| Comment Record|
Dr. Celso Bianco ||
2002-05-13 13:57:39 |
America's Blood Centers |
| Comments for FDA General |
1. General Comments
America’s Blood Centers
725 15th Street, N.W., Suite 700
Washington, D.C. 20005
May 13, 2002
Re: Docket No. 99D–5347: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts, Draft Guidance, Center for Biologics Evaluation and Research (CBER)
To Whom It May Concern:
America’s Blood Centers appreciates the opportunity to comment on CBER’s revised draft guidance. For your information, ABC represents nonprofit community blood centers that collect nearly half of the US blood supply for transfusion.
We appreciate the obvious effort by CBER to simplify this guidance compared to the 1999 iteration, most particularly the proposed questions. We also find the clearer definition of intimate contact useful. However, we continue to oppose a requirement for routine donor screening.
DONOR SCREENING IS UNNECESSARY AND WASTEFUL. We understand that the immunosuppression required by xenotransplant recipients places them at theoretical risk for productive infection with xenotic organisms that are not currently recognized as pathogens. Still, xenotransplantation remains rare and recipients are and will be ineligible to donate whole blood and components based on the illnesses for which they were exposed to xenotransplantation products and/or the immunosuppressive medications they receive. Querying 14,000,000 volunteer blood donors annually to identify the few hundreds of recipients who will be deferred anyway is not justified.
ABC reiterates its belief that the primary responsibility for informing and educating xenotransplant recipients about the risks of xenotic infection and their prohibition from donation remains with the investigators engaging in the research. Blood collection facilities should be required to screen donors actively only when the indications for xenotransplantation become clearer, the number of procedures performed increases and research has further explicated risk. Collection facility involvement should be limited at this time to the provision of written information in the pre-donation materials that donors are given.
DEFERRAL OF INTIMATE CONTACTS IS UNJUSTIFIED. We do not understand or accept the FDA conjecture that non-immunosuppressed intimate contacts of xenotransplantation recipients have risk sufficient to justify exclusion from donation. The inclusion of immune-intact donor contacts raises the concern that the next wave of deferrals will apply to those with extensive animal contact outside the limited setting of xenotransplantation—such as farmers, veterinarians, and abattoir workers.
Our approach is based on two factors:
(1)Xenotransplantation recipients will be deferred under any circumstances—based on their underlying disease and administration of immunosuppressive drugs, and
(2)Deferral of intimate contacts, who are not immunosuppressed, is excessively conservative at best, and at worst is a precedent that may lead to considering deferral of many others with repeated animal contacts outside the context of xenotransplantation, absent demonstrable risk to either donors or blood recipients.
ADDING DONOR SCREENING QUESTIONS MAY DECREASE SAFETY. While our members agree that the proposed questions are an improvement over the original questions, there is consensus that they remain too complicated for many donors, particularly in the context of the already formidable donor interview. The concern is that asking another long question with an intent that may be unclear to donors will compromise donor credulity and patience, and compromise the accuracy of other parts of the donor questionnaire that involve more immediate and substantive risks to the blood supply. This is especially important in view of the lengthy questions that are now being added for vCJD.
-—If FDA mandates donor interrogation about xenotransplantation, ABC urges CBER to validate the proposed questions by demonstrating that their addition will identify the intended donors but will not decrease the reliability of the answers to more important questions, nor increase donor frustration and inappropriate self-deferral.
IND PROTOCOLS. We recommend that when individual INDs for xenotransplant protocols are approved by FDA, blood collection facilities be notified of the IND and whether FDA believes that individual participants should be deferred.
FDA has stated that it intends to “consider on a case-by-case basis, deferral for certain ex vivo exposures.”
-—Our members request inclusion in the guidance of a specific mechanism to request such consideration.
CONSIGNEE AND RECIPIENT NOTIFICATION. ABC urges CBER to explicitly address the issue of consignee and recipient notification in section IV of the guidance. We interpret the current draft as implying that neither is required.
--We agree with this—if it is correct—but believe that the draft will be clearer if specific language is inserted regarding these issues.
Once again, thank you for the opportunity to comment on these issues.
Celso Bianco, M.D.
Executive Vice President
America's Blood Centers