Core Viewpoint - Vanda Pharmaceuticals Inc. is challenging the FDA's approval of two generic versions of its drug Hetlioz®, citing significant flaws in the studies and data presented by the generic manufacturers [2][3]. Group 1: FDA Decision and Vanda's Response - Vanda filed citizen petitions in 2023 against the FDA's approval of the generic drugs, arguing that the approvals were improper due to significant flaws in the studies [2]. - In July 2025, the outgoing CDER director upheld the FDA's decision, suggesting that small studies with limited demographics were sufficient for establishing bioequivalence [3]. - Vanda has requested a review of this decision from FDA Commissioner Martin Makary, emphasizing the need for adherence to legal and evidentiary standards [5]. Group 2: Concerns About Generic Drug Approvals - The decision to approve the generics reflects a concerning bias within the FDA towards generic drug approvals, potentially compromising public health [4]. - The outgoing director accepted data inconsistencies in measuring drug exposure levels, which raised alarms about the validity of the approval process [3]. Group 3: Company Background - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [6].