Plotting medical counter-measures out to 2023
Greatest potential for biological threat agents
A draft federal plan for development and acquisition of medical countermeasures against chemical, biological, radiological and nuclear (CBRN) threats includes the following overarching principles:
• Threat identification and prioritization: The Department of Health and Human Services (HHS) will consider the best available intelligence and scientific information to identify and prioritize CBRN threats. HHS' public health consequences assessments and corresponding medical countermeasure priorities and requirements will be informed by the Department of Homeland Security's material threat determinations which, as defined in the Project BioShield Act, present a material threat sufficient to affect national security.
• Medical/Public Health Consequence Assessment: HHS will utilize modeling, where available, to complement the subject matter experts' evaluation of the effectiveness of various medical countermeasure strategies and response capabilities.
• Establishment and Prioritization of Medical Countermeasures Requirements: HHS will establish baseline requirements based on unmitigated consequence assessments. HHS will assess the status of medical countermeasures available and in development including holding of the Strategic National Stockpile, relevant commercial products potentially accessible to the government, and candidate medical countermeasures in the developmental pipeline by government and industry.
HHS will establish a concept of operations including maintenance, utilization policies and deployment plans for each medical counter measure in the context of all available consequence mitigation strategies. HHS will assess medical countermeasure requirements vs. candidate and available medical and nonmedical countermeasures. HHS will define specific medical counter- measure requirements, including product specifications consistent with government storage plans and operational capabilities for deployment and utilization by federal, state, and local authorities.
• Establish and Prioritize Near-Term (FY07-08), Mid-Term (FY09-13), and Long-Term (FY14-23) Development, Acquisition, Stockpiling, and Maintenance Strategies: HHS will establish a research and development portfolio to address medical countermeasure gaps and to meet future acquisition targets (align requirements with priorities). HHS will identify and support critical infrastructure that enables medical countermeasure development such as biocontainment facilities, animal models, work force training, production, etc. HHS will establish short-, mid-, and long-term acquisition strategies that incorporate all relevant cost elements for acquisition, storage, maintenance, deployment and utilization of the medical countermeasure.
• Implementation Plan: After publishing a final strategy, HHS will develop and publish an implementation plan. Several critical policy issues will guide creation of the implementation plan, including the following:
1. Relative Hierarchy of CBRN Threat Classes (biological vs. chemical vs. radiological/nuclear). The implementation plan will address the relative value of medical countermeasures across all classes of threat agents. There is general consensus that the greatest potential for medical mitigation exists for biological threat agents. However, HHS also envisions identifying significant, though more limited, opportunities for medical countermeasures for radiological, nuclear, and chemical threats.
2. Addressing Top Priority vs. All Threats. While our primary goal is to prevent the health effects of an attack with weapons of mass destruction, we recognize that despite our best efforts we will not be able to develop and acquire medical countermeasures to prevent and reduce adverse health effects against all threats in all places at all times for all people. Consequently, the implementation plan will consider all CBRN threats weighing costs, risks, and benefits relative to medical countermeasures. Recognizing the scope of the threats and the limited resources, the investments will focus on the top priorities for medical mitigation. Where possible, HHS will aim to develop and acquire medical countermeasures that have the potential to address multiple threats, particularly for lower-priority threat agents.
Reference
- Department of Health and Human Services. Office of Public Health Emergency Preparedness; Draft HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy for Chemical, Biological, Radiological and Nuclear (CBRN) Threats. Fed Reg Sept. 8, 2006; 71[174]: 53,097-53,102.
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