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Evaluating the Effectiveness of Project Bioshield ONE YEAR LATER: EVALUATING THE EFFECTIVENESS OF PROJECT BIOSHIELD HEARING BEFORE THE COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED NINTH CONGRESS FIRST SESSION JULY 14, 2005 Serial No. 109–59 Printed for the use of the Committee on Government Reform ( Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html http://www.house.gov/reform U.S. GOVERNMENT PRINTING OFFICE 23–143 PDF WASHINGTON : 2005 For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800 Fax: (202) 512–2250 Mail: Stop SSOP, Washington, DC 20402–0001 VerDate 11-MAY-2000 12:10 Oct 11, 2005 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 D:\DOCS\23143.TXT HGOVREF1 PsN: HGOVREF1 COMMITTEE ON GOVERNMENT REFORM TOM DAVIS, Virginia, Chairman CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California DAN BURTON, Indiana TOM LANTOS, California ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. MCHUGH, New York EDOLPHUS TOWNS, New York JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland STEVEN C. LATOURETTE, Ohio DENNIS J. KUCINICH, Ohio TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois CHRIS CANNON, Utah WM. LACY CLAY, Missouri JOHN J. DUNCAN, JR., Tennessee DIANE E. WATSON, California CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland DARRELL E. ISSA, California LINDA T. SANCHEZ, California GINNY BROWN-WAITE, Florida C.A. DUTCH RUPPERSBERGER, Maryland JON C. PORTER, Nevada BRIAN HIGGINS, New York KENNY MARCHANT, Texas ELEANOR HOLMES NORTON, District of LYNN A. WESTMORELAND, Georgia Columbia PATRICK T. MCHENRY, North Carolina ——— CHARLES W. DENT, Pennsylvania BERNARD SANDERS, Vermont VIRGINIA FOXX, North Carolina (Independent) ——— ——— MELISSA WOJCIAK, Staff Director DAVID MARIN, Deputy Staff Director/Communications Director ROB BORDEN, Parliamentarian TERESA AUSTIN, Chief Clerk PHIL BARNETT, Minority Chief of Staff/Chief Counsel (II) VerDate 11-MAY-2000 12:10 Oct 11, 2005 Jkt 000000 PO 00000 Frm 00002 Fmt 5904 Sfmt 5904 D:\DOCS\23143.TXT HGOVREF1 PsN: HGOVREF1 C O N T E N T S Page Hearing held on July 14, 2005 ............................................................................... 1 Statement of: Kramer, Robert G., president and chief executive officer, BioPort Corp.; Richard B. Hollis, chairman and chief executive officer, Hollis-Eden Pharmaceuticals; and Gerald L. Epstein, senior fellow for science and security, Homeland Security Program, Center for Strategic and Inter- national Studies ............................................................................................ 73 Epstein, Gerald L. ..................................................................................... 96 Hollis, Richard B. ...................................................................................... 84 Kramer, Robert G. ..................................................................................... 73 Simonson, Stewart, Assistant Secretary, Office of Public Health Emer- gency Preparedness, U.S. Department of Health and Human Services; Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; and John Vitko, Jr., M.D., Director, Biological Countermeasures Portfolio, Science and Technology Directorate, Department of Homeland Security ..................... 12 Fauci, Anthony S. ...................................................................................... 30 Simonson, Stewart .................................................................................... 12 Vitko, John Jr. ........................................................................................... 50 Letters, statements, etc., submitted for the record by: Cummings, Hon. Elijah E., a Representative in Congress from the State of Maryland, prepared statement of ............................................................ 128 Davis, Chairman Tom, a Representative in Congress from the State of Virginia, prepared statement of ................................................................... 4 Epstein, Gerald L., senior fellow for science and security, Homeland Security Program, Center for Strategic and International Studies, pre- pared statement of ........................................................................................ 99 Fauci, Anthony S., M.D., Director, National Institute of Allergy and Infec- tious Diseases, National Institutes of , prepared statement of ................. 32 Hollis, Richard B., chairman and chief executive officer, Hollis-Eden Pharmaceuticals, prepared statement of .................................................... 86 Issa, Hon. Darrell E., a Representative in Congress from the State of California, prepared statement of ................................................................ 122 Kramer, Robert G., president and chief executive officer, BioPort Corp., prepared statement of ................................................................................... 76 Maloney, Hon. Carolyn B., a Representative in Congress from the State of New York, prepared statement of ........................................................... 125 Porter, Hon. Jon C., a Representative in Congress from the State of Nevada, prepared statement of .................................................................... 124 Ruppersberger, Hon. C.A. Dutch, a Representative in Congress from the State of Maryland, prepared statement of .................................................. 132 Shays, Hon. Christopher, a Representative in Congress from the State of Connecticut, prepared statement of ........................................................ 120 Simonson, Stewart, Assistant Secretary, Office of Public Health Emer- gency Preparedness, U.S. Department of Health and Human Services, prepared statement of ................................................................................... 15 Vitko, John Jr., M.D., Director, Biological Countermeasures Portfolio, Science and Technology Directorate, Department of Homeland Security, prepared statement of ................................................................................... 53 Waxman, Hon. Henry A., a Representative in Congress from the State of California, prepared statement of ........................................................... 8 (III) VerDate 11-MAY-2000 12:10 Oct 11, 2005 Jkt 000000 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 D:\DOCS\23143.TXT HGOVREF1 PsN: HGOVREF1 VerDate 11-MAY-2000 12:10 Oct 11, 2005 Jkt 000000 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 D:\DOCS\23143.TXT HGOVREF1 PsN: HGOVREF1 ONE YEAR LATER: EVALUATING THE EFFECTIVENESS OF PROJECT BIOSHIELD THURSDAY, JULY 14, 2005 HOUSE OF REPRESENTATIVES, COMMITTEE ON GOVERNMENT REFORM, Washington, DC. The committee met, pursuant to notice, at 11:30 a.m., in room 2154, Rayburn House Office Building, Hon. Tom Davis (chairman of the committee) presiding. Present: Representatives Davis of Virginia, Shays, Waxman, Issa, Foxx, Maloney, Cummings, Kucinich, Davis of Illinois, Clay, Watson, Van Hollen, Ruppersberger, and Norton. Staff present: Melissa Wojciak, staff director; David Marin, dep- uty staff director/communications director; Keith Ausbrook, chief counsel; Rob White, press secretary; Drew Crockett, deputy director of communications; Edward Kidd and Susie Schulte, professional staff members; John Brosnan, GAO detailee; Teresa Austin, chief clerk; Sarah D’Orsie, deputy clerk; Kristina Sherry, legislative as- sistant; Leneal Scott, computer systems manager; Josh Sharfstein, minority health policy advisor; Robin Appleberry, minority counsel; Earley Green, minority chief clerk; and Jean Gosa, minority assist- ant clerk. Chairman TOM DAVIS. The committee will come to order. I want to welcome everybody to today’s oversight hearing to assess the im- plementation of Project BioShield thus far. The purpose of this hearing is to consider whether the Project BioShield program is being adequately implemented to accelerate the research, develop- ment and purchase of effective countermeasures against agents of bioterrorism. Now that the Department of Health and Human Services has begun to utilize its special authorities granted by Congress through the Project BioShield Act of 2004, the committee feels it is time to review how these authorities are being executed. Specifically, the committee will consider whether adequate medical counter- measures to protect our population against a biological attack are being procured. As we tragically learned during the fall of 2001, our Nation is vulnerable to biological terrorism. Letters laced with anthrax caused the deaths of five individuals. Thousands more had to be treated. The death toll could have been higher if there had not been effective countermeasures to treat that particular form of an- thrax. The Project BioShield Act of 2004 gave the Federal Government better tools to develop and purchase vaccines and other drugs to (1) VerDate 11-MAY-2000 12:10 Oct 11, 2005 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 D:\DOCS\23143.TXT HGOVREF1 PsN: HGOVREF1 2 protect Americans in the event of bioterrorist attacks. If the United States were to be attacked with these deadly pathogens, the need for the corresponding vaccines, tests and treatments would be widespread and immediate. The Government has made some progress over the past year
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