Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/53

 decision. Courts must set aside agency action where there are “shortcomings in the agency’s explanations” or where “[n]o record evidence affirmatively makes” the agency’s case. ''Sw. Elec. Power Co., 920 F.3d at 1018–19; see also State Farm'', 463 U.S. at 56 (“While [an] agency is entitled to change its view … it is obligated to explain its reasons for doing so.”). That is the case here.

In the face of concededly limited data, and lacking more probative information from prescribers, FDA fell back on studies that were merely “not inconsistent” with its intended conclusion. It did not refer to any literature that affirmatively supported the notion that mifepristone would remain safe and effective even without the in-person dispensing requirement. We conclude that the Medical Organizations and Doctors are likely to succeed in showing that this action violated the APA.

We now proceed to the remaining steps of the preliminary-injunction analysis. First, we ask if the Medical Organizations and Doctors are likely to sustain irreparable harm absent an injunction. Garcia, 910 F.3d at 190. If so, we then balance the equities and consider whether an injunction serves the public interest. Winter, 555 U.S. at 20. And where the government appeals an injunction, its interests “merge” with the public interest. Tex. Democratic Party v. Abbott, 961 F.3d 389, 412 (5th Cir. 2020) (quoting Veasey v. Abbott, 870 F.3d 387, 391 (5th Cir. 2017)).

We have already concluded that the Medical Organizations and Doctors are likely to sustain injury; now we need only determine whether the threatened injuries are irreparable. They are. An irreparable harm is one