United States Government Accountability Office Washington, DC 20548 July 24, 2009 Congressional Committees Subject: Project BioShield Act: HHS Has Supported Development, Procurement, and Emergency Use of Medical Countermeasures to Address Health Threats This report formally transmits the attached briefing in response to section 247d-6c of title 42 of the United States Code. (See the enclosure.) The statute required the Comptroller General to examine the Department of Health and Human Services’ (HHS) support for the development and procurement of and authority for the emergency use of medical countermeasures to address chemical, biological, radiological, and nuclear threats to public health, and provide the results to the congressional committees by July 21, 2009.1 HHS determines priorities for medical countermeasure procurement based on those chemical, biological, radiological, and nuclear agents that have been identified by the Department of Homeland Security as posing a material threat to the U.S. population that could affect national security. We provided the briefing to staff of your committees to satisfy the mandate reporting requirement on July 20, 2009, and July 21, 2009. – – – – – We are sending copies of this report to the Secretary of HHS, the Secretary of Homeland Security, and other interested parties. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov. If you or your staff have any questions regarding this report, please contact me at (202) 512- 7114 or [email protected]. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Key contributions to this report were made by Karen Doran, Assistant Director; George Bogart; Natalie Herzog; Amy C. Leone; Roseanne Price; and Rasanjali Wickrema. Cynthia A. Bascetta Director, Health Care Enclosure 1The Project BioShield Act of 2004 also required the Comptroller General to review other issues, such as how HHS has used its Project BioShield Act contracting and purchasing authorities to enhance its ability to procure medical countermeasures, and the extent to which HHS has sufficient internal controls in place to manage and ensure the appropriate use of its Project BioShield Act contracting and purchasing authorities. We address these issues in a separate report, Project Bioshield: HHS Can Improve Agency Internal Controls for Its New Contracting Authorities, GAO-09-820 (Washington, D.C.: July 21, 2009). GAO-09-878R Project BioShield Act List of Congressional Committees The Honorable Edward M. Kennedy Chairman The Honorable Michael B. Enzi Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable Joseph I. Lieberman Chairman The Honorable Susan M. Collins Ranking Member Committee on Homeland Security and Governmental Affairs United States Senate The Honorable Robert C. Byrd Chairman The Honorable George Voinovich Ranking Member Subcommittee on Homeland Security Committee on Appropriations United States Senate The Honorable Tom Harkin Chairman The Honorable Thad Cochran Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Committee on Appropriations United States Senate The Honorable Henry A. Waxman Chairman The Honorable Joe Barton Ranking Member Committee on Energy and Commerce House of Representatives The Honorable Bennie G. Thompson Chairman The Honorable Peter T. King Ranking Member Committee on Homeland Security House of Representatives 2 GAO-09-878R Project BioShield Act The Honorable Edolphus Towns Chairman The Honorable Darrell Issa Ranking Member Committee on Oversight and Government Reform House of Representatives The Honorable David E. Price Chairman The Honorable Harold Rogers Ranking Member Subcommittee on Homeland Security Committee on Appropriations House of Representatives The Honorable David R. Obey Chairman The Honorable Todd Tiahrt Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Committee on Appropriations House of Representatives 3 GAO-09-878R Project BioShield Act Enclosure Project BioShield Act: HHS Has Supported Development, Procurement, and Emergency Use of Medical Countermeasures to Address Health Threats Briefing for the staffs of the Committee on Health, Education, Labor, and Pensions Committee on Homeland Security and Governmental Affairs Subcommittee on Homeland Security, Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations United States Senate Committee on Energy and Commerce Committee on Homeland Security Committee on Oversight and Government Reform Subcommittee on Homeland Security, Committee on Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations House of Representatives July 20, 2009, and July 21, 2009 1 4 GAO-09-878R Project BioShield Act Enclosure Overview • Introduction • Objectives • Scope and Methodology • Background • Results • Agency Comments 2 5 GAO-09-878R Project BioShield Act Enclosure Introduction • The terrorist attacks of September 11, 2001, and the subsequent attacks using anthrax-laced letters have raised congressional concerns that the United States is vulnerable to threats from chemical, biological, radiological, and nuclear (CBRN) agents, including agents responsible for naturally emerging infectious diseases that could cause illness on a scale that adversely affects national security. • Members of the Congress have noted the need for the United States to have medical countermeasures (MCM), such as vaccines, drugs, therapies, and diagnostic tools, to respond to CBRN agents and to adequately protect the public from such threats or provide after- exposure treatment. • Members of the Congress and others have attributed the limited availability of CBRN countermeasures to a lack of economic incentives to invest the millions of dollars required to bring treatments to market for uncommon diseases and conditions, such as anthrax. 3 6 GAO-09-878R Project BioShield Act Enclosure Introduction (cont.) • To encourage the development of new CBRN medical countermeasures, the Project BioShield Act of 2004 (Pub.L.No.108- 276), was enacted to, among other things, • facilitate the creation of a government market by authorizing the appropriation of about $5.6 billion from fiscal years 2004 through 2013 to purchase MCMs, including those that may require additional development; • under specified conditions, allow the Secretary of the Department of Health and Human Services (HHS) to authorize the temporary emergency use (through emergency use authorizations, or EUAs) of (1) certain medical products that have not yet received Food and Drug Administration (FDA) approval or (2) unapproved use of an FDA-approved product; and • provide HHS with authorities to facilitate CBRN MCM research- and development-related spending, including a streamlined authority for hiring experts. • The Project BioShield Act directs the Department of Homeland Security (DHS) to conduct assessments of the threats posed by CBRN agents and to issue material threat determinations for CBRN agents that pose a threat to the U.S. population that could affect national security. 4 7 GAO-09-878R Project BioShield Act Enclosure Objectives GAO is required to report on the implementation of the Project BioShield Act by provisions of the act. This briefing describes the status of 1.Medical countermeasures supported by the Project BioShield Act that are available or being developed to address identified and emerging threats to public health from CBRN agents determined by DHS. 2.HHS’s use of its authority to allow the temporary emergency use of medical countermeasures, and whether it developed procedures governing such use. 3.HHS’s use of its streamlined personnel authority under the Project BioShield Act. 5 8 GAO-09-878R Project BioShield Act Enclosure Scope and Methodology • We reviewed HHS and DHS information and documentation, including • HHS’s annual reports to the Congress on the implementation of the Project BioShield Act • HHS’s Public Health Emergency Medical Countermeasures Enterprise Strategy (referred to as the HHS Enterprise Strategy) • HHS’s Public Health Emergency Medical Countermeasures Enterprise Implementation Plan (referred to as the HHS Enterprise Implementation Plan), which guides MCM research, development, and procurement • FDA guidance on authorizing the emergency use of MCMs • DHS determinations of CBRN agents that pose threats to the U.S. population • We interviewed officials from • HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA) • Centers for Disease Control and Prevention (CDC) • National Institutes of Health (NIH) •FDA • DHS 6 9 GAO-09-878R Project BioShield Act Enclosure Scope and Methodology (cont.) • We also reviewed • legislation, • presidential directives, • Federal Register notices and federal agency letters about EUAs, and • documents from the Congressional Research Service. • We conducted our work from April 2009 through July 2009 in accordance with all sections of GAO’s Quality Assurance Framework that are relevant to our objectives. The framework requires that we plan and perform the engagement to obtain sufficient and appropriate evidence to meet our stated objectives and to discuss any limitations in our work. We believe that the information and