Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2178 Page 17 of 31
conducted a “full review” of REMS, including information about comparator drugs with mifepristone. ECF No. 60 at 7. In 2022, the ACOG and other medical and professional healthcare access organizations petitioned FDA to, in part, eliminate the REMS as medically unnecessary and unduly burdensome for uses of mifepristone, primarily for miscarriage management. ECF Nos. 35 at 47, ¶ 139; 60 at 4; 61-1. FDA rejected ACOG’s citizen petition. ECF No. 35 at 51, ¶ 144.
Based on the information and requests already put forth before FDA, FDA cannot credibly argue that its decision on the Mifepristone REMS Program would change upon another citizen petition. See, e.g., ECF Nos. 51-5 at 22–23 (assessing whether to retain Mifeprex REMS); 61-13 at 2 (chronology of FDA communications). Thus, the Court finds that administrative exhaustion through a citizen petition on the January 2023 REMS would be futile.
- 3. APA Claim
Plaintiffs assert they are likely to succeed on the merits of the claim that the 2023 REMS is contrary to law and arbitrary and capricious under the APA. ECF No. 3 at 19–29.
To obtain injunctive relief, Plaintiff must show that there are “serious questions going to the merits” of its claims or that it is “likely to succeed on the merits.” Cottrell, 632 F.3d at 1131; Farris, 677 F.3d at 865. Under the APA, a court shall “hold unlawful and set aside agency action, findings, and conclusions
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 17
