California Attorney General Rob Bonta, joined by the attorneys general of Massachusetts, New York, and New Jersey, has filed a petition with the U.S. Food and Drug Administration (FDA). The petition requests the removal of restrictions on the abortion medication mifepristone by eliminating the Mifepristone Risk Evaluation and Mitigation Strategy Program (REMS program). This includes removing requirements for prescriber certification, pharmacy certification, and patient agreement forms.
The petition argues that mifepristone is a safe and effective medication used for critical reproductive care such as abortions and miscarriage treatments. It emphasizes that medication abortion provides timely reproductive care, particularly benefiting individuals in rural and underserved communities.
Attorney General Bonta stated, “For decades, medication abortion has been recognized not only as effective but so safe that it presents lower risks of serious complications than taking Tylenol or getting a colonoscopy.” He further noted that restricting access to mifepristone harms patients and the healthcare system.
On May 14, 2025, Robert F. Kennedy Jr., Secretary of Health and Human Services (HHS), testified before the Senate Health Committee regarding an ordered review of mifepristone despite its proven safety record. Since its approval in 2000, approximately 7.5 million Americans have safely used mifepristone.
The current REMS program subjects mifepristone to restrictions typically reserved for drugs with known serious risks. The attorneys general argue these restrictions are medically unjustified given mifepristone’s safety record over 25 years. They claim it imposes unnecessary burdens on physicians and limits patient access to care.
The coalition also highlights that REMS requirements hinder access to care in rural areas and place undue strain on healthcare systems. Emergency rooms face challenges prescribing mifepristone due to certification hurdles. Pharmacies encounter administrative burdens from certification requirements.
Attorney General Bonta asserts that considering mifepristone’s strong safety record and essential role in reproductive care, the current REMS program is scientifically and legally indefensible. The attorneys general urge the FDA to eliminate the REMS program or allow states like California, Massachusetts, New York, and New Jersey to regulate mifepristone independently.
A copy of the petition is available for public viewing.
