Case: 23-10362 Document: 543-1 Page: 37 Date Filed: 08/16/2023
tinguish between branded and generic mifepristone. FDA Br. at 9 (“The same REMS covers both versions of mifepristone.”). As such, the generic version will be available under the same conditions as Mifeprex.
III. Merits
Having concluded that the Medical Organizations and Doctors have standing except as to the 2019 Generic Approval, we now turn to the merits of the district court’s stay order. That inquiry involves the traditional four-factor test for a preliminary injunction. To merit relief, a movant must show: (1) a substantial likelihood of success on the merits, (2) a substantial threat of irreparable harm, (3) that the threat of injury outweighs any harm that an injunction would cause, and (4) that the public interest is not disserved by an injunction. Garcia v. Jones, 910 F.3d 188, 190 (5th Cir. 2018).
In reviewing those factors, we review legal conclusions de novo and findings of fact for clear error. Jones v. Tex. Dep’t of Crim. Just., 880 F.3d 756, 759 (5th Cir. 2018). The parties agree that these preliminary-injunction factors apply even though the district court entered a stay under 5 U.S.C. § 705. That is so because a stay has the practical effect of an injunction. 28 U.S.C. § 1292(a); see All. for Hippocratic Med., 2023 WL 2913725, at *3 n.3; accord Colorado v. EPA, 989 F.3d 874, 883 (10th Cir. 2021) (“These four factors also determine when a court should grant a stay of agency action under section 705 of the APA.”).
The first question is whether the Medical Organizations and Doctors have shown a substantial likelihood of success on the merits. At the outset, we note that “substantial” does not mean “certain.” Byrne v. Roemer, 847 F.2d 1130, 1133 (5th Cir. 1988) (explaining that “the movant need not always show a probability of success on the merits”) (quoting Celestine v. Butler, 823 F.2d 74, 77 (5th Cir. 1987)); see Jefferson Cmty. Health Care Ctrs., Inc. v. Jefferson Parish, 849 F.3d 615, 626 (5th Cir. 2017) (“Though there is no partic-
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