Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Apr. 12, 2023).pdf/42

 mifepristone at all. So, there is no “irreconcilable” conflict. And we hesitate to find “clear and manifest” intention to repeal a 150-year-old statute that Congress has otherwise repeatedly declined to alter in the far reaches of a single section of the cavernous FDAAA.

Failing all else, the applicants argue that the Comstock Act does not mean what it says it means. Or rather, that judicial gloss and lax enforcement over the past century act to graft relevant exceptions onto it. The applicants rely on a memo authored by the Office of Legal Counsel to press this position. See FDA Add. 258–78. That memo’s thorough exploration of this topic notes that a variety of aging out-of-circuit opinions and a single footnote within one Supreme Court dissent favor the applicants’ position. FDA Add. 262–68) [sic].

The speed of our review does not permit conclusive exploration of this topic. To the extent the Comstock Act introduces uncertainty into the ultimate merits of the case, that uncertainty favors the plaintiffs because the applicants bear the burden of winning a stay. See Landis, 299 U.S. at 255. Since plaintiffs already prevail on most Nken factors concerning most of the agency items effectively enjoined by the district court’s order, we need not definitively interpret the Comstock Act to resolve this stay application.

As the stay applicants, defendants bear the burden of showing why “extraordinary circumstances” demand that we exercise discretion in their favor. To the extent the defendants make any such showing, they do so only with respect to the 2000 Approval—not the plaintiffs’ alternative arguments challenging FDA’s 2016 Major REMS Changes and all subsequent actions. Our decision to grant partial relief does not reflect our view on any merits question. The defendants’ motions to stay the district court’s order are GRANTED IN PART and DENIED IN PART. The appeal is EXPEDITED to the next available Oral Argument Calendar.