Case: 23-10362 Document: 543-1 Page: 79 Date Filed: 08/16/2023
“illness.” And Subpart H plainly contemplates the narrow sense, because it uses “condition” interchangeably with “illness.” A regulation about “cars” doesn’t cover bicycles just because its preamble sometimes mentions “vehicles.” Likewise, a regulation about “illnesses” doesn’t address pregnancy just because its preamble sometimes mentions “conditions.”[1]
C.
The agency’s brief proclaims that “FDA Properly Approved Mifepristone Under Subpart H.” Yet in the very next paragraph, the FDA turns around and denies that it used Subpart H to approve mifepristone—claiming that the approval was “based on FDA’s statutory authority under 21 U.S.C. § 355, not Subpart H.”
As the panel majority opinion details, Subpart H encompasses two different paths. The first is entitled “Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.” 21 C.F.R. § 314.510 (emphasis omitted). The second is entitled “Approval with restrictions to assure safe use.” 21 C.F.R. § 314.520 (emphasis omitted).
Mifepristone was approved under § 314.520 of Subpart H—approval with restrictions. But the FDA now suggests that § 314.520 isn’t really a method of approval at all—it’s just a method of adding restrictions on use.
This argument is belied by the regulations. The header explicitly refers to this second path as a method of “[a]pproval.” Id. § 314.520. More
- ↑ Danco responds by citing a Government Accountability Office report, which observes that the FDA has used Subpart H to approve drugs for treating “breakthrough cancer pain, specific symptoms of narcolepsy, and severe acne.” GAO, Approval and Oversight of the Drug Mifeprex at 10 (Aug. 2008). “Severe recalcitrant nodular acne” may well be a serious illness. Id. at 44. But that has nothing to do with whether pregnancy is a serious or life-threatening illness.
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