Case: 23-10362 Document: 543-1 Page: 60 Date Filed: 08/16/2023
FDA or Danco took some action to violate it. But of course, we have absolutely no reason to believe that such a motion would be necessary. And we should reiterate that the Supreme Court’s stay of the district court’s order will remain in effect pending disposition of any petition for certiorari.
Turning to Danco’s objection to a stay, we do not agree that the Medical Organizations and Doctors will be limited to remand without vacatur if they obtain a favorable judgment. “[V]acatur of an agency action is the default rule in this Circuit.” Cargill v. Garland, 57 F.4th 447, 472 (5th Cir. 2023) (en banc) (plurality op.); Data Mktg. P’ship, 45 F.4th at 859; accord United Steel v. Mine Safety & Health Admin., 925 F.3d 1279, 1287 (D.C. Cir. 2019) (“The ordinary practice is to vacate unlawful agency action.”). Given that presumption, remand without vacatur is appropriate only if “there is at least a serious possibility that the agency will be able to substantiate its decision given an opportunity to do so.” Texas v. United States, 50 F.4th 498, 529 (5th Cir. 2022) (quoting Texas Assn. of Mfrs. v. U.S. Consumer Prod. Safety Comm’n, 989 F.3d 368, 389–90 (5th Cir. 2021)); accord Radio-Television News Dirs. Ass’n v. FCC, 184 F.3d 872, 888 (D.C. Cir. 1999).
Remand without vacatur is likely not appropriate because “it is far from certain” that FDA could cure its mistakes with further consideration. Env’t Def. Fund v. FERC, 2 F.4th 953, 976 (D.C. Cir. 2021). FDA erred by failing to consider the cumulative effects of the 2016 Amendments on mifepristone’s safety and by disregarding the lack of recent data on adverse events when removing the in-person dispensing requirement. The record does not tend to show that FDA would have arrived at the same decision if it had considered those things. See Oglala Sioux Tribe v. U.S. Nuclear Regul. Comm’n, 896 F.3d 520, 536 (D.C. Cir. 2018) (declining to remand without vacatur because of the “seriousness” of the action’s “deficiency”); Pollinator Stewardship Council v. EPA, 806 F.3d 520, 532 (9th Cir. 2015) (same); cf. Sierra Club v. FERC, 68 F.4th 630, 652 (D.C. Cir. 2023) (remanding without vacatur be-
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