Medical Countermeasures for Biosecurity Threats: Opportunities for the Congress  | “Our greatest concern is that terrorists might acquire biological agents, or less likely, a nuclear device, either of which could cause mass casualties.” Mapping the Global Future – Report of the National Intelligence Council’s 2020 Project, Jan. 2005 | |
Bioterrorism is a Strategic Threat to the United States • Biological weapons have the potential to be highly lethal • There are no technical barriers to a non-state actor developing a biological weapon | | – All knowledge and technologies are accessible, inexpensive, dual-use, easily hidden | • Biological weapons have strong appeal as asymmetric weapons | | – No need for a “super-power” grade weapon – Al Qaeda and other non-state groups have clearly expressed interest in them – Unlike nuclear weapons, pathogens have no “return address,” so little to hold at risk | • The power of biological weapons is linked to the upwards trajectory of global bioscience in 21st century – biological research must proceed, but also must be aware of risks • The United States does not currently have sufficient medical countermeasures to respond to the majority of biosecurity threats – robust effort & investment required |
Developing Medical Countermeasures

Opportunities for the Congress 1. Fund BARDA advanced development activities appropriately | | • $1.07B authorized for FY06-08 in PAHPA (PL 109-417) • Only $99M appropriated to date • FY08 L-HHS conference report has $149M – Large gap in funding | | 2. Enable and support risk tolerance at HHS/BARDA | | • There will be future contract and product failures – the nature of drug development • HHS needs freedom to operate – excess caution has unintended negative consequences | | 3. Education of HHS, Congress, Private Sector | | • Each stakeholder needs a better understanding of the others to enable success | | 4. FDA Priority Review Vouchers to Reward Development of Medical Countermeasures | | • Vouchers would have limited social/indirect costs – potential for high value to developer • PRV for tropical diseases in 2007 FDA Act (PL 110-85) – expand to biosecurity threats |
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