Figure 3 shows the amount of this funding CBDP received by  fiscal year in constant fiscal year 2013 dollars. Our analysis of DOD data showed that most of the funding for medical  countermeasures against biological threat agents in fiscal years 2001  through 2013 was targeted to research and development efforts, with  research and development funding totaling approximately $3.75 billion, or  nearly 90 percent of the $4.3 billion in funding; the remaining amount was  for procurement. DOD Has Made Progress in Researching, Developing, and Making Available Medical Countermeasures Against Biological Threat Agents, but Has Not Updated Its List of Threat Priorities as Required

DOD is researching and developing over 40 candidates for medical  countermeasures for use against traditional, emerging, and genetically  modified biological threat agents, and is researching, developing, or has  obtained FDA approval for countermeasures that address 10 of the 19  biological threat agents it has identified as threats to the warfighter. Over  the past 15 years, the biological threat list that DOD’s CBDP uses to  prioritize its investments in medical countermeasures has been updated,  in various ways, to respond to policy changes, but DOD does not follow  its established process for annually updating the biological threat list. For example, officials told us the  2012 update assessed CBRN threats; however, it did not include input  from key stakeholders and it was not updated as part of an annual  process as required by DOD Directive 6205.3. By not following its directives and regularly updating its biological threat  list and priorities, DOD cannot be fully assured that its investments and  allocation of resources—and those of its partners—are being applied  toward developing medical countermeasures to respond to the most- serious and likely biological threat agents. DOD Has Taken Steps to Enhance Internal Coordination on Resource Allocation for Medical Countermeasures Against Biological Threat Agents

CBDP has taken steps to increase transparency and improve  coordination practices within DOD as it allocates resources to address  biological threat agents. To address  these concerns and better incorporate service priorities and perspectives,  CBDP issued a business plan in 2012, which updated its coordination  methods. Military service officials agreed with CBDP’s actions and  stressed the need for continuing dialogue and collaboration. DOD’s Efforts to Coordinate across Agency Boundaries Align with Best Practices

DOD’s efforts to coordinate with HHS and DHS align with best practices  we have 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 have also 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. Recommendation for Executive Action

To help ensure that DOD’s investments are being applied toward  developing medical countermeasures to respond to the most serious and  likely biological threat agents, we recommend that the Secretary of  Defense direct the appropriate DOD officials to develop and implement a  process to update and validate DOD’s list of biological threats, as  required by DOD Directives 5160.05E and 6205.3, or implement a  process that aligns with the department’s current policies, practices, and  priorities as reflected in the 2001 and 2010 Quadrennial Defense  Reviews. To evaluate DOD’s progress in researching, developing, and making  available medical countermeasures for use against prioritized biological  threat agents, including DOD’s process to prioritize biological medical  countermeasure development, we compared the requirements of DOD  Directive 6205.3, DOD Immunization Program for Biological Warfare  Defense and DOD Directive 5160.05E, Roles and Responsibilities  Associated with the Chemical and Biological Defense Program, to the  practices CBDP uses to prioritize investments in medical  countermeasures against biological threat agents. To evaluate the extent to which DOD’s efforts to coordinate with the  Department of Health and Human Services (HHS) and the Department of  Homeland Security (DHS) to research and develop medical  countermeasures against prioritized biological threat agents align with  best practices for collaboration, we reviewed DOD, HHS, and DHS  policies and procedures, strategies, memorandums of understanding, and  other documents on medical countermeasure efforts to understand how  the departments coordinate and communicate. GAO-13-466R.
Why GAO Did This Study

The spread of the scientific capabilities to produce effective biological weapons has contributed to concerns about the threat posed to the warfighter from biological attacks.
GAO was mandated to review DOD's efforts to research and develop medical countermeasures against prioritized biological threat agents. This report (1) describes DOD's funding of medical countermeasures against biological threat agents from fiscal years 2001 through 2013; (2) evaluates DOD's progress in researching, developing, and making available medical countermeasures against biological threat agents, including DOD's prioritization process; (3) describes DOD's internal coordination to allocate resources to medical countermeasures against biological threat agents; and (4) evaluates DOD's coordination with HHS and DHS to research and develop medical countermeasures against biological threat agents.
GAO analyzed DOD budget information from fiscal years 2001 through 2013, policies, and strategies relating to biological medical countermeasures and analyzed information and interviewed officials from DOD, HHS, and DHS on collaborative efforts to research and develop biological medical countermeasures.

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.

What GAO Recommends

GAO recommends that DOD implement a process to update its list of biological threats according to its current policies. DOD concurred and identified steps to address the recommendation.