Biodefense Countermeasure Development

BIODEFENSE PLANNING BY THE U.S. government emphasizes the use of medical countermeasures, including drugs and vaccines, to prepare for and respond to attacks involving biological weapons.1–4 Currently, medical countermeasures are available for only a fraction of biological threats, including those representing the highest risk, as determined by the Department of Homeland Security’s (DHS) threat assessments.2 It is generally acknowledged that incentives of the scale and structure needed to motivate the biopharmaceutical industry sufficiently to invest in countermeasure research and development (R&D) have been lacking.5–7 Although federal investment in countermeasure R&D has increased since 2001,8 few private pharmaceutical and biotechnology companies are engaged in countermeasure development, fewer have advanced candidates through clinical trials, and fewer still are likely to market products.9 Out of 11 requests for proposals issued by the Department of Health and Human Services (HHS) for biodefense countermeasures, only six products have been procured—none from a large pharmaceutical firm.10 In this article, we discuss the challenges to industrial investment in countermeasure development, review existing and proposed federal incentives for countermeasure R&D, and recommend measures to increase industry’s engagement in the medical countermeasure enterprise.