National Preparedness:

Improvements Needed for Acquiring Medical Countermeasures to Threats from Terrorism and Other Sources

GAO-12-121: Published: Oct 26, 2011. Publicly Released: Oct 26, 2011.

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What GAO Found

Through PHEMCE, HHS laid out its CBRN medical countermeasure development and acquisition priorities in 2007 in a publicly available plan based primarily on two types of CBRN risk assessments one from the Department of Homeland Security (DHS) and one from HHS but HHS has not updated the plan as intended. The 2007 plan outlined spending for these priorities through 2013, when special federal funding for countermeasure acquisition will expire. HHS invested about $1.9 billion in development and $2.4 billion for acquisition of countermeasures to fulfill these priorities from fiscal year 2007 to fiscal year 2010. Since 2007, DHS and HHS have continued to assess the risks that CBRN agents pose to national security and public health, and HHS has reassessed decisions on the quantities and types of medical countermeasures needed. However, HHS has not updated its plan, as it had intended to do biennially, to indicate whether any priorities have changed. Further, HHS has not provided specific information on anticipated budget priorities for countermeasure acquisition--information desired by companies to help them decide whether to invest in product development.

HHS has begun to address most recommendations from its August 2010 review of PHEMCE and of HHS's countermeasure activities, but HHS has not developed an adequate strategy to monitor implementation. HHS's initiatives to address the recommendations are intended to improve product development and acquisition and PHEMCE's structure and management. These initiatives are led by different agencies and offices for example, the Food and Drug Administration has begun efforts to improve its regulatory framework, while the National Institutes of Health has begun to implement a program to increase the number of potential products in the pipeline. HHS officials said they have a monitoring strategy that includes quarterly updates of a planning document and quarterly and annual reviews of progress. However, the planning document contains incomplete information and does not allow for measuring progress across all initiatives. Thus, HHS's monitoring strategy is not consistent with federal internal control standards and program management best practices. Given the initiatives' complexity and dispersed HHS leadership responsibilities, an adequate monitoring strategy would help HHS assess overall progress and provide information about whether HHS is meeting its countermeasure development and acquisition objectives.

HHS's establishment of PHEMCE in 2006 and its subsequent written agreements have facilitated intradepartmental coordination on the development and acquisition of CBRN medical countermeasures, but some coordination challenges remain. PHEMCE established an intradepartmental coordination process and documented the roles and responsibilities of its partners through written agreements. However, some industry and outside experts have reported that HHS's agencies and offices do not coordinate well to advance products through development to acquisition, which hampers industry's efforts to supply countermeasures. HHS officials are renewing the PHEMCE intradepartmental memorandum of understanding and charter for the governing body. These written agreements, once finalized, should continue to enhance and sustain intradepartmental coordination on countermeasure development and acquisition activities. In addition, effectively implementing some of the initiatives from HHS's August 2010 review may help mitigate these coordination challenges.

Why GAO Did This Study

The United States remains vulnerable to terrorist and other threats posed by chemical, biological, radiological, and nuclear (CBRN) agents. Medical countermeasures--drugs, vaccines, and diagnostic devices--can prevent or treat the effects of exposure, but few are currently available. The Department of Health and Human Services (HHS) leads federal efforts to develop and acquire countermeasures, primarily through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), an interagency body. This report examines the extent to which HHS (1) based its priorities for developing and acquiring countermeasures on CBRN risk assessments; (2) addressed its own recommendations to improve acquisition and development; and(3) coordinated internally for these efforts. GAO reviewed relevant laws, agency documents, CBRN risk assessments, and reports from outside experts; interviewed HHS and industry officials; and analyzed HHS funding for CBRN countermeasures from fiscal years 2007 through 2010.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: To improve HHS's countermeasure enterprise and activities and to ensure HHS's stated medical countermeasure development and acquisition priorities are based on current risk assessments for CBRN agents and the status of recent countermeasure research and development and are clearly and transparently communicated, the Secretary of HHS should update the PHEMCE implementation plan for CBRN medical countermeasure development and acquisition.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Implemented

    Comments: HHS issued its updated Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy in June 2012 and its updated PHEMCE Implementation Plan in December 2012. These documents articulates HHS and PHEMCE's strategic direction to protect the nation from public health threats through the use of medical countermeasures. The strategy lays out HHS's and PHEMCE's four strategic goals and underlying objectives for these activities. The implementation plan expands on the strategy by identifying the activities PHEMCE partners intend to conduct over the next five years to strengthen the regulatory, science, and policy base for countermeasure development. In addition, the plan lays out HHS's and PHEMCE's medical countermeasure development and acquisition priorities, which are based on DHS risk assessment and further medical consequence modeling.

    Recommendation: To improve HHS's countermeasure enterprise and activities and to ensure HHS's stated medical countermeasure development and acquisition priorities are based on current risk assessments for CBRN agents and the status of recent countermeasure research and development and are clearly and transparently communicated, the Secretary of HHS should incorporate into the updated plan more specific information on anticipated budget priorities for countermeasure acquisition.

    Agency Affected: Department of Health and Human Services

    Status: Open

    Comments: HHS issued an updated Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan in December 2012. However, the plan does not contain any information on anticipated budget priorities for countermeasure acquisition. In a May 2013 meeting with HHS for a follow on engagement to update this report, officials told us that HHS had developed budget estimates for countermeasure research, development, and acquisition for internal planning purposes but does not plan to make these estimates available to industry or publically. HHS is required by law to update the PHEMCE implementation plan annually.

    Recommendation: To improve HHS's countermeasure enterprise and activities and to provide reasonable assurance that HHS's initiatives will achieve the intended results of improving PHEMCE and its medical countermeasure activities, the Secretary of HHS should develop a strategy to monitor the overall progress and results of implementing the initiatives by obtaining complete information on all initiatives.

    Agency Affected: Department of Health and Human Services

    Status: Closed - Implemented

    Comments: In August 2010, HHS Issued its Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Review which outlined a number of initiatives and enhancements to transform the ability of the Department to provide critical medical countermeasures in the event of an intentional or unintentional health security event. We recommended that HHS establish a strategy to monitor the efficient completion of actions related to the PHEMCE Review. Such an effort will provide reasonable assurance that HHS's initiatives are achieving the indented results of improving PHEMCE. In April 2012, HHS issued the PHEMCE Review Implementation Plan, which reiterated the initiatives and enhancements and provides a roadmap for how each initiative will be brought to fruition. The PHEMCE Review Implementation Plan outlines the intermediate steps that HHS is conducting to successfully realize each initiative and enhancement.

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