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MICROCOMP Output File THE ADEQUACY OF FDA TO ASSURE THE SAFETY OF THE NATION’S DRUG SUPPLY HEARINGS BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS FIRST SESSION FEBRUARY 13, MARCH 22, 2007 Serial No. 110–5 ( Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PRINTING OFFICE 35–502 PDF WASHINGTON : 2007 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-SEP-98 15:43 Jun 06, 2007 Jkt 000000 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 Q:\DOCS\110-5 SCOM1 PsN: SCOM1 COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL, Michigan, Chairman HENRY A. WAXMAN, California JOE BARTON, Texas EDWARD J. MARKEY, Massachusetts Ranking Minority Member RICK BOUCHER, Virginia RALPH M. HALL, Texas EDOLPHUS TOWNS, New York J. DENNIS HASTERT, Illinois FRANK PALLONE, JR., New Jersey FRED UPTON, Michigan BART GORDON, Tennessee CLIFF STEARNS, Florida BOBBY L. RUSH, Illinois NATHAN DEAL, Georgia ANNA G. ESHOO, California ED WHITFIELD, Kentucky BART STUPAK, Michigan BARBARA CUBIN, Wyoming ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois ALBERT R. WYNN, Maryland HEATHER WILSON, New Mexico GENE GREEN, Texas JOHN SHADEGG, Arizona DIANA DEGETTE, Colorado CHARLES W. ‘‘CHIP’’ PICKERING, Vice Chairman Mississippi LOIS CAPPS, California VITO FOSSELLA, New York MIKE DOYLE, Pennsylvania STEVE BUYER, Indiana JANE HARMAN, California GEORGE RADANOVICH, California TOM ALLEN, Maine JOSEPH R. PITTS, Pennsylvania JAN SCHAKOWSKY, Illinois MARY BONO, California HILDA L. SOLIS, California GREG WALDEN, Oregon CHARLES A. GONZALEZ, Texas LEE TERRY, Nebraska JAY INSLEE, Washington MIKE FERGUSON, New Jersey TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan MIKE ROSS, Arkansas SUE WILKENS MYRICK, North Carolina DARLENE HOOLEY, Oregon JOHN SULLIVAN, Oklahoma ANTHONY D. WEINER, New York TIM MURPHY, Pennsylvania JIM MATHESON, Utah MICHAEL C. BURGESS, Texas G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee CHARLIE MELANCON, Louisiana JOHN BARROW, Georgia BARON P. HILL, Indiana PROFESSIONAL STAFF DENNIS B. FITZGIBBONS, Chief of Staff GREGG A. ROTHSCHILD, Chief Counsel SHARON E. DAVIS, Chief Clerk BUD ALBRIGHT, Minority Staff Director SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS BART STUPAK, Michigan, Chairman DIANA DEETTE, Colorado ED WHITFIELD, Kentucky CHARLIE MELANCON, Louisiana Ranking Minority Member HENRY A. WAXMAN, California GREG WALDEN, Oregon GENE GREEN, Texas MIKE FERGUSON, New Jersey MIKE DOYLE, Pennsylvania TIM MURPHY, Pennsylvania JAN SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas JAY INSLEE, Washington MARSHA BLACKBURN, Tennessee (II) VerDate 11-SEP-98 15:43 Jun 06, 2007 Jkt 000000 PO 00000 Frm 00002 Fmt 0486 Sfmt 0486 Q:\DOCS\110-5 SCOM1 PsN: SCOM1 C O N T E N T S FEBRUARY 13, 2007 Page Barton, Hon. Joe, a Representative in Congress from the State of Texas, opening statement ................................................................................................ 8 Burgess, Hon. Michael C., a Representative in Congress from the State of Texas, opening statement .................................................................................... 13 DeGette, Hon. Diana, a Representative in Congress from the State of Colo- rado, opening statement ...................................................................................... 5 Dingell, Hon. John D., a Representative in Congress from the State of Michi- gan, opening statement ....................................................................................... 7 Ferguson, Hon. Mike, a Representative in Congress from the State of New Jersey, opening statement ................................................................................... 5 Green, Hon. Gene, a Representative in Congress from the State of Texas, opening statement ................................................................................................ 11 Markey, Hon. Edward J., a Representative in Congress from the State of Massachusetts, prepared statement ................................................................... 51 Murphy, Hon. Tim, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement ................................................................... 10 Schakowsky, Hon. Jan, a Representative in Congress from the State of Illi- nois, opening statement ....................................................................................... 9 Stupak, Hon. Bart, a Representative in Congress from the State of Michigan, opening statement ................................................................................................ 1 Whitfield, Hon. Ed, a Representative in Congress from the Commonwealth of Kentucky, opening statement ......................................................................... 3 WITNESSES Cisneros, Ann Marie, independent clinical research associate ............................ 27 Prepared statement .......................................................................................... 83 Answers to submitted questions ...................................................................... 84 Graham, David J., M.D. .......................................................................................... 58 Prepared statement .......................................................................................... 129 Grassley, Hon. Chuck, a Senator from the State of Iowa .................................... 14 Prepared statement .......................................................................................... 90 Submitted material .......................................................................................... 94 Letter of August 24, 2005 to Dr. Lester Crawford ..................................... 94 Memorandum of Understanding .................................................................. 96 Letter of December 13, 2006 to Dr. von Eschenbach ................................. 100 Senate Committee on Finance timeline ...................................................... 120 Floor Statement of Senator Grassley, December 7, 2006 .......................... 122 Nissen, Steven E., M.D. .......................................................................................... 56 Prepared statement .......................................................................................... 85 Powers, John, M.D., Scientific Applications International Corporation ............. 29 Prepared statement .......................................................................................... 78 Answers to submitted questions ...................................................................... 79 Ross, David, M.D., National Clinical Health Programs, U.S. Department of Veterans Affairs ................................................................................................... 25 Prepared statement .......................................................................................... 134 Answers to submitted questions ...................................................................... 152 SUBMITTED MATERIAL FDA timeline ............................................................................................................ 157 FDA News Release of February 12, 2007 .............................................................. 181 Sanofi-Aventis timeline ........................................................................................... 168 (III) VerDate 11-SEP-98 15:43 Jun 06, 2007 Jkt 000000 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 Q:\DOCS\110-5 SCOM1 PsN: SCOM1 IV Page Mathews, Anna Wilde, ‘‘Fraud, Errors, Taint Key Study of Widely Used Sanofi Drug’’, the Wall Street Journal, May 1, 2006 ........................................ 185 Thornton, Mark, ‘‘The Clinical Trial’’, commentary from the Wall Street Jour- nal, February 12, 2007, submitted by Mr. Burgess ........................................... 183 Whistleblower timeline ............................................................................................ 171 MARCH 22, 2007 Barton, Hon. Joe, a Representative in Congress from the State of Texas, opening statement ................................................................................................ 197 Blackburn, Hon. Marsha, a Representative in Congress from the State of Tennessee, opening statement ............................................................................ 202 Burgess, Hon. Michael C., a Representative in Congress from the State of Texas, opening statement .................................................................................... 203 DeGette, Hon. Diana, a Representative in Congress from the State of Colo- rado, opening statement ...................................................................................... 201 Dingell, Hon. John D., a Representative in Congress from the State of Michi- gan, opening statement ....................................................................................... 195 Ferguson, Hon. Mike, a Representative in Congress from the State of New Jersey, opening statement ................................................................................... 205 Murphy, Hon. Tim, a Representative in Congress from the Commonwealth of Pennsylvania, opening statement ................................................................... 206 Schakowsky,
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