Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/73

 original scheme is now much more “worth challenging.” Id. at 1026 (quotation omitted).

Plaintiffs’ challenge to the 2000 approval easily satisfies the reopening doctrine. Both the 2016 and 2021 revisions made significant and unexpected alterations to the basic regulatory scheme. They took away key safeguards, significantly raising the stakes of judicial review for the underlying approval.

When it approved mifepristone in 2000, the FDA included a number of “necessary safeguards” to minimize harm from this dangerous drug. Sierra Club, 551 F.3d at 1025. For example, the FDA required an in-person follow-up appointment to protect the woman from sepsis, which occurs if the child’s remains are not removed from her body after the abortion. See FDA Approval Memorandum to Population Council at 3 (Sep. 28, 2000). It also limited the use of mifepristone to the first seven weeks, ensuring that the abortion took place early in pregnancy. See id. at 1. And it required a physician to supervise the administration of mifepristone, in order to “date pregnancies and diagnose ectopic pregnancies.” Id. at 5. See also id. at 6 (same).

The 2016 amendments removed these key safeguards. By approving the abortifacient for use up to ten weeks, by allowing non-physicians to prescribe and administer the drug, and by removing the in-person follow-up requirement, the 2016 revisions significantly altered the stakes of judicial review. “These are not mere ‘minor changes.’” Sierra Club, 551 F.3d at 1025. By modifying its original restrictions, the FDA constructively reopened the drug’s approval.

The 2016 amendments became final in 2021, when the FDA denied the 2019 Petition challenging them. See 21 C.F.R. § 10.45(d). Plaintiffs’ challenge is therefore timely.