HOMELAND SECURITY PRESIDENTIAL DIRECTIVE/HSPD-18

[Guest guest]

THE WHITE HOUSE

Office of the Press Secretary

For Immediate Release February 7, 2007

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 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.

Accord & shy;ingly, 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 counter & shy;measures 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;

( Yield a rapidly deployable and flexible capability to address both

existing and evolving threats;

© 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.

( 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.

© 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, bio & shy;logical 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 anthracis

(anthrax) and Yersinia pestis (plague).

( 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.

© 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.

( 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.

© 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.

( Traditional Chemical Warfare Agents: Traditional chemical warfare

agents encompass the range of blood, blister, choking, and nerve agents

historically developed for warfighter use.

© 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 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 counter & shy;measures might become less effective, we will invest in

a

n 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.

( 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.

© 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 develop & shy;ment 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

counter & shy;measures. 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.

( 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 candi & shy;dates 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 that meet safety and regulatory

needs, and the development and use of novel approaches to manufacturing.

© Integrate the products of new and traditional approaches: We must

address the challenges that will arise from inte & shy;grating these new

approaches

with existing processes. We must incorporate the use of non-pharmacological

inter & shy;ventions 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 under & shy;standing 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 desig & shy;nated 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 require & shy;ments 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

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.

( 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 develop & shy;ment. The Secretary of Defense shall ensure that

DOD

continues to draw upon its longstanding investment and experience in WMD

medical countermeasure research, develop & shy;ment, 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.

© The Secretary of Homeland Security shall develop a strategic,

integrated all-CBRN risk assessment that integrates the findings of the

intelligence

and law enforcement communi & shy;ties 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

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;

( 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

© 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

Louis N. Molino, Sr., CET

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