FDA’S FOREIGN DRUG INSPECTION PROGRAM: WEAKNESSES PLACE AMERICANS AT RISK HEARING BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED TENTH CONGRESS SECOND SESSION APRIL 22, 2008 Serial No. 110–107 ( Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov U.S. GOVERNMENT PRINTING OFFICE 52–415 PDF WASHINGTON : 2008 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) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001 VerDate Nov 24 2008 12:46 Oct 05, 2009 Jkt 037690 PO 00000 Frm 00001 Fmt 5011 Sfmt 5011 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-107 SCOM1 PsN: JIMC COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL, Michigan, Chairman HENRY A. WAXMAN, California JOE BARTON, Texas EDWARD J. MARKEY, Massachusetts Ranking Member RICK BOUCHER, Virginia RALPH M. HALL, Texas EDOLPHUS TOWNS, New York FRED UPTON, Michigan FRANK PALLONE, JR., New Jersey CLIFF STEARNS, Florida BART GORDON, Tennessee NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky ANNA G. ESHOO, California BARBARA CUBIN, Wyoming BART STUPAK, Michigan JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York HEATHER WILSON, New Mexico ALBERT R. WYNN, Maryland JOHN B. SHADEGG, Arizona GENE GREEN, Texas CHARLES W. ‘‘CHIP’’ PICKERING, DIANA DEGETTE, Colorado Mississippi Vice Chairman VITO FOSSELLA, New York LOIS CAPPS, California STEVE BUYER, Indiana MICHAEL F. DOYLE, Pennsylvania GEORGE RADANOVICH, California JANE HARMAN, California JOSEPH R. PITTS, Pennsylvania TOM ALLEN, Maine MARY BONO, California JAN SCHAKOWSKY, Illinois GREG WALDEN, Oregon HILDA L. SOLIS, California LEE TERRY, Nebraska CHARLES A. GONZALEZ, Texas MIKE FERGUSON, New Jersey JAY INSLEE, Washington MIKE ROGERS, Michigan TAMMY BALDWIN, Wisconsin SUE WILKINS MYRICK, North Carolina MIKE ROSS, Arkansas JOHN SULLIVAN, Oklahoma DARLENE HOOLEY, Oregon TIM MURPHY, Pennsylvania ANTHONY D. WEINER, New York MICHAEL C. BURGESS, Texas JIM MATHESON, Utah MARSHA BLACKBURN, Tennessee G.K. BUTTERFIELD, North Carolina 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 DAVID L. CAVICKE, Minority Staff Director SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS BART STUPAK, Michigan, Chairman DIANA DeGETTE, Colorado ED WHITFIELD, Kentucky CHARLIE MELANCON, Louisiana Ranking Member Vice Chairman GREG WALDEN, Oregon HENRY A. WAXMAN, California MIKE FERGUSON, New Jersey GENE GREEN, Texas TIM MURPHY, Pennsylvania MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee JAY INSLEE, Washington JOE BARTON, Texas (ex officio) JOHN D. DINGELL, Michigan (ex officio) (II) VerDate Nov 24 2008 12:46 Oct 05, 2009 Jkt 037690 PO 00000 Frm 00002 Fmt 0486 Sfmt 5904 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-107 SCOM1 PsN: JIMC C O N T E N T S Page Hon. Bart Stupak, a Representative in Congress from the State of Michigan, opening statement ................................................................................................ 1 Hon. Joe Barton, a Representative in Congress from the State of Texas, prepared statement .............................................................................................. 4 Hon. John D. Dingell, a Representative in Congress from the State of Michi- gan, prepared statement ...................................................................................... 6 Hon. John Shimkus, a Representative in Congress from the State of Illinois, opening statement ................................................................................................ 7 Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement .................................................................................... 9 Hon. Gene Green, a Representative in Congress from the State of Texas, prepared statement .............................................................................................. 55 WITNESSES Andrew C. von Eschenbach, M.D., Commissioner, Food and Drug Administra- tion ........................................................................................................................ 11 Prepared statement .......................................................................................... 15 Marcia G. Crosse, Director of Public Health and Military Health Issues, U.S. Government Accountability Office .............................................................. 65 Prepared statement .......................................................................................... 68 Gail H. Cassell, Ph.D., Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company ......... 93 Prepared statement .......................................................................................... 97 William K. Hubbard, Former FDA Associate Commissioner and Current Sen- ior Advisor to the Coalition for a Stronger FDA ............................................... 100 Prepared statement .......................................................................................... 102 Carl R. Nielsen, Retired Director of the Division of Import Operations, Office of Regulatory Affairs, Food and Drug Administration, U.S. Department of Health and Human Services ........................................................................... 105 Prepared statement .......................................................................................... 107 Benjamin L. England, Esq., Benjamin L. England & Associates, LLC, and FDAimports.com ................................................................................................... 117 Prepared statement .......................................................................................... 120 SUBMITTED MATERIAL Slides accompanying Mr. Stupak’s opening statement ........................................ 146 Subcommittee exhibit binder .................................................................................. 154 (III) VerDate Nov 24 2008 12:46 Oct 05, 2009 Jkt 037690 PO 00000 Frm 00003 Fmt 5904 Sfmt 5904 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-107 SCOM1 PsN: JIMC VerDate Nov 24 2008 12:46 Oct 05, 2009 Jkt 037690 PO 00000 Frm 00004 Fmt 5904 Sfmt 5904 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-107 SCOM1 PsN: JIMC FDA’S FOREIGN DRUG INSPECTION PROGRAM: WEAKNESSES PLACE AMERI- CANS AT RISK TUESDAY, APRIL 22, 2008 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON ENERGY AND COMMERCE, Washington, D.C. The subcommittee met, pursuant to call, at 11:00 a.m., in room 2123, Rayburn House Office Building, Hon Bart Stupak (chairman of the subcommittee) presiding. Present: Representatives Stupak, Melancon, Green, Dingell (ex officio), Shimkus, Burgess, and Barton (ex officio). Staff Present: Chris Knauer, John Sopko, Kevin Barstow, David Nelson, Kyle Chapman, Calvin Webb; Alan Slobodin, Peter Spen- cer, and Whitney Drew. OPENING STATEMENT OF HON. BART STUPAK, A REPRESENT- ATIVE IN CONGRESS FROM THE STATE OF MICHIGAN Mr. STUPAK. This meeting will come to order. Today we have a hearing titled ‘‘FDA’s Foreign Drug Inspection Program: Weak- nesses Place Americans at Risk.’’ Each member will be recognized for an opening statement of 5 minutes. I will begin. Today’s hearing will once again explore the question of whether the Food and Drug Administration, FDA, is adequately regulating the overseas manufacture of pharmaceutical products. As this sub- committee has reported before, a significant and still growing quantity of pharmaceutical products used by Americans are now manufactured with ingredients obtained overseas from countries on almost every continent. With exact quantities and sources for these drugs difficult to determine, the general consensus is that at least 80 percent of all active pharmaceutical ingredients, APIs, used by U.S. manufacturers to produce drugs are imported. More impor- tantly, much of this production occurs in regions that lack robust regulatory systems, such as China and India. China alone has more firms registered to export drugs to the U.S. than any other country, posing major challenges to the FDA. As was noted by former FDA Commissioner David Kessler in a major news produc- tion, I quote: ‘‘China is ‘as close to an unregulated environment as you can get.’ In fact, it is a lot like the U.S. was in 1906, he says— ’That’s why we developed an FDA.’’’ The U.S. Food and Drug Administration is the Agency respon- sible for overseeing the safety and effectiveness of all human drugs (1) VerDate Nov 24 2008 12:46 Oct 05, 2009 Jkt 037690 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\110-107 SCOM1 PsN: JIMC 2 marketed in the U.S. As part of its effort to oversee the safety and quality of these products, FDA’s policy is to physically inspect for- eign establishments that ship drugs to the American market. Last year this subcommittee asked the Government Account- ability Office, GAO, to undertake a comprehensive audit of FDA’s foreign drug regulatory system. The preliminary findings of that audit were presented at a hearing before this subcommittee on No- vember 1st of last year. The GAO reported that a substantial lack of human and economic resources, weaknesses in databases in IT systems used by the