Case: 23-10362 Document: 543-1 Page: 78 Date Filed: 08/16/2023
to Subpart H uses the terms “illness,” “disease,” and “condition” interchangeably. See, e.g., 57 Fed. Reg. 58942, 58948 (“The drug in question must be for a serious or life-threatening condition.”). So they argue that Subpart H allows the FDA to approve drugs that treat life-threating conditions, as well as life-threating illnesses. And although pregnancy is plainly not an “illness,” the argument goes, pregnancy is at least a “condition.”
There are two problems with this argument. First, we do not use preambles to expand the meaning of clear regulatory text. See District of Columbia v. Heller, 554 U.S. 570, 578 n.3 (2008) (“[I]n America ‘the settled principle of law is that the preamble cannot control the enacting part of the statute in cases where the enacting part is expressed in clear, unambiguous terms.’”); Antonin Scalia & Bryan A. Garner, {{sc|Reading Law}] 218 (2012) (“[T]he prologue cannot give words and phrases of the dispositive text a meaning that they cannot bear.”).
Second, this argument—that the preamble broadens “illness” to include “conditions”—equivocates between two distinct meanings of the word “condition.” As used in the preamble, “condition” means a “defective state of health.” Merriam-Webster’s Collegiate Dictionary (11th ed. 2007), s.v. condition, sense 4c. In this sense, “condition” is a synonym of “illness.” See Merriam-Webster’s Collegiate Thesaurus (1988), s.v. condition, sense 6 (listing “disease,” “aliment,” and “sickness” as synonyms of “condition”).
Of course, “condition” can also mean “a state of being” more broadly. Merriam-Webster’s Collegiate Dictionary, s.v., condition, sense 4a. And pregnancy is certainly a “condition” in this broader sense.
But the fact that pregnancy is a “condition” in the broad sense of “state of being” does not make it a “condition” in the narrow sense
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