On November 7, 2023, the Department of Justice ("DOJ") and Danco Laboratories ("Danco"), the distributor of mifepristone, filed briefs in opposition to Alliance for Hippocratic Medicine's ("Alliance") Conditional Cross-Petition for a Writ of Certiorari requesting that the U.S. Supreme Court dismiss a challenge brought forth by Alliance. See, https://www.shipmangoodwin.com/insights/abortion-opponents-seek-full-supreme-court-review-of-fifth-circuit-holding.html.
Alliance, in its legal argument sought to invoke a legal doctrine known as the "reopening" doctrine to circumvent the statute of limitations issue which initially rendered their challenge untimely. This doctrine allows for an otherwise untimely challenge to proceed if the agency reconsiders its former decision. Alliance asserted that the Federal Drug Administration's ("FDA") actions in 2016 and 2021 effectively reopened the 2000 approval of Mifeprex, thereby resetting the statute of limitations. However, the Fifth Circuit rejected this argument, concluding that the reopening doctrine did not apply.
The DOJ and Danco argue that Alliance's challenge to the 2000 approval was untimely, and have requested that the U.S. Supreme Court dismiss the challenge. Specifically, in its brief, Danco contends that Alliance's request does not align with legal precedent and addresses a question that "no court has addressed." See, Danco's Brief in Opposition, page 20. Moreover, Danco maintains that even if the reopening doctrine is valid, it does not apply to the FDA's actions concerning Mifeprex. Id. at page 14. The arguments presented by the DOJ and Danco emphasize that neither express nor constructive "reopening" amount to a substantive reconsideration of the 2000 approval. Id. at page 16.
As it stands, the U.S. Supreme Court's decision to take up or reject this case will be a pivotal moment in the ongoing debate over reproductive rights and drug regulation.
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