ASA requested Dr. Joe Dudley, Chief Scientist for Biosecurity & Biosurveillance, EAI Corporation, a subsidiary of SAIC, to review and provide an executive summary report on the following exceptionally important notice from the US Department of Health and Human Services (DHHS). This Program's acronym is PHEMCE

          This notice was issued 15 March 2007 by the Office of the Assistant Secretary for Preparedness and Response, DHHS, and published 20 March 2007 in Federal Register Volume 72, Number 53: 13109 - 13114. It is available at: http://frwebgate.access.gpo.gov/cgi-bingetdoc.cgi?dbname= 2007_register&docid =%5b DOCID:fr20mr07-65.

The Department of Health and Human Services (DHHS)
and the establishment of the
The Public Health Emergency Medical Countermeasures Enterprise Strategy for Chemical, Biological, Radiological and Nuclear Threats

Summary by
Joseph Dudley

EXECUTIVE SUMMARY

          The United States faces serious public health and national security threats from the use of weapons of mass destruction (WMD) - chemical, biological, radiological, or nuclear (CBRN) - by hostile governments or terrorists, and from naturally emerging infectious diseases that have the potential to disrupt the public health or economic infrastructure of our nation. The HHS Public Health Emergency Medical Countermeasures Enterprise Strategy (HHS PHEMCE Strategy) establishes the goals and objectives for an intra-agency effort including the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health (NIH) to prioritize and implement the development of medical countermeasures against CBRN threats, to include research, development, acquisition, storage/maintenance, deployment, and utilization. The HHS PHEMCE Strategy sets the policy framework for development of a PHEMCE Implementation Plan that is to be published in early 2007.

          The PHEMCE Strategy states that HHS intends to use the new authorities created by the Pandemic and All-Hazards Preparedness Act of 2006, and lessons-learned from the implementation of Project BioShield, to leverage to establishment and implementation of an effective CBRN medical countermeasures response capability for the United States.

Objective

          The United States must be able to effectively develop, stockpile, and rapidly deploy critical medical countermeasures to prevent, mitigate, and treat the adverse health consequences of threats both natural and man made. Given the diverse and dynamic nature of these threats, and the expense and time required to develop threat agent-specific medical countermeasures, a strategy must be developed that prioritizes investment and optimizes the ability to protect the Nation.

          The United States faces serious public health threats from:

• the deliberate use of chemical, biological, radiological, or nuclear (CBRN) weapons of mass destruction (WMD) by hostile states or terrorists, and
• emerging or re-emerging infectious diseases that have the potential to cause illness on a scale that could adversely impact national security.

          Advances in biotechnology support the development of new medical treatments, but also make those same tools more widely available to adversaries who might use them to modify biological organisms with the intention to inflict harm. New or formerly obscure diseases of animals are emerging as potential global public health treats Nuclear technologies may proliferate despite international efforts to contain them.

Authorities

          Department of Health and Human Services (HHS) has been tasked with leading the research, development, acquisition, deployment, and use of effective medical countermeasures to protect the civilian population from WMD under the provisions of

• National Strategy to Combat Weapons of Mass Destruction¹
  
• Presidential Directive For Biodefense for the 21st Century²
  
• Presidential Directive for Medical Countermeasures against Weapons of Mass Destruction³

          The Presidential Directive for Medical Countermeasures against Weapons of Mass Destruction provides a policy framework for promoting and coordinating research, development, acquisition, and deployment of medical countermeasures against CBRN threats. The HHS PHEMCE Strategy specifically excludes actions and programs related to pandemic influenza preparedness and response addressed under the National Pandemic Influenza Plan.⁴

          HHS will use the Biomedical Advanced Research and Development Authority (BARDA) in the Pandemic and All-Hazards Preparedness Act (Pub. L. 109-417)⁵ to provide direct investment in medical countermeasure advanced research and development. Finally, HHS will use the Project BioShield special reserve fund and the Strategic National Stockpile resources to acquire, store, maintain and deploy top priority medical countermeasures.

          HHS will establish the National Biodefense Science Board (NBSB) mandated under the Pandemic and All-Hazards Preparedness Act to provide expert advice and guidance to the HHS Secretary on scientific, technical, and other matters concerning CBRN agents, whether naturally occurring, accidental, or deliberate. The membership of the NBSB will include:

• scientific, public health, and medical experts
• federal agencies
  
• the pharmaceutical and biotechnology industry
  
• academia
  
• healthcare professionals
  
• healthcare consumer organizations
  
• other members deemed appropriate by the Secretary

Background

          The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) was first established in July 2006 as an internal HHS mechanism to coordinate and leverage the CBRNE countermeasure activities of the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health (NIH). Objectives of the PHEMCE are:

• Defining and prioritizing public health emergency medical countermeasure requirements;
  
• integrate and coordinate research, product development, and procurement;
  
• establish deployment and use strategies for medical countermeasures (including smallpox vaccine) held in the Strategic National Stockpile (SNS).

          The Project BioShield Act of 2004 requires the Secretary of Homeland Security, in consultation with the Secretary of Health and Human Services and the heads of other agencies, as appropriate, to determine which current and emerging CBRN threats present a material threat against the United States population sufficient to affect national security. Project BioShield was established in 2004 to accelerate the research, development, acquisition, and availabilityÑincluding through use of the Emergency Use Authorization (EUA)Ñof safe and effective medical countermeasures to protect the United States from CBRN threats, and created a $5.6 billion special reserve fund for use over 10 years (FY04ÑFY13) to acquire these medical countermeasures. Project BioShield investments to date have been focused on medical countermeasures for anthrax, smallpox, botulinum toxins, and radiological/nuclear agents.

          CBRN medical countermeasures resources in HHS, exclusive of Project BioShield, include

• NIH: $1.8 billion in FY06, up from $53 million in FY01.
  
• Strategic National Stockpile: $530 million in FY06, up from from $52 million in FY01

Approach

Stage One
          Development of the Public Health Emergency Medical Countermeasures Enterprise Strategy(1) (HHS PHEMCE Strategy) to establish the goals and objectives that HHS will employ to ensure that the most appropriate medical countermeasures are developed and acquired for use against the highest priority CBRN threats facing the Nation.

Stage Two
          Development of the HHS PHEMCE Implementation Plan to outline the medical countermeasure programs that reflect threat priorities, threat agent characteristics, medical/public health consequence assessments, and the likelihood that effective medical and public health intervention will prevent and mitigate adverse health consequences.

          The four strategic goals for the PHEMCE Implementation Plan are identified as:

Goal 1. Identify and Prioritize Programs for the Development and Acquisition of Medical Countermeasures
Goal 2. Build Balanced, Effective Programs Across the HHS Public Health Emergency Medical Countermeasures Enterprise
Goal 3. Increase Transparency and More Actively Engage the Private Sector
Goal 4. Develop, Recruit, and Support a World-Class Workforce

          The HHS PHEMCE Implementation Plan will incorporate valuable lessons learned from the initial implementation of Project BioShield; consider new authorities made available in the Pandemic and All-Hazards Preparedness Act; and outline HHS near-, mid- and long-term goals for research, development, and acquisition of medical countermeasures, consistent with the goals defined in this HHS PHEMCE Strategy. The HHS Implementation Plan will be reviewed at least biennially and revised to reflect changes in the threat scope and the availability of new or improved countermeasures. HHS partners for development of the HHS PHEMCE Implementation Plan include Department of Defense (DOD), Department of Homeland Security (DHS), Department of Labor (DOL), Department of Transportation (DOT), Department of State (DOS), Department of Veterans Affairs (DVA), Department of Energy (DOE), and Department of Agriculture (USDA).

          The implementation plan will establish priorities for countermeasure development and deployment based on strategic evaluations of the relative costs and benefits between the available alternatives, including:

• Medical Countermeasures (pharmaceuticals, PPE) versus Non-Medical Countermeasures (isolation, social distancing, quarantine)
  
• Prevention and Mitigation versus Treatment.
  
• Acute and Immediate Health Threats versus Chronic and Longterm Health Threats
  
• Specific versus Broad-spectrum Threats / Fixed versus Flexible Defenses
  
• General versus Special Risk Populations
  
• Domestic versus International.

          HHS plans to enhance communication between the Federal government and external stakeholders through several mechanisms, including annual PHEMCE Stakeholder Workshops and ad hoc meetings, and a dedicated website to be developed in support of this initiative. The MedicalCountermeasures.gov website will be developed as a secure Web site designed to enhance industry's access to and rapid communication with the relevant USG agencies regarding medical countermeasure development, will provide frequent updates on Federal medical countermeasure activities, and will feature upcoming events, pre-solicitation notices, key Federal resources, announcements, and links to related USG Web sites. The MedicalCountermeasures.gov website will be enabled to allow stakeholders to submit information on products in development, and to request meetings with USG departments or agencies.

Conclusion

          The HHS PHEMCE Strategy outlines HHS's new policy directions and priorities for the development, acquisition, and use of medical countermeasures against CBRN threats, and underscores the commitment by HHS executive leadership to craft and execute a robust, integrated, and end-to-end Public Health Emergency Medical Countermeasure Enterprise that will provide the United States with an "all hazards" capability to protect against, respond to, and enable recovery from attacks against our country involving chemical, biological, radiological, or nuclear weapons.

REFERENCES

1. National Strategy to Combat Weapons of Mass Destruction http://www.whitehouse.gov/news/releases/2002/12/WMDStrategy.pdf
2. Presidential Directive for Biodefense for 21st Century http://www.whitehouse.gov/homeland/20040430.html
3. Presidential Directive for Medical Countermeasures against Weapons of Mass Destruction http://www. whitehouse.gov/news/releases/2007/02/20070207-2.html .
   
4. National Strategy for Pandemic Influenza: Implementation Plan http://www.whitehouse.gov/homeland/pandemic-influenza-implementation.html
5. Pandemic and All-Hazards Preparedness Act (Pub. L. 109-417) http://www.dshs.state.tx.us/comprep/stakeholders/PL%20109-417.pdf

Ed.Note: Our thanks to Joe Dudley for this comprehensive executive summary of a DHHS notice, which provides a roadmap in their, and the US, efforts at getting a handle on the sometimes diverse and divisive objectives and strategies for reaching the same goals, even within our own organizations. Because the issue is Public Health, the outcome of the streamlined goals spelled out in this notice will directly effect all.