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Hearing Committee on Government Refor THE NATION’S FLU SHOT SHORTAGE: WHERE ARE WE TODAY AND HOW PREPARED ARE WE FOR TOMORROW? HEARING BEFORE THE COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED EIGHTH CONGRESS SECOND SESSION NOVEMBER 17, 2004 Serial No. 108–246 Printed for the use of the Committee on Government Reform ( Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform U.S. GOVERNMENT PRINTING OFFICE 97–448 PDF WASHINGTON : 2004 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 11:47 Jan 22, 2005 Jkt 000000 PO 00000 Frm 00005 Fmt 5011 Sfmt 5011 D:\DOCS\97448.TXT HGOVREF1 PsN: HGOVREF1 COMMITTEE ON GOVERNMENT REFORM TOM DAVIS, Virginia, Chairman DAN BURTON, Indiana HENRY A. WAXMAN, California CHRISTOPHER SHAYS, Connecticut 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 MARK E. SOUDER, Indiana CAROLYN B. MALONEY, New York STEVEN C. LATOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland DOUG OSE, California DENNIS J. KUCINICH, Ohio RON LEWIS, Kentucky DANNY K. DAVIS, Illinois TODD RUSSELL PLATTS, Pennsylvania JOHN F. TIERNEY, Massachusetts CHRIS CANNON, Utah WM. LACY CLAY, Missouri ADAM H. PUTNAM, Florida DIANE E. WATSON, California EDWARD L. SCHROCK, Virginia STEPHEN F. LYNCH, Massachusetts JOHN J. DUNCAN, JR., Tennessee CHRIS VAN HOLLEN, Maryland NATHAN DEAL, Georgia LINDA T. SANCHEZ, California CANDICE S. MILLER, Michigan C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland TIM MURPHY, Pennsylvania ELEANOR HOLMES NORTON, District of MICHAEL R. TURNER, Ohio Columbia JOHN R. CARTER, Texas JIM COOPER, Tennessee MARSHA BLACKBURN, Tennessee BETTY MCCOLLUM, Minnesota PATRICK J. TIBERI, Ohio ——— KATHERINE HARRIS, Florida BERNARD SANDERS, Vermont MICHAEL C. BURGESS, Texas (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 11:47 Jan 22, 2005 Jkt 000000 PO 00000 Frm 00006 Fmt 5904 Sfmt 5904 D:\DOCS\97448.TXT HGOVREF1 PsN: HGOVREF1 C O N T E N T S Page Hearing held on November 17, 2004 ...................................................................... 1 Statement of: Gerberding, Dr. Julie L., Director, Centers for Disease Control and Pre- vention; Dr. Anthony S. Fauci, Director, National Institute of Allergy and Infectious Diseases; and Dr. Lester M. Crawford, Acting Commis- sioner, Food and Drug Administration ....................................................... 137 Pien, Howard, president, chief executive officer, and chairman of the board, Chiron Corp.; Kathleen Coelingh, senior director, regulatory and scientific affairs, MedImmune, Inc.; Dr. Robert Stroube, Virginia State health commissioner, Association of State and Territorial Health Offi- cials; and Dr. Jerome Klein, professor of pediatrics, Boston University School of Medicine ........................................................................................ 245 Letters, statements, etc., submitted for the record by: Burgess, Hon. Michael C., a Representative in Congress from the State of Texas, prepared statement of .................................................................. 404 Coelingh, Kathleen, senior director, regulatory and scientific affairs, MedImmune, Inc., prepared statement of ................................................... 266 Crawford, Dr. Lester M., Acting Commissioner, Food and Drug Adminis- tration, prepared statement of ..................................................................... 192 Cummings, Hon. Elijah E., a Representative in Congress from the State of Maryland, prepared statement of ............................................................ 392 Davis, Chairman Tom, a Representative in Congress from the State of Virginia, prepared statement of ................................................................... 5 Fauci, Dr. Anthony S., Director, National Institute of Allergy and Infec- tious Diseases, prepared statement of ........................................................ 170 Gerberding, Dr. Julie L., Director, Centers for Disease Control and Pre- vention, prepared statement of .................................................................... 140 Klein, Dr. Jerome, professor of pediatrics, Boston University School of Medicine, prepared statement of ................................................................. 287 Kucinich, Hon. Dennis J., a Representative in Congress from the State of Ohio, prepared statement of .................................................................... 396 Lantos, Hon. Tom, a Representative in Congress from the State of Cali- fornia, prepared statement of ...................................................................... 308 Maloney, Hon. Carolyn, a Representative in Congress from the State of New York, prepared statement of ........................................................... 390 Mica, Hon. John L., a Representative in Congress from the State of Florida, article dated October 23–24, 2004 ................................................. 221 Owens, Hon. Major R., a Representative in Congress from the State of New York, prepared statement of ........................................................... 309 Pien, Howard, president, chief executive officer, and chairman of the board, Chiron Corp., prepared statement of ............................................... 248 Shays, Hon. Christopher, a Representative in Congress from the State of Connecticut, prepared statement of ........................................................ 306 Stroube, Dr. Robert, Virginia State health commissioner, Association of State and Territorial Health Officials, prepared statement of ................. 278 Towns, Hon. Edolphus, a Representative in Congress from the State of New York, prepared statement of ........................................................... 387 Watson, Hon. Diane E., a Representative in Congress from the State of California, prepared statement of ........................................................... 398 Waxman, Hon. Henry A., a Representative in Congress from the State of California: Memo dated November 17, 2004 .............................................................. 10 Prepared statement of ............................................................................... 130 (III) VerDate 11-MAY-2000 11:47 Jan 22, 2005 Jkt 000000 PO 00000 Frm 00007 Fmt 5904 Sfmt 5904 D:\DOCS\97448.TXT HGOVREF1 PsN: HGOVREF1 VerDate 11-MAY-2000 11:47 Jan 22, 2005 Jkt 000000 PO 00000 Frm 00008 Fmt 5904 Sfmt 5904 D:\DOCS\97448.TXT HGOVREF1 PsN: HGOVREF1 THE NATION’S FLU SHOT SHORTAGE: WHERE ARE WE TODAY AND HOW PREPARED ARE WE FOR TOMORROW? WEDNESDAY, NOVEMBER 17, 2004 HOUSE OF REPRESENTATIVES, COMMITTEE ON GOVERNMENT REFORM, Washington, DC. The committee met, pursuant to notice, at 1:05 p.m., in room 2154, Rayburn House Office Building, Hon. Tom Davis (chairman of the committee) presiding. Present: Representatives Davis, Shays, Mica, Duncan, Deal, Murphy, Waxman, Lantos, Owens, Towns, Sanders, Maloney, Cummings, Kucinich, Tierney, Clay, Watson, Van Hollen, Ruppersberger, Norton, Cooper, and McCollum. Staff present: Melissa Wojciak, staff director, David Marin, dep- uty staff director/communications director; Keith Ausbrook, chief counsel; Ellen Brown, legislative director and senior policy counsel; Jennifer Safavian, chief counsel for oversight and investigations; Anne Marie Turner, counsel; Robert Borden, counsel/parliamen- tarian; Robert White, press secretary; Drew Crockett, deputy direc- tor of communications; Susie Schulte, professional staff member; Teresa Austin, chief clerk; Sarah Dorsie, deputy clerk; Allyson Blandford, office manager; Corinne Zaccagnini, chief information officer; Phil Barnett, minority staff director; Kristin Amerling, mi- nority deputy chief counsel; Karen Lightfoot, minority communica- tions director/senior policy advisor; Anna Laitin, minority commu- nications and policy assistant; Sarah Despres and Naomi Seller, minority counsels; Richard Butcher and Josh Sharfstein, minority professional staff members; Earley Green, minority chief clerk; and Jean Gosa, minority assistant clerk. Chairman TOM DAVIS. Good morning. A quorum being present, the Committee on Government Reform will come to order. I want to welcome everybody to today’s oversight hearing regarding this year’s U.S. influenza vaccine supply. As most are now aware, on October 5, 2004, the Medicines and Healthcare Products Regulatory Agency, United Kingdom’s version of the U.S. Food and Drug Administration, suspended Chiron Corp.’s manufacturer’s license for a period of 3 months. Chiron planned on delivering 46 to 48 million doses of flu vaccine, almost half of the U.S. supply. This committee’s investigation into the issues surrounding the flu vaccine shortage began at a flu pandemic hearing in February of this year. The committee informed U.S. health officials of its con- (1) VerDate 11-MAY-2000 11:47 Jan 22, 2005 Jkt 000000 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 D:\DOCS\97448.TXT HGOVREF1 PsN: HGOVREF1 2 cern that Chiron did not have a manufacturing plant located with- in the United States. So should a flu pandemic occur, it was theo- rized that the U.K. could nationalize Chiron’s
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