Case: 23-10362 Document: 543-1 Page: 40 Date Filed: 08/16/2023
52 (5th Cir. 2021), rev’d on other grounds, 142 S. Ct. 2528 (2022). Actually, the opposite is true. FDA took the restrictions imposed in 2000 as a given, and considered only whether the REMS amendments were safe and effective. As explained by the motions panel: “FDA’s 2016 decision to relax many of the REMS was issued in response to Danco’s supplemental application requesting as much.” All. for Hippocratic Med., 2023 WL 2913725, at *13.
The Medical Organizations and Doctors respond that the 2016 Amendments were so significant as to constitute a change to the “basic regulatory scheme,” Nat’l Biodiesel Bd., 843 F.3d at 1017, thereby constructively reopening the 2000 Approval. It is certainly true that the amendments meaningfully altered the conditions under which mifepristone is prescribed and taken. But a regulatory amendment, even a major one, is insufficient to satisfy the reopening doctrine. Nat. Res. Def. Council, Inc. v. EPA, 571 F.3d 1245, 1265–66 (D.C. Cir. 2009); see also Nat’l Ass’n of Reversionary Prop. Owners v. Surface Transp. Bd., 158 F.3d 135, 144–46 (D.C. Cir. 1998); United Transp. Union-Ill. Legis. Bd. v. Surface Transp. Bd., 132 F.3d 71, 76 (D.C. Cir. 1998) (Ginsburg, J.). To meet this high bar and trigger the reopening doctrine, the amendment must fundamentally alter the nature of the regulation such that it “could not have been reasonably anticipated.” Env’t Def. v. EPA, 467 F.3d 1329, 1334 (D.C. Cir. 2006).
The 2016 Amendments do not clear that bar. They do not alter FDA’s basic assumption that mifepristone is safe and effective, subject to certain conditions for use. To be sure, the amendments put the public on notice of a significant change in the degree of mifepristone’s availability and restriction. Disagreement with that decision would support challenging the new amendments—and that is exactly what the Medical Organizations did. But as to mifepristone’s approval per se, the 2016 Amendments tell the public nothing they did not already know. As before, FDA approved a drug that chemically induces abortion, with the knowledge that the drug causes medi-
40
