January 31, 2007

(1)  Weapons of Mass Destruction (WMD) -- chemical, biological, radiological, and nuclear agents (CBRN) -- in the possession of hostile states or terrorists represent one of the greatest security challenges facing the United States.  An attack utilizing WMD potentially could cause mass casualties, compromise critical infrastructure, adversely affect our economy, and inflict social and psychological damage that could negatively affect the American way of life.

(2)  Our National Strategy to Combat Weapons of Mass Destruction (December 2002) and Biodefense for the 21st Century (April 2004)entify response and recovery as key components of our Nation's ability to manage the consequences of a WMD attack.  Our primary goal is to prevent such an attack, but we must be fully prepared to respond to and recover from an attack if one occurs.  Accord­ingly, we have made significant investments in our WMD consequence management capabilities in order to mitigate impacts to the public's health, the economy, and our critical infrastructure.  The development and acquisition of effective medical counter­measures to mitigate illness, suffering, and death resulting from CBRN agents is central to our consequence management efforts.

(3)  It is not presently feasible to develop and stockpile medical countermeasures against every possible threat.  The development of vaccines and drugs to prevent or mitigate adverse health effects caused by exposure to biological agents, chemicals, or radiation is a time-consuming and costly process.  This directive builds upon the vision and objectives articulated in our National Strategy to Combat Weapons of Mass Destruction and Biodefense for the 21st Century to ensure that our Nation's medical countermeasure research, development, and acquisition efforts:

(a)  Target threats that have potential for catastrophic impact on our public health and are subject to medical mitigation;

(b)  Yield a rapidly deployable and flexible capability to address both existing and evolving threats;

(c)  Are part of an integrated WMD consequence management approach informed by current risk assessments of threats, vulnerabilities, and capabilities; and

(d)  Include the development of effective, feasible, and pragmatic concepts of operation for responding to and  recovering from an attack.

(4)  In order to address the challenges presented by the diverse CBRN threat spectrum, optimize the investments necessary for medical countermeasures development, and ensure that our activities significantly enhance our domestic and international response and recovery capabilities, our decisions as to the research, development, and acquisition of medical countermeasures will be guided by three overarching principles:

(a)  Our preparations will focus on countering current and anticipated threat agents that have the greatest potential for use by state and non-state actors to cause catastrophic public health consequences to the American people.

(b)  We will invest in medical countermeasures and public health interventions that have the greatest potential to prevent, treat, and mitigate the consequences of WMD threats.

(c)  We will link acquisition of medical countermeasures to the existence of effective deployment strategies that are supportable by the present and foreseeable operational and logistic capabilities of Federal, State, and local assets following a WMD attack or other event that presents a catastrophic public health impact.

(5)  Mitigating illness and preventing death are the principal goals of our medical countermeasure efforts.  As a , bio­logical agents offer the greatest opportunity for such medical mitigation, and this directive prioritizes our countermeasure efforts accordingly.  This directive also provides for tailoring our Nation's ongoing research and acquisition efforts to continue to yield new countermeasures against CBRN agents and for incorporating such new discoveries into our domestic and international response and recovery planning efforts.

(6)  The biological threat spectrum can be framed in four distinct categories, each of which presents unique challenges and significant opportunities for developing medical countermeasures:

(a)  Traditional Agents:  Traditional agents are naturally occurring microorganisms or toxin products with the potential to be disseminated to cause mass casualties.  Examples of traditional agents include Bacillus anthracis (anthrax) and Yersinia pestis (plague).

(b)  Enhanced Agents:  Enhanced agents are traditional agents that have been modified or selected to enhance their ability to harm human populations or circumvent current countermeasures, such as a bacterium that has been modified to resist antibiotic treatment.

(c)  Emerging Agents:  Emerging agents are previously unrecognized pathogens that might be naturally occurring and present a serious risk to human populations, such as the virus responsible for Severe Acute Respiratory Syndrome (SARS).  Tools to detect and treat these agents might not exist or might not be widely available.

(d)  Advanced Agents:  Advanced agents are novel pathogens or other materials of biological nature that have been artificially engineered in the laboratory to bypass traditional countermeasures or produce a more severe or otherwise enhanced spectrum of disease.

(7)  Threats posed by fissile and other radiological material will persist.  Our Nation must improve its biodosimetry capabilities and continue to develop medical countermeasures as appropriate to mitigate the health effects of radiation exposure from the following threats:

(a)  Improvised Nuclear Devices:  Improvised nuclear devices incorporate radioactive materials designed to result in the formation of a nuclear-yield reaction.  Such devices can be wholly fabricated or can be created by modifying a nuclear weapon.

(b)  Radiological Dispersal Devices:  Radiological Dispersal Devices (RDDs) are devices, other than a nuclear explosive device, designed to disseminate radioactive material to cause destruction, damage, or injury.

(c)  Intentional Damage or Destruction of a Nuclear Power Plant:  Deliberate acts that cause damage to a reactor core and destruction of the containment facility of a nuclear reactor could contaminate a wide geographic area with radioactive material.

(8)  Existing and new types of chemicals present a range of threats.  Development of targeted medical countermeasures might be warranted for materials in the following categories:

(a)  Toxic Industrial Materials and Chemicals:  Toxic Industrial Materials and Chemicals are toxic substances in solid, liquid, or gaseous form that are used or stored for use for military or commercial purposes.

(b)  Traditional Chemical Warfare Agents:  Traditional chemical warfare agents encompass the range of blood, blister, choking, and nerve agents historically developed for warfighter use.

(c)  Non-traditional Agents:  Non-traditional agents (NTAs) are novel chemical threat agents or toxicants requiring adapted countermeasures.

(9)  Creating defenses against a finite number of known or anticipated agents is a sound approach for mitigating the most catastrophic CBRN threats; however, we also must simultaneously employ a broad-spectrum "flexible" approach to address other current and future threats.  We must be capable of responding to a wide variety of potential challenges, including a novel biological agent that is highly communicable, associated with a high rate of morbidity or mortality, and without known countermeasure at the time of its discovery.  Although significant technological, organizational, and procedural challenges will have to be overcome, such a balanced strategic approach would mitigate current and future CBRN threats and benefit public health.

(10)  It is the policy of the United States to draw upon the considerable potential of the scientific community in the public and private sectors to address our medical countermeasure requirements relating to CBRN threats.  Our Nation will use a twotiered approach for development and acquisition of medical countermeasures, which will balance the immediate need to provide a capability to mitigate the most catastrophic of the current CBRN threats with long-term requirements to develop more flexible, broader spectrum countermeasures to address future threats.  Our approach also will support regulatory decisions and will permit us to address the broadest range of current and future CBRN threats.

Tier I:  Focused Development of Agent-Specific Medical Countermeasures

(11)  The first tier uses existing, proven approaches for developing medical countermeasures to address challenges posed by select current and anticipated threats, such as traditional CBRN agents.  Recognizing that as threats change our counter­measures might become less effective, we will invest in an integrated and multi-layered defense.  Department-level strategies and implementation plans will reflect the following three guiding principles and objectives:

(a)  Evaluate and clearly define investments in near- and midterm defenses:  We will develop and use risk assessment processes that integrate data and threat assessments from the life science, consequence management, public health, law enforcement, and intelligence communities to guide investment priorities for current and anticipated threats.  We will openlyentify the high-risk threats that hold potential for catastrophic consequences to civilian populations and warrant development of targeted countermeasures.

(b)  Target medical countermeasure strategies to satisfy practical operational requirements:  We will model the potential impact of high-risk threats and develop scenario-based concepts of operations for medical consequence management and public health mitigation and treatment of a large-scale attack on our population.  These concepts of operations will guide complementary decisions regarding medical countermeasure development and acquisition.

(c)  Take advantage of opportunities to buttress U.S. defenses:  We will coordinate interagency efforts toentify and evaluate vulnerabilities in our current arsenal of countermeasures to protect the U.S. population.  Where appropriate, we will target the development of alternate or supplementary medical countermeasures to ensure that a multi-layered defense against the most significant high-impact CBRN threats is established.

Tier II:  Development of a Flexible Capability for New Medical Countermeasures

(12)  Second tier activities will emphasize the need to capitalize upon the development of emerging and future technologies that will enhance our ability to respond flexibly to anticipated, emerging, and future CBRN threats.  Importantly, this end-state will foster innovations in medical technologies that will provide broad public health benefit.  Department-level strategic and implementation plans will reflect the following guiding principles and objectives:

(a)  Integrate fundamental discovery and medical development to realize novel medical countermeasure capabilities:  We will target some investments to support the develop­ment of broad spectrum approaches to surveillance, diagnostics, prophylactics, and therapeutics that utilize platform technologies.  This will require targeted, balanced, and sustained investments between fundamental research to discover new technologies and applied research for technology development to deliver new medical capabilities and counter­measures.  Although by no means all-inclusive, our goals could includeidentification and use of early markers for exposure, greater understanding of host responses to target therapeutics, and development of integrated technologies for rapid production of new countermeasures.

(b)  Establish a favorable environment for evaluating new approaches:  We must ensure that our investments lead to products that expand the scientific data base, increase the efficiency with which safety and efficacy can be evaluated, and improve the rate at which products under Investigational New Drug or Investigational Device Exemption status progress through the regulatory or approval process.  In addition, we must continue to use new tools to evaluate and utilize promising candi­dates in a time of crisis.  Examples of such tools include the "Animal Rule" for testing the efficacy of medical countermeasures against threat agents when human trials are not ethically feasible and the Emergency Use Authorization.  Although by no means all-inclusive, our desired end-state could includethe use of novel approaches for improved evaluation tools, streamlined clinical trials that meet safety and regulatory needs, and the development and use of novel approaches to manufacturing.

(c)  Integrate the products of new and traditional approaches: We must address the challenges that will arise from inte­grating these new approaches with existing processes.  We must incorporate the use of non-pharmacological inter­ventions in our response planning.  This integration will forge a flexible biodefense capability that aligns our national requirements for medical countermeasures with the concepts of operation that are used in conjunction with other strategies for mitigating the public health impacts of WMD attacks.

(13)  In order to achieve our Tier I and II objectives, it will be necessary to facilitate the development of products and technologies that show promise but are not yet eligible for procurement through BioShield or the Strategic National Stockpile.

We will support the advanced development of these products through targeted investments across a broad portfolio, with the under­standing that some of these products may be deemed unsuitable for further investment as additional data becomes available, but the expectation that others will become candidates for procurement.

(14)  We will employ an integrated approach to WMD medical countermeasure development that draws upon the expertise of the public health, life science, defense, homeland security, intelligence, first responder, and law enforcement communities, as well as the private sector, to promote a seamless integration throughout the product development life cycle.

(a)  The Secretary of Health and Human Services (Secretary) will lead Federal Government efforts to research, develop, evaluate, and acquire public health emergency medical countermeasures to prevent or mitigate the health effects of CBRN threats facing the U.S. civilian population.  The Department of Health and Human Services (HHS) will lead the i

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