Case: 23-10362 Document: 543-1 Page: 43 Date Filed: 08/16/2023
*** For the reasons stated above, we conclude that the claim as to the 2000 Approval is untimely. Consequently, the Medical Organizations and Doctors are not likely to succeed on that claim. And that means that we must vacate the component of the district court’s order that stays the 2000 Approval. Willey v. Harris Cnty. Dist. Att’y, 27 F.4th 1125, 1129 (5th Cir. 2022).
B. 2016 Amendments
In addition to the 2000 Approval claim, which is not likely to succeed, the Medical Organizations and Doctors challenge two other actions taken by FDA: the 2016 Amendments to the mifepristone REMS and the 2021 decision to not enforce regulations requiring in-person prescription. The parties agree that the claims as to the 2016 Amendments and the 2021 Non-Enforcement decision are timely, so we proceed to the merits.
The Medical Organizations and Doctors ground their claims in the Administrative Procedure Act. That law requires federal courts to “hold unlawful and set aside agency action, findings, and conclusions found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.” 5 U.S.C. § 706(2)(A). The Supreme Court has explained that the “arbitrary-and-capricious standard requires that agency action be reasonable and reasonably explained.” FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021). That standard of review is “deferential,” id., but “not toothless.” Sw. Elec. Power Co. v. EPA, 920 F.3d 999, 1013 (5th Cir. 2019).
On the contrary, our review is “searching and careful.” Univ. of Texas M.D. Anderson Cancer Ctr. v. U.S. Dep’t of Health and Hum. Servs., 985 F.3d 472, 475 (5th Cir. 2021) (quoting Marsh v. Or. Nat. Res. Council, 490 U.S. 360, 378 (1989)). Above all, an agency must “examine the relevant data and articulate a satisfactory explanation for its action including a ‘rational connection between the facts found and the choice made.’” Motor Vehicle Mfrs.
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