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Public Health and ​Emergency Medical Countermeasures Enterprise

Strategy and  Implementation Plan 2022

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The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) was established by the Department of Health and Human Services (HHS) in 2006, and codified by Congress in 2019, to advance the country's medical countermeasure (MCM) preparedness against chemical, biological, radiological, nuclear, and emerging infectious disease threats.

The PHEMCE is a collaboration of federal partners that have expertise in the different MCM functions that are necessary to ensure countermeasure availability and use to protect people during public health emergencies. The PHEMCE exists to bridge the gaps in the country’s MCM portfolio that might otherwise occur between these federal programs. PHEMCE members1 include the Director of the Centers for Disease Control and Prevention (CDC), Director of the National institutes of Health (NIH), Commissioner of the U.S. Food and Drug Administration (FDA), Secretary of Defense, Secretary of Homeland Security, Secretary of Agriculture, Secretary of Veterans Affairs (VA), and the Director of National Intelligence. Members work together to advise the Assistant Secretary for Preparedness and Response (Assistant Secretary)2, who then makes recommendations to the Secretary of HHS on MCMs—including vaccines, treatments, devices, and personal protective equipment—that may be used to protect the American people during an emergency or other disaster.  

Specifically, the Public Health Service (PHS) Act dictates the PHEMCE shall make recommendations to the Secretary of HHS regarding MCM research and development (R&D), procurement, stockpiling, distribution, and utilization; identify national health security needs; develop strategies for logistics, deployment, distribution, dispensing of countermeasures, particularly as it relates to the Strategic National Stockpile (SNS). With limited funding, the U.S. Government (USG) will always need to prioritize and strategize to ensure MCM needs are met with the limited resources available.

Medical countermeasures3 include both pharmaceutical interventions (e.g., vaccines, antimicrobials, antidotes, and antitoxins) and non-pharmaceutical interventions (e.g., medical devices—including diagnostics—ventilators, personal protective equipment, and patient decontamination), as well as other needed medical products that may be used to prevent, mitigate, or treat the adverse health effects of an intentional, accidental, or naturally occurring public health emergency.

PHEMCE coordination will include the full range of partners, processes, and products outlined above. This strategy captures our vision and goals for the newly relaunched PHEMCE moving forward.

Table of Contents

For purposes of this document and other PHEMCE documents, members will refer to the statutorily named organizations, and partners to the larger group those members interact with, e.g., industry and SLTT response organizations whose input is outlined in 42 U.S.C. § 300hh–10 - Coordination of preparedness for and response to all-hazards public health emergencies, “(d)(2)(H) incorporate input from Federal, State, local, and tribal stakeholders.” Enterprise is an overarching term that comprises both members and partners. 

2 In 2022, HHS Secretary Becerra announced that the ASPR organization would move from a Staff Division to an Operating Division (OpDiv) and approved the organization’s name change to the Administration for Strategic Preparedness and Response (ASPR). The individual title leading that organization remains the Assistant Secretary for Preparedness and Response. More about the announcement can be found here on the HHS website.

3 They include (but are not limited to) qualified countermeasures as defined in section 319F–1(a)(2) of the PHS Act (42 U.S.C. § 247d–6a(a)(2)); qualified pandemic or epidemic products as defined in section 319F–3(i)(7) of the PHS Act (42 U.S.C. § 247d–6d(i)(7))), and security countermeasures as defined in section 319F‐2(c)(1)(B) of the PHS Act (42 U.S.C. § 247d–6b(c)(1)(B)).