Case: 23-10362 Document: 543-1 Page: 71 Date Filed: 08/16/2023
That standard is easily met here. It seems obvious that the 2016 and 2021 revisions significantly altered the regulatory landscape. Indeed, the FDA recently told the Supreme Court that setting aside those revisions would “upend the regulatory regime for mifepristone” and “unleash[] regulatory chaos.” Application to Stay the Order Entered by the United States District Court for the Northern District of Texas and for An Administrative Stay, 2023 WL 3127519, at *2–3, FDA v. Alliance for Hippocratic Medicine, 143 S. Ct. 1075 (2023). If switching from the 2016/2021 regime to the 2000-era regime significantly alters the “basic regulatory scheme,” NRDC, 571 F.3d at 1266, then surely the reverse does, too.
So the district court was correct that “FDA’s 2016 and 2021 Changes … significantly departed from the agency’s original approval of the abortion regimen. FDA … altered its original decision by removing safeguards and changing the regulatory scheme for chemical abortion drugs.” Alliance for Hippocratic Medicine v. FDA, _ F. Supp. 3d _, 2023 WL 2825871, at *11 (N.D. Tex. Apr. 7, 2023). As a result, the 2016 and 2021 revisions triggered the reopening doctrine. Plaintiffs’ challenge to the 2000 approval is timely.
A.
Challenges to federal administrative action are subject to a six-year statute of limitations. See 28 U.S.C. § 2401(a). This six-year clock initially started ticking in March 2016, when the FDA denied Plaintiffs’ 2002 petition objecting to the 2000 approval. See 21 C.F.R. § 10.45(d). Absent reopening, Plaintiffs’ challenge to the 2000 approval would be barred by this six-year statute of limitations, because Plaintiffs filed this suit after March 2022.
But under the administrative reopening doctrine, the agency can restart the clock in two ways: (1) if “the agency opened the issue up anew, and then reexamined and reaffirmed its prior decision,” NRDC, 571 F.3d at 1265 (cleaned up), or (2) “if the revision of accompanying regulations
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