Whether Cross-Petitioners' challenge to FDA's 2000 mifepristone approval is timely

QUESTIONS PRESENTED In 2000, the U.S. Food and Drug Administration (FDA) approved the drug mifepristone to cause abortions. Central to FDA’s controversial approval was its conclusion that in-person doctor visits and dispensing requirements, gestational limits, and adverse event reporting were crucial to protect women. Beginning in 2016, FDA stripped away those safety measures in violation of the Administrative Procedure Act (APA). The Fifth Circuit rightly held that FDA acted unlawfully in removing those safety measures, and healthcare organizations and doctors harmed by FDA’s actions—oppose FDA’s and Danco Laboratories’ interlocutory petitions in Case Nos. 23-235 and 23-236. As set forth in the Brief in Opposition, the Court should deny those petitions. But if the Court grants review, it should also grant this conditional cross-petition and review FDA’s approval of mifepristone. As Judge Ho explained in dissent, the “challenge to the 2000 approval is timely,” FDA.Pet.App.84a, and “the 2000 approval [is] unlawful,” FDA.Pet.App.89a. The questions presented in this conditional cross-petition are: 1. Whether Cross-Petitioners’ challenge to FDA’s 2000 mifepristone approval is timely. 2. Whether FDA’s 2000 approval of mifepristone under Subpart H, which applies only to drugs that “treat[ ] serious or life-threatening illnesses,” 21 C.F.R. 314.500, and FDA’s subsequent approval of generic mifepristone were unlawful.