March 17,2006

Grassley Asks FDA to Answer Ethicists’ Concerns Over Blood Substitute Study

March 17, 2006

Via Electronic Transmission

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, 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.


Charles E. Grassley

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