The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
BARDA was established to provide funding and coordination to address challenges in medical countermeasure development. For CBRN threats, for example, the medical countermeasures required to address the highest priority threats are generally not supported by a commercial market. Large pharmaceutical firms and small biotechnology companies, whose product development strategies are driven by market forces, are reluctant to develop medical countermeasures for which there is no clearly-defined, robust, sustainable, commercial market. In many cases, the anticipated rate of return on development of a new medical countermeasure for a specific threat may not justify the required resource allocations. BARDA was created to enhance incentives – in conjunction with Project BioShield Act12 authorities – to industry by providing greater government transparency. Furthermore, BARDA was created to increase funding for advanced research and development and to better coordinate the USG medical countermeasure development and acquisition process.BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. In addition, BARDA manages the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).