Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/50

 Defendants maintain “there is no legal basis for Plaintiffs’ contention that the approved conditions of use of a drug must duplicate the protocol requirements for the clinical trials supporting its approval.” ECF No. 28 at 35. But FDA’s actions must not be arbitrary and capricious. See 5 U.S.C. § 706(2)(A); United States v. An Article of Device … Diapulse, 768 F.2d 826, 832–33 (7th Cir. 1985) (concluding FDA’s denial was not arbitrary and capricious because the proposed labeling did not “specify conditions of use that are similar to those followed in the studies”). “The scope of review under the arbitrary and capricious standard is narrow and a court is not to substitute its judgment for that of the agency.” ''Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co.'', 463 U.S. 29, 43 (1983) (internal marks omitted). “Nevertheless, 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.” Id. (internal marks 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”). Courts must “consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment.” Id. (internal marks 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.” Id. Defendants fail this test.