Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 44 of 67 PageID 4466
hand, is defined as “the time during which one or more offspring develops (gestates) inside a woman’s uterus (womb).”[1]
Most readers would not define pregnancy to be a serious or life-threatening illness. Even FDA does not earnestly defend that position. True, complications can arise during pregnancy, and said complications can be serious or life-threatening. But that does not make pregnancy itself an illness. See ECF No 1-13 at 21. And even if the regulation were genuinely ambiguous after exhausting all traditional tools of statutory construction, Defendants’ interpretation: (1) is not reasonable; (2) does not implicate their substantive expertise; and (3) does not reflect fair and considered judgment. Accordingly, Defendants are not entitled to Auer deference on their interpretations of “serious or life-threatening illnesses.” By interpreting Subpart H’s scope as reaching any state or side effect that can be considered an undefined “condition,” Defendants broaden the regulation on accelerated approval of new drugs farther than the text of the regulation would ever suggest. Therefore, FDA’s approval of chemical abortion drugs under Subpart H exceeded its authority under the regulation’s first requirement.
- c. Chemical Abortion Drugs do not provide a “Meaningful Therapeutic Benefit”
FDA also exceeded its authority under the second requirement of Subpart H. In addition to treating a serious or life-threatening illness, chemical abortion drugs must also provide a “meaningful therapeutic benefit” to patients over surgical abortion. 21 C.F.R. § 314.500. As explained, this cannot be the case because chemical abortion drugs do not treat “serious or life-threatening illnesses” — a prerequisite to reaching the second requirement. Id. Similarly, chemical abortion drugs cannot be “therapeutic” because the word relates to the treatment or curing of disease.[2] But even putting that aside, chemical abortion drugs do not provide a meaningful
- ↑ Pregnancy, Wikipedia, https://en.wikipedia.org/wiki/Pregnancy (last visited Mar. 22, 2023).
- ↑ Therapeutic, Dictionary.com, https://www.dictionary.com/browse/illness (last visited Mar. 28, 2023).
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