Case: 23-10362 Document: 543-1 Page: 76 Date Filed: 08/16/2023
administrative law that an agency must abide by its own regulations.”). The FDA violated that principle when it approved mifepristone under Subpart H—as even the drug’s sponsor, the Population Council, admitted in 2000.
A.
Subpart H authorizes the FDA to approve only those drugs that treat “serious or life-threatening illnesses.” 21 C.F.R. § 314.500. See also 57 Fed. Reg. 58958 (Dec. 11, 1992) (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses). It “applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.” 21 C.F.R. § 314.500 (emphasis added).
Pregnancy is not an illness. An “illness” is a “[b]ad or unhealthy condition of the body.” Oxford English Dictionary (2nd ed. 1989), s.v. illness, sense 3. It’s a “disease, ailment, sickness, malady.” Id. Pregnancy, by contrast, is when a woman is “with child.” Oxford English Dictionary, s.v. pregnancy, sense II.3.a.
Pregnancy is not a bad or unhealthy condition of the body—it’s a natural consequence of a healthy and functioning reproductive system. See, e.g., Gudenkauf v. Stauffer Communications, Inc., 922 F. Supp. 465, 473 (D. Kan. 1996) (“Being the natural consequence of a properly functioning reproductive system, pregnancy cannot be called an impairment.”); Lacount v. South Lewis, 2017 WL 319217, at *3 (N.D. Okla. Jan. 20, 2017) (same); Whitaker v. Bosch Braking Sys. Div. of Robert Bosch Corp., 180 F. Supp. 2d 922, 928 (W.D. Mich. 2001) (pregnancy is “not a serious health condition”); Brennan v. National Telephone Directory Corp., 850 F. Supp. 331, 343 (E.D. Pa. 1994) (“it cannot be said that [a woman’s] reproductive system is negatively affected” by pregnancy).
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