"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 entered the case to defend state law. Bryant named Stein as lead defendant in the lawsuit. The state Health and Human Services Secretary, Orange-Chatham district attorney, and members of the state Medical Board are also named defendants.
Stein opposes lawmakers' efforts to end the suit. The attorney general also stands against state legislators, and supports the plaintiffs' pursuit of a preliminary injunction, in a separate case challenging North Carolina's new abortion law. The law restricts most abortions after 12 weeks of pregnancy.
Berger and Moore filed paperwork on Aug. 7 opposing a preliminary injunction in that case. U.S. District Judge Catherine Eagles is scheduled to hold a Sept. 21 hearing in Greensboro to address the injunction.
Plaintiffs Planned Parenthood and Duke Health Dr. Beverly Gray seek to block two pieces of the law that otherwise took effect on July 1. One requires doctors using abortion drugs to document an intrauterine pregnancy. The other requires abortions performed after 12 weeks of pregnancy to take place in hospitals.
Eagles already has issued a temporary order blocking the "IUP requirement." The hospitalization requirement is scheduled to take effect on Oct. 1.
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