Overview

• HHS Secretary Robert F. Kennedy Jr. has directed the FDA to conduct a full review of mifepristone regulations, citing new safety data from a contested study.
• The study by the Ethics & Public Policy Center claims a 10.93% rate of serious adverse events, a figure significantly higher than FDA-approved labeling indicates.
• The analysis has faced criticism from medical experts for being unreviewed and for mischaracterizing complications such as ectopic pregnancies and procedural follow-ups.
• Anti-abortion groups are leveraging the study to push for reinstating restrictions, including bans on telemedicine prescriptions and limiting use to seven weeks of pregnancy.
• The FDA, under Commissioner Marty Makary, will evaluate the data to determine if changes to mifepristone labeling or access protocols are warranted.