The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) coordinates Federal efforts to enhance chemical, biological, radiological and nuclear threats (CBRN) and emerging infectious diseases (EID) preparedness from a medical countermeasure (MCM) perspective
The PHEMCE is comprised of multiple agencies across the federal government which works to optimize our preparedness for public health emergencies with respect to the creation, stockpiling, and use of medical countermeasures.
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The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) is a leader in preparing the nation and its communities to respond to and recover from public health and medical disasters and emergencies. ASPR focuses on preparedness planning and response; building federal emergency medical operational capabilities; countermeasures research, advanced development, and procurement; and grants to strengthen the capabilities of hospitals and health care systems to minimize the health impacts of disasters and public health emergencies. The office provides federal support, including medical professionals through the National Disaster Medical System, to augment state and local capabilities during an emergency or disaster.
ASPR leads the PHEMCE, which coordinates the full spectrum of federal medical countermeasure activities that enhance the nation's preparedness for chemical, biological, radiological and nuclear threats and emerging infectious diseases (including pandemic influenza).
ASPR plays a critical role in many of the PHEMCE mission components. ASPR's Office of Policy and Planning (OPP) leads the requirements-setting process with engagement from all PHEMCE partners and utilizes expert input, including medical consequence and public health response assessments. ASPR also supports the Department of Homeland Security (DHS) in conducting Material Threat Assessments.
Within the PHEMCE, ASPR's Biomedical Advanced Research and Development Authority (BARDA) leads the advanced development and scale-up of manufacturing capacity for medical countermeasures that would be used by civilians, including promoting partnerships with developers and manufacturers.
ASPR operations offices provide oversight and operational support to the ASPR in the planning and management of public health response programs. The Office of Acquisitions Management, Contracts and Grants (AMCG) supports acquisitions and grants management, strategy development, and tracking assistance. AMCG also developed and provides the ASPR Business Toolkit, a support and assistance guide for companies responding to a solicitation for funding from ASPR.
Within the PHEMCE, both the Centers for Disease Control and Prevention (CDC) and ASPR/BARDA have lead roles in procuring medical countermeasures for stockpiling. ASPR/BARDA procures certain medical countermeasures for the Strategic National Stockpile using the Special Reserve Fund authorized under the Project BioShield Act of 2004.
ASPR's Office of Emergency Management (OEM) is beginning to synchronize its All Hazards planning with the requirements-setting process and is developing ways to incorporate the medical consequence and public health response assessments into the development of their plans. Additionally, OEM coordinates with PHEMCE and BARDA by developing Chemical, Biological, Radiation, and Nuclear (CBRN) clinical guidance for end users and providing CBRN operational and scientific subject matter expertise to the requirement setting working groups and medical countermeasure development selection and progress reviews.
ASPR coordinates with CDC on the development of federal response plans, policy, guidance, and communication, and development of clinical utilization and allocation strategies as appropriate for medical countermeasures and assets.
ASPR and CDC also coordinate interactions with state, local, tribal, territorial, and private entities to provide timely and effective deployment, distribution, dispensing, and administration of medical countermeasures in an emergency.
The NIH is the Nation's premier medical research agency. As a member of the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE), the NIH is responsible for conducting research to better understand public health threats and establish a foundation for developing medical countermeasures. The Institutes and Centers within the NIH fund and conduct basic, clinical, and translational research to expand scientific knowledge and apply it to enhance health, lengthen life, and reduce the burdens of illness and disability. The NIH works in partnership with other PHEMCE members involved in the medical countermeasure enterprise.
NIH research provides the foundation for developing medical products and strategies to diagnose, treat and prevent a wide range of infectious diseases, whether those diseases emerge naturally or are deliberately introduced as an act of bioterrorism. The National Institute of Allergy and Infectious Diseases (NIAID) is the lead agency at the NIH for research in the development of medical countermeasures for Chemical, Biological, Radiation, and Nuclear (CBRN) threats. NIAID supports research on viruses, bacteria, and other infectious agents that cause diseases of public health concern chemical threats, and radiological and nuclear threats. In addition, NIAID partners with other NIH Institutes and Centers, to coordinate research and programmatic activities related to medical countermeasure development.
Following the terrorist attacks of Sept. 11, 2001, and the subsequent anthrax mailings of that fall, NIH has played a key supportive role in the larger national strategy to develop medical products and strategies to counter bioterrorism and emerging and re-emerging infectious diseases. NIH focuses on basic and translational research. Basic research is needed to better understand infectious agents and mechanisms of chemical or radiologic injury and to identify therapeutic targets and drug candidates. Translational research advances promising concepts and product candidates along the development pathway. For example, research conducted and supported by NIH lays the groundwork for developing broad-spectrum antibiotics and antivirals-drugs that can prevent or treat diseases caused by multiple types of bacteria or viruses-and multi-platform technologies that could be used to more efficiently develop vaccines and diagnostics against a variety of infectious agents.
This move from the "one bug-one drug" approach toward a more flexible, broad approach using sophisticated genomic and proteomic technologies has yielded numerous scientific advances and has equipped the United States with a much more integrated, coordinated approach to addressing public health crises. This was demonstrated during the SARS epidemic, pandemic flu preparedness efforts resulting from the H5N1 avian influenza outbreak, and the 2009 H1N1 influenza pandemic.
NIH's medical countermeasure work supports the White House-mandated Concept Acceleration Program (CAP). CAP is one of four complementary initiatives designed to enhance and streamline the medical countermeasure (MCM) development process to develop promising, high-priority MCMs more rapidly.
NIH supports research on MCMs against radiological and nuclear threats. These programs, part of NIH's larger medical countermeasures program aim to identify and develop new diagnostic tools and therapeutics to protect against and mitigate radiological injury. In addition, NIH coordinates a program on MCMs against chemical threats, a joint effort between multiple NIH Institutes and Centers. The overall goal of the program is to integrate cutting-edge research with the latest technological advances in science and medicine for a more rapid and effective response during an emergency.
FDA plays a pivotal role in protecting our nation from chemical, biological, radiological, and nuclear threats, and from emerging infectious diseases. FDA's responsibility is to ensure that medical countermeasures (MCMs)-such as drugs, vaccines, and diagnostic tests-to counter these threats are safe, effective, and secure. Working closely with its partners through the U.S. Department of Health and Human Services' Public Health Emergency Medical Countermeasures Enterprise FDA develops and sustains the MCM programs necessary to respond to a public health emergency.
In August 2010, FDA launched the Medical Countermeasures initiative (MCMi) to build on existing FDA MCM programs and strengthen FDA activities by enhancing the regulatory review process for the highest priority MCMs and related technologies; advancing regulatory science for MCM development; and modernizing our regulatory and legal framework.
The Centers for Disease Control and Prevention (CDC), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting public health activities in the United States. The Centers of Disease Control and Prevention (CDC) leads the emergency preparedness and response activities by providing strategic direction, support, and coordination for activities across CDC as well as with local, state, tribal, national, territorial, and international public health partners. CDC provides funding and technical assistance to states to build and strengthen public health capabilities. Ensuring that states can adequately respond to threats will result in greater health security; a critical component of overall U.S. national security.
The CDC leads the procurement of medical countermeasures and their associated inventory management in the nation's Strategic National Stockpile (SNS ). The SNS is the Federal cache of pharmaceuticals, vaccines, medical supplies, equipment, and other items established to augment local supplies of critical medical countermeasures that may be needed for a public health emergency or disaster. The CDC and the Assistant Secretary for Planning and Response coordinate the development of Federal response plans and allocation strategies for medical countermeasures and assets in the SNS.
The SNS is a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, IV administration, airway maintenance supplies, and medical/surgical items. The SNS has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency severe enough to cause local supplies to run out.The SNS is designed to supplement and re-supply state and local public health agencies in the event of a national emergency anywhere and at anytime within the U.S. or its territories. SNS holdings are supplied to state and local jurisdictions at their request upon federal authorization. Once Federal and local authorities agree that the SNS is needed, medicines will be delivered to any state in the U.S. in time for them to be effective. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible.
Biological agents can be spread through the air, through water, or in food. These agents are typically found in nature, but it is possible that they could be changed to increase their ability to cause disease, make them resistant to current medicines, or to increase their ability to be spread into the environment. A bioterrorism attack is the deliberate release of viruses, bacteria, or other germs (agents) used to cause illness or death in people, animals, or plants. Terrorists may use biological agents because they can be extremely difficult to detect and do not cause illness for several hours to several days. Some bioterrorism agents, like the smallpox virus, can be spread from person to person and some, like anthrax, can not.
A number of agents to counter biological threats are included in the SNS, such as smallpox and anthrax vaccines. The U.S. Department of Health and Human Services and the CDC consider many factors, such as current biological threats, the availability of medical materiel, and the ease of dissemination of pharmaceuticals. One of the most significant factors in determining SNS composition, however, is the medical vulnerability of the U.S. civilian population.
For more information, view the Bioterrorism page at the CDC website.
CDC has a key role in protecting the public's health in an emergency involving the release of radiation that could harm people's health. Radiation can affect the body in a number of ways, and the adverse health effects of exposure may not be apparent for many years. These can range from mild effects, such as skin reddening, to serious effects such as cancer and death, depending on the amount of radiation absorbed by the body (the dose), the type of radiation, and how and for how long the person was exposed.
Four drugs in the Strategic National Stockpile (SNS) are specifically designated for use in a radiation emergency. The first three drugs, potassium iodide, DTPA, and Prussian blue, may be used to treat internal contamination. Each countermeasure is specific, not only in the way it works, but also for the radioisotopes it is used to treat. Neupogen, the fourth countermeasure in the SNS, can be used to improve a victim's chances for survival by stimulasting certain types of cells that remain in the bone marrow to produce mature granulocytes -- white blood cells critical to fighting infection.
For more information, view the Radiation Emergencies page at the CDC website.
A chemical emergency occurs when a hazardous chemical has been released and the release has the potential for harming people's health. Chemical releases can be unintentional, as in the case of an industrial accident, or intentional, as in the case of a terrorist attack.
Some chemicals that are hazardous have been developed by military organizations for use in warfare. Examples are nerve agents such as sarin and VX, mustards such as sulfur mustards and nitrogen mustards, and choking agents such as phosgene. It might be possible for terrorists to get these chemical warfare agents and use them to harm people. Other hazardous chemicals are used in industry (for example, chlorine, ammonia, and benzene) or found in nature (for example, poisonous plants). Some could be made from everyday items such as household cleaners. These types of hazardous chemicals also could be obtained and used to harm people, or they could be accidentally released.
For more information, view the Chemical Emergencies page at the CDC website.
The CDC has continuing programmatic efforts in both seasonal and pandemic influenza. One hallmark of influenza viruses is that they are constantly changing. If a non-human (novel) influenza virus gains the ability for efficient and sustained human-to-human transmission and spreads globally, an influenza pandemic occurs.
CDC's pandemic preparedness efforts include ongoing surveillance of human and animal influenza viruses, risk assessments of influenza viruses with pandemic potential, and the development and improvement of preparedness tools that can aid public health practitioners in the event of an influenza pandemic.
For more information, view the Pandemic Influenza page at the CDC website.
The Project BioShield Act of 2004 (P.L. 108-276), requires the Secretary of Homeland Security, in consultation with the Secretary of Health and Human Services (HHS) and the heads of other agencies as appropriate, to make determinations of CBRN agents that are material threats to the U.S. population and authorizes the Secretary of HHS to determine the public health consequences and recommend countermeasures to such threats. If suitable countermeasures do not already exist, this process can culminate in a joint DHS-HHS recommendation to the President or his delegate, the Director of the Office of Management and Budget, to authorize the use of BioShield special reserve funds.
Under Homeland Security Presidential Directives (HSPD) 10, 22, and 18, DHS is mandated to conduct the Biological Terrorism Risk Assessment, the Chemical Terrorism Risk Assessment, the Radiological and Nuclear Terrorism Risk Assessment, and the Integrated CBRN Terrorism Risk Assessment.
The first step in the BioShield process is threat identification and prioritization in order to inform medical countermeasure development and acquisition. DHS has the lead in threat identification and leverages the DHS Integrated Terrorism Risk Assessment findings to determine which CBRN agents present a greater risk based on the relative risk ranking against the U.S. population sufficient to affect national security. Specifically, for the highest ranked agents in the TRA, DHS evaluates the intelligence and threat information and develops and models a highly plausible consequence scenario taking into account acquisition, production, dissemination efficacy, source strength and meteorological conditions. This model is used to derive an estimate of the number of potentially exposed individuals at various levels of exposure, which becomes part of the MTA. The estimates are provided to HHS, which conducts its Public Health Consequence Modeling (PHCM) as the basis for determining public health impacts.
For agents considered to be a material threat, HHS determines whether these agents lack an existing, effective countermeasure and whether a countermeasure should be procured using BioShield reserve funds. If so, then HHS coordinates activities within the interagency Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) to define countermeasure requirements and acquisition options.
Visit the Department of Homeland Security Webpage
BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases (IEID).Learn More
Medical countermeasure policy and implementation development with the PHEMCE is coordinated by the Enterprise Senior Council, a body comprised of senior leadership from the PHEMCE agencies which serves as the decision forum for MCM development policy and implementation. Together, the PHEMCE organizations and agencies work to optimize the Nation's preparedness for public health emergencies in regards to the development, manufacturing, stockpiling, and administration of medical countermeasures.