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• The petition challenges the FDA’s Risk Evaluation and Mitigation Strategy rules as outdated hurdles that limit access in primary care settings and rural communities.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.