[Weekly Compilation of Presidential Documents Volume 43, Number 6 (Monday, February 12, 2007)]
[Pages 128-134]
[Online from the Government Publishing Office, www.gpo.gov]

<R04>
Directive on Medical Countermeasures Against Weapons of Mass Destruction

January 31, 2007

Homeland Security Presidential Directive/HSPD-18

Subject: Medical Countermeasures against Weapons of Mass Destruction

BACKGROUND

    (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

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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) 
identify 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 class, 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.

Biological Threats

    (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

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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.

Nuclear and Radiological Threats

    (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.

Chemical Threats

    (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.

POLICY

    (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 two-tiered 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

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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 mid-term 
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 openly identify 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 to identify 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 include identification 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 include the use of novel approaches for improved 
evaluation tools, streamlined clinical trials

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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.

POLICY ACTIONS

    (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 
interagency process and strategic planning and will manage programs 
supporting medical countermeasures development and acquisition for 
domestic preparedness.

(i)         Stewardship. Not later than 60 days after the date of this 
            directive, the Secretary shall establish an interagency 
            committee to provide advice in setting medical 
            countermeasure requirements and coordinate HHS research, 
            development, and procurement activities. The committee will 
            include representatives designated by the Secretaries of 
            Defense and Homeland Security and the heads of other 
            appropriate executive departments and agencies. This 
            committee will serve as the primary conduit for 
            communication among entities involved in medical 
            countermeasure development. The chair of the committee shall 
            keep the joint Homeland Security Council/National Security 
            Council Biodefense Policy Coordination Committee apprised of 
            HHS efforts to integrate investment strategies and the 
            Federal Government's progress in the development and 
            acquisition of medical countermeasures.

(ii)        Strategic Planning. Not later than 60 days after the date of 
            this directive, the Secretary shall establish a dedicated 
            strategic planning activity to integrate risk-based 
            requirements across the threat spectrum and over the full 
            range of research, early-, 
            mid-, and late-stage development, acquisition, deployment, 
            and life-cycle management of medical countermeasures. The 
            Secretary shall align all relevant HHS programs and 
            functions to support this strategic planning.

(iii)       Execution. The Secretary shall ensure that the efforts of 
            component agencies, centers and institutes are coordinated 
            and targeted to facilitate both development of near-term 
            medical countermeasures and transformation of our capability 
            to address future challenges. The Secretary shall also 
            establish an advanced development portfolio that targets 
            investments in

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            promising countermeasures and technologies that are beyond 
            early development, but not yet ready for acquisition 
            consideration. In order to realize the full potential for 
            broad partnership with academia and industry, the Secretary 
            shall ensure that HHS coordinates strategies and 
            implementation plans in a manner that conveys integrated 
            priorities, activities, and objectives across the spectrum 
            of relevant Federal participants.
(iv)        Engaging the Private Sector and Nongovernmental Entities. 
            The Secretary shall develop and implement a strategy to 
            engage the unique expertise and capabilities of the private 
            sector in developing medical countermeasures to combat WMD, 
            and shall provide clear and timely communication of HHS 
            priorities and objectives. The Secretary shall consider 
            creating an advisory committee composed of leading experts 
            from academia and the biotech and pharmaceutical industries 
            to provide insight on barriers to progress and help identify 
            promising innovations and solutions to problems such as 
            life-cycle management of medical countermeasures. The 
            Secretary shall designate one office within HHS as the 
            principal liaison for nongovernmental entities who wish to 
            bring new technologies, approaches, or potential medical 
            countermeasures to the attention of the Federal Government.
    (b) The Secretary of Defense shall retain exclusive responsibility 
for research, development, acquisition, and deployment of medical 
countermeasures to prevent or mitigate the health effects of WMD threats 
and naturally occurring threats to the Armed Forces and shall continue 
to direct strategic planning for and oversight of programs to support 
medical countermeasures development and acquisition for our Armed Forces 
personnel. The Secretaries of Health and Human Services and Defense 
shall ensure that the efforts of the Department of Defense (DOD) and HHS 
are coordinated to promote synergy, minimize redundancy, and, to the 
extent feasible, use common requirements for medical countermeasure 
development. The Secretary of Defense shall ensure that DOD continues to 
draw upon its longstanding investment and experience in WMD medical 
countermeasure research, development, acquisition, and deployment to 
ensure protection of the Armed Forces, but also to accelerate and 
improve the overall national effort, consistent with Departmental 
authorities and responsibilities, and shall ensure that DOD continues to 
place a special focus on medical countermeasure development for CBRN 
threat agents because of the unique facilities, testing capabilities, 
and trained and experienced personnel within the Department. These 
efforts will constitute the basis for interagency partnership and 
combined investment to safeguard the American people.
    (c) The Secretary of Homeland Security shall develop a strategic, 
integrated all-CBRN risk assessment that integrates the findings of the 
intelligence and law enforcement communities with input from the 
scientific, medical, and public health communities. Not later than June 
1, 2008, the Secretary of Homeland Security shall submit a report to the 
President through the Assistant to the President for Homeland Security 
and Counterterrorism, which shall summarize the key findings of this 
assessment, and shall update those findings when appropriate, but not 
less frequently than every 2 years. The Department of Homeland Security 
shall continue to issue Material Threat Determinations for those CBRN 
agents that pose a material threat to national security.
    (d) The Secretaries of Health and Human Services, Defense, and 
Homeland Security shall ensure the availability of the infrastructure 
required to test and evaluate medical countermeasures for CBRN threat 
agents.
 (i)         The Secretaries of Health and Human Services, Defense, and 
            Veterans Affairs shall leverage their partnership to 
            identify and accelerate research, development, testing, and 
            evaluation programs for the acquisition of medical 
            countermeasures for CBRN threats.
 (ii)        The Secretary of Health and Human Services and the 
            Secretary of Homeland Security shall develop effective and 
            streamlined processes, including

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            mutually agreed-upon timelines, to assist the respective 
            Secretaries in jointly recommending that the Special Reserve 
            Fund (SRF) be used for the acquisition of specified security 
            countermeasures.
 (iii)       The Director of National Intelligence shall facilitate 
            coordination across the intelligence community and, in 
            coordination with the Attorney General, engage the law 
            enforcement community to provide all relevant and 
            appropriate WMD-related intelligence information to DHS for 
            the development of the integrated CBRN risk assessment that 
            is used in prioritizing the development, acquisition, and 
            maintenance of medical countermeasures.

GENERAL

    (15) This directive:
    (a) shall be implemented consistent with applicable law and the 
authorities of executive departments and agencies, or heads of such 
departments and agencies, vested by law, and subject to the availability 
of appropriations;
    (b) shall not be construed to impair or otherwise affect the 
functions of the Director of the Office of Management and Budget 
relating to budget, administrative, and legislative proposals; and
    (c) is not intended to, and does not, create any rights or benefits, 
substantive or procedural, enforceable at law or in equity by a party 
against the United States, its agencies, instrumentalities, or entities, 
its officers, employees, or agents, or any other person.
                                                George W. Bush

Note: This directive was released by the Office of the Press Secretary 
on February 7.