Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/41

 complications in a definite percentage of women. We cannot say that the amendments “significantly alter[ed] the stakes of judicial review” so as to allow the Medical Organizations and Doctors to challenge the 2000 Approval sixteen years after the fact. Sierra Club, 551 F.3d at 1025.

The Medical Organizations and Doctors also contend that FDA reopened the 2000 Approval when it denied their 2019 citizen petition. They emphasize the agency’s use of the phrase “full review,” and argue that FDA actively questioned whether mifepristone was safe.

The record does not bear out that claim. To start, the citizen petition did not actually ask FDA to reconsider its approval of mifepristone; it requested that FDA “restore” previous restrictions and “retain” others currently in place. 2019 Citizen Petition at 1, 2. So FDA had no reason to reevaluate mifepristone from the ground up. Turning to the denial itself, FDA did not reexamine its prior approval. It certainly described its action as “a full review of the Mifepristone REMS Program,” 2021 Denial Letter at 6, but the letter’s context shows that the agency reviewed the conditions for use that the citizen petition had put at issue—not mifepristone’s underlying approval.

Nor did FDA constructively reopen the 2000 Approval by adopting a significant amendment to the mifepristone REMS. As with the 2016 Amendments, removing the in-person dispensing requirement does not change the basic concept of allowing women to use mifepristone. Nat’l Biodiesel Bd., 843 F.3d at 1017. Between an “incremental adjustment[]” to the 2000 Approval and a “substantive reconsideration” of it, the decision to allow remote prescription and dispensing of mifepristone looks more like the former. Texas, 20 F.4th at 953, 952 (citations omitted). And so if the reopening doctrine is a valid exception to the statute of limitations, and we are not sure that it is, that doctrine does not apply here because neither the 2016 Amendments nor