The attorneys general from New York, California, Massachusetts, and New Jersey have collectively urged the U.S. Food and Drug Administration (FDA) to relax certain restrictions surrounding the accessibility of mifepristone, commonly known as the “abortion pill.” In their petition, the states advocate for the FDA to eliminate the medication’s risk evaluation and mitigation strategies (REMS), including the Prescriber Certification, Pharmacy Certification, and the Patient Agreement form, describing these measures as “unnecessary, duplicative, and burdensome.” This request reflects wider debates over reproductive rights and regulatory measures governing pharmaceuticals.
Notably, mifepristone received FDA approval over two decades ago. Following an exhaustive scientific assessment, it was deemed safe for terminating pregnancies up to 70 days of gestation. During the COVID-19 pandemic, the medication’s accessibility was broadened, allowing patients to receive it via mail, although other regulatory constraints remained intact.
REMS, a strategy employed by the FDA, aims to ensure that a drug’s benefits surpass its potential risks. Generally, REMS is applied to certain drugs where specific safety measures are deemed necessary, and mifepristone has been subject to such a program. The FDA, in its evaluation framework, emphasizes ensuring prescribers are adequately qualified, certified pharmacies handle its dispensation, and patients are well-informed about potential complications (FDA).
The attorneys general argue that mifepristone’s associated fatality rate—reported as a mere 0.00048 percent over 25 years—is negligible, with no deaths directly attributable to the drug alone. They stress that the REMS requirements do not pertain to any “specific risk” of mifepristone and assert that these decisions should rest in the hands of healthcare professionals rather than federal agencies. Further, the states argue the current regulatory framework represents unnecessary intervention (JURIST).
This move is part of a broader response to what some view as restrictive measures from previous federal administrations. Recently, Attorney General Letitia James spearheaded a 20-state coalition urging the American Medical Association to ease certification requirements linked to reproductive health and gender-affirming care (Press Release).