Attorneys general from New York, California, Massachusetts, and New Jersey have submitted a formal petition to the Food and Drug Administration (FDA), asking the agency to remove restrictions on the abortion medication mifepristone. The move follows FDA Commissioner Marty Makary’s recent announcement that the agency plans to review the drug’s safety.
The petition does not specifically seek to eliminate the Risk Evaluation and Mitigation Strategy (REMS) program tied to mifepristone. Instead, it aims to prompt the FDA to formally review and recognize what the petitioners describe as extensive data supporting the drug’s safety. A source from the Massachusetts attorney general’s office confirmed that the petition is partly intended to counter a report by the conservative Ethics and Public Policy Center, which has questioned mifepristone’s safety without disclosing data sources or receiving peer-reviewed validation.
In April, Republican Senator Josh Hawley cited the same report in a letter urging the FDA to initiate a review. Two weeks later, Health and Human Services Secretary Robert F. Kennedy Jr. testified before the Senate Health, Education, Labor, and Pensions Committee that he had directed Commissioner Makary to conduct a “complete review” of the pill, pointing to unspecified “alarming” new data.
Since the U.S. Supreme Court overturned Roe v. Wade in 2022, mifepristone’s use has increased. A 2021 FDA decision removed the in-person requirement for receiving the drug, and in 2023, the Supreme Court upheld mail-order access. Currently, the FDA must respond to the petition within 180 days. If denied, legal action from the states is possible.
The petition challenges several FDA REMS requirements, including mandates that prescribers be listed in abortion provider registries, patients sign attestations of their intent to terminate pregnancy, and pharmacies adhere to specific recordkeeping. The states argue these measures are no longer justified by current scientific or legal standards, especially in jurisdictions where abortion is legal and regulated.
New York Attorney General Letitia James emphasized the impact of the restrictions on underserved areas: “There is simply no scientific or medical reason to subject it to such extraordinary restrictions,” she said. “The FDA must follow the science.”
A spokesperson for the Department of Health and Human Services said Makary will apply “gold standard science” along with practical regulatory considerations.
Seventeen other Democratic-led states and Washington, D.C., are pursuing a separate lawsuit in Spokane, Washington, seeking to loosen mifepristone regulations and allow broader access through standard medical and pharmacy channels.
