Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2176 Page 15 of 31
Rittenhouse, 305 F.3d 957, 965 (9th Cir. 2002) (citing 5 U.S.C. § 704). Administrative exhaustion allows “the administrative agency in question to exercise its expertise over the subject matter and to permit the agency an opportunity to correct any mistakes that may have occurred during the proceeding, thus avoiding unnecessary or premature judicial intervention into the administrative process.” Buckingham v. Secretary of U.S. Dept. of Agr., 603 F.3d 1073, 1080 (9th Cir. 2020) (internal citation omitted). While the APA does not mandate a process by which a plaintiff must exhaust remedies, the APA provides for exhaustion “to the extent that it is required by statute or by agency rule as a prerequisite to judicial review.” Darby v. Cisneros, 509 U.S. 137, 153 (1993).
As relevant here, the FDA created a regulatory mechanism by which interested persons may challenge agency activities under the Food, Drug, and Cosmetic Act (“FDCA”). See 21 C.F.R. §§ 10.1(a), 10.25(a), 10.45(b). “An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action …. in the form of a citizen petition.” 21 C.F.R. § 10.25(a). “A request that the Commissioner take … administrative action must first be the subject of a final administrative decision based upon a petition submitted under § 10.25(a) … before any legal action is filed in a court complaining of the action or failure to act.” 21 C.F.R. § 10.45(b). The purpose of administrative exhaustion is
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 15
