Case: 23-10362 Document: 543-1 Page: 4 Date Filed: 08/16/2023
tions—which generally loosen the protections and regulations relating to the use of mifepristone—will be stayed during the pendency of this litigation.
Finally, we note that our holding is subject to the prior order of the Supreme Court, which stayed the district court’s order pending resolution of this appeal and disposition of any petition for writ of certiorari. Danco Lab’ys, LLC v. All. for Hippocratic Med., 143 S. Ct. 1075 (2023) (mem.).
I. Background
This case arises under the Federal Food, Drug, and Cosmetic Act and related amendments. 21 U.S.C. ch. 9. The Department of Health and Human Services is charged with responsibility for implementing that law, and has delegated that obligation to FDA, its subagency. Id. § 393. The relevant events center on the particular duty of approving new drugs.
The approval process begins with a new drug application. Id. § 355(a). At this stage, it is the applicant’s burden to prove that the proposed drug is safe and effective. The Act directs FDA to deny a new drug application if, among other reasons, the applicant fails to include tests and data that show that the drug “is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling”; if “any other information” before FDA tends to show that the drug is not safe; or if “there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions for use prescribed, recommended, or suggested in the proposed labeling thereof.” Id. § 355(d); see 21 C.F.R. § 314.125 (regulations expanding on those requirements).
Certain new drug applications may be designated for “accelerated approval.” 21 C.F.R. § 314 subpt. H. This category applies to drugs treating “serious or life-threatening illnesses” and that “provide meaningful therapeutic benefit to patients over existing treatments.” Id. § 314.500. The regulations also require FDA to impose “postmarketing restrictions” where
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