Case: 23-10362 Document: 543-1 Page: 45 Date Filed: 08/16/2023
(prescription by non-physician). And some clinical trials considered “multiple changes.” FDA Summary Review of 2016 Amendments at 5–9. But FDA neither considered the effects as a whole, nor explained why it declined to do so. The cumulative effect of the 2016 Amendments is unquestionably an important aspect of the problem; indeed, that was the whole point of FDA’s action. Because FDA failed to seek data on the cumulative effect, and failed to explain why it did not, its decision to approve the amendments was likely arbitrary and capricious. Michigan, 576 U.S. at 752; State Farm, 463 U.S. at 43; Sw. Elec. Power Co., 920 F.3d at 1019.
FDA and Danco defend the 2016 Amendments, asserting that FDA is not required to conduct a study that perfectly mirrors the conditions under which the drug will be used. That is true, so far as it goes. Indeed, the APA gives agencies discretion “in determining whether a study is adequate and well controlled.” FDA Br. at 43 (quoting Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 621 n.17 (1973)).
But Defendants attack a rule that is not at issue. The problem is not that FDA failed to conduct a clinical trial that included each of the proposed changes as a control. It is that FDA failed to address the cumulative effect at all. At a minimum, the agency needed to acknowledge the question, determine if the evidence before it adequately satisfied the concern, and explain its reasoning. See All. for Hippocratic Med., 2023 WL 2913725, at *17 (“[FDA] relied on zero studies that evaluated the safety-and-effectiveness consequences of the 2016 Major REMS Changes as a whole. This deficiency shows that FDA failed to consider ‘an important aspect of the problem’ when it made the 2016 Major REMS Changes.”) (quoting Michigan, 576 U.S. at 752). FDA did not do those things, and so likely violated the APA.
The second important aspect that FDA failed to consider is whether it needed to continue to collect data of non-fatal adverse events in light of the
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