HOUSE HEARING, 105TH CONGRESS - FDA OVERSIGHT: BLOOD SAFETY AND THE IMPLICATIONS OF POOL SIZES IN THE MANUFACTURE OF PLASMA DERIVATIVES | Blood Donation

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Congressional Hearing Held: 1997-07-31
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  U . S . GOVERNMENT PRINTING OFFICEWASHINGTON : For sale by the Superintendent of Documents, U.S. Government Printing OfficeInternet: bookstore.gpo.govPhone: toll free (866) 512–1800; DC area (202) 512–1800Fax: (202) 512–2250Mail: Stop SSOP, Washington, DC 20402–000145–902 CC 1998 FDA OVERSIGHT: BLOOD SAFETY AND THE IMPLI-CATIONS OF POOL SIZES IN THE MANUFAC-TURE OF PLASMA DERIVATIVES HEARING BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES OF THE   COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT HOUSE OF REPRESENTATIVES ONE HUNDRED FIFTH CONGRESS FIRST SESSIONJULY 31, 1997 Serial No. 105–70 Printed for the use of the Committee on Government Reform and Oversight (   VerDate Jan 31 2003 09:52 Apr 14, 2003Jkt 086131PO 00000Frm 00001Fmt 5011Sfmt 5011W:\DISC\4590245902  (II) COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York J. DENNIS HASTERT, Illinois CONSTANCE A. MORELLA, Maryland CHRISTOPHER SHAYS, Connecticut STEVEN SCHIFF, New Mexico CHRISTOPHER COX, California ILEANA ROS-LEHTINEN, Florida JOHN M. M C HUGH, New York STEPHEN HORN, California JOHN L. MICA, Florida THOMAS M. DAVIS, Virginia DAVID M. M C INTOSH, Indiana MARK E. SOUDER, Indiana JOE SCARBOROUGH, Florida JOHN B. SHADEGG, Arizona STEVEN C. L  A  TOURETTE, Ohio MARSHALL ‘‘MARK’’ SANFORD, South Carolina JOHN E. SUNUNU, New Hampshire PETE SESSIONS, Texas MICHAEL PAPPAS, New Jersey  VINCE SNOWBARGER, Kansas BOB BARR, Georgia ROB PORTMAN, Ohio HENRY A. WAXMAN, California TOM LANTOS, California ROBERT E. WISE, J R ., West Virginia MAJOR R. OWENS, New York EDOLPHUS TOWNS, New York PAUL E. KANJORSKI, Pennsylvania GARY A. CONDIT, California CAROLYN B. MALONEY, New York THOMAS M. BARRETT, Wisconsin ELEANOR HOLMES NORTON, Washington, DC CHAKA FATTAH, Pennsylvania ELIJAH E. CUMMINGS, Maryland DENNIS J. KUCINICH, Ohio ROD R. BLAGOJEVICH, Illinois DANNY K. DAVIS, Illinois JOHN F. TIERNEY, Massachusetts JIM TURNER, Texas THOMAS H. ALLEN, Maine HAROLD E. FORD, J R ., Tennessee ———BERNARD SANDERS, Vermont (Independent) K  EVIN B INGER , Staff Director D  ANIEL R. M OLL ,  Deputy Staff Director W ILLIAM M OSCHELLA  ,  Deputy Counsel and Parliamentarian J UDITH M C C OY  , Chief Clerk P HIL S CHILIRO ,  Minority Staff Director S UBCOMMITTEE ON H UMAN R ESOURCES   CHRISTOPHER SHAYS, Connecticut, Chairman  VINCE SNOWBARGER, Kansas BENJAMIN A. GILMAN, New York DAVID M. M C INTOSH, Indiana MARK E. SOUDER, Indiana MICHAEL PAPPAS, New Jersey STEVEN SCHIFF, New Mexico EDOLPHUS TOWNS, New York DENNIS J. KUCINICH, Ohio THOMAS H. ALLEN, Maine TOM LANTOS, California BERNARD SANDERS, Vermont (Ind.) THOMAS M. BARRETT, Wisconsin E  X  O FFICIO   DAN BURTON, Indiana HENRY A. WAXMAN, California L  AWRENCE J. H  ALLORAN , Staff Director and Counsel  A  NNE M  ARIE F INLEY  ,  Professional Staff Member R. J  ARED C  ARPENTER , Clerk C HERRI B RANSON ,  Minority Counsel VerDate Jan 31 2003 09:52 Apr 14, 2003Jkt 086131PO 00000Frm 00002Fmt 5904Sfmt 5904W:\DISC\4590245902  (III) C O N T E N T S Page Hearing held on July 31, 1997...............................................................................1Statement of: Crooker, Dolores, R.N., parent; Glenn Pierce, M.D., Ph.D., National He-mophilia Foundation; and Charlotte Cunningham-Rundles, M.D., Ph.D., Immune Deficiency Foundation.......................................................102Davey, Richard, M.D., chief medical officer, American Red Cross; Robert Reilly, executive director, International Plasma Products Industry As-sociation; Michael Fournel, vice president, Biologicals Division, Bayer Corp.; Ed Gomperts, M.D., vice president, Medical Affairs & Clinical Development, Baxter Healthcare Corp.; Fred Feldman, Ph.D., vice president, Centeon Corp.; and M. Sue Preston, vice president, Quality & Regulatory Affairs, Alpha Therapeutic Corp..........................................136Satcher, David, M.D., Ph.D., Director, Centers for Disease Control and Prevention, accompanied by Mary Chamberland, Bruce Evatt, and Lawrence Schonberger; Paul W. Brown, M.D., senior research scientist, Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health; and Kathryn Zoon, Ph.D., Director, Center for Biologics Evaluation and Research, Food and Drug Administration..................................................8Letters, statements, etc., submitted for the record by: Brown, Paul W., M.D., senior research scientist, Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Stroke, National Institutes of Health, prepared statement of...........26Crooker, Dolores, R.N., parent, prepared statement of.................................105Cunningham-Rundles, Charlotte, M.D., Ph.D., Immune Deficiency Foun-dation, prepared statement of......................................................................125Davey, Richard, M.D., chief medical officer, American Red Cross, pre-pared statement of........................................................................................140Feldman, Fred, Ph.D., vice president, Centeon Corp.: Information concerning recalls.................................................................416Prepared statement of...............................................................................196Fournel, Michael, vice president, Biologicals Division, Bayer Corp., pre-pared statement of........................................................................................170Gomperts, Ed, M.D., vice president, Medical Affairs & Clinical Develop-ment, Baxter Healthcare Corp., prepared statement of............................181Hall, Zach W., Ph.D., Director, further information......................................100Pierce, Glenn, M.D., Ph.D., National Hemophilia Foundation, prepared statement of...................................................................................................113Preston, M. Sue, vice president, Quality & Regulatory Affairs, Alpha Therapeutic Corp., prepared statement of..................................................255Reilly, Robert, executive director, International Plasma Products Industry  Association, prepared statement of.............................................................148Satcher, David, M.D., Ph.D., Director, Centers for Disease Control and Prevention, prepared statement of..............................................................11Shays, Hon. Christopher, a Representative in Congress from the State of Connecticut, prepared statement of........................................................3Towns, Hon. Edolphus, a Representative in Congress from the State of New York, prepared statement of...........................................................6Zoon, Kathryn, Ph.D., Director, Center for Biologics Evaluation and Re-search, Food and Drug Administration, prepared statement of...............41 VerDate Jan 31 2003 09:52 Apr 14, 2003Jkt 086131PO 00000Frm 00003Fmt 5904Sfmt 5904W:\DISC\4590245902  VerDate Jan 31 2003 09:52 Apr 14, 2003Jkt 086131PO 00000Frm 00004Fmt 5904Sfmt 5904W:\DISC\4590245902
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