23-10362
had concluded that “the in-person dispensing requirement is no longer necessary.” FDA Add. 842.
Finally, in January 2023, FDA approved a modified REMS for mifepristone lifting the in-person dispensing requirement. See REMS Single Shared System for Mifepristone 200 mg (Jan. 2023), https://perma.cc/MJT5-35LF (the “2023 Mail-Order Decision”).[1]
C.
In November 2022, plaintiffs (physicians and physician organizations) filed this suit against FDA, HHS, and a several agency heads in the official capacities. Plaintiffs first challenged FDA’s 2000 Approval of the drug. But they also requested multiple grounds of alternative relief for FDA’s subsequent actions. Immediately after filing, plaintiffs moved for a preliminary injunction ordering FDA to withdraw or suspend (1) FDA’s 2000 Approval and 2019 Generic Approval, (2) FDA’s 2016 Major REMS Changes, and (3) FDA’s 2021 Mail-Order Decision and its 2021 Petition Denial of the 2019 Citizen Petition. If that’s confusing, we hope this chart helps:
- ↑ Danco suggests the 2023 Mail-Order Decision moots part of plaintiffs’ claims. See Danco Stay App. 22. We disagree. The Supreme Court has explicitly instructed this court to review a new agency action finalized after litigation commenced and while the appeal was pending because this decision was a “final agency action” for purposes of 5 U.S.C. § 704. Biden v. Texas, 142 S. Ct. 2528, 2544-45 (2022) (quotation omitted).
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