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framework” and whether the agency has “work[ed] a change that [plaintiffs] could not have reasonably anticipated.” Nat’l Biodiesel Bd., 843 F.3d at 1017.
Under Sierra Club and its progeny, FDA’s 2016 Major REMS Changes and 2021 Petition Denial seemingly reopened its 2000 Approval decision. Of course, FDA did not expressly reconsider its mifepristone approval. But it eliminated the “necessary safeguards,” Sierra Club, 551 F.3d at 1025, that had accompanied and limited the impact of that approval for two decades. The in-person dispensing requirement, for example, was critical to FDA’s initial approval of mifepristone in 2000, which relied on the in-person dispensing requirement to dismiss concerns about provider qualifications, improper use, illicit distribution, and detection of adverse events. See PI App. 519–23. And the in-person dispensing requirement was also the cornerstone of the REMS for mifepristone that FDA approved in 2011 and then relied on in its 2016 rejection of plaintiffs’ 2002 Citizen Petition. See PI App. 578–82, 605, 608.
Thus FDA’s elimination of the in-person distribution requirement—not to mention various other REMS—arguably worked a “sea change” in the legal framework governing mifepristone distribution that plaintiffs “could not have reasonably anticipated” and that “significantly alters the stakes of judicial review.” Nat’l Biodiesel Bd., 843 F.3d at 1017 (quotation omitted). That’s because the in-person dispensing requirement was FDA’s primary tool for ensuring the safe distribution and use of mifepristone, so plaintiffs arguably had little reason to anticipate this important change before 2021. FDA does not argue otherwise, appearing to concede that its 2021 announcement was a stark departure from previous regulatory approaches. And because this change eliminates a major safeguard against complications and adverse effects arising from improper mifepristone use, it can be said to “significantly alter[] the stakes of judicial review” for plaintiff doctors who treat patients with these complications. Ibid. (quotation omitted).
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