23-10362
days. See 21 C.F.R. § 10.30(e)(2). Instead of timely responding, FDA responded to plaintiffs’ first petition fourteen years after it was filed. And it responded to the second petition over two years after it was filed. FDA plainly and repeatedly refused to follow its own regulations here. Even assuming any of plaintiffs’ challenges were unexhausted and that it wasn’t futile to raise them before FDA, FDA’s repeated failure to follow its own regulations indicates that the district court did not abuse its “discretion to waive exhaustion.” Wash. Ass’n for Television & Child., 712 F.2d at 681.
D.
As applicants recognize, FDA’s actions are constrained by the APA’s arbitrary-and-capricious standard. See 5 U.S.C. § 706(2)(A). Under that standard, “the 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. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (quotation omitted); see also Sw. Elec. Power Co. v. EPA, 920 F.3d 999, 1013 (5th Cir. 2019) (judicial review of agency action “is not toothless”). We must “consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment.” State Farm, 463 U.S. at 43 (quotation omitted). An agency’s action is “arbitrary and capricious” if it “entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.” Ibid.
When an agency acts, it must “reasonably consider[] the relevant issues and reasonably explain[]” its actions. FCC v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021); see also ibid. (“The APA’s arbitrary-and-capricious standard requires that agency action be reasonable and reasonably
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