The U.S. Government has a responsibility to protect the health and safety of its citizens. The American people continue to face a host of national health security threats from chemical, biological, radiological, and nuclear (CBRN) agents and emerging infectious diseases. Under the leadership of HHS, the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) is the coordinating body for the federal agencies in charge of protecting the civilian population from potential adverse health impacts through the use of medical countermeasures, which are medicines, devices, or other medical interventions that can lessen the harmful effects of these threats.
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2012 HHS PHEMCE Strategy articulates the strategic direction and will guide policies and decisions for the end-to-end mission of the PHEMCE. The companion 2012 HHS PHEMCE Implementation Plan is planned for release in summer 2012. This Strategy and the Implementation Plan together will provide the blueprints the PHEMCE will follow in the near, mid-, and long-terms to make the best use of available resources to enhance national health security.
2012 HHS PHEMCE Strategy
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Above all, the PHEMCE mission and outputs must preserve and protect people’s lives against a wide range of dangerous threats and do so as good stewards of the taxpayer’s dollars. These are two core principles of the PHEMCE Strategy. Standing on past progress and seeking to make the best use of available resources, the 2012 PHEMCE Strategy establishes these strategic goals for the PHEMCE over the next five years:
- Identify, create, develop, manufacture, and procure critical medical countermeasures.
- Establish and communicate clear regulatory pathways to facilitate medical countermeasure development and use.
- Develop logistics and operational plans for optimized use of medical countermeasures at all levels of response.
- Address medical countermeasure gaps for all sectors of the American civilian population.
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PHEMCE Leadership has identified a set of criteria against which all investments must be prioritized. These include (1) addressing the most significant threats, (2) fostering approaches with the potential to provide protection against multiple important threats, and (3) maintaining the capability to effectively use the assets developed in the envisioned operational setting.
2012 PHEMCE Implementation Plan
The 2012 PHEMCE Implementation Plan will be released in summer 2012 and will detail those programs and initiatives throughout the Department that will be prioritized in pursuit of the goals and objectives presented in this document. Both documents together constitute the blueprints the PHEMCE will follow in the near-, mid-, and long-terms to make the best use of available resources to contribute to national health security.
2007 HHS PHEMCE Strategy and Implementation Plan
The 2007 HHS PHEMCE Strategy and Implementation Plan for Chemical, Biological, Radiological, and Nuclear Threats predominantly focused on advanced development and acquisition priorities for medical countermeasures using funds available in the Special Reserve Fund authorized under the Project BioShield Act of 2004.
2007 HHS PHEMCE Strategy
The HHS PHEMCE Strategy established the goals and objectives that HHS used to ensure that medical countermeasures are available for effective use against the highest priority CBRN threats facing the Nation.
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2007 HHS PHEMCE Implementation Plan
The HHS PHEMCE Implementation Plan is a prioritized plan with near-term (FY07-08), mid-term (FY09-13) and long-term (FY14-23) goals for research, development, and acquisition of medical countermeasures.
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Key Accomplishments under the 2007 HHS PHEMCE Strategy and Implementation Plan:
The 2007 PHEMCE Strategy and Implementation Plan for CBRN Threats described advanced development and acquisition priorities for CBRN medical countermeasures. Consonant with these plans, seven new critical medical countermeasures have been delivered to the Strategic National Stockpile (SNS) or are in the process of delivery. These medical countermeasures address threats including anthrax, smallpox, botulism toxin, and radiological and nuclear agents. They will allow HHS to better respond to public health emergencies caused by intentional threats or natural events, ultimately saving lives and reducing illness. Some notable examples of medical countermeasure advancements under the 2007 PHEMCE Strategy and Implementation Plan include:
- National preparedness levels for botulism were greatly enhanced through completion of stockpile delivery of a new botulinum antitoxin. This new antitoxin is currently used for treatment of sporadic, naturally occurring cases of botulism in the U.S.
- The clinical trial infrastructure developed for biodefense applications was used to support essential clinical studies required for licensure of the 2009 H1N1 vaccines.
- State and local preparedness activities have improved, including laboratory capabilities and response readiness planning for medical countermeasures distribution. For example, CDC has assisted planning by Cities Readiness Initiative (CRI) participants which has evolved from single hazard, agency-centric plans to all-hazards multi-agency and private partnership plans.
- FDA has issued critical guidance documents that have helped clarify certain pathways to medical countermeasure regulatory approval .
For more details on the program accomplishments under the 2007 PHEMCE Strategy and Implementation Plan, see Appendix 4 of the 2012 PHEMCE Strategy. In the aggregate, these PHEMCE accomplishments have greatly enhanced our public health emergency preparedness for a wide range of threats and scenarios, and have informed the future directions of the PHEMCE.