23-10362
The applicants’ principal defense against the Comstock Act is that FDA was not required to consider it. After all, say the applicants, 21 U.S.C. §§ 355 and 355-1 guide FDA’s discretion over drug approval and REMS, and those statutes do not explicitly require consideration of other statutes like 14 U.S.C. § 1462.
Even assuming that’s true, however, the Comstock Act nevertheless undermines applicants’ showing on the final three Nken factors. For example, if the Comstock Act is construed in-line with its literal terms, then Danco cannot say it is irreparably harmed by the district court’s order, because Danco has no interest in continuing to violate the law, which (under a plain view of the Act) it does every time it ships mifepristone. For further example, if the Comstock Act is strictly understood, then applicants may lose the public interest prong entirely, because there is no public interest in the perpetuation of illegality. See Louisiana v. Biden, 55 F.4th 1017, 1035 (5th Cir. 2022).
The applicants raise other defenses. For example, they argue that the Food and Drug Administration Amendments Act, Pub. L. No. 110-85, 121 Stat. 823 (2007) (“FDAAA”) sub silentio repealed the Comstock Act, at least where mifepristone is concerned. That’s because the FDAAA in 2007 created a statutory framework governing REMS and drugs with then-existing distribution restrictions. See id. § 909(b). Mifepristone was one such drug. So, say applicants, the FDAAA acted to legalize shipment of mifepristone, regardless of what the Comstock Act might say. But “repeals by implication are not favored.” Maine Cmty. Health Options v. United States, 140 S. Ct. 1308, 1323 (2020) (quotation omitted). We regard each of Congress’s statutes as effective unless either “intention to repeal” one of them is “clear and manifest” or the two laws are “irreconcilable.” Ibid. (quotation omitted). Section 909(b) did not expressly legalize mifepristone; agency action (not statute) did that. Section 909(b)’s brief text makes no mention of
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