In an assertive push to expand access to abortion medication, Attorney General Letitia James of New York, along with her counterparts from California, Massachusetts, and New Jersey, filed a petition urging the U.S. Food and Drug Administration (FDA) to remove restrictions on mifepristone, as reported by the Attorney General's Office. James argues that the REMS program, which currently governs the distribution of mifepristone, does not significantly enhance patient safety while unnecessarily limiting access to the medication.
The petition arrives amid a comprehensive review by the FDA of the drug's labeling requirements, initiated by HHS Secretary Robert F. Kennedy, Jr. The attorneys general are leveraging a federal regulation that allows individuals and organizations to request that the FDA issue, alter, or revoke a regulation, or take another type of action. They seek to have the FDA to fully reconsider and ultimately lift the REMS restrictions they believe are unjustified. "Given mifepristone’s 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions," Letitia James stated in a recent push for the drug's deregulation, as per the Attorney General's Office.
Mifepristone, when combined with misoprostol, is the leading method for terminating early pregnancy in the U.S. and also serves as the standard treatment for early miscarriage management. According to the coalition of attorneys general, over 7.5 million Americans have used mifepristone since its FDA approval in 2000, with serious complications being "extremely rare." The World Health Organization includes mifepristone on its list of essential medicines.
According to the Attorney General's Office, despite its safety profile and importance in reproductive healthcare, the REMS program for mifepristone includes stringent requirements like prescriber certification that deters many clinicians from prescribing the drug due to safety and legal concerns. Additionally, there are patient agreement forms that must be signed for the treatment of miscarriages and pharmacy certification that imposes complex logistical burdens. Attorney General James emphasized that these barriers severely limit the drug's availability, especially impacting rural and underserved communities. "The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care," said Attorney General James.
Moreover, the attorneys general compare the regulations on mifepristone to the looser restrictions of other drugs with higher risks, suggesting a regulatory discrepancy that inhibits access to a crucial reproductive health option. The current REMS program for mifepristone, they argue, is not "unduly burdensome" as federal law mandates for REMS requirements. Hence, they are calling for the FDA to fully eliminate or, at the very least, greatly reduce enforcement of the program's elements in New York, California, Massachusetts, and New Jersey. The petition also refutes claims against the safety of mifepristone that are founded on research they call methodologically flawed.
Attorney General James has a history of advocating for reproductive rights, including leading efforts against dangerous certification requirements for abortion providers, calling for the reinstatement of federal reproductive health funds, and taking legal action against anti-abortion groups. Most recently, James led a lawsuit against Red Rose Rescue for clinic invasions and has been active in filing amicus briefs in court cases relating to emergency abortion care and access to mifepristone.
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