Background

		Federal Roles and Responsibilities Related to Medical Countermeasures

Several federal departments and agencies have responsibilities as part of  their mission for assessing the threat of biological agents and determining  requirements and priorities for developing and obtaining countermeasures  for these agents.
Department of Defense. DOD has exclusive responsibility for research,  development, and acquisition of medical countermeasures to prevent or  mitigate the health effects of biological agents and naturally occurring  diseases on armed forces personnel. DOD contributes to DHS’s  terrorism risk assessments, including the identification of biological global  threats, and also coordinates with HHS on efforts to identify common  medical countermeasure priorities and jointly stockpile countermeasures,  as appropriate. The Defense Intelligence Agency also performs its own  threat analysis for Chemical, Biological, and Radiological Defense, called  a Capstone Threat Assessment, at least every 2 years. CBDP leads  DOD’s efforts to anticipate, respond to, mitigate, and manage the health  effects of biological threat agents that could affect the warfighter.  According to DOD Directive 5160.05E, which assigns roles and  responsibilities associated with CBDP, the Assistant Secretary of Defense  for Nuclear, Chemical, and Biological Defense Programs, through the  Deputy Assistant Secretary of Defense for Chemical and Biological  Defense, is responsible for overseeing CBDP activities, policy guidance,  and interagency coordination.have key roles in medical countermeasure efforts:   Within CBDP, the following organizations
Chairman of the Joint Chiefs of Staff, in consultation with the  commanders of the combatant commands; the Secretaries of the  military departments; and the Director, Defense Intelligence Agency,  validates and prioritizes CBRN threats to DOD personnel, equipment,  and weapon systems.
Joint Requirements Office, which is part of the Joint Staff, sets  requirements for medical countermeasures—including performance  parameters and quantity—and develops DOD’s biological threat lists  and Joint Priorities List to ensure that countermeasures will be  feasible for DOD use.
Joint Science and Technology Office performs applied research and engages in early development of medical countermeasures  against biological threat agents.
Joint Program Executive Office supports advanced development   of potential medical countermeasures.
The Army, as CBDP Executive Agent, supports the views of the  military services and combatant commands during the Program  Objective Memorandum process, and is responsible for reviewing CBDP’s funding requirements.
Department of Homeland Security. DHS leads federal interagency  coordination and planning for emergency response to CBRN incidents in  the United States and is responsible for assessing the risks to the civilian  population posed by various CBRN agents, as directed by the Project  BioShield Act of 2004,10 (Biodefense for the 21st Century), HSPD 18 (Medical  Countermeasures against Weapons of Mass Destruction), and HSPD 22  (National Domestic Chemical Defense). DHS’s Science and Technology   Homeland Security Presidential Directive (HSPD)
Applied, or translational, research builds on basic research by validating and testing  concepts in practical settings to identify potential products. Successful concepts move  from the applied research stage into the early development stage to demonstrate basic  safety, reproducibility, and ability to be used in humans.  “Life-cycle management” includes the maintenance of medical countermeasures that  have been acquired and the removal of expired products from stockpiles.
Directorate develops CBRN Terrorism Risk Assessments (TRA) and  Material Threat Assessments, which include assessments of the relative  risks posed by CBRN agents based on variable threats, vulnerabilities,  and consequences. Since 2004, DHS has developed TRA reports every  other year.
Department of Health and Human Services. HHS leads all federal  public health and medical response to public health and medical  emergencies covered by the National Response Framework. Additionally,  HHS is responsible for the protection of the civilian population against  biological threat incidents, as stipulated by the Project BioShield Act.  Within HHS, the following organizations play key roles in leading the  federal response:
Public Health Emergency Medical Countermeasures Enterprise is  an interagency decision-making body that makes recommendations to  the Secretary of Health and Human Services regarding CBRN and  emerging infectious-disease medical countermeasure development  and acquisition. PHEMCE is led by the HHS Office of the Assistant  Secretary for Preparedness and Response and includes three primary  HHS internal agency partners: the Centers for Disease Control and  Prevention, the Food and Drug Administration (FDA), and the National  Institutes of Health, as well as several interagency partners: DOD,  DHS, the Department of Veterans Affairs, and the Department of  Agriculture.
Office of the Assistant Secretary for Preparedness and Response  leads PHEMCE and the federal medical and public health response to  public health emergencies, including strategic planning, medical  countermeasure prioritization, medical requirements development,  and support for developing and procuring medical countermeasures.
Biomedical Advanced Research and Development Authority,  within the Office of the Assistant Secretary for Preparedness and  Response, coordinates and supports advanced research and  development, manufacturing, and initial procurement of medical  countermeasures for CBRN threats, pandemic influenza, and  emerging infectious diseases. The Biomedical Advanced Research  and Development Authority also oversees HHS’s efforts to develop  and utilize flexible manufacturing capabilities for medical  countermeasure development and medical emergency response.
National Institutes of Health conducts and funds basic and applied  research to develop new or enhanced medical countermeasures and  related medical tools to protect the nation against threats posed by  CBRN agents and emerging infectious diseases.
Centers for Disease Control and Prevention maintains the  Strategic National Stockpile—the national repository for medical  countermeasures for use in a public health emergency—and  provides guidance and recommendations for the mass distribution  and use of medical countermeasures for public health emergencies.
Food and Drug Administration assesses the safety and efficacy of  medical countermeasures and regulates their development, approval,  licensure, emergency use, and postmarket surveillance. The FDA  makes the primary determination of the safety and efficacy of medical  countermeasures for DOD, and is involved throughout the research  and development process to help facilitate the approval of new  medical countermeasures.

		The Medical Countermeasure Development Process and DOD’s Funding

DOD’s medical countermeasure research and development process for  the warfighter is similar to the process used by DHS and HHS for the  civilian population. In consultation with DHS, DOD leads the first step in  the process to assess, on an ongoing basis, the threat of biological  agents and determine which of these agents pose a threat to the  warfighter. Step two of the process is applied research and early  development of medical countermeasures, which can take from 4.5 to 11  years. DOD may have multiple candidates at a particular stage of the  development process in support of a single medical countermeasure.  Successful concepts are moved into the early development stage to be  tested for product modes, such as vaccines, therapeutics, or diagnostics.  Step three is advanced development, which includes further evaluation of  potential medical countermeasures in animal studies to demonstrate  safety and effectiveness for use in humans. DOD officials told us that  human clinical trials must also be performed at this stage of development  to further assess the safety of the product. In addition, in this stage,  manufacturing of the vaccine, drug, or diagnostic is increased from the  level used for early development to the proposed commercial scale and  the product is further evaluated for approval and licensure. This stage  could take from 4 to 12 years. The licensing and acquisition of medical  countermeasures is the final stage of the development process. In figure  2, we show DOD’s, DHS’s, and HHS’s role in the process to develop  medical countermeasures.
The federal government faces a variety of challenges in its medical  countermeasure efforts, including lengthy, complex, and expensive  research and development processes and the risk of technical failure. It  can take about 12 years for a medical countermeasure to progress from  research and early development to the point at which the vaccine, drug,  or diagnostic has been approved by the FDA and is available for use.  DOD officials told us the costs to research and develop a new medical  countermeasure average $1.2 billion. Additionally, DOD officials told us  the lack of a commercial market for most medical countermeasures for  biological threat agents hindered large pharmaceutical companies from  entering the market, although HHS officials told us this has changed over  the last 2 years.
As noted above, from fiscal year 2001 through fiscal year 2013, DOD  received about $20 billion in funding for CBDP to protect the warfighter  against a wide range of threats using approaches such as medical  countermeasures, personal protective equipment, and threat-detection  sensors. Figure 3 shows the amount of this funding CBDP received by  fiscal year in constant fiscal year 2013 dollars. Appendix II presents the  original, noninflation adjusted figures (in nominal dollars).

	DOD Received about $6 Billion since 2001 in Total Funding for Medical Countermeasures, of Which $4.3 Billion Was Targeted Against Biological Threat Agents

Of the $20 billion in total funding that DOD received for CBDP in fiscal  year 2001 through fiscal year 2013 to protect military personnel against a  wide range of threats, DOD budgeted about one-third, or about $6 billion  over that same period for medical countermeasures against chemical,  biological, and radiological threats. According to our analysis of data in  the Joint Service Chemical and Biological Information System, of the $6  billion in funding for these medical countermeasures, nearly 70 percent,  or about $4.3 billion, was for medical countermeasures against biological  threat agents. CBDP officials told us they are concentrating research and  development on biological medical countermeasures because they have  already fielded a number of effective medical countermeasures against   While total medical countermeasure funding generally  chemical threats.increased between fiscal years 2001 and 2013, the percentage budgeted  for medical countermeasures against biological threat agents remained  above 50 percent, but has fluctuated from year to year, as shown in   figure 4.
According to CBDP officials, these fluctuations are due to varying needs  each year, such as funding for specific initiatives or the need to support  specific countermeasures as they move into more-expensive stages of  development. During the fiscal year 2001 through 2013 period, the  percentage of funding for research and early development averaged  about 55 percent of the $4.3 billion in funding for medical  countermeasures against biological threat agents, while the funding for  advanced development—including procurement—averaged about 45  percent. Figure 5 shows how the funding for research and early  development and the funding for advanced development varied by fiscal  year.
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. According to CBDP officials, this emphasis is due in part  to the lengthy time frames for researching and developing new medical  countermeasures.
According to DOD’s directive for chemical and biological defense roles  and responsibilities, CBDP oversees the allocation of funds for medical  countermeasures. The various organizations within CBDP oversee  funds within the stage of research and development for which they are  responsible. For example, the Joint Science and Technology Office  manages funding for research and early development, while the Joint  Program Executive Office manages funding for advanced development.  CBDP officials told us that they track budget and obligation data using the  Joint Service Chemical and Biological Information System. According to  CBDP officials, they began using this tool in 1996, and all organizations  within CBDP can access the funding data using the tool. CBDP officials  indicated that the tool is intended to track funding by different categories,  such as stage of development or specific countermeasure program, and  could also be used to help track specific countermeasure costs at the per- dose level.

	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.

		DOD Researched, Developed, and Made Available Medical Countermeasures against Traditional, Emerging, and Genetically Modified Biological Threat Agents

			Medical Countermeasures Against Biological Threat Agents

DOD’s CBDP is researching, developing, or has obtained FDA approval  for medical countermeasures that address 10 of the 19 biological threat  agents it has identified as threats to the warfighter. CBDP is researching,  developing, or has available 47 medical countermeasures or candidates  for medical countermeasures for use by the warfighter to respond to  biological agents on its threat list; 4 of these medical countermeasures  are FDA-approved and they respond to 2 of DOD’s 19 identified threats.  Nine candidates for medical countermeasures are in advanced  development, and 34 are in research or early development. Of the  medical countermeasure candidates, 13 are being developed using  broad-spectrum technologies that show promise for use against a variety  of threats, including emerging or genetically modified threats. According  to DOD officials, medical countermeasures are used as part of a layered  defense strategy meant to protect the warfighter from the effects of CBRN  threats. Figure 6 shows the status of DOD’s medical countermeasures  against biological threat agents.
DOD is using a number of strategies to research, develop, and make  available medical countermeasures for use against emerging and  genetically modified (i.e., “novel”) threats. CBDP’s 2012 Strategic Plan  indicates that to protect the warfighter against novel threats, CBDP will  leverage cutting-edge and broad-spectrum capabilities that address  current threat agents as a model for rapid response to novel threats that  may arise in the future. DOD is investing in threat-specific medical  countermeasures for certain threats, but is also researching and  developing broad-spectrum medical countermeasures, which have the  possibility of addressing more than one threat on its biological threat list  as well as providing capability against emerging and genetically modified  threats. For example, of the 47 medical countermeasures or candidates  for medical countermeasures that CBDP is researching, developing, or  has made available, 13 are designed to be used against multiple threats.  Furthermore, DOD has also developed and continues to invest in  diagnostic capabilities that allow for the identification and characterization  of biological threat agents. Specifically, CBDP is researching additional  capabilities to add to the Joint Biological Agent Identification and  Diagnostic System, which currently can diagnose five biological threat  agents. DOD officials believe that CBDP’s efforts to develop medical  countermeasures more quickly are aided by DOD’s investment in  enabling technologies and platform technologies. Officials told us that one  key enabling technology is represented by the Defense Advanced  Research Projects Agency’s research to produce a pandemic flu vaccine  using tobacco plant-based manufacturing, as opposed to the traditional  egg-based production techniques that require much more lead time and  more-controlled environments. Furthermore, CBDP officials told us that  DOD is investing in platform-based vaccines for filoviruses and various  strains of encephalitis in order to reduce the time and costs associated  with developing medical countermeasures. Officials told us that platform  technologies might be adapted to other various emerging or genetically  modified threats (similar to the process used to develop the annual  influenza vaccine, which is altered to be effective against different strains  of that virus every year).
Another component of DOD’s strategy to address emerging and  genetically modified biological threats is a new facility for advanced  development and manufacturing of medical countermeasures to be  located near Gainesville, Florida. CBDP officials said that this facility,  which is currently under construction and is projected to be operational in  April 2015, will be designed with a focus on disposable or rapidly  adaptable equipment so that it can produce small batches of numerous  medical countermeasures with a relatively short lead time, while also  providing the capability to increase production, when needed. DOD  officials believe that this facility represents an opportunity for DOD to  efficiently maintain fresh stockpiles of countermeasures that are rarely  used, quickly produce new medical countermeasures in small amounts as  may be needed for DOD’s purposes, and to provide a capability to scale  up production in the event of a national emergency.

		DOD Has Not Used Its Established Process to Annually Update Its Validated List of Biological Threat Priorities

According to DOD Directive 6205.3, DOD Immunization Program for  Biological Warfare Defense, the Chairman of the Joint Chiefs of Staff  shall, annually and as required, validate and prioritize the biological  warfare threats to DOD personnel in consultation with the combatant  commands, military service chiefs, and the Director of the Defense  Intelligence Agency, and forward that list to the CBDP Executive Agent  (the Army) through the Assistant Secretary of Defense for Health  Affairs.
Since April 2000, the list that DOD uses to prioritize the validated  biological threat agents that pose a risk to the warfighter has only been  updated occasionally, usually in response to broader policy or strategy  changes made within the department. 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. Examples of DOD’s  biological threat lists include:
Chairman of the Joint Chiefs of Staff Threat List (April 2000)  serves as the basis for each of the ensuing lists. DOD officials told us  this list was developed in response to DOD Directive 6205.3, issued in  November 1993, which establishes policy for DOD’s immunization  program for biological warfare defense and requires that the  Chairman of the Joint Chiefs of Staff annually validate and prioritize  biological warfare threats to DOD personnel.
Medical Risk Management Matrix (May 2001). DOD officials told us  this list was developed in response to the 2001 Quadrennial Defense  Review, which was under development at the same time, and  advocated for a capabilities-based approach to defense, focusing  more on how an adversary might fight than who an adversary might  be. Officials said this analysis was carried out by a contracting  service that applied a risk analysis to the 2000 Chairman of the Joint  Chiefs of Staff Threat List to develop the new list, which maintained  many similar threats, but categorized them into risk categories based  on the likelihood and effect of such an attack.
Medical Operational Consequence Assessment (September  2012) is an assessment of all CBRN threats. The assessment used a  similar methodology to the Medical Risk Management Matrix, but also  included chemical and radiological inputs. A CBDP official told us the  Medical Operational Consequence Assessment was used indirectly to  inform DOD’s budget for fiscal year 2015, since the fiscal year 2015  budget was based on previous budgets, which directly relied on the  same assessment to help prioritize investments for specific medical  countermeasures.
We found that DOD’s May 2001 and September 2012 biological threat list  updates were not performed in accordance with DOD Directives 6205.3  and 5160.05E. For example, key stakeholders, such as officials from the  CBDP Executive Agent and military service officials from the chemical  and biological countermeasure community, were unaware of an updated  biological threat list because the list was not sent to them for review or  input, as required by the directives. Officials from the Joint Requirements  Office—which is part of the Joint Staff—expressed uncertainty about the  applicability of DOD Directive 6205.3, which they believe was made  obsolete when the 2001 Quadrennial Defense Review established DOD’s  emphasis on capability-based planning over threat-specific planning, an  emphasis that was continued through the more recent 2010 Quadrennial  Defense Review. However, DOD Directive 6205.3 remains in effect and  has not been formally superseded or cancelled. In commenting on a draft  of this report, officials from DOD said the 2001 and 2012 analyses were  assessments based on the 2000 list rather than updates to the official  threat list. However, we continue to believe that the process described in  DOD Directive 6205.3 should have been applied to these assessments  because the biological threats listed changed as a result of these  analyses, reflecting changes in CBDP priorities.
The requirement that the Chairman of the Joint Chiefs of Staff validate  and prioritize CBRN threats also is contained in a more-recent directive,  which addresses roles and responsibilities within CBDP. While DOD  has moved toward capability-based planning and risk-informed analysis,  DOD officials told us that they continue to seek information about current  threats to assist their planning efforts. In addition, as shown in figure 7,  the changes to the methodology—which did not always include input from  key stakeholders—resulted in changes to the threats included in the lists.  Specifically, some threats included in the 2000 list were removed in the  2001 list, and then reinstated as part of the 2012 list.
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. Military service officials with whom we met  indicated that prior to the most-recent budget development cycle, there  was a lack of transparency in how CBDP prioritized requirements and  made resourcing decisions for medical countermeasures. 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. In addition,  CBDP also has established processes for internal DOD coordination  throughout the stages of research and development of specific medical  countermeasures against biological threat agents.

		CBDP Has Taken Steps to Enhance Coordination and Address Military Service Concerns

CBDP is responsible for establishing both medical and nonmedical  defense capabilities, and is also responsible for overseeing its budget  processes and allocating funds. However, military service officials  indicated that, in the past, CBDP did not have transparent processes for  prioritizing requirements and allocating funding among these capabilities  during the preparation of the budget. Specifically, officials expressed  concern that while the Army, as CBDP Executive Agent, works to build  consensus among the military services as it coordinates and integrates  requirements, CBDP has made key prioritization decisions without  communicating its justification to key stakeholders, including the Army.  For instance, CBDP and military service officials told us that CBDP  officials decided to prioritize medical countermeasure research and  development, while transferring funds from military service requirements,  such as personal protective equipment and threat-detection sensors.  Specifically:
According to Army officials, during preparation of future budget plans  in 2010, CBDP leadership transferred funding from programs that  would have provided personal protective equipment in order to  increase funding for a medical countermeasures initiative. According  to Army officials, this occurred after the Army had integrated and  coordinated priorities with the other military services and combatant  commands, and CBDP leadership did not coordinate this change with  key stakeholders. CBDP’s actions affected 24 different programs and  totaled about $1.2 billion over the course of the 4-year budget,  according to Army officials. Though the Army, in its role as Executive  Agent, ultimately concurred with the final CBDP budget plan, it  expressed its concern about CBDP’s decisions when doing so.
During the same time frame, CBDP transferred funding from an Air  Force threat-detection sensor program, according to Air Force  officials. The officials indicated that the program was a high priority for  their service and had, until that point, received sufficient funding.  However, according to the officials, CBDP removed nearly all of the  funding, approximately $50 million, in order to support other priorities,  including medical countermeasures.
Navy officials indicated that in fiscal year 2013, CBDP removed $90  million in funding for upgrades to a ship-based threat-detection sensor  program. This program would have addressed issues with the current  version of the system, such as false alarms and high rates of repair.  According to Navy officials, though they met frequently with the Joint  Requirements Office to advocate for the program, CBDP leadership  removed the funding during its review of the proposed budget.
CBDP officials acknowledged that they did not effectively communicate  with the military services regarding some of these actions, but stated that  their decisions were driven by the need to balance resources among all  priorities, including medical countermeasures. Also, CBDP officials noted  that the services had equipment available to respond to short-term  requirements. Additionally, CBDP officials told us that some of the  increased investments in medical countermeasures would not continue,  but were necessary to initiate specific programs, such as the creation of a  DOD facility for advanced development and manufacturing of medical  countermeasures. According to CBDP officials, they are now strategically  planning how they fund medical countermeasures for the future, so that  they do not have to transfer funding from other programs, though they  recognize that they will not always be able to meet all military service  resource-allocation requests. In addition, Army and Navy officials stated  that the Office of Cost Assessment and Program Evaluation within the  Office of the Secretary of Defense is conducting a study of DOD’s  biological defense capabilities and, among other things, the most- effective balance between capabilities, such as medical countermeasures  and personal protective equipment and threat-detection sensors. Army  officials told us that this study, which is slated for completion in mid-2014,  will help inform CBDP prioritization and resourcing decisions in the future.
Since CBDP made some of these funding decisions, it has updated its  practices for collaboration by issuing a business plan that details how it  will coordinate with stakeholders in the future, and military service officials  have agreed that these changes have resulted in improvements in  coordination among CBDP components. CBDP intends for its business  plan, issued in October 2012, to help it manage the program and develop  capabilities in a focused and collaborative manner by laying out a  framework through which CBDP stakeholders can align strategies. CBDP  established a yearly cycle to develop strategic guidance and establish  priorities, which ultimately inform CBDP’s budget planning and resource  decisions. In order to implement this cycle, CBDP created multiple teams,  at varying levels of authority, to provide input and recommendations. For  example, the Integrated Product Team includes representatives from all  of the military services and other members of CBDP. Members of this  team assess the composition of the CBDP portfolio, coordinate and align  CBDP efforts across the program, provide input on portfolio priorities, and  support budget development. Similar teams and boards at higher  organizational levels then review this input and make decisions.  Additionally, CBDP can charter teams to address specific issues as  needed. For example, CBDP officials said that a Medical Working  Integrated Product Team began holding meetings in January 2014 to  examine specific threats and determine which medical countermeasures  against biological threat agents DOD needs, and how to prioritize among  them.
According to the business plan, these processes support decision making  and incorporate perspectives from key stakeholders, including the military  services. According to CBDP officials, these efforts have resulted in  increased predictability, transparency, and representation of stakeholder  perspectives, including agreement on budget plans. Military service  officials complimented CBDP’s work to improve coordination, especially  the ability to provide early input into the strategic priorities, and said that  this change has resulted in a more-transparent budget process. These  officials told us that it will be important for CBDP to continue to improve  coordination and collaboration in the future. In particular, Army officials  expressed concern that potential revisions to the DOD directive on CBDP  roles and responsibilities could weaken their role and authorities as  Executive Agent. Under the current directive, the Army reviews the  CBDP funding plan, and provides senior-level input to CBDP leadership.  Army officials indicated that the Army nonconcurred on a draft revision to  this directive in October 2012, and CBDP officials told us that they  informally provided the Army an updated draft in March 2014.

		CBDP Coordinates the Activities of DOD Components Involved in the Research and Development of Medical Countermeasures against Biological Threat Agents

In addition to the internal DOD coordination processes that CBDP has  established for resource-allocation priorities and plans, CBDP has also  created groups to coordinate the stages of development of medical  countermeasures against biological threat agents. As previously  discussed, multiple DOD components are involved in researching and  developing medical countermeasures against biological threat agents,  and some countermeasure programs can shift back and forth between  components. According to CBDP officials, consistent coordination among  the components is needed to ensure that DOD provides mature  capabilities to the warfighter. To help improve coordination, CBDP  established the following teams.
Translational Teams. Members from multiple components within  CBDP participate in these teams to help transition medical  countermeasures against biological threat agents among the various  stages of development, such as moving from a research prototype  into advanced development. The teams provide visibility into the  status of each program, enabling each organization to better prepare  to support the programs, and also assist with CBDP resource  allocation, as they enable the shifting of funds among the  organizations depending upon the pace of development. Additionally,  the teams can serve as technical support, and help identify solutions  for DOD requirements.
Integrated Product Teams. These multidisciplinary teams integrate  all activities that DOD would need to perform to plan for and ultimately  acquire a medical countermeasure against biological threat agents.  According to officials, one team exists for each specific program, such  as filoviruses, and assesses the cost, schedule, and performance of  each program.

	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.

		DOD, HHS, and DHS Share a Joint Biological Research Campus

DOD, HHS, and DHS share a joint biological research campus, known as  the National Interagency Biodefense Campus, at Fort Detrick, Maryland,  which has its own governance structure. The campus is intended to  maximize resource sharing and facilitate scientific exchange on the study  of dangerous biological pathogens.campus and governance structure, which leverages available resources  and establishes joint strategies, aligns with our best practices for  collaborating across agency boundaries to help ensure that the  departments reach desired outcomes. DOD’s, HHS’s, and DHS’s  respective biological facilities at the shared campus include the following:   The creation of the research
DOD’s U.S. Army Medical Research Institute for Infectious Diseases  (USAMRIID) engages in scientific research of dangerous biological  threat agents. Its work after the terrorist attacks of September 11,  2001, expanded to include biological threat characterization,  enhanced studies of disease, and the development of medical  countermeasures.
HHS’s National Institute of Allergy and Infectious Diseases, of the  National Institutes of Health, built the Integrated Research Facility  (IRF) that includes biocontainment laboratories, which are shared with  other federal departments at the joint campus. The IRF allows HHS to  support its mission to study disease and develop improved methods  of treatment.
DHS’s National Biodefense Analysis and Countermeasures Center,  also located at the shared campus, allows DHS to share its repository  of pathogens and specimens to identify biological threat agents, and  characterize the potential threats to the civilian population through  studies to determine the cause of diseases.
In 2003, officials developed a governance structure for the Fort Detrick  research campus—the National Interagency Confederation for Biological  Research (NICBR)—that includes DOD, HHS, and DHS scientists who  engage in interagency scientific research of dangerous biological  pathogens. The primary goal of the NICBR is to respond to the need for  a “whole of government” effort by the federal government to address  bioterrorism. Most, if not all, aspects of medical countermeasure research  and development activities and associated finances fall under the  auspices of many federal departments that have different requirements,  funding sources, metrics, and areas of expertise and responsibility. No  one agency within the departments is involved in the end-to-end  development of medical countermeasures, nor does any one agency  have a complete overview of the medical countermeasure landscape  across the federal government. In an effort to link agency activities,  NICBR partners engage in shared efforts related to biological threat  characterization, studies to determine the cause of disease, and the  development of medical countermeasures to treat diseases resulting from  exposure to the pathogens. DOD, HHS, and DHS have ratified a strategic  plan to enhance coordination among the members of the NICBR. These  efforts align with our best practices for collaborating across agency  boundaries to help ensure that the departments reach desired outcomes,  specifically by leveraging available resources and establishing joint  strategies.
The NICBR governance structure includes the Fort Detrick Interagency  Coordinating Committee, made up of all NICBR partner representatives,  leading multiple subcommittees and working groups. NICBR officials, the various members that make up NICBR meet weekly,  at a minimum, and subcommittee and working group members meet  routinely to share scientific expertise, information, and technical services,  in accordance with their interagency agreements. NICBR partners share  responsibility for the governance structure and ongoing collaborative  research efforts. Along with regular meetings, DOD officials said that  NICBR partners also meet on an ad hoc basis due to the professional  relationships that have formed since the establishment of the governance  structure. In an example of this interagency collaboration and  coordination, according to DOD officials, the NICBR members facilitated  joint research efforts on the emerging infectious disease known as the  Middle East respiratory syndrome coronavirus. To advance the study of  the disease, Navy scientists collected specimens of the pathogen from a  foreign site and shared it with other DOD, DHS, and HHS scientists at  Fort Detrick, who conducted studies to understand the cause of the  disease. DOD scientists also collaborated with DHS and HHS scientists  at the campus to conduct other research towards a potential medical  countermeasure for the disease. DOD and IRF officials described the  interagency coordination to research the Middle East respiratory  syndrome coronavirus as mutually reinforcing research by leveraging  available expertise and facilitating scientific exchange. These efforts  correspond with best practices for enhancing collaborative efforts by  facilitating information sharing and communication and leveraging  available resources.
The Fort Detrick Interagency Coordinating Committee reports to an Executive Steering  Committee comprising of equivalent leadership officials from all partner agencies. The  Executive Steering Committee reports to a Board of Directors consisting of senior leaders  from all the partner agencies. improved their understanding of emerging diseases. DOD officials said  that shared biocontainment laboratories also facilitate scientific exchange,  data sharing, and collaboration on research. For example, IRF officials  told us that working with DOD scientists on biological defense helps HHS  understand how medical requirements to treat diseases can be defined to  support both the military and civilian population. DOD officials added that  because the field of senior-level scientists and officials involved in  research on biological threat agents at the shared campus is relatively  small, and scientists often move from one department to another within  the NICBR organization, valuable insights have been shared and  collaborative relationships have improved significantly.

		DOD and HHS Have Established Interagency Agreements and Collaboration Tools to Promote Coordination

			Interagency Agreements

DOD and HHS have signed various interagency agreements to support  joint activities for the various stages of the medical countermeasure  process. For example, the departments share interagency agreements  and memorandums of understanding that support interagency  coordination for medical countermeasure activities, such as coordinating  on early research and development, sharing certain resources at  advanced development facilities, and stockpiling medical  countermeasures, such as anthrax and smallpox vaccines. Together, the  agreements, which stipulate the roles and responsibilities for  coordination, are consistent with best practices for collaboration and  generally serve to promote agency collaboration by defining common  outcomes and providing interagency agreement on roles and  responsibilities, as called for in our previous work.
To support early research and development, DOD and HHS developed  various interagency agreements intended to promote coordination. The  agreements generally describe the basis for joint activities to mitigate the  threat of CBRN agents and global public health challenges, including  emerging infectious diseases. For example, one memorandum of  understanding supports the transfer of information and shared intellectual  property between DOD and HHS. DOD officials told us that sharing  medical countermeasure research has facilitated the ability to understand  the causes of disease. Another memorandum of understanding supports  information sharing between DOD and HHS regarding cutting-edge,  broad-spectrum capabilities that address current threat agents for both  military and civilian use. DOD officials said that collaborating on broad- spectrum countermeasures is important to support efforts to address  novel threats that may arise in the future. HHS officials said that these  broad-spectrum countermeasures, which provide the capability of  addressing more than one threat, also offer opportunities for financial  savings, commercial investment, and scientific efficiencies.
HHS officials said that the centers’ efforts also are intended to augment domestic  manufacturing surge capacity against pandemic influenza. of disposable equipment and alternative technologies for product  development and rapid manufacturing—to aid in the development and  production of medical countermeasures. DOD and HHS plan to  collaborate at their respective centers by sharing access to a network of  biodefense medical countermeasure innovators (including those from the  private sector) that can use emerging platform technologies to enhance  the production of biological medical countermeasures. The two  departments also plan to use their separate centers to reduce scientific  research and development expenses, risks of scientific failure, and to  provide more-reliable and sustainable medical countermeasure  manufacturing during times of need. According to DOD and HHS officials,  the centers are expected to advance scientific discovery through the use  of flexible technologies that support large-scale surge capacity for  biological medical countermeasures in quantities that will be sufficient  during emergencies and available for shared purposes.
To make medical countermeasures available for the warfighter, DOD and  HHS also have developed interagency agreements that allow DOD to  purchase, and HHS to rotate, certain products from HHS’s Strategic  National Stockpile for use by DOD’s military personnel. For example,  DOD and HHS have agreements that establish a framework allowing  DOD to purchase smallpox and anthrax vaccines from the Strategic  National Stockpile. According to DOD officials, DOD’s ability to  purchase the vaccines from the Strategic National Stockpile benefits both  departments financially and minimizes duplicative efforts. A similar  agreement facilitates coordination in the event of a shortfall in critical  medical countermeasures needed by either department in the event of a  public health incident related to a domestic catastrophic incident. Under  this agreement, HHS and DOD agree to share medical countermeasures,  including pharmaceuticals, biologics, medical and surgical supplies and  equipment that are needed by HHS or DOD to prepare for, respond to, or  recover from a public health incident of national significance. The  agreement is intended to create a standardized approach to coordinate  mutual support in the event of a medical countermeasures shortfall during  an emergency. DOD officials said that the agreement includes materials  and products from the Strategic National Stockpile as well as DOD  contingency materiel stockpiles. DOD officials said that the shared  stockpile benefits DOD both financially and in terms of logistics. For  example, DOD is able to access products it needs through the Strategic  National Stockpile, which provides efficiencies for the federal government  because the Centers for Disease Control and Prevention is able to rotate  medical countermeasures out of its stockpile. HHS officials agreed that  the ability to share stockpiles of medical countermeasures contributes  significantly during federal emergencies.

			Collaboration Tools

DOD and HHS, through the PHEMCE’s Integrated Portfolio, collaborate  on the status of medical countermeasure activities using tools intended to  promote communication on product development timelines and  milestones, clinical progress achieved, and other metrics for tracking and  monitoring. DOD and HHS have initiated actions consistent with practices  identified in our past work as well as federal internal control standards to  enhance information sharing and coordination. Specifically, DOD and  HHS have established the Integrated Portfolio Charter and other tools to  channel information across and within the departments to help ensure  that agency officials at all levels are informed of each department’s  medical countermeasures efforts. Both DOD and HHS officials said that  they often talk and meet more often than the monthly meetings that the  Integrated Portfolio Charter specifies. The Integrated Portfolio, made up  of senior-level HHS and DOD officials with responsibility for portfolio  analysis of CBRN medical countermeasures, has developed tools such  as a portfolio tracking system and knowledge-based standard terms to  help agencies communicate about the stages of research and  development. According to DOD and HHS officials, the tools have  enabled DOD and HHS to leverage investments and resources by  sharing information and metrics to understand each department’s  requirements, scope, schedule, and budget for developing  countermeasures. For example, the medical countermeasure Portfolio  Tracking Tool currently is being updated to support real-time viewing of  the status of all medical countermeasure products, allowing users to  analyze the status of countermeasures; develop estimates of key  planning parameters, including investments needed to meet  requirements; and minimize duplication of effort by anticipating transition  points. According to DOD officials, the ability to have an overview of all  existing medical countermeasure activities in one location has helped to  inform recommendations related to portfolio planning, including for  funding transitions and to improve gaps in each agency’s medical  countermeasure stockpiles. The Integrated Portfolio also aligned  Technology Readiness Levels, which is a shared language for medical  countermeasure research and development terms that are intended to  provide a common method to understand, at a general level, the maturity  of medical countermeasure development products over the development  life cycles. According to HHS officials, the aligned definitions facilitate  interagency communication during all stages of the medical  countermeasure process.

		DOD and DHS Have a Shared Process for Identifying Domestic Biological Threat Agents and Risks

DOD and DHS officials coordinate on the identification of biological threat  agents that pose risk to the nation through DOD’s participation in DHS’s  senior-level, quarterly terrorism risk-assessment working group meetings.  These efforts align with practices we have identified for collaborating  across agency boundaries—specifically, implementing practices that  enhance and sustain collaboration, including frequent communication  among and within the agencies. DOD provides input at the meetings  where information is gathered that is used to produce DHS’s biennial  Biological Terrorism Risk Assessments, which are distributed to national  organizations for the prioritization of medical countermeasures. While  DHS is responsible for assessing and prioritizing biological threat agents  that pose a risk to the civilian population, as directed by the Project  BioShield Act of 2004 and various HSPDs, DHS officials told us they  provide informal feedback to DOD on DOD’s prioritized biological threat  lists or risk assessments. DOD officials told us that DOD makes limited  use of information from DHS to prioritize its own threat list because DHS  focuses on domestic threats to civilians, while DOD focuses its threat and  risk assessments on global scenarios that pose a risk to the warfighter.  DOD and DHS also have agreements to operate across agency  boundaries, which aligns with our best practices. For example, DOD  and DHS have developed a memorandum of understanding to foster  information sharing and collaboration in areas of chemical and biological  defense, including science and technology research. Areas of  cooperation that are considered include use of facilities, exchange of  information and personnel, jointly produced documentation, and joint  project ventures. DHS officials told us the interagency cooperation would  generally occur at the Fort Detrick campus where the National Biodefense  Analysis and Countermeasures Center performs biological research using  its biocontainment laboratories with forensic capabilities. Although DHS  has agreements to share its facilities and resources with DOD, DHS  officials told us that to-date they have not performed extensive work for  DOD at the biological research facilities, though the departments have  had initial conversations for such efforts.

	Conclusions

DOD’s efforts within the department and with interagency partners have  resulted in progress in DOD’s ability to plan for and develop medical  countermeasures to respond to biological threat agents. However, some  elements need attention to capitalize on this progress. To ensure that  DOD officials are able to better prepare for and respond to potentially  catastrophic attacks with a biological threat agent, DOD guidance  requires annual updates and revalidation of its biological threat list. Yet,  DOD does not follow its established process for updating its biological  threat priorities, which has, in the past, led to conditions in which the list  has been updated without including input and review from key  stakeholders and in which the list has not been updated for long periods  of time—years in some cases. By following DOD guidance for updating its  biological threat list or by revising the list development process to reflect  its emphasis on capabilities- and risk-based planning, DOD could help  ensure that the list remains current and is validated regularly using input  from all key stakeholders. This, in turn, would help DOD sustain the  progress it has made in planning for medical countermeasures against  biological threat agents.

	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.

	Agency Comments and Our Evaluation

In written comments on a draft of this report, DOD concurred with our  recommendation to develop and implement a process for updating and  validating the department’s list of biological threats to ensure that they  align with current policies, practices, and priorities. DOD officials indicated  that they will review the relevant directives addressing biological warfare  threats to ensure that they align with DOD’s capabilities-based planning  processes and reflect a threat-informed, risk-based assessment. We  believe this effort, and any related specific actions, will address the intent  of our recommendation. The full text of DOD’s comments is reprinted in  appendix III. DOD also provided us with technical comments, which we  incorporated, as appropriate.
HHS did not provide formal agency comments on a draft of this report, but  provided technical comments, which we incorporated, as appropriate.  DHS also did not provide formal agency comments and had no technical  comments.
We are sending copies of this report to interested congressional  committees; the Secretaries of Defense, Health and Human Services,  and Homeland Security; the Assistant Secretary of Defense for Nuclear,  Chemical, and Biological Defense Programs; the Acting Deputy Assistant  Secretary of Defense for Chemical and Biological Defense; the Chairman  of the Joint Chiefs of Staff; the Secretaries of the Army, the Navy, and the  Air Force; the Commandant of the Marine Corps; the Director, Centers for  Disease Control and Prevention; the Commissioner, Food and Drug  Administration; the Director, National Institutes of Health; and the  Director, Office of Management and Budget. In addition, the report is  available at no charge on the GAO website at http://www.gao.gov.
If you or your staff have any questions concerning this report, please  contact Joseph Kirschbaum at (202) 512-9971 or KirschbaumJ@gao.gov  or Marcia Crosse at (202) 512-7114 or CrosseM@gao.gov. Contact  points for our Offices of Congressional Relations and Public Affairs may   be found on the last page of this report. GAO staff who made key  contributions to this report are listed in appendix IV.

Appendix I: Scope and Methodology

For the purposes of our review, we defined “medical countermeasures” as  the vaccines, drugs, and diagnostics that respond to chemical, biological,  and radiological threats. We defined “medical countermeasures against  biological threat agents” as the pretreatments, prophylaxes, therapeutics,  and diagnostics that respond specifically to biological threats. We did not  include personal protective equipment, such as gas masks, gloves, and  boots, or biosurveillance and detection equipment in our analysis. We  included in our definition of “biological threat agents” traditional,  emerging, and genetically modified agents. We defined “traditional”  biological agents as those naturally occurring microorganisms or toxin  products with the potential to be disseminated to cause mass casualties.  We defined “emerging” biological agents as previously unrecognized  pathogens that might be naturally occurring and present a serious risk to  human populations, and “genetically modified” agents as organisms that  have either been modified or developed to bypass traditional  countermeasures or produce a more-severe or enhanced disease. We  included budget data from fiscal year 2001 through fiscal year 2013, since  that period would be sufficient to allow us to analyze funding since the  2001 anthrax attacks.
To describe the Department of Defense’s (DOD) funding for medical  countermeasures from fiscal year 2001 through fiscal year 2013, we  obtained and analyzed data from the Chemical and Biological Defense  Program (CBDP) budget office and identified the total funding related  specifically to medical countermeasures against biological threat agents.  For the purposes of this objective, we defined medical countermeasures  against biological threat agents in alignment with the data DOD provided,  which did not include diagnostics. Specifically, we reviewed results from  CBDP’s Joint Service Chemical and Biological Information System, which  is used by CBDP for tracking this information. CBDP officials confirmed  that the data reflected obligations for fiscal year 2001 through 2012, and  budget allocations for fiscal year 2013. Using DOD’s National Defense  Budget Estimates for Fiscal Year 2014, we adjusted all figures for  inflation. Specifically, we used the research, development, test, and  evaluation deflation index for fiscal year 2013 from the Total Obligational  Authority by Appropriation Title table. After adjusting figures to fiscal year  constant 2013 dollars, we converted figures from thousands to millions  when appropriate for presentation purposes, and conducted analysis to  determine totals and percentages. Further, we interviewed agency  officials about how they use the Joint Service Chemical and Biological  Information System and how they ensured the accuracy of the data  provided, but we did not independently verify or validate the data provided  by DOD. Through these steps, we determined that the funding data  provided by DOD were sufficiently reliable to provide an overview of total  funding levels for medical countermeasures against biological threat  agents.
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. Further, we compared  the threats listed on DOD’s Chairman of the Joint Chiefs of Staff Threat  List, the Medical Risk Management Matrix, and the Medical Operational  Consequence Assessment, which were all developed by CBDP’s Joint  Requirements Office to identify significant biological threats to the  warfighter, and compared them to the medical countermeasures DOD is  researching, developing, and has made available for use. Finally, we  examined DOD’s efforts to research and develop medical  countermeasures against emerging and genetically modified biological  threat agents by reviewing DOD’s efforts to facilitate development of  broad-spectrum medical countermeasures and other unique production  and diagnosis capabilities that would be effective against a wide variety of  pathogens, including genetically modified threat agents. To corroborate  our understanding of the documents we reviewed, we interviewed officials  from CBDP and its component offices, and obtained these officials’  perspectives on their methodology and practices for updating lists of  prioritized threat agents.
To describe the status of DOD’s efforts to internally coordinate the  allocation of resources to medical countermeasures against biological  threat agents, we compared the coordination requirements established in  DOD’s policies, priorities, and strategies for its medical countermeasure  efforts to the way DOD agencies actually coordinate with each other to  prioritize, research, develop, and budget for medical countermeasures.  Specifically, we reviewed DOD Directive 5160.05E, Roles and  Responsibilities Associated with the Chemical and Biological Defense  Program, and CBDP’s 2012 business plan. To corroborate our  understanding of these policies and processes, and to understand how  DOD has applied its practices, we interviewed officials from within DOD  organizations responsible for researching and developing medical  countermeasures regarding each office’s responsibilities to coordinate  medical countermeasure efforts, including CBDP, Joint Requirements  Office, Joint Science and Technology Office, Joint Program Executive  Office, and Office of the Assistant Secretary of Defense for Health Affairs.  To understand service perspectives on DOD’s current practices, we  interviewed officials from the Army, the Navy, and the Air Force, and  reviewed documentation for the examples they cited. We also reviewed  guidelines established by DOD that are relevant to the organization and  structure of DOD’s medical countermeasure coordination efforts,  including the CBDP Strategic Plan and the Chairman of the Joint Chiefs  of Staff’s National Military Strategy to Counter Weapons of Mass  Destruction.
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. We interviewed DOD,  HHS, and DHS officials responsible for medical countermeasure efforts  against prioritized biological threat agents. Specifically, we compared the  coordination efforts of DOD, HHS, and DHS with the 2008 National  Defense Strategy, which advocates for a “whole of government” approach  to national security issues that requires that federal partners improve  efficiencies by working together on roles and missions, as well as prior  GAO reports on federal practices to enhance and sustain agency  collaboration that require, in particular, that agencies leverage available  resources, establish mutually reinforcing joint strategies, and develop  compatible policies, procedures, and other tools to operate across agency  boundaries.Internal Control in the Federal Government, which call for (1)  management to ensure that there are adequate means of communicating  with, and obtaining information from, external stakeholders, and (2)
We also compared the efforts against the Standards for  effective communication flowing down, across, and up the organization to  enable managers to carry out their internal control responsibilities.  Finally, we interviewed selected subject-matter experts from academia to  obtain their perspectives on DOD’s interagency coordination efforts with  HHS and DHS for the research and development of medical  countermeasures against biological threat agents.
We obtained relevant data and documentation and interviewed officials  from the following organizations:
Office of the Under Secretary of Defense for Acquisition, Technology
Office of the Assistant Secretary of Defense for Nuclear,  Chemical, and Biological Defense Programs
Office of the Deputy Assistant Secretary of Defense for
Office of the Assistant Secretary of Defense for Health Affairs  Joint Staff Directorate for Force Structure, Resources and  Assessment (J-8)
Defense Threat Reduction Agency  Joint Science and Technology Office
Defense Advanced Research Projects Agency
Office of the Assistant Secretary of the Army for Acquisitions,  Logistics, and Technology  Joint Program Executive Office for Chemical and Biological  Defense
Office of the Deputy Chief of Staff for Programming (G-8)
Office of The Surgeon General and U.S. Army Medical
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Materiel Development Activity
U.S. Army Medical Research Institute of Infectious
Chief of Naval Operations, Surface Warfare (N96), Chemical,  Biological, Radiological, and Nuclear Defense Branch
Operations, Plans and Requirements
Logistics, Installations and Mission Support  Department of Health and Human Services
Assistant Secretary for Preparedness and Response
Biomedical Advanced Research and Development Authority
Public Health Emergency Medical Countermeasures Enterprise
National Institutes of Heath
National Institute of Allergy and Infectious Diseases
Centers for Disease Control and Prevention
Food and Drug Administration
Science and Technology Directorate
Office of Health Affairs
National Biodefense Analysis and Countermeasures Center
University of Pittsburgh Medical Center for Health Security
National Interagency Confederation for Biological Research  We conducted this performance audit from August 2013 to May 2014 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

Appendix II: Department of Defense (DOD) Funding for Chemical and Biological Defense Program and Medical Countermeasures, in Nominal Dollars

	Dollars in thousands

		Fiscal year 2001

Appendix III: Comments from the Department of Defense

Appendix IV: GAO Contact and Staff Acknowledgments

	GAO Contacts

	Staff Acknowledgments

In addition to the contact named above, GAO staff who made key  contributions to this report include Mark A. Pross, Assistant Director;  Karen Doran, Assistant Director; Natalya Barden; Richard Burkard; Mae  Jones; Amie Lesser; Carolina Morgan; Randy Neice; Carol Petersen;  Terry Richardson; Jennifer Spence; and Elaine Vaurio.

Related GAO Products

National Preparedness: HHS Has Funded Flexible Manufacturing  Activities for Medical Countermeasures, but It Is Too Soon to Assess  Their Effect. GAO-14-329. Washington, D.C.: March 31, 2014.
National Preparedness: HHS Is Monitoring the Progress of Its Medical  Countermeasure Efforts but Has Not Provided Previously Recommended  Spending Estimates. GAO-14-90. Washington, D.C.: December 27, 2013.
National Preparedness: Efforts to Address the Medical Needs of Children  in a Chemical, Biological, Radiological, or Nuclear Incident. GAO-13-438.  Washington, D.C.: April 30, 2013.
High-Containment Laboratories: Assessment of the Nation’s Need Is  Missing. GAO-13-466R. Washington, D.C.: February 25, 2013.
National Preparedness: Countermeasures for Thermal Burns.  GAO-12-304R. Washington, D.C.: February 22, 2012.
National Preparedness: Improvements Needed for Acquiring Medical  Countermeasures to Threats from Terrorism and Other Sources.  GAO-12-121. Washington, D.C.: October 26, 2011.
Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be  Incorporated into Future Planning. GAO-11-632. Washington, D.C.: June  27, 2011.
Influenza Vaccine: Federal Investments in Alternative Technologies and  Challenges to Development and Licensure. GAO-11-435. Washington,  D.C.: June 27, 2011.
National Preparedness: DHS and HHS Can Further Strengthen  Coordination for Chemical, Biological, Radiological, and Nuclear Risk  Assessments. GAO-11-606. Washington, D.C.: June 21, 2011.
Public Health Preparedness: Developing and Acquiring Medical  Countermeasures Against Chemical, Biological, Radiological, and  Nuclear Agents. GAO-11-567T. Washington, D.C.: April 13, 2011.
High-Containment Laboratories: National Strategy for Oversight Is  Needed. GAO-09-1045T. Washington, D.C.: September 22, 2009.
High-Containment Laboratories: National Strategy for Oversight Is  Needed. GAO-09-1036T. Washington, D.C.: September 22, 2009.
High-Containment Laboratories: National Strategy for Oversight Is  Needed. GAO-09-574. Washington, D.C.: September 21, 2009.
High-Containment Biosafety Laboratories: Preliminary Observations on  the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the  United States. GAO-08-108T. Washington, D.C.: October 4, 2007.

Summary:
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.