Massachusetts Attorney General Andrea Joy Campbell announced that she, along with District of Columbia Attorney General Brian Schwalb, has co-led a coalition of 18 attorneys general in opposing needless barriers to mifepristone access imposed by the state of North Carolina. 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 determination that North Carolina cannot impose restrictions on mifepristone access that the Food and Drug Administration (FDA) has explicitly determined are unnecessary to ensure patient safety.
“Decades of evidence show us that mifepristone is safe, effective, and critical to reproductive healthcare,” said AG Campbell. “We know that when one state restricts access to reproductive healthcare, neighboring states suffer the effects of patients traveling out of state to seek treatment. I’m proud to be co-leading this effort to urge the Court to honor the District Court’s decision, which protects patient access to essential reproductive healthcare without jeopardizing states’ rights.”
In their brief, the attorneys general argued that mifepristone has been safely used as an integral part of reproductive healthcare 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. Therefore, they argue that North Carolina’s restrictions on mifepristone, which re-instate the same restrictions that the FDA has explicitly considered and removed, create unnecessary burdens to reproductive healthcare.
Mifepristone is an 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 healthcare system. These restrictions included physician-only prescribing; in-person prescribing, dispensing, and administering; the scheduling of in-person follow-up appointments; and non-fatal adverse event reporting to the FDA.
Ultimately, 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.
This matter is AG Campbell’s latest effort to expand and protect access to reproductive care, address disparities in maternal health, and tackle misinformation that prevents access to care. To help achieve these goals, AG Campbell released updated “Know Your Rights” guidance about abortion care, the Shield Law, and contraception.
This matter was handled by Deputy State Solicitor Tasha Bahal, Assistant Attorney General Trini Gao of the AGO’s Civil Rights Division, and Assistant Attorney General Phoebe Fischer-Groban of the AGO’s Constitutional and Administrative Law Division.
Joining Massachusetts and the District of Columbia in filing the brief were the attorneys general from California, Colorado, Connecticut, Delaware, Illinois, Maine, Maryland, Michigan, Minnesota, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont, and Washington.
Original source can be found here.