Case: 23-10362 Document: 543-1 Page: 44 Date Filed: 08/16/2023
Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (quoting Burlington Truck Lines v. United States, 371 U.S. 156, 168 (1962)). An agency violates these rules where it “entirely fail[s] to consider an important aspect of the problem,” or offers “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.; see also Michigan v. EPA, 576 U.S. 743, 752 (2015); Mexican Gulf Fishing Co. v. U.S. Dep’t of Com., 60 F.4th 956, 971 (5th Cir. 2023); Sw. Elec. Power Co., 920 F.3d at 1018–19 (explaining that courts must set aside agency action where there are “shortcomings in the agency’s explanations”).
With those standards in mind, we first address the 2016 Amendments and hold that the Medical Organizations and Doctors are substantially likely to succeed on the merits of that claim. Byrne, 847 F.3d at 1133. That is so for two instances of the same defect: failing to consider an important aspect of the problem. Michigan, 576 U.S. at 752; State Farm, 463 U.S. at 43.
First, FDA did not consider the cumulative effect of the 2016 Amendments. Those changes include: increasing the maximum gestational age from forty-nine days to seventy days; allowing non-physicians to prescribe mifepristone; removing the requirement that the administration of misoprostol and the subsequent follow-up appointment be conducted in person; eliminating prescribers’ obligation to report non-fatal adverse events; switching the method of administration for misoprostol from oral to buccal; and changing the dose of mifepristone (600 mg to 200 mg) and misoprostol (400 mcg to 800 mcg). FDA Summary Review of 2016 Amendments at 2.
FDA admits that none of the studies it relied on examined the effect of implementing all of those changes together. It studied the amendments individually. FDA Medical Review of 2016 Amendments at 32–38 (Mar. 29, 2016) (gestational age); id. at 38–41 (in-person appointments); id. at 43–44
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