Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/24

 Plaintiffs’ right of action against the 2000 Approval and 2016 Petition Denial first accrued on March 29, 2016—the date FDA issued its final decision rejecting their 2002 Petition challenging the 2000 Approval. See 21 C.F.R. § 10.45. But plaintiffs didn’t file suit until November 18, 2022, more than six months beyond the statute of limitations. The district court nevertheless found timely the plaintiffs’ challenges to the 2000 Approval and the 2016 Petition Denial. How? First, the district court held that FDA “reopened” those decisions in 2016 and 2021, thus restarting the statute of limitations. Second—and alternatively—the district court decided plaintiffs were entitled to equitable tolling.

We consider each justification in turn.

First, reopening. “The reopen[ing] doctrine allows an otherwise untimely challenge to proceed where an agency has—either explicitly or implicitly—undertaken to reexamine its former choice.” ''Nat’l Biodiesel Bd. v. EPA'', 843 F.3d 1010, 1017 (D.C. Cir. 2016) (quotation omitted). Put simply, the purpose of the reopening doctrine is “to pinpoint an agency’s final action in cases where the agency has addressed the same issue multiple times.” Texas v. Biden, 20 F.4th at 951. The limitations period runs from the agency’s earlier decision unless the later decision “opened the issue up anew.” Ibid. (quotation omitted). This makes good sense: Because a key step in the timeliness inquiry is determining when an agency action became final, it’s sometimes necessary to determine whether an agency’s subsequent action “actually reconsidered” its former action, Growth Energy v. EPA, 5 F.4th 1, 21 (D.C. Cir. 2021) (per curiam) (quotation omitted), or merely “reaffirm[ed] its prior position,” Sierra Club v. EPA, 551 F.3d 1019, 1024 (D.C. Cir. 2008) (quotation omitted); see also Texas v. Biden, 20 F.4th at 951 (“If the agency opened the issue up anew, and then reexamined and reaffirmed its prior decision, the agency’s second action (the reaffirmance) is reviewable. … But if the agency merely reaffirmed its decision without