National Preparedness: HHS Has Funded Flexible Manufacturing Activities for Medical Countermeasures, but It Is Too Soon to Assess Their Effect.

摘要

Public health emergencies, such as the 2001 anthrax attacks and the 2009 H1N1 influenza pandemic, raise concerns about the nation's vulnerability to threats from CBRN agents and new or reemerging infectious diseases, such as pandemic influenza. HHS is the federal agency primarily responsible for identifying medical countermeasures needed to address the potential health effects from exposure to CBRN agents and emerging infectious diseases. HHS conducted a review to assess how to better address these concerns. Its August 2010 review concluded that the advanced development and manufacture of CBRN medical countermeasures needed greater support. The review recommended that HHS develop centers to provide such support, in part by using flexible manufacturing technologies, such as disposable equipment, to aid in the development and rapid manufacture of products. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 requires GAO to examine HHS's flexible manufacturing initiatives and the activities these initiatives will support. This report addresses (1) how much funding HHS has awarded for flexible manufacturing activities for medical countermeasures, and (2) the extent to which these activities will support the development and production of CBRN medical countermeasures. To address these objectives, GAO examined HHS documents and interviewed HHS officials, contractors, and stakeholders. In comments on a draft of the report, HHS agreed with its findings and provided additional information.