Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 41 of 67 PageID 4463
complications or negative psychological experiences arising from pregnancy as “illnesses” is materially different than classifying pregnancy itself as a serious or life-threatening illness per se. Tellingly, FDA never explains how or why a “condition” would not qualify as a “serious or life-threatening illness.” Suppose that a woman experiences depression because of lower back pain that inhibits her mobility. Under FDA’s reading, a new drug used to treat lower back pain — which can cause depression, just like unplanned pregnancy — could obtain accelerated approval under Subpart H.
Defendants cite zero cases reading Subpart H like FDA reads Subpart H. On the contrary, courts have read “serious or life-threatening illnesses” to mean what it says. See, e.g., Tummino v. Hamburg, 936 F. Supp. 2d 162, 182 (E.D.N.Y. 2013) (“Whether an illness is ‘serious or life-threatening’ ‘is based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.’”) (quoting 57 Fed. Reg. at 13235). The preamble to the final rule also clarified the terms “would be used as FDA has defined them in the past.” 57 Fed. Reg. at 13235.
Likewise, the Final Rule expressly stated this nomenclature “is the same as FDA defined and used the terms” in two rulemakings: the first in 1987; the second in 1988. 57 Fed. Reg. at 58,945. In the 1988 rulemaking, FDA defined “life-threatening” to include diseases or conditions “where the likelihood of death is high unless the course of the disease is interrupted (e.g., AIDS and cancer), as well as diseases or conditions with potentially fatal outcomes where the end point of clinical trial analysis is survival (e.g., increased survival in persons who have had a stroke or heart attack).” See 53 Fed. Reg. at 41517; id. at 41516 (referencing “AIDS, cancer, Parkinson’s disease, and other serious conditions”); CSX Transp., Inc. v. Ala. Dep’t of Revenue, 562 U.S. 277, 294 (2011) (the canon of ejusdem generis “limits general terms that follow specific ones to matters
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