Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/77

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Case: 23-10362 Document: 543-1 Page: 77 Date Filed: 08/16/2023

To be sure, pregnancy can sometimes result in illness. Cf. Spees v. James Marine, Inc., 617 F.3d 380, 397 (6th Cir. 2010) (“Pregnancy-related conditions have typically been found to be impairments where they are not part of a ‘normal’ pregnancy.”). But that does not make the pregnancy itself an illness. See Whitaker, 180 F. Supp. 2d at 929 (“pregnancy per se does not constitute a serious health condition”).

The same could be said about old age. Many people become ill as they grow older. But growing older itself is obviously not an illness. Like pregnancy, it’s the “natural consequence” of a healthy and functioning body. It’s entirely normal to celebrate pregnancies, just as it’s normal to celebrate birthdays. We don’t typically celebrate “bad or unhealthy conditions.”

So pregnancy does not qualify as a “serious or life-threatening illness” within the meaning of 21 C.F.R. § 314.500. The FDA implausibly “determined” that it does. FDA Approval Memorandum to Population Council at 6. Courts do not defer to agency interpretations of unambiguous regulations. See Kisor v. Wilkie, 139 S. Ct. 2400, 2415 (2019). There’s “only one reasonable construction” of the word “illness”—and it doesn’t include pregnancy. Id.

There is accordingly no basis for deferring to the agency. The FDA simply got it wrong. As even the sponsor of mifepristone, the Population Council, admitted, “[n]either pregnancy nor unwanted pregnancy is an illness, and Subpart H is therefore inapplicable for that reason alone.” Population Council Letter to FDA at 1–2. “The plain meaning of these terms does not comprehend normal, everyday occurrences such as pregnancy and unwanted pregnancy.” Id. at 2.

B.

The FDA does not even try to argue that pregnancy is an “illness.” Instead, the FDA, along with intervenor Danco, points out that the preamble

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