FDA launches six‑month safety review of mifepristone

The U.S. Food and Drug Administration is moving forward with a safety study of the abortion medication mifepristone, a review that has sparked intense debate over its scientific necessity and political motivations. The study, confirmed by senior agency officials, is expected to take approximately six months, with interim results potentially available in July.

The FDA stated it has been actively working on a science-based review for months. An agency spokesperson said any reporting suggesting the study is just beginning is false or based on a misunderstanding of how complex scientific safety studies work. Officials described the review as a retrospective analysis of hundreds of thousands of cases using existing drug-safety surveillance systems, with the potential involvement of a contractor.

Mifepristone, first approved by the FDA in 2000, is used in combination with another drug, misoprostol, to terminate early pregnancies. The agency currently states on its website that the pill is safe and effective for its indicated use. According to reproductive health researchers, more than 7.5 million people have used the medication over the past 25 years for abortion and miscarriage care.