Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 67 of 67 PageID 4489
Accordingly, the Court hereby STAYS the effective date of FDA’s September 28, 2000, Approval of mifepristone and all subsequent challenged actions related to that approval — i.e., the 2016 Changes, the 2019 Generic Approval, and the 2021 Actions. This Court acknowledges that its decision in Texas v. Biden has been appealed to the Fifth Circuit. See 2:21-CV-067-Z, ECF No. 184 (Feb. 13, 2023). If the Fifth Circuit reverses this Court’s Section 705 analysis, the Court clarifies that it alternatively would have ordered Defendants to suspend the chemical abortion approval and all subsequent challenged actions related to that approval until the Court can render a decision on the merits.
- Conclusion
For the foregoing reasons, the Court GRANTS the Motion IN PART. FDA’s approval of mifepristone is hereby STAYED. The Court STAYS the applicability of this opinion and order for seven (7) days to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit.
SO ORDERED.
April 7, 2023
MATTHEW J. KACSMARYK
UNITED STATES DISTRICT JUDGE
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