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U.S. Department of Health and Human Services

Goal 3: Promote an Effective Medical Countermeasures Enterprise

The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) provides an essential interagency coordinating and integrating framework to enable the provision of needed medical products—such as vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures—to protect or treat the U.S. population in public health emergencies arising from naturally occurring events, such as pandemic influenza or emerging infectious diseases, as well as chemical, biological, radiological, and nuclear threats. This requires a host of complex and interdependent efforts, including early detection of emerging diseases, developing, manufacturing, and stockpiling medical products for potential threats, distributing and administering countermeasures to an affected population, and evaluating the effectiveness of the countermeasures. The ultimate national goal is a flexible and modern countermeasures enterprise that quickly delivers safe and effective products to the population in need.
 
The ASPR role includes a policy coordinating responsibility for the MCMs enterprise, including development of national policy and requirements; an operational responsibility for the advanced development and acquisition of products that address civilian requirements; and an operations coordinating responsibility to assure that MCMs can be effectively provided and administered when needed. ASPR’s activities depend upon and are conducted in close partnership with all HHS OPDIVs and STAFFDIVs, federal departments, state and local governments, national and international public health partners, health care providers, and private industry. ASPR's Office of Policy and Planning and the Immediate Office lead the policy coordinating portion of this effort. ASPR’s Biomedical Advanced Research and Development Authority (BARDA) oversees and manages the development and acquisition of MCMs, working with our industry partners to facilitate the transition of promising MCM candidates from early research through advanced development to potential licensure. As BARDA has matured, it has poised itself to become a broader national asset, facilitating the development of MCMs to be administered for a wider range of foreseeable health emergencies, particularly those caused by serious or life-threatening emerging infectious diseases.

Strategies

  • Review and revise medical countermeasure requirements in light of full life cycle costs and budgetary constraints. Proposed activities:
    • Provide a capability, similar to the Influenza Risk Assessment Tool, for risk assessment of emerging infectious disease threats that informs the needs for development, large-scale production and/or stockpiling of MCMs [OPP, BARDA];
    • Create a decision triggers framework to implement MCM development, stockpiling, and large scale production in response to an emerging infectious disease [IO, BARDA];
    • Develop a more efficient MCM requirement setting process incorporating capability and end-user considerations that aligns with PHEMCE and other strategic and implementation plans [OPP, BARDA].
Outcome: An agile and responsive decision support framework using scientifically-relevant and evidence-based methods, providing decision makers with a range of feasible options and a preferred course of action to consider when responding to emerging public health threats.
 
  • Promote development and acquisition of MCMs with an emphasis on innovation, flexibility, and broad spectrum application. Proposed activities:
    • Provide core advanced development and manufacturing services to MCM innovators [BARDA];
    • Promote the establishment of an MCM Strategic Investor that will pursue the strategic objectives of the PHEMCE while acting as—and provide all the services and benefits of—a venture capital firm [BARDA];
    • Establish a program to support the development of platforms and countermeasures to address the threats of emerging infectious diseases and antimicrobial resistance [BARDA];
    • Enhance investments in host-directed therapeutics, such as immunomodulators, anti-inflammatories, and other countermeasures that are pathogen non-specific [BARDA];
    • Improve processes governing the solicitation, review, and award of medical countermeasure contracts [AMCG, BARDA].
    • Develop an all-hazards framework for MCM development, stockpiling of resources, and large-scale production in response to emerging infectious diseases. The framework will be based on creating robust capabilities such as platform technologies and host-directed therapies [BARDA, OPP].
Outcome: The nation will have a robust and sustainable MCM development and manufacturing infrastructure, calling upon innovators to identify promising candidate products against novel disease threats, manufacture those candidates using state of the art, modular production capacity technology, rapidly evaluate animal and human studies, and make available useable products to stakeholders allowing better mitigation of public health and medical consequences.
 
  • Manage and continue to improve the PHEMCE. Proposed activities:
    • Examine investment priorities and complete annual portfolio reviews, including making course corrections where necessary [IO, all parts of ASPR];
    • Support the development of pandemic influenza vaccines, other MCMs, and vaccine manufacturing infrastructure [BARDA];
    • Develop and implement a five-year budget for MCM development, acquisition, stockpiling, and other methods of provision, with flexibility for emergency needs [BARDA & OFPA, OPP & AMCG]
    • Improve the functions, structure, and scope of working groups and Integrated Program Teams [OPP, BARDA & IO];
    • Implement end-to-end project management teams to better coordinate development activities [BARDA, OPP & IO];
    • Annually update the 2012 PHEMCE Strategy and Implementation Plan, as called for in PAHPRA [OPP, IO];
    • Lead PHEMCE in conducting the Strategic National Stockpile (SNS) Annual Review [OPP, IO].
Outcome: The planning and response to public health emergencies across a range of identified and emerging threats will be managed, governed, and coordinated through a highly- integrated, productive collaboration of organizations to achieve pragmatic and scientifically-grounded prioritization of need and effective stewardship of the end-to-end life cycle management of MCMs for public health emergencies.
 
  • Support domestic and international partners in their activities to improve regulatory science, translational research, concepts of operation, and the procurement and dispensing of MCMs. Proposed activities:
    • Contribute to the development and implementation of a regulatory science agenda as it applies to the advanced development of MCMs [BARDA];
    • Promote the development of a precompetitive collaboration space within the PHEMCE to address cross-cutting problems of MCM development, including regulatory science [IO, BARDA];
    • Assure coordination between policies and the development of products to promote rapid distribution and use of MCMs [BARDA, IO];
    • Integrate ASPR responsibilities and planning for MCM development, manufacturing, and acquisition during a response, while addressing the capabilities and needs of end-users [IO, BARDA];
    • Complete the development and acquisition of products designed to provide maximal flexibility and responsiveness at the federal, state, local, and community levels [BARDA, OEM & IO];
    • Explore collaborations with bilateral and multilateral partners on research, development, procurement, and deployment of medical countermeasures [BARDA, IO].
Outcome: Medical products that are developed for domestic and international use against the multiple types of high-consequence public health threats will be maximally responsive to the needs of health care providers and patients with regard to clinical benefit, safety, ease of use, cost, and availability as a function of leveraging regulatory scientific expertise, superlative logistics support, multinational partnerships, and highly committed business partners.
 
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  • This page last reviewed: February 18, 2014