23-10362
court’s removal of mifepristone from the market. The applicants make no arguments as to why the 2016 Major REMS Changes, the 2019 Generic Approval, or the 2021 and 2023 Mail Order Decisions are similarly critical to the public even though they were on notice of plaintiffs’ alternative requests for relief. And it would be difficult for applicants to argue that the 2016 Major REMS Changes and subsequent FDA activity were so critical to the public given that the Nation operated—and mifepristone was administered to millions of women—without them for sixteen years following the 2000 Approval.
The applicants have made some showing that the public interest warrants equitable relief from the district court’s treatment of the 2000 Approval. Motivated in part by the accelerated posture of our review, we credit their showing.
D.
The parties vehemently dispute how their competing interpretations of the Comstock Act of 1873 might impact the validity of the district court’s order. The Comstock Act prohibits the carriage in interstate commerce of “any drug, medicine, article, or thing designed, adapted or intended for producing abortion.” 18 U.S.C. § 1462. It similarly prohibits the mailing of any “article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion.” Id. § 1461.
Both statutory provisions specify a mens rea of “knowingly.” Id. §§ 1461–62. The plain text does not require that a user of the mails or common interstate carriage intend that an abortion actually occur. Rather, a user of those shipping channels violates the plain text merely by knowingly making use of the mail for a prohibited abortion item.
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