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independent review that far exceeded the issues raised in the 2019 Citizen Petition.
Especially because the dangerousness of a drug is grounds to withdraw its approval, see 21 U.S.C. § 355(e)—and REMS are required to “ensure that the benefits of the drug outweigh the risks,” id. § 355-1(a)(1)–(2)—plaintiffs reasonably argue that FDA’s 2021 “full review” of the entire REMS Program was in effect a reconsideration of FDA’s 2000 Approval. Indeed, plaintiffs might very well prevail on that claim later in this litigation. But at this early juncture—and in light of our necessarily truncated review—we are not yet confident enough to say that viewed in “the entire context,” FDA “has undertaken a serious, substantive reconsideration of the [2000 Approval]” rather than “incremental adjustments to existing regulations.” Texas v. Biden, 20 F.4th at 952–93 (quotation omitted).
The result is the same under the second reopening test. Recall that under the second test, “[a] constructive reopening occurs if the revision of accompanying regulations significantly alters the stakes of judicial review as the result of a change that could have not been reasonably anticipated.” Sierra Club, 551 F.3d at 1025 (quotation omitted).
Sierra Club is the seminal case. In 1994, EPA adopted a rule that exempted major sources of air pollution from the Clean Air Act’s emission standards during startups, shutdowns, and malfunctions (the “SSM exemption”). Id. at 1022. But the 1994 rule also required sources to develop an SSM plan in order to receive the benefit of the SSM exemption. Ibid. An SSM plan required “the source to demonstrate how it will do its reasonable best to maintain compliance with the standards, even during SSMs.” Ibid. (quotation omitted). SSM plans were publicly available and were incorporated into the sources’ permits under Title V of the Clean Air Act. Ibid.
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