In a recent report to Congressional Committees on Biological Defense, the General Accountability Office (GAO) revealed that the Defense Department has not followed its own directive to update its list of biological agents that pose the greatest threat to the military.
The DoD list on new biological threats serves as a guideline for the government’s investments in countermeasures such as vaccines and new drugs. Yet, it has only been updated twice since its creation in 2000. The GAO reports that Pentagon officials stated they were under the impression that the DoD directive was no longer in effect.
Billions of of dollars were spent by the DoD from 2001 to 2013 on research and development of medical countermeasures. However, without updated lists, GAO was not able to determine whether DoD was dealing with the latest deadly biological agents. Even in the years that DoD did update the list, the GAO audit found that it didn’t reach out to the department’s Chemical and Biological Defense Program and other concerned agencies.
The DoD’s classified list names 19 biological agents. But only four had available countermeasures and several others appear to be at an advanced stage of development.
The GAO noted that the DoD and the Department of Homeland Security (DHS) have established processes for identifying biological agents that pose domestic threats. But the lack of information from DoD, and the absence of medical countermeasures program to prepare for pandemics and bioterror attacks in coordination with the Department of Health and Human Services, makes it impossible to know whether both programs are covering the ground necessary to protect the U.S. military and civilian population.
United States Government Accountability Office
Report to Congressional Committees
Biological Defense
DOD Has Strengthened Coordination on Medical Countermeasures but Can Improve Its Process for Threat Prioritization
May 2014
What GAO Found
From fiscal years 2001 through 2013, the Department of Defense (DOD) received over $4.3 billion in total funding (in constant fiscal year 2013 dollars) to research, develop, and make available medical countermeasures that respond to biological threat agents. Of that $4.3 billion, approximately $3.75 billion was for the research and development of new medical countermeasures.
DOD has made progress in researching, developing, and making available medical countermeasures against biological threat agents, but does not use its established process for annually updating its list of threat priorities. DOD’s Chemical and Biological Defense Program (CBDP) is researching, is developing, or has obtained Food and Drug Administration approval for countermeasures that address 10 of the 19 biological threat agents DOD has identified as threats to the warfighter. Of DOD’s 43 candidates for medical countermeasures, 13 use technologies that may allow them to respond to various emerging or genetically modified biological threat agents. However, DOD does not use its established process to annually update its list of biological threat priorities. DOD Directive 6205.3, DOD Immunization Program for Biological Warfare Defense, establishes roles and responsibilities and an annual process for updating DOD’s biological threat list. GAO found that the list has not been updated annually and, when it was updated in 2001 and 2012, DOD did not receive input from key stakeholders. By not following its established process for annually updating its biological threat list, DOD cannot ensure that its investments—and those of its partners—are applied toward responding to the most-serious and likely biological threats.
CBDP has taken steps to increase transparency and improve coordination practices within DOD to allocate resources to address biological threats. In response to concerns raised by military service officials that CBDP was not completely transparent in how it prioritized requirements and made resourcing decisions, CBDP issued a business plan in 2012 to update its coordination methods. While military service officials were supportive of CBDP’s actions, they stressed the need for continuing dialogue and collaboration in the future.
DOD’s efforts to coordinate with the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) align with best practices GAO has identified for collaborating across agency boundaries—specifically, to leverage available resources; establish mutually reinforcing joint strategies; and develop compatible policies, procedures, and other tools to operate across agency boundaries. DOD, HHS, and DHS share a joint research campus—the National Interagency Biodefense Campus at Fort Detrick, Maryland—to study biological threat agents. The campus has its own governance structure, which allows the agencies to leverage available resources and facilitate scientific exchange. Senior leaders at DOD and HHS also have developed interagency agreements and other tools that facilitate communication on the various stages of medical countermeasure development. Finally, DOD and DHS have established processes for identifying biological agents that pose domestic threats and risks.
The full GAO report may be found here.