Page:Washington v. U.S. Food and Drug Administration (Order on Motion for Clarification, Apr. 13, 2023).pdf/2

 BEFORE THE COURT are Defendants’ Motion for Clarification and Motion to Expedite. ECF Nos. 81 and 82. The Court has reviewed the record and files herein and is fully informed.

On April 7, 2023, this Court ordered that Defendants are preliminary enjoined from altering the status or rights of the parties under the operative Mifepristone REMS Program until a determination on the merits.

According to Defendants’ motion: "[T]he United States District Court for the Northern District of Texas entered an order invoking 5 U.S.C. § 705 to stay the approval of the new drug application and abbreviated new drug application for mifepristone. See Alliance for Hippocratic Medicine v. FDA, 2:22-cv-00223-Z, Dkt. 137 (Apr. 7, 2023). That court stayed its order for seven days to give FDA time to seek relief from the United States Court of Appeals for the Fifth Circuit, and FDA is seeking an emergency stay pending appeal. But if the Texas district court’s order takes effect, the order would—of its own force and without any further action by FDA—stay the effectiveness of FDA’s prior approvals of mifepristone nationwide. See id."

ECF No. 81 at 2–3.