Requirements Setting

Medical countermeasure requirements in BARDA provide a solid foundation for establishing advanced development and acquisition programs that support the overarching ASPR mission of reducing the adverse health effects of public health emergencies, including those caused by pandemic influenza, CBRN threat agents and emerging diseases. The requirements we set for medical countermeasure development and acquisition are critical to establishing programs to meet our preparedness goals. Our stated requirements also create incentives for industry participation and shape the market for countermeasure products. Transparency in the process for establishing medical countermeasure requirements will remain a top priority for BARDA, as will be the communication of those requirements to product developers and end users.

Requirements for medical countermeasures for CBRN threats are defined with input from stakeholders across the federal government within the structure of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). Once established, these requirements drive BARDA advanced development and acquisition programs, as well as research, development, and acquisition efforts in HHS. CBRN medical countermeasure requirements are consistent with the planning and prioritization expressed in the HHS PHEMCE Implementation Plan for CBRN Threats released in April of 2007, as well as subsequent updates.

Pandemic Influenza requirements are defined by strategic objectives established in the National Strategy for Pandemic Influenza and the HHS Pandemic Influenza Plan (November 2005).

Threat Assessments:

Setting medical countermeasure requirements begins by defining the scenarios that inform our preparedness and response planning. For Pandemic Influenza, the Pandemic Severity Index serves this purpose. For CBRN threats, the Department of Homeland Security identifies threats of particular concern by issuing Material Threat Determinations (MTDs), and Population Threat Assessments (PTAs). Each PTA defines plausible, high consequence scenarios which include estimates of the number of people who would be exposed to the threat. The BARDA Computer Modeling unit provided extensive support for determination of the needs, gaps, and effects of medical countermeasure portfolio packages to mitigate the mortality and morbidity associated with anthrax, smallpox, pandemic influenza, and other threats.

Medical and Public Health Consequence Assessments:

The medical consequence modeling team at BARDA supports the PHEMCE decision-making process by conducting medical and public health consequence modeling to estimate the potential public health impact of PTA-class events. The resulting morbidity and mortality projections are then used to help to determine the appropriate strategies for mitigating adverse health effects, and to estimate the types and quantities of medical countermeasures that would be required.

Requirements Documents:

Medical countermeasure requirements are established through four central documents that each address particular needs for portfolio planning.

  • Threat-Specific White Paper: Provides scientific background on the threat agent and the resulting adverse health effects of exposure.
  • Scenario-Based Requirements Paper: Defines the current medical treatment for exposure to the given threat agent, and establishes the types and quantities of medical countermeasures that will be required during a medical and public health response to an event similar to the one described in the Population Threat Assessment.
  • Utilization Policy: Establishes the relative roles of the medical countermeasures defined above before, during, and following a PTA-sized event. This includes consideration of pre-event use, prioritization of scarce resources during an event, standards of care during a mass casualty response, and pre-positioning of medical countermeasures.
  • Product-Specific Requirements Paper: Provides a specific description of the minimum acceptable and ideal characteristics of a desired medical countermeasure, including details such as dosage form, shelf life, and storage conditions.

Medical countermeasure requirements are then established based on the answers to key questions:

  • Medical Countermeasure Types: What types of medical countermeasures (e.g., vaccines, drugs for prophylaxis, and drugs for treatment) or other interventions could mitigate adverse health effects based on the severity of illness? Additional modeling can be especially helpful when multiple medical countermeasure types may be available, and the relative effectiveness of an array of medical countermeasure strategies can be evaluated.
  • Scale: How many medical countermeasures are needed? Answers to this question are dependent on threat-specific strategies for prophylaxis and therapy.
  • Medical Countermeasure Characteristics: What product-specific characteristics of the medical countermeasure would facilitate an effective public health and medical response to a mass casualty event? This Target Product Profile (TPP) could include desired indications, formulations, dosing, delivery mechanisms, packaging, storage and transport, shelf life, or other considerations. What is the priority for use of a medical countermeasure?

Strategies And Reports

PHEMCE