Attorney General Kwame Raoul, as part of a coalition of 18 attorneys general, today filed a brief opposing efforts in North Carolina to restrict access to the medication abortion drug mifepristone.
Raoul and the coalition filed the amicus brief in Bryant v. Stein, asking the U.S. Court of Appeals for the Fourth Circuit to uphold the district court’s determination that North Carolina cannot impose restrictions on mifepristone access that the Food and Drug Administration (FDA) has explicitly determined, pursuant to Congress’ express instruction, are unnecessary to ensure patient safety.
“Attacks on access to medication abortion and reproductive health care continue across the nation, threatening the lives of women,” Raoul said. “Mifepristone has been safely utilized by millions of American patients because it has proven to be safe, effective and accessible. I will continue to defend against these attacks on reproductive freedom both in Illinois and across the country.”
In their brief, Raoul and the attorneys general argue that mifepristone has been safely used as an integral part of reproductive health care for decades since its initial approval by the FDA, and over that period, the FDA has carefully balanced patient safety and access to the drug by removing certain restrictions on mifepristone distribution. Raoul and the coalition argue that North Carolina’s restrictions on mifepristone, which reinstate the same restrictions the FDA has explicitly considered and removed, create unnecessary burdens to reproductive health care.
Mifepristone is a historically safe, FDA-approved form of medication abortion. 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.
In 2023, North Carolina revised its laws governing pregnancy termination. The state added several archaic and needless restrictions around the use and distribution of mifepristone. These restrictions included some of the same restrictions that were initially imposed by the FDA in 2000 but later removed, as the FDA found that those restrictions neither improved patient safety nor adequately minimized burdens on the health care system. The restrictions included physician-only prescribing, in-person prescribing, dispensing and administering, scheduling follow-up appointments in person, and non-fatal adverse event reporting to the FDA.
A North Carolina federal district court judge ruled that while North Carolina may impose certain restrictions on abortion care, it cannot override the FDA’s determination to remove these specific restrictions on mifepristone. The coalition’s amicus brief defends the district court’s decision as striking the proper balance between state authority and FDA regulation. The attorney general of North Carolina has declined to defend the challenged restrictions, agreeing that the state legislature went too far in imposing them.
The brief is the latest action taken by Raoul to protect access to mifepristone and medication abortion. Raoul, as part of a coalition of 18 states, proactively filed a lawsuit to preserve access to mifepristone for patients in Illinois. On April 7, 2023, a federal judge in Washington issued an injunction preventing the FDA from reducing the availability of medication abortion in Illinois and other participating states.
Joining Raoul in submitting amicus brief are the attorneys general of California, Colorado, Connecticut, Delaware, the District of Columbia, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.
Original source can be found here.