Case 1:23-cv-03026-TOR ECF No. 80 filed 04/07/23 PageID.2182 Page 21 of 31
risks of the drug.” 21 U.S.C. § 355-1(g)(4)(B). Implicit in this assessment is whether the drug’s risks require REMS and/or ETASU. 21 U.S.C. § 355-1(a)(1), (f)(1). Thus, it would be contrary to the plain language of the statute that the agency need not consider arguments that mifepristone’s REMS and ETASU should be removed in whole or part based on criteria under 21 U.S.C. § 355-1(a)(1), (f)(1).
It is not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks without REMS and/or ETASU. That is precisely FDA’s role. However, based on the present record, FDA did not assess whether mifepristone qualifies for REMS and ETASU based on the criteria set forth under 21 U.S.C. § 355-1(a)(1), (f)(1). See ECF No. 51-4. Even under a deferential review, it appears FDA failed to consider an important aspect of the problem. Turtle Island, 878 F.3d at 732. Moreover, the record demonstrates potentially internally inconsistent FDA findings regarding mifepristone’s safety profile. Nat’l Parks Conservation, 788 F.3d at 1141; see, e.g., ECF Nos. 51-5 at 8–9 (“Serious adverse events … are rare” [and] mifepristone “is safe and effective through 70 days gestation.”); 51-9 (approving mifepristone for Cushing’s syndrome without a REMS considering risks of fetal loss).
Therefore, the Court finds there are serious issues going to the merits of Plaintiffs’ APA claims. Cottrell, 632 F.3d at 1131. The Court emphasizes this finding is not binding at a trial on the merits. Univ. of Texas v. Camenisch, 451
ORDER GRANTING IN PART PLAINTIFFS’ MOTION FOR
PRELIMINARY INJUNCTION ~ 21
