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Medical Countermeasures for Biosecurity Threats: Opportunities for the Congress PDF

“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

Image of 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