From: Linda Barnes [LindaB@psbc.org]
Sent: Friday, December 20, 2002 5:52 PM
To: 'fdadockets@oc.fda.gov'
Subject: Docket No. [02D-0266] 



The Puget Sound Blood Center and the Northwest Tissue Center submits these
comments in response to the draft guidance on "Preventive Measures to Reduce
the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps)".  We agree that for most tissue
donors, application of these criteria is reasonable.  We encourage the
Agency, however, to allow for use of tissue if the most knowledgeable
next-of-kin responds with uncertainty (e.g., "I don't know").  Tissue would
only be rejected if risk were specifically identified.

It is important to note that it is not uncommon to hold some tissue-based
products in inventory for years.  For those products currently in inventory
and distributed in the future (even eight or more years from now), donors or
donor families will not have been asked questions about the donor's possible
increased risk for CJD/vCJD.  We do not, however, recommend that the Agency
require that these additional questions be posed for HCT/Ps already in
inventory.  

Additionally, since this guidance does not apply to organ donors, it is
important for the Agency to understand the challenges in even getting these
questions asked in the case of a heart-beating organ donor who will also
provide tissue.  In order to minimize intrusion in the family grieving
process, many agencies use a common history questionnaire.  Since these
Organ Procurement Agencies are not bound to ask these questions, there is a
concern that it may be very difficult to obtain the information required for
determination of CJD/vCJD risk.

Appropriately, the draft guidance allows for HLA-matched hematopoietic stem
cells to be used for purpose of transplantation even if the donor is at
increased risk for CJD/vCJD.  We agree with this observation.  By the time
that the potential donor has been selected for collection, a HLA match has
typically been established and the donor has been identified as the best
source.  Exclusion is not appropriate in these cases.  However, it is
important that both the recipient and transplanting physician acknowledge
the potential for increased CJD/vCJD risk.

Existing National Marrow Donor Program (NMDP) procedures currently allow for
donors with exceptional or "abnormal" findings to be collected.  The
procedures do not require the transplanting center to provide any written
record to the donor or collection center regarding physician acceptance of
an exceptional product.  They are maintained by the NMDP to ensure donor and
patient confidentiality.  Assurances are received from NMDP that exceptional
information has been disclosed and is acceptable.  The form that this
assurance takes is typically an email.  We do not recommend that the donor
or collection center be required to obtain copies of any written
acknowledgement from the recipient and physician as this may be burdensome
and delay time-critical activities.

In the case of exceptional use for in clinical applications, we do not
anticipate labeling the product differently.  There are currently varying
standards and practices in this area as the AABB requires products to bear a
biohazard label if the product has TSE risk, however it is arguable whether
travel, for example, is truly a risk meriting a biohazard label.  There is
some concern that transplant center staff may be unjustifiably concerned if
the product were labeled in a manner that suggested the product was
unsuitable.  

This guidance poses challenges for other products that have unique matching
requirements but are not hematopoietic stem cells.  For example, islet cell
isolates, minimally manipulated or others more than minimally manipulated
may have very restrictive criteria for establishing a fit between the donor
and recipient.  Applying these recommendations to in-process INDs or even
approved products deserves closer examination.  In these areas, it is
unlikely that CJD-risk factors would play any actual role in the final
determination of suitability.  However, in the interest of full disclosure,
it may be important that this information be collected and included as part
of the collection and/or transplant record.

Thank you for the opportunity to provide input.

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