From: Eiber, Gail A [Gail.Eiber@allina.com]
Sent: Tuesday, October 14, 2003 6:13 PM
To: FDADockets@oc.fda.gov
Cc: regulatory@AABB.org
Subject: Proposed Suspected Adverse Reaction

Dear Sir or Madam,
The FDA's proposed rule for "Safety Reporting Requirements for Human Drug and Biological Products" will require massive reporting by Transfusion Services, not the "insignificant burden" as expressed by the FDA.  The amount of work needed to fulfills the FDA's requirements will place a great hardship on hospitals' Transfusion Services already strapped by extremely low blood reimbursements. At the 600 bed hospital where I am employed, it would require one full-time staff person just to do these additional proposed tasks.

The second item of concern is the FDA's change of the definition of an adverse reaction.  The FDA proposes to include all those adverse events where there is a "reasonable possibility" of a causal relationship exists with the transfusion.  Classifying a case as "probably related, possibly related, remotely related , unlikely related" means that a relationship cannot be ruled out.  The scope of this proposal is overwhelming!!

The proposed new form for reporting these adverse event is NOT suitable for reporting patient reactions.  The proposed requirement that the terminology must be from the "Medical Dictionary for Regulatory Activities" (MedDRA) means additional fees for the license.

Adverse reactions which are already reviewed by transfusion service medical directors and captured and investigated by quality assessment programs are already in place in most institutions. The proposed new rule requires that significant resources be spent and does little to advance meaningfully patient safety. 

I  propose that the FDA work with the AABB, America's Blood Centers, the American Red Cross and other blood banks and transfusion services to develop a risk-based approach to adverse reaction reporting.  Hopefully, they will arrive at a solution that does not strain the resources of blood banks and transfusion services and produces meaningful results!


Gail Eiber, MS, MT(ASCP)
Technical Consultant, Blood Bank
Allina Medical Laboratories
Minneapolis, MN

Phone: 612-863-4382
Fax:  612-863-3089
E-mail: gail.eiber@allina.com