Mapping U.S. responses to the 2023 cisplatin shortage: A timeline analysis of policy and regulatory action
Description
Introduction: Drug shortages in the United States are a growing public health challenge, with implications for patient care. Cisplatin, a widely used chemotherapy drug, entered a critical shortage in early 2023 following FDA inspection-related production halts at a major overseas manufacturer. The shortage disrupted cancer care and prompted a rapid sequence of regulatory and policy responses. While national supply eventually rebounded, the timing and coordination of these actions remain poorly understood.
Objective: This study maps the sequence of FDA regulatory actions, shortage declarations, and policy interventions to better understand how key stakeholders responded to the 2023 cisplatin shortage.
Methods: Our approach involves a structured review of publicly available FDA announcements, Federal Register notices, professional society statements, and media coverage from October 2022 to June 2024. Events will be categorized and compiled into an annotated timeline to illustrate the sequence and overlap of regulatory, legislative, and professional responses
Results: Preliminary findings reveal a multi-pronged response, including FDA emergency importation of international cisplatin, rapid clinical guidance from oncology societies, congressional hearings, and federal policy proposals. Notably, the U.S. Department of Health and Human Services issued guidance to strengthen transparency, early warning, and improved public-private coordination for protecting the supply chains of essential medicines.
Conclusions: The 2023 cisplatin shortage highlights the complexity of U.S. policy responses to essential drug disruptions. Timeline analysis offers a novel lens for evaluating response coordination and may inform future strategies to forecast and mitigate similar shortages.
Citation Information
Loftus, Claire and Devine, Joshua, "Mapping U.S. responses to the 2023 cisplatin shortage: A timeline analysis of policy and regulatory action" (2026). Office of Research DMU Research Symposium. 9.
https://digitalcommons.dmu.edu/researchsymposium/2025rs/2025abstracts/9
Mapping U.S. responses to the 2023 cisplatin shortage: A timeline analysis of policy and regulatory action
Introduction: Drug shortages in the United States are a growing public health challenge, with implications for patient care. Cisplatin, a widely used chemotherapy drug, entered a critical shortage in early 2023 following FDA inspection-related production halts at a major overseas manufacturer. The shortage disrupted cancer care and prompted a rapid sequence of regulatory and policy responses. While national supply eventually rebounded, the timing and coordination of these actions remain poorly understood.
Objective: This study maps the sequence of FDA regulatory actions, shortage declarations, and policy interventions to better understand how key stakeholders responded to the 2023 cisplatin shortage.
Methods: Our approach involves a structured review of publicly available FDA announcements, Federal Register notices, professional society statements, and media coverage from October 2022 to June 2024. Events will be categorized and compiled into an annotated timeline to illustrate the sequence and overlap of regulatory, legislative, and professional responses
Results: Preliminary findings reveal a multi-pronged response, including FDA emergency importation of international cisplatin, rapid clinical guidance from oncology societies, congressional hearings, and federal policy proposals. Notably, the U.S. Department of Health and Human Services issued guidance to strengthen transparency, early warning, and improved public-private coordination for protecting the supply chains of essential medicines.
Conclusions: The 2023 cisplatin shortage highlights the complexity of U.S. policy responses to essential drug disruptions. Timeline analysis offers a novel lens for evaluating response coordination and may inform future strategies to forecast and mitigate similar shortages.
