Overview
- The FDA confirmed on Friday, June 5, 2026 that it has launched a retrospective safety study of mifepristone that will analyze hundreds of thousands of real-world cases.
- Agency officials say the review will take about six months, could yield interim findings in July, and is being paced to provide an October update to a Louisiana court.
- The study will use existing FDA drug-safety surveillance systems and the agency may hire an outside contractor to acquire and analyze additional data.
- Public-health groups and researchers point to hundreds of studies and more than 7.5 million users over decades that show mifepristone is safe and effective.
- Anti-abortion groups and some Republican lawmakers pushed the review and say its findings could justify reinstating in-person dispensing rules that would reduce mail and telehealth access, with consequences for patients in states that restrict abortion.