AG James and 17 AGs File Amicus Brief to Protect Access to Mifepristone in North Carolina
New York Attorney General Letitia James and a coalition of 17 attorneys general filed an amicus brief in support of a district court decision finding that North Carolina can not impose unnecessary and burdensome restrictions to access mifepristone that were rejected by the U.S. Food and Drug Administration (FDA). The coalition filed an amicus brief in Bryant v. Stein, asking the United States Court of Appeals for the Fourth Circuit to uphold the district court’s decision. The coalition argues that mifepristone has been safely and widely used for decades, and barriers to accessing mifepristone can drive up medical risks for patients.
“Mifepristone is a safe medication that has been used by millions of people, and these dangerous restrictions are causing real harm to people across the country,” said Attorney General James. “Reproductive health care should not be weaponized as a tool to win political points; it is a human right that should be accessible to everyone who needs it. I will always defend people’s reproductive rights and access to this critical health care.”
Mifepristone is a historically safe, FDA-approved medication used for abortion, as well as for treatment of miscarriage. When the FDA first approved its use in 2000, it added conditions for its distribution to ensure safe use. Since then, pursuant to its federal mandate to balance drug safety with patient access, the FDA has adopted a risk evaluation and mitigation strategy (REMS) program for mifepristone. As required by federal law, the FDA has periodically reevaluated the mifepristone REMS program and has reduced the original restrictions imposed on mifepristone to better balance safety with access.
Since 2016, the FDA has removed certain restrictions on mifepristone access, such as the requirement to obtain mifepristone in person and from a physician, on the grounds that these restrictions neither improved patient safety nor adequately minimized burdens on the health care system. In 2023, North Carolina imposed various restrictions on the use and distribution of mifepristone, including many of the restrictions that were expressly removed by the FDA. The plaintiff, an abortion provider in North Carolina, sued to challenge the state restrictions as preempted by federal law. The district court held that, while states have broad authority to regulate health care, a state law that reimposes restrictions removed by the FDA under the agency’s statutory authority to create REMS would be preempted. The coalition’s amicus brief defends the district court’s decision as striking the proper balance between state authority and FDA regulation.
Joining Attorney General James in filing the brief are the attorneys general of California, Colorado, Connecticut, Delaware, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, and the District of Columbia.
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