Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 40 of 67 PageID 4462
treatment plan under the supervision of a physician”). Thus, to satisfy Subpart H, FDA deemed pregnancy a “serious or life-threatening illness[]” and concluded that mifepristone “provide[d] [a] meaningful therapeutic benefit to patients over existing treatments.” See 21 C.F.R. §§ 314.500; 314.560. FDA was wrong on both counts.
- a. Pregnancy is not an “Illness”
Pregnancy is a normal physiological state most women experience one or more times during their childbearing years — a natural process essential to perpetuating human life. Defendants even admit pregnancy is not an “illness.” FDA claims the Final Rule explained Subpart H was available for serious or life-threatening “conditions,” whether or not they were understood colloquially to be “illnesses.” ECF No. 28 at 36. But the Final Rule says no such thing. “One comment asserted that neither depression nor psychosis is a disease, nor is either one serious or life-threatening.” 57 Fed. Reg. 58,946. FDA responded to the comment that “signs of these diseases are readily studied” and that its reference to depression and psychosis “was intended to give examples of conditions or diseases that can be serious for certain populations or in some or all of their phases.” Id. In other words, FDA’s response to this comment was not that depression and psychosis qualify because they are “conditions” even though they are not colloquially understood as “illnesses.” Rather, FDA simply disagreed with the comment’s characterization of these conditions and explained that they were examples of “diseases” that can be “serious.” Nothing in the Final Rule supports the interpretation that pregnancy is a serious or life-threatening illness.
FDA’s 2016 Denial of the 2002 Petition is similarly unpersuasive. For example, FDA noted that approximately fifty percent of pregnancies in the United States are unintended and that unintended pregnancies may cause depression and anxiety. ECF No. 1-28 at 5. But categorizing
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