Case: 23-10362 Document: 543-1 Page: 75 Date Filed: 08/16/2023
even if the ancien régime of 2000 “may not have been” on its own. Kennecott Utah Copper Corp., 88 F.3d at 1227.
Indeed, the FDA itself has characterized the switch from one regime to the other as a “sea change.” NRDC, 571 F.3d at 1266. Under the limited stay issued by a previous panel of our court, the FDA was required to return to the regulatory regime that existed between 2000 and 2016. See Alliance, 2023 WL 2913725, at *1. The FDA vigorously protested the substitution of the 2016 and 2021 regime with the original 2000 regulations. It urged the Supreme Court to restore the 2016 and 2021 regulations by granting a stay of the entire district court order. Switching back to the 2000 restrictions, it argued, would “upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority.” FDA Stay Application, 2023 WL 3127519, at *3. It would “unleash[] regulatory chaos” for “patients, prescribers, and the health care delivery system.” Id. at *2, *4.
In sum, the FDA insisted that switching from one regime to the other would “change the basic regulatory scheme.” NRDC, 571 F.3d at 1266. It claimed that switching from the 2016/2021 scheme back to the 2000 scheme counts as a sweeping change with huge stakes. The same must be true of switching from 2000 to 2016/2021—that too “upend[ed] the regulatory regime for mifepristone, with sweeping consequences.”
Plaintiffs’ challenge to the 2000 approval of mifepristone is timely.
III.
Turning to the merits, I would hold the 2000 approval unlawful. It’s a longstanding principle that agencies must follow their own regulations. See Arizona Grocery Co. v. Atchison, Topeka & Santa Fe Ry. Co., 284 U.S. 370, 386 (1932) (agency’s legislative rule “has the force of a statute”); Fort Stewart Schools v. FLRA, 495 U.S. 641, 654 (1990) (“It is a familiar rule of
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