District Court Decisions Regarding Approval and Regulation of Mifepristone by the U.S. Food and Drug Administration

On April 7, 2023, a judge in Texas ruled that the U.S. Food and Drug Administration’s initial authorization of mifepristone was improper and the drug should no longer be approved in the U.S. A separate decision in a multistate lawsuit was released later the same day by a District Court in Washington barring the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.” Both rulings have equal standing.

The federal government is appealing the Texas decision, which disregards more than two decades of robust scientific and medical evidence, as well as real world experiences, relating to mifepristone, the first of two medicines in the FDA-approved medication abortion regimen. Studies by Gynuity Health Projects and many others have consistently shown high effectiveness, safety, and acceptability.

Gynuity Health Projects has always viewed mifepristone abortion as a revolutionary technology with the potential to increase autonomy and choice in the reproductive realm. Our position remains unchanged.

Dr. Beverly Winikoff, founder and president of Gynuity Health Projects, was part of the team at the Population Council that worked on the registration of mifepristone in the U.S. in 2000, and has spent over three decades working to ensure safe abortion access in the U.S. and many other parts of the world.

The Resources section of our website includes articles published in peer-reviewed journals that testify to the safety and efficacy of medication abortion.