23-10362
C.
Next exhaustion. Stay applicants contend they are likely to succeed on the merits because plaintiffs failed to exhaust their claims before FDA. We disagree.
“As a general rule, claims not presented to the agency may not be made for the first time to a reviewing court.” Wash. Ass’n for Television & Child. v. FCC, 712 F.2d 677, 680 (D.C. Cir. 1983); cf. United States v. L.A. Tucker Truck Lines, 344 U.S. 33, 37 (1952). For challenges to FDA actions, the general administrative exhaustion requirement is codified at 21 C.F.R. § 10.45(b). Section 10.45(b) states that a “request that the [FDA] Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a petition submitted under § 10.25(a).” See id. § 10.25(a) (“An interested person may petition the [FDA] Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.”).
No one disputes that every argument the plaintiffs raised in their 2019 Citizen Petition is exhausted. That includes all of plaintiffs’ challenges to the 2016 Major REMS Changes and everything fairly embraced by those challenges. For example, the 2019 Citizen Petition argued explicitly that FDA should “[c]ontinue limiting the dispensing of Mifeprex to patients in clinics, medical offices, and hospitals.” FDA Add. 193, 209–16. When FDA rejected that request in the 2021 Petition Denial, it expressly reaffirmed its commitment to mail-order abortion drugs. As such, plaintiffs have properly exhausted their challenge to FDA’s by-mail distribution regime by raising it in the 2019 Citizen Petition.
Even if plaintiffs failed to exhaust their claims, courts retain “discretion to waive exhaustion” where one of the “traditionally
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