Case: 23-10362 Document: 543-1 Page: 58 Date Filed: 08/16/2023
be clear, the evidence does not show that mifepristone is unsafe in all applications. But on this record and at this preliminary stage, the Medical Organizations and Doctors have made a substantial showing that the 2016 Amendments and 2021 Non-Enforcement Decision were taken without sufficient consideration of the effects those changes would have on patients.
Weighing all of these considerations, we conclude that the balance of the equities favors the Medical Organizations and Doctors. They face a substantial risk of irreparable harm to their medical practice, mental and emotional health, and conscience. The limited relief affirmed by our judgment threatens neither FDA nor Danco with substantial harm. Nor does it offend the public interest. The Medical Organizations and Doctors therefore satisfy the remaining preliminary-injunction factors. Winter, 555 U.S. at 20.
V. Form of Relief
Finally, FDA and Danco challenge the form of the relief entered by the district court—a stay of the actions’ effective dates. FDA argues that the Medical Organizations and Doctors were required to first seek an administrative stay, but failed to do so. See 21 C.F.R. § 10.45(c) (“A request that administrative action be stayed must first be the subject of an administrative decision based upon a petition for stay of action … before a request is made that a court stay the action.”). It also contends that § 705 authorizes only requests made at the same time the challenged action is enacted. Here, by contrast, the Medical Organizations and Doctors seek a stay years after the relevant policies took effect. And Danco maintains that injunctive relief is categorically unavailable, reasoning that if the Medical Organizations and Doctors prevailed, they would only be entitled to remand without vacatur.
We hold that the district court entered an appropriate form of relief. To begin, consider the nature of a “stay” under § 705. In the same way that a preliminary injunction is the temporary form of a permanent injunction, a
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