AG James Pushes for Mifepristone Access Expansion

New York – In a bold move against restrictive health policies, New York Attorney General Letitia James has joined forces with her counterparts in California, Massachusetts, and New Jersey to file a joint petition urging the U.S. Food and Drug Administration (FDA) to end the REIMS program restrictions on mifepristone.

Attorney General James, citing mifepristone’s 25-year track record of proven safety and efficacy, argues that the FDA’s current Risk Evaluation and Mitigation Strategy (REMS) unnecessarily hinders access to medication abortion. The coalition asserts that the REIMS program imposes excessive burdens without enhancing patient safety.

Mifepristone, when used in conjunction with misoprostol, is the predominant method for terminating early pregnancy in the U.S. Since its approval by the FDA in 2000, over 7.5 million individuals have safely utilized mifepristone. Leading medical organizations, including the FDA itself, confirm that serious complications are extremely rare, and no deaths have been definitively linked to the drug.

Despite these facts, mifepristone remains under a REIMS program originally designed for drugs with known serious risks. This program includes prescriber certification, patient agreement forms, and pharmacy certification requirements that Attorney General James and the coalition argue are unnecessary and impede access to care, particularly in rural and underserved areas.

The attorneys general highlight that the administrative burden of REIMS has largely confined medication abortion to specialized settings, with only one percent occurring at primary care facilities. They note that nearly 90 percent of U.S. counties lack an abortion provider. In contrast, they argue that mifepristone should be readily available in family medicine practices.

Attorney General James concludes by emphasizing the FDA’s responsibility to follow the science and remove these unnecessary barriers to medication abortion access, stating, ‘New Yorkers, and all Americans, deserve access to this safe, effective, and essential medication without burdensome, unjustified restrictions.’

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