Particle.news

Download on the App Store

Four States Petition FDA to Remove Mifepristone Restrictions

The petition contends that FDA safety rules dating to the pill’s approval create medically unnecessary barriers for patients outside metropolitan areas.

Sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
Boxes of Mifepristone, the first pill in a medical abortion, are seen at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 9, 2024. REUTERS/Evelyn Hockstein/File Photo
Attorney General Letitia James on May 8, 2025, in Valhalla, New York.

Overview

  • The attorneys general of California, New York, Massachusetts and New Jersey filed a regulatory petition to strip mifepristone of requirements under its Risk Evaluation and Mitigation Strategy program.
  • The states argue prescriber certification, patient agreement forms and pharmacy certification mandates now lack scientific justification given the pill’s 25-year safety record.
  • Their filing follows a directive from Health and Human Services Secretary Robert F. Kennedy Jr. to have FDA Commissioner Marty Makary review mifepristone’s safety based on newly cited adverse event data.
  • Republican lawmakers and conservative groups point to a recent study alleging higher complication rates, but reproductive health researchers have dismissed the report as methodologically flawed.
  • In parallel, seventeen additional Democratic-led states and Washington, D.C., are suing the FDA in Spokane, Washington, to further loosen restrictions on the abortion pill.