Tuesday, April 11, 2023

FDA Seeks Stay Pending Appeal of Order Ending Approval of Mifepristone

The Justice Department on behalf of the U.S. Food and Drug Administration yesterday filed an Emergency Motion for a Stay Pending Appeal (full text of motion) in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, (5th Cir., filed 4/10/2023). The motion seeks a stay while an appeal is heard by the 5th Circuit of a Texas federal district court decision setting aside the 2000 FDA order approving doctors prescribing mifepristone for medical abortions. The FDA argues in part:

The [district] court repeatedly characterizes mifepristone as unsafe. But over the last two decades, the available evidence conclusively demonstrates that mifepristone is safe under the approved conditions of use. More than five million women have used mifepristone to terminate their pregnancies in the United States.... Mifepristone is also approved in dozens of other countries..... The literature reflects “exceedingly rare” rates of serious adverse events.

AP reports on the appeal.