Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 50 of 67 PageID 4472
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.[1] 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.
- ↑ Plaintiffs also frame what the Court characterized as the “study-match problem” as a statutory violation of the FFDCA. See ECF No. 7 at 22. The Court does not read 21 U.S.C. § 355(d) as necessarily requiring an exact “match” between trial conditions and the conditions on the approved labeling of a new drug. But Section 355(d) does mandate the Secretary “issue an order refusing to approve the application” if he finds the investigations do not show the drug is safe for use under the suggested conditions in the proposed labeling. FDA made such a finding yet did not deny the Application. See ECF No. 1-24 at 6 (“We have concluded that adequate information has not been presented to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.”). Thus, even if Defendants could survive “arbitrary and capricious” analysis of the “study-match problem,” Defendants still violated Section 355(d) on their own terms.
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