GAO urges HHS to improve drug shortage response coordination

Editor's Note

The Government Accountability Office (GAO) has called on the Department of Health and Human Services (HHS) to implement a formal mechanism for coordinating efforts to address ongoing drug shortages, which continue to jeopardize patient care nationwide. In a report released April 9, 2025, the GAO highlighted the critical need for structured collaboration within HHS and with other federal entities to effectively mitigate these shortages.​

As of July 31, 2024, the Food and Drug Administration (FDA) was monitoring 102 active drug shortages. While the annual number of new shortages has declined since the onset of the COVID-19 pandemic in 2020, the duration of these shortages has lengthened, GAO reports. Particularly affected are sterile injectable drugs essential for hospital procedures and cancer treatments. The pandemic exacerbated existing supply chain vulnerabilities; for instance, increased demand during the pandemic intensified shortages of anticoagulants used in surgeries, adversely impacting patient care in critical situations.​

The full report also offers additional detail and context on FDA-initiated measures to combat drug shortages. However, GAO maintains that the multifaceted nature of drug shortages necessitates a comprehensive governmental approach, and that HHS’s lack of a department-wide coordinating structure hampers the department's ability to respond. The report also calls out the pending expiration of funds and job positions dedicated to coordinating drug shortage activities.