OFFICIALS LEGISLATION INTEREST GROUPS PUBLIC STATEMENTS COMMITTEES VETOES

Letter to Dr. Andrew C. von Eschenbach Acting Commissioner U.S. Food and Drug Administration

Date: March 17, 2006
Location: Washington, DC
Issues: Agriculture and Food Drugs


Letter to Dr. Andrew C. von Eschenbach Acting Commissioner U.S. Food and Drug Administration

Dr. Andrew C. von Eschenbach
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. von Eschenbach:

Thank you for scheduling a briefing next Wednesday, March 22, 2006, for my Committee on Finance (Committee) staff regarding the clinical trial the Food and Drug Administration (FDA) approved for a blood substitute called PolyHeme, which is
manufactured by Northfield Laboratories, Inc. (the PolyHeme Study).1 The PolyHeme Study was approved by local institutional review boards (IRBs) in 18 states - California, Colorado, Delaware, Georgia, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Utah, and Virginia - and disapproved by an unknown number of IRBs. According to information posted at ClinicalTrials.gov, four of the thirty-one medical institutions participating in the PolyHeme Study have suspended recruiting patients, as of March 10, 2006.1

As chairman of the Committee, I request that the FDA officials, who will brief my Committee staff, come prepared to address in detail the issues and arguments raised in a letter published recently in The American Journal of Bioethics entitled, "An Open Letter to IRBs Considering Northfield Laboratories' PolyHeme Trial," among other issues related to the PolyHeme Study.

Thank you for your full attention to this urgent matter. Should you have any questions please contact Dan Donovan at (202) 224-4515.

Sincerely,
Charles E. Grassley
Chairman

http://finance.senate.gov/press/Gpress/2005/prg031706.pdf

arrow_upward