Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/19

Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 19 of 67 PageID 4441

This includes Plaintiffs’ challenges to: (1) the 2000 Approval and FDA’s 2016 Response to the 2002 Petition challenging that approval; (2) the 2019 Generic Approval; and (3), the April 2021 letter. As for FDA’s December 2021 Response to the 2019 Petition, Defendants maintain review is limited to the narrow issues presented in the 2019 Petition — which did not include arguments concerning the Comstock Act. Id. at 27–28.^[1] The Court disagrees with each of these arguments.

1. FDA “Reopened” its Decision in 2016 and 2021

FDA’s final decision on a citizen petition constitutes “final agency action” under the APA. 21 C.F.R. § 10.45(c). Challenges to agency actions have a six-year statute of limitations period. See 28 U.S.C. § 2401(a). Therefore, the statute of limitations for challenging the 2000 Approval began running on March 29, 2016 — the date of FDA’s denial of the 2002 Petition. Because the 2016 Denial of the 2002 Petition occurred more than six years before Plaintiffs filed this suit, Defendants argue the challenge is untimely. ECF No. 28 at 26. But if “the agency opened the issue up anew, and then reexamined and reaffirmed its prior decision,” the agency’s second action — rather than the original decision — starts the limitations period. See Texas v. Biden, 20 F.4th 928, 951 (5th Cir. 2021), rev’d in part on other grounds, 142 S. Ct. 2528 (2022).

The reopening doctrine arises “where an agency conducts a rulemaking or adopts a policy on an issue at one time, and then in a later rulemaking restates the policy or otherwise addresses the issue again without altering the original decision.”^[2] Wash. All. of Tech. Workers v. U.S. Dep’t of Homeland Sec., 892 F.3d 332, 345 (D.C. Cir. 2018); see also Nat’l Biodiesel Bd. v. EPA, 843 F.3d 1010, 1017 (D.C. Cir. 2016) (“The reopener doctrine allows an otherwise untimely challenge

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1. The Court refers to the 2000 Approval, the 2016 Changes and denial of the 2002 Petition, and the 2019 Generic Approval collectively as FDA’s “Pre-2021 Actions.” Similarly, the Court refers to FDA’s April 2021 letter and December 2021 Response as FDA’s “2021 Actions.”
2. Courts have even applied the doctrine where agencies decide not to engage in rulemaking and then revisit and reaffirm that decision. See Pub. Citizen v. Nuclear Regul. Comm’n, 901 F.2d 147, 152 (D.C. Cir. 1990).

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