Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2177 Page 16 of 31
to prevent “premature interference with agency processes, so that the agency may function efficiently and so that it may have an opportunity to correct its own errors, to afford the parties and the courts the benefit of its experience and expertise, and to compile a record which is adequate for judicial review.” Tamosaitis v. URS Inc., 781 F.3d 468, 478 (9th Cir. 2017).
Under exceptional circumstances, administrative exhaustion of an APA claim is not required. See Anderson v. Babbitt, 230 F.3d 1158, 1164 (9th Cir. 2000). Exceptional circumstances include where there is “objective and undisputed evidence” of administrative bias rendering pursuit of an administrative remedy futile. Id. (brackets omitted); see also SAIF Corp./Oregon Ship v. Johnson, 908 F.2d 1434, 1441 (9th Cir. 1990). Thus, where it appears the agency’s position is “already set” and it is “very likely” what the result would be, such recourse is futile. El Rescate Legal Servs., Inc. v. Exec. Off. of Immigr. Rev., 959 F.2d 742, 747 (9th Cir. 1991) (citation omitted); see also Chinook Indian Nation v. Zinke, 326 F. Supp. 3d 1128, 1144 (W.D. Wash. 2018) (“There is virtually no chance that requiring Plaintiffs to go through [agency’s] formal request process will make any difference.”).
In 2020, fifteen Plaintiff States asked FDA to eliminate the REMS patient agreement and certification requirements as “onerous and medically unnecessary” and received a form response from FDA. ECF No. 60 at 5. In 2021, FDA
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 16
