Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/23

 This injury is also traceable to FDA’s elimination of non-fatal adverse events in the 2016 Major REMS Changes. And it’s redressable by an order vacating those changes. Accordingly, these associations also have standing.

Next we turn to timeliness.

Everyone acknowledges that 28 U.S.C. § 2401(a)’s six-year limitations period applies to all of this case’s challenged actions. And plaintiffs’ right of action against the lion’s share of the challenged actions are squarely within the six-year window. That includes all of plaintiffs’ alternative arguments challenging the 2016 Major REMS Changes, the 2019 Generic Approval, the 2021 Mail-Order Decision, and the 2021 Petition Denial of the 2019 Citizen Petition.

True, FDA’s March 2016 Major REMS Changes were promulgated more than six years before plaintiffs filed suit in November 2022. But Section 2401(a) instructs that the six-year period begins when “the right of action first accrues.” “And ‘[t]he right of action first accrues on the date of the final agency action.’” Texas v. Biden, 20 F.4th 928, 951 n.3 (5th Cir. 2021), rev’d on other grounds, 142 S. Ct. 2528 (2022) (quoting Wash. All. of Tech. Workers v. DHS, 892 F.3d 332, 342 (D.C. Cir. 2018)). Though FDA promulgated the Major REMS Changes in 2016, the Agency didn’t respond to plaintiffs’ 2019 Petition challenging those changes until December 16, 2021. So plaintiffs’ right of action against FDA’s final decision first accrued in December of 2021. See 21 C.F.R. § 10.45. That’s less than a year before plaintiffs sued, which is well within the limitations period.

Next, applicants claim that plaintiffs’ primary challenges to the 2000 Approval and FDA’s 2016 Petition Denial to their 2002 Citizen Petition are time-barred. Though admittedly a close question, we ultimately agree with applicants at this preliminary juncture.