partners from across federal, state, and local governments, industry, and academia. Despite its successes, certain structural, strategic, and technical elements of the countermeasures enterprise continue to impede research, development, and production of medical countermeasures. The National Institutes of Health (NIH) and the Department of Defense (DoD) support much of the basic research in the relevant health and disease areas. However, this research is not always aligned with the top priorities identified based on threat assessments, which limits the number of discoveries that are applicable for further development as medical countermeasures. Once potential candidates for advanced development are identified, they are often not yet at a stage of development where they can be handed off to the Biomedical Advance Research and Development Authority (BARDA)3 in the U.S. Department of Health and Human Services (HHS). Furthermore, because the commercial market is limited for most medical countermeasures, it can be difficult to engage private-sector pharmaceutical and biotechnology companies to participate in the development and manufacturing of these products.

To begin to address the efficiency and effectiveness issues of the PHEMCE, on December 1, 2009, HHS Secretary Kathleen Sebelius charged the “Office of the Assistant Secretary for Preparedness and Response [ASPR] to lead a review of its entire public health countermeasures enterprise, to be completed in the first quarter of next year.” Subsequently, in response to a request from the Assistant Secretary, the Institute of Medicine’s (IOM’s) Forum on Medical and Public Health Preparedness for Catastrophic Events and Forum on Drug Discovery, Development, and Translation jointly convened a workshop on February 22–24, 2010, titled The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from Discovery Through Approval. The workshop was designed to examine federal policies and activities that affect medical countermeasure discovery, development, and approval, and to explore potential opportunities to enhance the countermeasures enterprise by

PHEMCE mission is to optimize national preparedness for public health emergencies, specifically by the creation, stockpiling, and use of medical countermeasures.

3

BARDA’s mission is to provide countermeasures for chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases through product requirement setting, product development, stockpile acquisition/building, manufacturing infrastructure building, and product innovation. BARDA resides within ASPR, manages the PHEMCE, and has the procurement authority for Project BioShield acquisitions using the Special Reserve Fund (http://www.hhs.gov/aspr/barda/index.html).



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