Advancing Federal Coordination to Address Drug Shortages.

Abstract

Persistent shortages of essential medicines in the United States, especially generic oncology drugs, continue to compromise timely cancer care and patient safety. The presence of multiple high-level reports from federal agencies and industry experts has outlined similar recommendations, including the creation of a unified essential medicines list, transparent supply chain monitoring, domestic manufacturing incentives, and centralized federal coordination, among others, giving an optimistic direction. This manuscript synthesizes key findings from these reports and highlights misalignment across agency roles and priorities as a barrier to sustained progress. Case studies of cisplatin, vincristine, and methotrexate shortages underscore the high stakes of inaction. Drawing on recent coordination successes during the COVID-19 response, we propose a practical path forward: establishing a central federal coordinating body, legislating an essential medicines list developed using an established criticality-reach-vulnerability framework, reforming procurement incentives, and expanding the Strategic National Stockpile.