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ABOUT THE PHEMCE

The Public Health Emergency Medical Countermeasures Enterprise, otherwise known as the PHEMCE, was established by the U.S. Department of Health and Human Services (HHS) in 2006 to coordinate Federal efforts to enhance preparedness and response for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging and infectious diseases.

The PHEMCE is led by the Office of the Assistant Secretary for Preparedness and Response (ASPR) and is a coordinated interagency effort responsible for:

  • Defining and prioritizing requirements for public health emergency medical Countermeasures
  • Focusing research, development, and procurement activities on the identified Requirements
  • Establishing deployment and use strategies for medical countermeasures in the Strategic National Stockpile

PHEMCE AGENCIES

The PHEMCE is comprised of numerous 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.

  • Assistant Secretary For Preparedness and Response (ASPR)

    ASPR leads the Public Health Emergency Medical Countermeasures Enterprise (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).

  • Biomedical Advanced Research and Development Authority (BARDA)

    The Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services, supports a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.

  • National Institutes of Health (NIH)

    NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services conducting and supporting basic, clinical, and translational medical research on the causes, treatments, and cures for both common and rare diseases.

  • Food and Drug Administration (FDA)

    The FDA is responsible for assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The FDA helps to establish clear regulatory pathways for product innovators based on the most advanced science-to accelerate medical countermeasure development.

  • Centers for Disease Control (CDC)

    The CDC is responsible for protecting people in the event of a public health threat through health promotion, prevention of disease, injury and disability, and preparedness for new health threats. CDC leads 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.

  • Department of Defense (DoD)

    The DoD is a key part of a comprehensive national strategy to counter the threat, and mitigate the risk, of chemical, biological, radiological, and nuclear (CBRN) threats. The DoD conducts research and develops capabilities to rapidly and effectively mitigate the effects of a CBRN attack used against our deployed forces and in the homeland.

  • Department of Homeland Security (DHS)

    The DHS has a wide-ranging mission to secure the nation against a variety of threats. DHS plays a key role as a member of the PHEMCE in developing threat assessments and developing medical countermeasure requirements.

PHEMCE IMPLEMENTATION

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.

The PHEMCE mission components include:

  • Requirements Setting
  • Early Stage Research
  • Advanced Development and Manufacturing
  • Regulatory Science Management
  • Procurement/Inventory Management/Stockpiling
  • Response Planning, Policy, Guidance, and Communications
  • Deployment/Distribution/ Dispensing/ Administration
  • Monitoring/Evaluation/ Assessment

In 2012, HHS released the Public Health Emergency Medical Countermeasures Enterprise Strategy outlining the PHEMCE goals and objectives that will guide the policies and decisions of the partner agencies in regards to medical countermeasure capabilities that will enable our nation to have a nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat.

The 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy establishes the goals and objectives that HHS will use to ensure that medical countermeasures are available for effective use against the highest priority CBRN threats facing the Nation. The accompanying 2012 PHEMCE Implementation Plan details those programs and initiatives throughout the Department that will be prioritized in pursuit of the goals and objectives presented in the strategy document. Both documents together constitute the blueprints the PHEMCE will follow in the near-, mid-, and long-terms to make the best use of available resources to contribute to national health security.
Learn more about the PHEMCE Strategy and Implementation Plans

REQUIREMENTS SETTING

The requirements we set for medical countermeasure development and acquisition are critical to establishing programs to meet our preparedness goals. Medical countermeasure requirements in BARDA provide a solid foundation for establishing advanced development and acquisition programs that support the overarching ASPR mission and PHEMCE goals of reducing the adverse health effects of public health emergencies, including those caused by pandemic influenza, CBRN threat agents and emerging diseases.

Learn more about Requirements Setting