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Democratic-Led States Petition FDA to Remove Mifepristone Restrictions

The petition argues that decades-old FDA safeguards have become medically unnecessary obstacles to care during the agency’s safety review of the abortion pill.

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
© Anna Moneymaker/Getty Images

Overview

  • Attorneys general of California, New York, Massachusetts and New Jersey filed a citizen petition urging the FDA to drop prescriber certification, patient agreement and pharmacy tracking requirements for mifepristone.
  • The petition challenges the FDA’s Risk Evaluation and Mitigation Strategy rules as outdated hurdles that limit access in primary care settings and rural communities.
  • Mifepristone has a 25-year safety record and is used in more than half of U.S. abortions, with telehealth prescriptions and mail delivery allowed since 2021.
  • The FDA is conducting a safety review of the pill at Health and Human Services Secretary Robert F. Kennedy Jr.’s request following a contested non-peer-reviewed study.
  • Under federal procedures, the FDA must respond to the petition within 180 days and petitioners may seek reconsideration or pursue judicial review if their request is denied.