Case: 23-10362 Document: 543-1 Page: 49 Date Filed: 08/16/2023
Second, FDA’s formalization of the policy it announced in 2021 does not render this claim moot. At bottom, the mootness doctrine asks whether the court faces a live dispute. Freedom from Religion Found., Inc. v. Abbott, 58 F.4th 824, 831 (5th Cir. 2023). That is, a case is moot if “the parties lack a legally cognizable interest in the outcome.” Id. (quoting Already, LLC v. Nike, Inc., 568 U.S. 85, 91, (2013)).
A live dispute exists as to the 2021 Non-Enforcement Decision. The decision that FDA made in 2021—to permanently not enforce in-person prescription and dispensing requirements—remains in force. FDA may have formalized that policy by modifying the mifepristone REMS. But the effect is the same, as is FDA’s ultimate judgment that mifepristone can be safely used without in-person prescription and dispensing.
Moreover, the Supreme Court has recognized that the government does not moot a controversy when it introduces the final form of a previous, identical policy. Biden v. Texas, 142 S. Ct. 2528, 2544–45 (2022) (considering a prior agency action even after it was formalized by a later, similar action); see All. for Hippocratic Med., 2023 WL 2913725, at *2 n.2. That type of action is different in kind than the repeal or modification of a government policy. Freedom from Religion Found., 58 F.4th at 832. Unlike a repealed policy, FDA’s policy remains unchanged and on the books (albeit in a permanent form). We see no jurisdictional obstacle to reviewing the claim as to the 2021 Non-Enforcement Decision.
2. Merits
Because the 2021 Non-Enforcement claim is not moot, we must proceed to the question of whether that action was arbitrary and capricious. For two reasons, we hold that it likely was. First, FDA gave dispositive weight to adverse-event data in FAERS—despite the uncontested limitations of doing so. Recall that, because of the 2016 Amendments, FDA no longer had access
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