Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 42 of 67 PageID 4464
similar to those specified”) (internal marks omitted). Therefore, “diseases” and “conditions” are used interchangeably, and even “conditions” must be “serious” or “life-threatening” as defined.
Food and Drug scholars have understood Subpart H’s scope the same way. See, e.g., Charles Steenburg, The Food and Drug Administration’s Use of Postmarketing (Phase IV) Study Requirements: Exception to the Rule?, 61 Food & Drug L.J. 295, 323 (2006) (Subpart H “extend[s] only to drugs and biological products that target[] ‘serious or life-threatening illnesses’ and offer[] a ‘meaningful’ benefit over existing treatments”). Even the Population Council argued to FDA that “the imposition of Subpart H is unlawful” because “[t]he plain meaning of these terms does not comprehend normal, everyday occurrences such as pregnancy and unwanted pregnancy.” ECF No. 1-14 at 21. This reading is also consistent with the fact that aside from mifepristone, FDA had approved fewer than forty NDAs under Subpart H by early 2002. See id. at 20. And of those other approvals, twenty were for the treatment of HIV and HIV-related diseases, nine were for the treatment of various cancers and their symptoms, four were for severe bacterial infections, one was for chronic hypertension, and one was for leprosy. Id. “One of these things is not like the others, one of these things just doesn’t belong.” See Sesame Street.
- b. Defendants are not entitled to Auer Deference
Courts sometimes extend Auer deference “to agencies’ reasonable readings of genuinely ambiguous regulations.” Kisor v. Wilkie, 139 S. Ct. 2400, 2408 (2019). Auer deference is rooted in an “always rebuttable” presumption “that Congress would generally want the agency to play the primary role in resolving regulatory ambiguities.” Id. at 2412. “Auer deference is sometimes appropriate and sometimes not.” Id. at 2408. “First and foremost, a court should not afford Auer deference unless the regulation is genuinely ambiguous.” Id. at 2415. “And before concluding that a rule is genuinely ambiguous, a court must exhaust all the traditional tools of construction.” Id.
42
