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Public health preparedness: HHS should plan for medical countermeasure development and manufacturing risks : report to Congressional committees
Public health preparedness: HHS should plan for medical countermeasure development and manufacturing risks : report to Congressional committees
Why GAO Did This Study. The COVID-19 pandemic and other recent public health emergencies highlight the threat of widespread illness and death posed by new and emerging infectious diseases. GAO has designated HHS’s leadership and coordination of public health emergencies as a high-risk area due to the need to be prepared for, and effectively respond to, future public health threats. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines (1) how HHS used Centers for Innovation in Advanced Development and Manufacturing (CIADM) program funds prior to and during the COVID-19 pandemic, (2) what challenges affected the CIADM program’s effectiveness in developing and manufacturing countermeasures, and (3) how HHS plans to use its new program model to address the challenges of the CIADM program. To address these objectives, GAO examined HHS documents and leading practices for managing program risks and interviewed and reviewed written correspondence with representatives from HHS and the three CIADM sites. What GAO Recommends. GAO is recommending that HHS incorporate into the development of its new program model an approach to systematically assess, and respond to, known challenges and risks associated with advanced development and manufacturing of medical countermeasures. We provided a draft of this report to HHS for review and comment. HHS concurred with our recommendation.
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