Case: 23-10362 Document: 543-1 Page: 61 Date Filed: 08/16/2023
cause it was possible that FERC could “adequately explain its decision” if given another opportunity). If the Medical Organizations and Doctors succeed on the merits, it is likely that the default remedy—vacatur—will be appropriate. And the temporary version of vacatur is a stay.
We are also unpersuaded by FDA’s contentions. First, FDA argues Medical Organizations and Doctors cannot seek a stay before the district court because they failed to seek one from the agency. But the record shows that FDA would have denied any request for an administrative stay. See Gulf Restoration Network v. Salazar, 683 F.3d 158, 176 (5th Cir. 2012). FDA unequivocally denied the 2019 citizen petition, rejecting the premise that 2016 Amendments made mifepristone less safe. It discussed the 2021 Non-Enforcement Decision in the same document, and then formalized the policy in 2023. These pronouncements show that FDA was committed to implementing these changes, and foreclose any notion that the agency would have granted an administrative stay. Tesoro Refin. & Mktg. Co. v. FERC, 552 F.3d 868, 874 (D.C. Cir. 2009) (explaining that the exhaustion requirement does not apply “when resort to administrative remedies [would be] clearly useless”) (citations omitted). That FDA denied a request to stay the 2000 Approval further aids this conclusion. See 2016 Denial Letter at 32 (“As described above, we are denying your Petition. Therefore, your request for a stay pending final action on your Petition is moot.”).
Second, FDA provides no authority for its assertion that § 705 of the APA limits stays to contemporaneous agency actions. The text does not provide such a limitation. Instead, it empowers a reviewing court to “issue all necessary and appropriate process to postpone the effective date of an agency action or to preserve status or rights pending conclusion of the review proceedings.” 5 U.S.C. § 705. Circuit courts have interpreted this statute as providing something akin to the general stay power recognized by Rule 18 of the Federal Rules of Appellate Procedure, see Ohio v. Nuclear Regul. Comm’n,
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