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HEARING

FDA Foreign Drug Inspection Program: A System at Risk

Subcommittee on Oversight and Investigations
Thursday, November 1, 2007, 10:00 a.m.
2123 Rayburn House Office Building

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Witness List & Prepared Testimony

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Panel I
Marcia G. Crosse, Ph.D. Director, Health Care U.S. Government Accountability Office 441 G Street, NW, Room 5K21 Washington, DC 20548 Drug Safety Findings by the GAO Power Point	Mr. William Hubbard Senior Advisor Coalition for a Stronger FDA 202 Weaver Mine Trail Chapel Hill, NC 27517
Ben England, Esq. Special Counsel Jones, Walker, Waechter, Poitevent, Carrère, & Denègre, L.L.P. The Watergate 2600 Virginia Avenue, NW, Suite 1113 Washington, DC 20037	Mr. Carl R. Nielsen Director (Retired) Division of Import Operations Office of Regulatory Affairs Food and Drug Administration
Panel II
John Dubeck, Esq. Partner Keller and Heckman, LLP And Counsel Bulk Pharmaceuticals Taskforce Synthetic Organic Chemical Manufacturers Association 1001 G Street, NW, Suite 500 West Washington, DC 20001	Mr. Bruce Downey Chairman and CEO Barr Pharmaceuticals, Inc. And Chairman Generic Pharmaceutical Association 25 Massachusetts Avenue, NW, Suite 440 Washington, DC 20001
Mr. Guido Villax Immediate Past Chairman Pharmaceuticals Business Committee Member of the Board of Directors European Fine Chemicals Group (A CEFIC Sector Group) Brussels, Belgium And Chief Executive Officer Hovione FarmaCiencia SA SeteCasas 2674-506 Loures Portugal
Panel III
The Honorable Andrew C. von Eschenbach, M.D. Commissioner Food and Drug Administration U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857	Accompanied by Ms. Margaret O’K. Glavin Associate Commissioner for Regulatory Affairs Food and Drug Administration U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857

Supplementary Documents:

"FDA Foreign Drug Inspection Program: A System At Risk" -- October 30, 2007 Committee Staff Report
FDA Foreign Inspections -- Power Point by Chairman Stupak
"Foreign Drugs Get Little Scrutiny by FDA" -- November 1, 2007 AP article
"FDA's Foreign Inspection Budget Lean" -- November 1, 2007 Washington Post article
"Chinese Chemicals Flow Unchecked Onto World Drug Market" -- October 31, 2007 New York Times article

Hearing Transcript

Not available at this time. The printed hearing should be available within 90-120 days of the conclusion of the hearing. When available, the text of the printed hearing may be viewed at the U.S. Government Printing Office Web site.