Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2179 Page 18 of 31
found to be … arbitrary [and] capricious … or otherwise not in accordance with law [or] in excess of statutory … authority, or limitations.” 5 U.S.C. § 706(2)(A), (C). Courts must uphold an agency action unless it (1) “relied on factors which Congress has not intended it to consider,” (2) “entirely failed to consider an important aspect of the problem,” (3) “offered an explanation for its decision that runs counter to the evidence before the agency,” or (4) the “decision is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.” Turtle Island Restoration Network v. U.S. Dep’t of Commerce, 878 F.3d 725, 732–33 (9th Cir. 2017) (internal quotation marks omitted). Additionally, a decision is arbitrary and capricious if it is internally inconsistent with the underlying analysis. Nat’l Parks Conservation Ass’n v. EPA, 788 F.3d 1134, 1141 (9th Cir. 2015). Review is “at its most deferential” regarding an agency’s scientific determinations within its area of expertise. Baltimore Gas & Elec., Co. v. Nat. Res. Def. Council, Inc., 462 U.S. 87, 103 (1982).
Regulations are valid if they are “consistent with the statute under which they are promulgated.” United States v. Larionoff, 431 U.S. 864, 873 (1977). Under the FDCA, a new drug cannot be marketed and prescribed until it undergoes a rigorous approval process to determine that it is safe and effective. 21 U.S.C. § 355. For certain drugs, a risk evaluation and mitigation strategy (REMS) is required when the agency determines, after considering six factors, it is “necessary
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 18
