National Preparedness: HHS Is Monitoring the Progress of Its Medical Countermeasure Efforts but Has Not Provided Previously Recommended Spending Estimates
Published: 2013-12-27T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Public health emergencies--the 2001 anthrax attacks, the 2009 H1N1 influenza pandemic, and others--have raised concerns about national vulnerability to threats from chemical, biological, radiological, and nuclear agents and new infectious diseases. There are some medical countermeasures--drugs, vaccines, and medical devices such as diagnostics--available to prevent, diagnose, or mitigate the public health impact of these agents and diseases, and development continues. HHS leads federal efforts to develop and procure countermeasures through the interagency PHEMCE. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 mandated GAO to examine HHS's and PHEMCE's planning documents for medical countermeasure development and procurement needs and priorities.
This report examines the extent to which HHS developed timelines, milestones, and spending estimates for PHEMCE priorities. GAO reviewed relevant laws; analyzed HHS's 2012 PHEMCE Strategy and Implementation Plan, HHS's tools for tracking the implementation of PHEMCE activities, and data on countermeasure spending from fiscal years 2010 through 2013; and interviewed HHS officials.
section_title: What GAO Found
paragraphs: The Department of Health and Human Services (HHS) has established timelines and milestones for the 72 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) priorities--33 activities, 25 threat-based approaches, and 14 capabilities--that HHS selected as key to fulfilling PHEMCE strategic goals. However, HHS has not made spending estimates for its medical countermeasure development or procurement priorities (priority countermeasures) publicly available. In the PHEMCE implementation plan, HHS has grouped the 72 PHEMCE priorities into three time frames for completion--near-term (fiscal years 2012 through 2014), midterm (fiscal years 2015 through 2017), and long-term (fiscal year 2018 and beyond). For 21 priority activities, 10 priority threat-based approaches, and 8 priority capabilities, HHS and PHEMCE have identified specific deliverables, each tied to a milestone or set of milestones that delineate the steps necessary to complete deliverables, and established more specific timelines for completion of deliverables and milestones. For example, HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR) is to lead the development of medical countermeasure requirements, which outline countermeasure quantity, type, and desired characteristics. Deliverables are the threat-specific requirements, such as for antidotes for mustard gas and other blister agents. Milestones for mustard gas antidote requirements reflect the PHEMCE activities to develop the requirements and the necessary approvals; the milestones are tied to interim timelines and culminate in approval by the ASPR Assistant Secretary by September 2013. HHS has not established specific deliverables, milestones, or timelines for the remaining 12 priority activities, 15 priority threat-based approaches, and 6 priority capabilities other than their overall completion within the specified near- or midterm time frame. HHS monitors progress in completing deliverables and milestones for the priorities monthly, with PHEMCE partners meeting to discuss potential barriers to completing deliverables or meeting milestones and possible options to mitigate these barriers. As of September 2013 (the most recent information available), HHS reported that PHEMCE partners have completed 10 deliverables for the 72 priorities, resulting in completion of 5 priorities. GAO did not examine the status of the priorities that did not have specific deliverables, timelines, and milestones.
HHS has developed spending estimates for priority countermeasures for internal planning purposes but has not made them publicly available. In 2011, GAO recommended that HHS provide more specific anticipated spending information in an updated plan to assist with long-term planning. HHS's 2012 plan contains information on how countermeasures may be funded, such as through advanced development funds, but does not include estimates of how much PHEMCE may spend to develop specific countermeasures. HHS officials said they are hesitant to provide estimates because they do not want to create the expectation that estimates would reflect final contract amounts. However, consistent with our prior recommendation and Pandemic and All-Hazards Preparedness Reauthorization Act requirements, HHS plans to include spending estimates in the next iteration of the plan, anticipated in September 2014, but has not determined the nature and format of the estimates that would be included. Providing estimates would allow HHS's industry partners to suitably target research and development to fulfill countermeasure priorities, especially in tighter budget climates.
section_title: What GAO Recommends
paragraphs: Although GAO is not making any new recommendations, based on prior work GAO is continuing to emphasize its 2011 recommendation that HHS make more specific anticipated spending information available to countermeasure developers. In its comments, HHS discussed its efforts to develop spending estimates.

section_title: Letter
paragraphs: Public health emergencies in the new millennium—the 2001 anthrax  attacks, the 2009 H1N1 influenza pandemic, the Middle East respiratory  syndrome coronavirus currently circulating in Saudi Arabia and other  countries, and others—continue to raise concern about our nation’s  vulnerability to threats from chemical, biological, radiological, and nuclear  (CBRN) agents and new or reemerging infectious diseases. Rapid  diagnosis, treatment, and prevention may minimize the public health  effects of a release of a CBRN agent or the spread of a new or  reemerging infectious disease. There are some medical  countermeasures—drugs, vaccines, and devices to diagnose, treat,  prevent, or mitigate potential health effects of exposure—available for  these agents and diseases. However, research and development to  create usable countermeasures is a lengthy, complex, and expensive  process that requires public and private investment. Since 2004,  Congress has authorized over $8 billion for the procurement of medical   However, the general  countermeasures for use against CBRN agents.lack of a commercial market for medical countermeasures against these  agents and diseases may reduce incentives for industry—pharmaceutical  and medical device manufacturers—to invest millions of dollars to  develop CBRN medical countermeasures instead of other products that  may be more lucrative.
The Department of Health and Human Services (HHS) is the federal  agency primarily responsible for identifying needed medical  countermeasures to prevent or mitigate potential health effects from  exposure to CBRN agents and new or reemerging infectious diseases  and for engaging with industry to develop those countermeasures. In  2006, HHS established the Public Health Emergency Medical  Countermeasures Enterprise (PHEMCE), a federal interagency body  whose partners include certain HHS agencies and offices, the  Department of Homeland Security (DHS), the Department of Defense,  and other federal agencies. PHEMCE is responsible for providing  recommendations to the Secretary of Health and Human Services on  medical countermeasure priorities and development and procurement  activities. PHEMCE also coordinates the life cycle of medical  countermeasure research and development from basic research, through  advanced research and development, to procurement for the Strategic  National Stockpile (SNS)—the national repository for medications,  medical supplies, and equipment for use in a public health emergency— and develops policies, plans, and guidance for the use of countermeasure  products.
In October 2011, we reported on HHS’s and PHEMCE’s efforts to develop  and procure priority medical countermeasures and found that some improvements were needed for HHS to effectively oversee these efforts.For example, we found that HHS lacked an adequate strategy to monitor  the implementation of recommendations from its 2010 PHEMCE review.  We also found that HHS had not yet updated the first PHEMCE  Implementation Plan for procuring CBRN countermeasure priorities,  published in 2007, even though HHS had planned to update it biennially.  We recommended that the department update the plan, include more  specific information about anticipated spending, and strengthen its  oversight of how HHS agencies and offices were implementing certain  activities intended to enhance PHEMCE. HHS agreed with our overall  recommendations but did not provide any comments specifically about its  plans to include anticipated spending estimates in any implementation  plan updates. We discuss the current status of this recommendation later  in the report. In June 2012, HHS published the PHEMCE Strategy, and  in December 2012 it published the PHEMCE Implementation Plan,serves to update the 2007 implementation plan.
The Pandemic and All-Hazards Preparedness Reauthorization Act of  2013 (PAHPRA) requires GAO to examine HHS’s PHEMCE strategy and  implementation plan, which lay out PHEMCE’s strategic goals and  activities for achieving these goals and developing and procuring priority  medical countermeasures. This report addresses the extent to which HHS has developed timelines, milestones, and anticipated spending  estimates to achieve PHEMCE priorities laid out in these documents. We  provide information on HHS’s spending on medical countermeasure  development and procurement from fiscal year 2010 through fiscal year  2013 in appendix I.
To determine the extent to which HHS has developed timelines,  milestones, and anticipated spending estimates to achieve the PHEMCE  priorities, we reviewed relevant laws to determine requirements for HHS  to develop the PHEMCE Strategy and Implementation Plan and any  required elements to be included in these documents. We obtained and  analyzed HHS’s most recent PHEMCE planning documents, including its  2012 PHEMCE Strategy and 2012 PHEMCE Implementation Plan, to  identify PHEMCE priorities, and we reviewed the 72 items in the  implementation plan that HHS selected as key priorities for fulfilling  PHEMCE’s strategic goals within the next 5 years. We also analyzed  these documents and other documents HHS uses to track the  implementation of PHEMCE activities to identify any timelines,  milestones, and anticipated spending estimates HHS may have  established to achieve these priorities. We compared these documents to  the Project Management Institute’s The Standard for Program  Management—which calls for development of timelines, milestones, and  cost estimates as program management leading practices—to determine  whether HHS had appropriate controls in place to oversee the  implementation of PHEMCE activities.the progress PHEMCE participants had made in meeting timelines and  milestones to achieve the priorities, based on HHS reporting from its  tracking documents through September 2013, the most recent information  available at the time of our review. We did not conduct further analysis of  the progress that has been made because of the relatively short period  from the publication of the implementation plan in December 2012 to the  time we completed our review. We interviewed PHEMCE partners from  HHS agencies and offices—including the Office of the Assistant Secretary  for Preparedness and Response (ASPR), the Biomedical Advanced  Research and Development Authority (BARDA), the National Institutes of  Health (NIH), the Centers for Disease Control and Prevention (CDC), and  the Food and Drug Administration (FDA)—to obtain information on HHS  timelines, milestones, and spending estimates for PHEMCE priorities;  how HHS tracks the progress of PHEMCE partners in implementing the  PHEMCE priorities; and progress made to date.
We also examined information on  In addition, to provide information on HHS’s spending on medical  countermeasure development and procurement in appendix I, we  obtained and analyzed HHS data on its spending for medical  countermeasure advanced research, development, and procurement from   We chose this period because  fiscal year 2010 through fiscal year 2013. we previously reported on HHS’s medical countermeasure spending from  fiscal year 2007 through fiscal year 2010. We obtained information from  HHS and interviewed officials about how they ensure the accuracy of the  funding information provided. We did not independently verify the  spending information provided by HHS, but we determined, through  interviews and reviews of supporting information, that the data we  received from HHS were sufficiently reliable for our purposes.
We conducted this performance audit from May 2013 through December  2013 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.
subsections: section_title: Background
paragraphs: Since 2004, Congress has authorized over $8 billion for medical  countermeasure procurement. The Project BioShield Act of 2004  authorized the appropriation of $5.6 billion from fiscal year 2004 through  fiscal year 2013 for the Project BioShield Special Reserve Fund, and  funds totaling this amount were appropriated. The act facilitated the  creation of a government countermeasure market by authorizing the  government to commit to making the Special Reserve Fund available to  purchase certain medical countermeasures, including those  countermeasures that may not be FDA-approved, cleared, or licensed.  In 2013, PAHPRA authorized an additional $2.8 billion to be available  from fiscal year 2014 through fiscal year 2018 for these activities,funding has not yet been appropriated for these years. In addition to the   but  Special Reserve Fund, Congress has also made funding available  through annual and supplemental appropriations to respond to influenza  pandemics, including developing vaccines and other drugs.
subsections: section_title: Federal Roles and Responsibilities Related to Medical Countermeasures
paragraphs: HHS is the primary federal department responsible for public health  emergency planning and response, including medical countermeasure  development, procurement, and distribution. HHS also coordinates with  other federal departments, such as DHS, through PHEMCE.
Within HHS, several offices and agencies have specific responsibilities for  public health preparedness and response.
HHS’s ASPR leads PHEMCE and the federal medical and public  health response to public health emergencies, including strategic  planning, medical countermeasure prioritization, and support for  developing, procuring, and planning for the effective use of medical  countermeasures.
Within ASPR, BARDA—established by the Pandemic and All-Hazards  Preparedness Act of 2006—oversees and supports advanced  development and procurement of some medical countermeasures into  the SNS.
NIH conducts and funds basic and applied research and early  development needed to develop new or enhanced medical  countermeasures and related medical tools for CBRN and infectious  disease threats.
CDC maintains the SNS, including purchasing commercially available  products as necessary, and supports state and local public health  departments’ efforts to detect and respond to public health  emergencies, including providing guidance and recommendations for  the mass dispensing and use of medical countermeasures from the  SNS.
FDA assesses the safety and effectiveness of medical  countermeasures; regulates their development; approves, clears, or  licenses them; and conducts postmarket surveillance as part of its  overall role to assess the safety and effectiveness of medical  products. FDA also provides technical assistance to help ensure that  product development meets FDA’s regulatory requirements and  provides technical support for the development of regulatory science  tools. FDA may authorize the emergency use of medical products that  have not yet been approved, cleared, or licensed or were approved,  cleared, or licensed only for other uses.
DHS develops material threat assessments (MTA), in coordination with  HHS, to assess the threat posed by given CBRN agents or classes of  agents and the potential number of human exposures in plausible, high- consequence scenarios. DHS uses the MTAs to determine which CBRN  agents pose a material threat sufficient to affect national security and to  provide HHS with a basis for determining needed countermeasures for  those agents. DHS also develops terrorism risk assessments (TRA) to  assess the relative risks posed by CBRN agents based on variable  threats, vulnerabilities, and consequences.
HHS’s PHEMCE is responsible for establishing civilian medical  countermeasure priorities for CBRN and emerging infectious disease  threats, including influenza; coordinating federal efforts to research,  develop, and procure medical countermeasures to enhance  preparedness and response for public health threats; and developing  policies, plans, and guidance for the use of countermeasure products in a  public health emergency. PHEMCE is composed of officials from ASPR,  including BARDA; CDC; FDA; NIH; and other federal departments,  including the Departments of Agriculture, Defense, Homeland Security,  and Veterans Affairs. HHS and PHEMCE establish federal medical  countermeasure development and procurement priorities through a  multistep process. This process includes assessing the threat posed by  CBRN agents and the potential consequences they pose to public health,  determining medical countermeasure requirements—the type of  countermeasure (vaccines, drugs, or medical devices such as  diagnostics), the amount needed, and characteristics of the  countermeasures (such as formulations, dosing, and packaging)—for  these agents, evaluating public health response capability, and  developing and procuring countermeasures against these CBRN agents.  (See fig. 1.)
section_title: PHEMCE Strategy, Implementation Plan, and Priorities
paragraphs: The 2012 PHEMCE Strategy lays out the four PHEMCE strategic goals  and their underlying objectives for building HHS’s countermeasure  capabilities to respond to a public health emergency. The 2012 PHEMCE  Implementation Plan updates the 2007 implementation plan and  describes the activities that HHS and its interagency partners plan to  conduct to achieve the four strategic goals and their associated  objectives, the medical countermeasures HHS wants to develop and  procure, and the capabilities HHS wants to build to support  countermeasure development and procurement. The plan also includes  72 items that HHS selected as key priorities for fulfilling PHEMCE’s  strategic goals within the next 5 years, which the agency placed into three  categories. For the purposes of this report we refer to the items in these  categories as “priority activities,” “priority threat-based approaches,” and  “priority capabilities.”
The 33 priority activities reflect activities that support PHEMCE’s  overall mission and include pursuits such as developing systems to  track countermeasure activities across all PHEMCE partners,  enhancing national laboratory capabilities, and developing guidance  documents and information for the public on using medical  countermeasures in an emergency. (See table 1 for examples of  PHEMCE priority activities by strategic goal.)
In addition to the 33 priority activities, the 25 items identified as  priorities for threat-based approaches are intended to directly address  threats such as anthrax or smallpox. These priorities include pursuits  such as publishing updated clinical guidance for anthrax  countermeasures; developing and qualifying with FDA animal models  to test the safety and efficacy of medical countermeasures for certain  biological, radiological, and nuclear threats; and developing new  plans for the distribution and dispensing of pandemic influenza  antivirals.
The remaining 14 items identified as priority capabilities reflect what  HHS refers to as crosscutting capabilities. The priority capabilities are  a mix of programs or technological applications that may, for example,  support the development of countermeasures for a range of existing  CBRN threats or for any new threats that may emerge in the future, or  build infrastructure to provide countermeasure developers assistance  with advanced development and manufacturing services. The priority  capabilities include such pursuits as initiating a research program to  fill gaps in knowledge in the area of patient decontamination in a  chemical incident and establishing a network of facilities to support  the filling and finishing of vaccines and other countermeasures.
In addition to the 72 items HHS selected as key priorities for fulfilling  PHEMCE’s strategic goals, the implementation plan also identifies the  medical countermeasures that constitute HHS’s priorities for development  and procurement to fulfill strategic goal 1, which we refer to as “priority  countermeasures” for the purposes of this report. (See table 2.) Many of  the threat-specific countermeasures for which PHEMCE set procurement  priorities in 2007 continue to be priorities for development and  procurement in the 2012 plan, such as anthrax vaccine, smallpox  antivirals, chemical agent antidotes, and diagnostic devices for  radiological and nuclear agents. The 2012 plan also includes pandemic  influenza countermeasures and nonpharmaceutical countermeasures,  such as ventilators, as priorities, whereas the 2007 plan focused on  CBRN medical countermeasures only.
section_title: HHS Has Established Timelines and Milestones for Key PHEMCE Priorities but Has Not Yet Provided Previously Recommended Anticipated Spending Estimates for Priority Countermeasures
paragraphs: HHS has established timelines and milestones for the 72 priority  activities, threat-based approaches, and capabilities identified in the 2012  PHEMCE Implementation Plan as key to fulfilling PHEMCE’s strategic  goals. However, while HHS has developed spending estimates for its  priority medical countermeasures for internal planning purposes, it has  not made these estimates publicly available, as we previously  recommended in 2011.
subsections: section_title: HHS Has Established Timelines and Milestones for Key PHEMCE Priorities
paragraphs: HHS has established timelines and milestones for the 72 items it selected  as key priorities for fulfilling PHEMCE’s strategic goals. Leading practices  for program management call for establishing time frames and milestones  as part of a plan to ensure that organizations achieve intended results.In the implementation plan, HHS has assigned each of the 33 priority  activities, the 25 priority threat-based approaches, and the 14 priority  capabilities to one of three time frames for completion—near-term (fiscal  years 2012 through 2014), midterm (fiscal years 2015 through 2017), and  long-term (fiscal year 2018 and beyond). In addition, HHS has placed  PHEMCE’s priority countermeasures into these time frames. All but 2 of  the 33 priority activities, and all of the priority threat-based approaches  and capabilities, are slated for completion in either the near term or the  midterm.
HHS has also identified deliverables and milestones for some of the  priority activities, threat-based approaches, and capabilities, and  assigned them more specific timelines. For 21 of the 33 priority activities,  10 of the 25 priority threat-based approaches, and 8 of the 14 priority  capabilities, HHS and the PHEMCE agency or office responsible for  carrying out the activity have identified specific deliverables intended to  complete them. PHEMCE partners have tied each deliverable to a  specific milestone or set of milestones, which delineate the steps  necessary to complete the deliverable. In addition, the deliverables and  milestones may have more specific timelines, such as an actual month or  year of expected completion within the broader multiyear near- or  midterm time frame. Examples of deliverables, milestones, and more  specific timelines for PHEMCE priorities include the following:
For the priority activity that states that ASPR is to lead PHEMCE in  developing or updating medical countermeasure requirements for  certain CBRN threats by the end of fiscal year 2014, ASPR has  identified the requirements for each specific threat—such as  requirements for countermeasures for mustard gas and other blister  agents—as the individual deliverables for this activity. The blister  agents requirement deliverable has four associated milestones that  reflect the various activities of a PHEMCE working group to develop  the requirements and the levels of PHEMCE and HHS approval  needed, culminating in the approval by the ASPR Assistant Secretary  by September 2013.
For the priority threat-based approach of qualifying animal models for  biological threats, the deliverable is FDA qualification of the animal  model, and the three milestones are the development of animal models for anthrax, plague, and tularemia in fiscal year 2015.
For the priority capability of initiating funding for the development of  diagnostic systems for biological and chemical threat agents, and  systems to identify and characterize unknown threats, the deliverable  is NIH’s awarding of funds to eligible applicants; the set of milestones  for this deliverable are obtaining NIH approval to publish a solicitation  for proposals for development of the diagnostics, publishing the  solicitation in July 2013, and making awards in fiscal year 2014. NIH  also plans to award additional funds in fiscal year 2015 for the  development of multiplex diagnostic platforms for multiple threats.
For the priority countermeasures, HHS officials told us that the  department includes specific milestones in the contracts it awards to  developers; these milestones reflect the expected course for research  and development, such as holding and completing clinical trials to test  the efficacy of a countermeasure or submitting inventory and storage  plans, and have associated completion dates.
For the remaining 12 priority activities, 15 priority threat-based  approaches, and 6 priority capabilities, HHS has not established specific  deliverables with milestones and timelines other than the overall  completion of the priority within the specified near- or midterm time frame.  HHS officials told us that some activities do not have specific timelines  because HHS considers them to be ongoing activities that PHEMCE  conducts regularly. For example, at least every 18 months, ASPR  conducts formal reviews across participating PHEMCE agencies of  medical countermeasure portfolios for specific threats in order to monitor  progress in developing and procuring medical countermeasures for those  threats, identify remaining gaps and challenges to developing and  procuring countermeasures, and develop potential solutions. For activities  in the implementation plan that are slated for completion in the long term,  HHS officials said that they intend to develop more specific timelines as  the near- and midterm activities are completed.
ASPR tracks the progress of participating PHEMCE partners in  implementing the priority activities, threat-based approaches, and  capabilities by holding monthly meetings to collect information on  progress. According to HHS officials, during these monthly meetings,  PHEMCE participants discuss their progress in completing deliverables,  potential barriers to completion, and any options to help mitigate these  barriers. ASPR officials told us they rely on the PHEMCE partner  responsible for the activity to have adequate project management  controls in place to determine the amount of progress that the partner  agency has made. If an agency anticipates delays in or barriers to  completing and meeting certain milestones, ASPR officials may assist in  identifying additional support within PHEMCE partner agencies or within  other federal agencies. For example, HHS officials told us that for one  priority activity’s deliverable—developing requirements for anthrax  antitoxins—CDC and FDA officials differed in their professional opinions  on guidance for clinicians to administer the drug. PHEMCE senior  management worked with the agencies to develop consensus wording for  the guidance document to complete that deliverable. ASPR officials told  us that they enter information collected in the meetings into a  spreadsheet that contains descriptions of the PHEMCE priority activities,  threat-based approaches, and capabilities; their associated deliverables,  milestones, and timelines; and information on current progress, barriers to  completion, and mitigation options. ASPR follows up with PHEMCE  partners after the meetings to obtain any additional information, if  necessary. ASPR distributes the finalized spreadsheet to PHEMCE  partners about 1 week in advance of the next monthly meeting for them to  use as reference for that meeting. ASPR officials told us they developed  the tracking spreadsheet in response to the recommendation in our 2011  report that HHS develop a written strategy to monitor the implementation  of recommendations from HHS’s 2010 PHEMCE review and incorporated  the PHEMCE priorities into the spreadsheet when HHS updated the  implementation plan.
At the completion of our review, PHEMCE was halfway through its near- term period of fiscal year 2012 through fiscal year 2014. As of September  2013 (the most recent information available):
PHEMCE partners reported completing five deliverables for the 21  priority activities. For example, for the priority activity that specifies  that HHS, DHS, and other federal partners are to formalize roles,  responsibilities, policies, and procedures for conducting the next  generation of MTAs and TRAs, HHS and DHS completed one of two  deliverables by developing and cosigning a strategic implementation  plan to conduct MTAs.
PHEMCE partners reported completing three deliverables for the 10  priority threat-based approaches. For example, for one of the threat- based approaches, PHEMCE partners report completing the sole  deliverable of developing guidance that establishes the order in which  different groups of affected individuals would receive anthrax  vaccination in a public health emergency. The completion of the three  deliverables resulted in the completion of three priority threat-based  approaches.
PHEMCE partners reported completing two deliverables for the eight  priority capabilities. For example, for one of the priority capabilities,  PHEMCE partners have reported completing the sole deliverable that  specifies that BARDA will initiate a research program to address  knowledge gaps in chemical decontamination of exposed individuals  by awarding a contract to a university to gather data and develop  decontamination procedures. The completion of the two deliverables  resulted in the completion of two priority capabilities.
section_title: HHS Has Not Provided Previously Recommended Spending Estimates for Priority Countermeasures
paragraphs: HHS has not provided publicly available spending estimates for research,  development, or procurement for the countermeasures it identified as  priorities in the 2012 implementation plan. We previously recommended  that HHS provide more specific information on anticipated  countermeasure spending when it updated its 2007 plan. Additionally,  PAHPRA directs HHS to include anticipated funding allocations for each  countermeasure priority in the PHEMCE strategy and implementation  plan. The implementation plan contains information on the source of the  funds for research, development, and procurement, such as the Special  Reserve Fund. However, the plan does not include any estimates of how  much of these funds HHS may spend to develop or procure specific  priority countermeasures. HHS officials told us that while PHEMCE has  developed spending estimates for internal planning, they are hesitant to  provide these estimates to manufacturers because they do not want to  create the expectation that the estimates would reflect any final contract  amounts. In addition, anticipated spending estimates for future years may  be unreliable because, according to HHS officials, the Special Reserve  Fund will be appropriated annually after fiscal year 2014, as opposed to  the fiscal year 2004 appropriation, which appropriated funds for a 10-year  period. Additionally, officials stated that because HHS published the  PHEMCE Implementation Plan prior to the passage of PAHPRA, the  department did not include any spending estimates in the plan because it  was unaware that PAHPRA would include that requirement. HHS officials  said that they plan to include estimates in the next iteration of the plan,  which they anticipate publishing in September 2014, based on the time  frames laid out in PAHPRA. However, the nature and format of the  spending estimates that would be included in the plan had not been  determined. As we stated in our previous recommendation, information  on anticipated spending would allow HHS’s industry partners to suitably  target research and development to fulfill PHEMCE’s countermeasure  priorities, especially in tighter budget climates. While HHS officials  expressed concerns regarding sharing internal spending estimates and  the short-term nature of annual appropriations, these concerns could be  addressed by agency communications with manufacturers when  providing the spending estimates to make clear that spending estimates  may not reflect final contract amounts, which depend on enacted  appropriations levels, among other factors.
section_title: Concluding Observations
paragraphs: Developing and procuring medical countermeasures is a complex  process that requires engagement across the federal government and  with countermeasure developers in private industry. HHS has  strengthened PHEMCE planning and oversight and has made progress in  developing and procuring some medical countermeasures. However,  given its almost 10-year efforts and the continuing lack of available  countermeasures to fulfill PHEMCE’s many priorities, HHS would benefit  from sharing information on its anticipated spending estimates with  industry, to assist countermeasure developers with long-term business  planning. PAHPRA’s requirement for HHS to include spending estimates  for each medical countermeasure priority in future PHEMCE  implementation plans is consistent with our 2011 recommendation. HHS’s  plans to include more specific spending estimates in future plan updates  could help implement both this requirement and our 2011  recommendation, provided the department makes meaningful estimates  of spending for countermeasure research, development, and procurement  available to industry. These estimates—or ranges of estimates—will  provide HHS’s industry partners with more transparency on anticipated  returns on investment in the face of competing priorities for developing  other drugs with a commercial market. We believe the value of making  this information available outweighs HHS’s concerns, especially those  related to uncertainty over future appropriations; anticipated  countermeasure spending would provide industry with the information it  needs to determine whether and how to suitably target their research and  development programs in tight budget climates.
section_title: Agency Comments
paragraphs: We provided a draft of this report to HHS, and its comments are reprinted  in appendix II. In its comments, HHS acknowledged the effort we have  taken to document HHS’s tracking processes for the activities in the 2012  PHEMCE Implementation Plan. HHS commented that the 72 activities we  focused on in this review—which were described in the implementation  plan as key to HHS’s efforts in the near and midterm—were a subset of  255 near- and midterm activities delineated in the implementation plan  and that these 72 items were meant to be an illustrative but not  comprehensive list of priorities. Further, HHS stated that it considered all  255 near- and midterm activities as priorities. HHS provided information  on its efforts to track its progress on the remainder of these items that we  did not discuss in the report and to establish deliverables and interim  milestones for the activities slated for the midterm (fiscal years 2015  through 2017) as that period approaches. Finally, HHS provided  information on its efforts to quantify its resource needs and provide more  transparent anticipated spending information for its medical  countermeasure development efforts while maintaining the integrity of the  federal contracting process. HHS stated that it is working to find a  compromise solution that will provide this transparency in light of statutory  requirements and GAO’s 2011 recommendation. HHS also provided  technical comments, which we incorporated as appropriate.
We are sending copies of this report to the Secretary of Health and  Human Services. In addition, the report is available at no charge on the  GAO website at http://www.gao.gov.
If you or your staffs have any questions about this report, please contact  me at (202) 512-7114 or dsouzav@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 III.
section_title: Appendix I: HHS Spending on Advanced Research, Development, and Procurement of Medical Countermeasures
paragraphs: The Department of Health and Human Services (HHS) spent  approximately $3.6 billion in advanced research, development, and  procurement of chemical, biological, radiological, and nuclear (CBRN)  and pandemic influenza medical countermeasures from fiscal year 2010  through fiscal year 2013. Of this amount, HHS spent 30 percent for  countermeasures against influenza, 20 percent for smallpox  countermeasures, and 19 percent for anthrax countermeasures. (See   fig. 2.) The spending on influenza countermeasures reflects, in part,  HHS’s response to the 2009 H1N1 influenza pandemic using annual and  supplemental funds appropriated for that response.
Of HHS’s total medical countermeasure spending of $3.6 billion, from  fiscal year 2010 through fiscal year 2013, HHS spent almost $2.1 billion  on contracts dedicated to advanced research and development, of which  HHS’s Biomedical Advanced Research and Development Authority  (BARDA) spent nearly $700 million (almost 34 percent) for influenza  antivirals, diagnostics, and vaccines. (See table 3.) Of the remaining   $1.5 billion, HHS spent nearly $403 million on contracts dedicated to the  procurement of pandemic influenza antivirals and vaccines. (See table 4.)  BARDA also spent almost $1.2 billion on contracts dedicated to both  advanced research and development and procurement of CBRN medical  countermeasures. (See table 5.) In addition to the contracts that have  already been awarded, HHS issues annual announcements for additional  funding opportunities in the areas of advanced research and development  of CBRN medical countermeasures; advanced development of medical  countermeasures for pandemic influenza; and innovative science and  technology platforms for medical countermeasure development. The  announcements state anticipated funding for the overall program. For  example, the announcement for CBRN countermeasure advanced  research and development states that anticipated funding for the overall  effort—not per award—ranges from an estimated $2 million to an  estimated $415 million, subject to congressional appropriations, and does  not reflect a contractual obligation for funding.
section_title: Appendix II: Comments from the Department of Health and Human Services
section_title: Appendix III: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Karen Doran, Assistant   Director; Shana R. Deitch; Carolyn Feis Korman; Tracey King; and  Roseanne Price made significant contributions to this report.
section_title: Related GAO Products
paragraphs: 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.
National Preparedness: Improvements Needed for Measuring Awardee  Performance in Meeting Medical and Public Health Preparedness Goals.  GAO-13-278. Washington, D.C.: March 22, 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.
Chemical, Biological, Radiological, and Nuclear Risk Assessments: DHS  Should Establish More Specific Guidance for Their Use. GAO-12-272.  Washington, D.C.: January 25, 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.
Combating Nuclear Terrorism: Actions Needed to Better Prepare to  Recover from Possible Attacks Using Radiological or Nuclear Materials.  GAO-10-204. Washington, D.C.: January 29, 2010.