Case: 23-10362 Document: 543-1 Page: 80 Date Filed: 08/16/2023
importantly, the regulatory text repeatedly refers to § 314.520 as a method of drug approval. See id. § 314.530(a) (“new drugs approved under … 314.520”); id. § 314.530(b) (“an application approved under … § 314.520”); id. § 314.560 (“drug products approved under § 314.520”).
The FDA’s argument contradicts not only the text, but also its own statements over the past 23 years. See Chenery, 318 U.S. at 95; Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29, 50 (1983) (“[C]ourts may not accept appellate counsel’s post hoc rationalizations for agency action.”).
In its original 2000 approval memo, the FDA expressly stated that “[t]his drug is being approved under Subpart H.” FDA Approval Memorandum to Population Council at 8. And it has repeatedly reaffirmed this view in the years since. See FDA Supplemental Approval Letter to Danco Labs at 1 (June 6, 2011) (application “approved under the provisions of 21 CFR 314.520 (Subpart H)”); FDA Letter Denying 2002 Citizen Petition at 2 (Mar. 29, 2016) (“The application was approved under 21 CFR part 314, subpart H.”); FDA Letter Denying 2019 Citizen Petition at 2 (Dec. 16, 2021) (same).
The GAO report cited by both the FDA and Danco likewise repeatedly describes mifepristone as having been “approved” under Subpart H. GAO, Approval and Oversight of the Drug Mifeprex at 1 (Aug. 2008) (“FDA approved the drug under a provision of the agency’s Subpart H regulations.”); id. at 5 (“FDA approved Mifeprex under the restricted distribution provision of its Subpart H regulations.”); id. at 6 (FDA “approved the Mifeprex [application] under Subpart H.”). See also id. at 10, 14–15, 21–24, 32, 44 (same). The report also notes that the FDA used Subpart H to “approve” other drugs. See id. at 5 n.13, 25 n.46, 27 n.50, 29 n.53, 36 n.63. And it explicitly refers to § 314.520 as an “approval provision.” Id. at 1 n.2.
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