Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/64

, Circuit Judge, concurring in part and dissenting in part:

The Constitution vests “the authority to regulate abortion” in “the people and their elected representatives.” Dobbs v. Jackson Women’s Health Org., 142 S. Ct. 2228, 2279 (2022). Congress has enacted a number of laws that affect the regulation of abortion, including the Administrative Procedure Act and the Comstock Act. Those laws dictate the outcome in this case.

Congress has conferred significant regulatory power on administrative agencies such as the FDA. In exchange, Congress has enacted the APA to ensure that agency action is subject to meaningful judicial review. It requires courts to “hold unlawful and set aside agency action” that we determine to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A).

That’s precisely what occurred here. Plaintiffs challenge the FDA’s approval of mifepristone in 2000, as well as its 2016 and 2021 revisions to its mifepristone regulations. I agree with the panel majority that the FDA’s 2016 and 2021 revisions to its mifepristone regulations must be set aside as arbitrary and capricious under the APA. I would add that the FDA’s initial approval of mifepristone in 2000 also violates the agency’s own rules and thus must be set aside under the APA as well.

The FDA approved mifepristone under its Subpart H regulations. But Subpart H only authorizes the FDA to approve drugs that “treat[] serious or life-threatening illnesses.” 21 C.F.R. § 314.500. And pregnancy is plainly not an illness. So it was unlawful for the FDA to approve mifepristone under Subpart H. To quote the Population Council, the entity that sought FDA approval of mifepristone in 2000: “Neither pregnancy nor unwanted pregnancy is an illness, and Subpart H is therefore inapplicable for that reason alone.” Population Council Letter to FDA at 1–2 (Sep. 6, 2000).