Overview

• On June 2, FDA Commissioner Marty Makary wrote to Senator Josh Hawley pledging a full agency review of mifepristone’s safety data and regulatory framework.
• HHS Secretary Robert F. Kennedy Jr. formally instructed the FDA to reevaluate all mifepristone regulations in response to new safety claims.
• Mifepristone has been FDA-approved since 2000 and is used in nearly two-thirds of U.S. abortions with an adverse event rate below 1%, according to agency records.
• A study by the Ethics and Public Policy Center asserts that severe complications occur at rates up to 22 times higher than FDA data indicate, reporting more than one in ten serious outcomes.
• Ongoing lawsuits are challenging telemedicine prescriptions and mail delivery of the pill, with some courts considering reinstating in-person dispensing requirements.