Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2175 Page 14 of 31
licensure requirements. ECF Nos. 3 at 29–30; 60 at 7–10 (citations to the record omitted).
Plaintiffs have shown a reasonably probable threat to their economic interests in the form of unrecoverable costs that are fairly traceable to the 2023 REMS, which are allegedly in violation of the APA. See California v. Azar, 911 F.3d 558, 571–73 (9th Cir. 2018) (finding state had standing due to economic interests where state was responsible for reimbursing women who will seek contraceptive care through state-run programs). Therefore, Plaintiffs have established standing.
- 2. Administrative Exhaustion
Defendants contend Plaintiffs failed to exhaust their administrative remedies by not filing a citizen petition under the 2023 REMS. ECF No. 51 at 14–19. Plaintiffs maintain that a new citizen petition would be futile where FDA had the same information and arguments prior to the January 2023 REMS decision. ECF No. 60 at 4–7.
Under the APA, “[a] person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof.” 5 U.S.C. § 702. However, the APA requires a plaintiff to “exhaust available administrative remedies before bringing their grievances to federal court.” Idaho Sporting Congress, Inc. v.
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 14
