Case: 23-10362 Document: 543-1 Page: 55 Date Filed: 08/16/2023
FDA also points to the “disruptive practical effects” of a stay, FDA Br. at 66–67, arguing that it will incur substantial costs if it complies with the stay order, only for the order to be reversed later. As a preliminary matter, this argument is also highly duplicative of the merits. FDA’s injury only comes into play if the stay order is vacated—that is, if the Medical Organizations and Doctors are not likely to succeed on the merits. After careful consideration, we have concluded that these claims are likely to succeed. Accordingly, we do not consider the costs that might be incurred if the stay order goes into effect and is later vacated. Moreover, we doubt whether an agency’s interim compliance costs could outweigh a threat of irreparable harm. See Al Otro Lado v. Wolf, 952 F.3d 999, 1008 (9th Cir. 2020).
Turning to Danco’s interest, we acknowledge that the district court’s stay order would impose significant injury. See Texas v. EPA, 829 F.3d 405, 434 (5th Cir. 2016) (explaining that financial harm may be irreparable “where the loss threatens the very existence of the [party’s] business”) (quoting Wis. Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985)). That threat, however, is substantially lessened because we vacate the component of the stay order that would pause FDA’s initial approval of mifepristone in 2000.
What remains is any injury that Danco will face as a result of the stay order as amended. The Medical Organizations and Doctors point out that Danco already has drug labels and documentation that comply with the mifepristone REMS as of 2011. Danco does not deny this, but responds that “[r]equiring a return to a prior and outdated REMS and label would also create months-long loss of access, while FDA and Danco work through the sNDA process.” Danco Br. at 61 (citing Declaration of Dr. Janet Woodcock ¶ 14). But this potential injury is greatly diminished by the fact that the Supreme Court’s stay of the district court’s order will remain in effect pending disposition of any petition for certiorari.
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