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explained.”); Michigan v. EPA, 576 U.S. 743, 750, 752 (2015) (“[A]gency action is lawful only if it rests on a consideration of the relevant factors” and “important aspect[s] of the problem.” (quotation omitted)). Of course, we cannot “substitute” our “own policy judgment for that of the agency.” Prometheus, 141 S. Ct. at 1158. We nonetheless must still carefully ensure that “the agency has acted within a zone of reasonableness and, in particular, has reasonably considered the relevant issues and reasonably explained the decision.” Ibid. The upshot is that we “must set aside any action premised on reasoning that fails to account for ‘relevant factors’ or evinces ‘a clear error of judgment.’” Univ. of Tex. M.D. Anderson Cancer Ctr. v. HHS, 985 F.3d 472, 475 (5th Cir. 2021) (quoting Marsh v. Or. Nat. Res. Council, 490 U.S. 360, 378 (1989)).
Here, applicants have failed to carry their burden at this preliminary stage to show that FDA’s actions[1] were not arbitrary and capricious. We have two principal concerns in that regard. First, FDA failed to “examine the relevant data” when it made the 2016 Major REMS changes. State Farm, 463 U.S. at 43. That’s because FDA eliminated REMS safeguards based on studies that included those very safeguards. FDA Add. 59, 122–23, 171. Imagine that an agency compiles studies about how cars perform when they have passive restraint systems, like automatic seatbelts. See State Farm, 463 U.S. at 34–36. For nearly a decade, the agency collects those studies and continues studying how cars perform with passive safety measures. Then one day the agency changes its mind and eliminates passive safety measures based only on existing data of how cars perform with passive safety measures. Cf. id. at 47–
- ↑ Here we limit our discussion to FDA’s decisions in the 2016 Major REMS Changes and its subsequent agency actions. As described above in Part III.B, it appears at this preliminary juncture that plaintiffs’ challenges to the 2000 Approval and 2016 Petition Denial are untimely.
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