| Comment Record|
Dr. Pamela Jett, MD ||
2003-04-28 12:45:56 |
Mississippi Blood Services |
Health Professional |
| Comments for FDA General |
1. General Comments
COMMENTS ON THE SARS GUIDANCE The blood community appreciates the FDA's prompt review of the alternate approach that was subbmitted by America's Blood Centers.
a. Process and timing – the guidance was issued without seeking public comments because “SARS may pose immediate safety risks to the blood supply”. While it is possible that this risk may be documented in the future, at the time of issuance of the guidance there were 35 cases of SARS reported to the CDC. FDA could have issued the guidance as a draft or convened an emergency meeting of the Blood Products Advisory Committee in order to have input from the public, including our membership.
b. Scope of the guidance. The final guidance was issued in the absence of scientific knowledge, when the total number of cases in the US was 35 (about 1/8,000,000 population in the US) with no clinical evidence of transfusion transmission. Ninety four percent of those cases were in travelers returning from CDC listed countries. However, the guidance covers the entire gamut of issues, based on unverified theoretical assumptions, without regard for the impact that it may have on collecting facilities and volunteer blood donors. The guidance should have had a much more limited scope: addressing the potential that a traveler returning from one of the countries listed by CDC may have asymptomatic viremia with the putative SARS agent(s). Future guidances or “triggers” for a broader scope could have been built into this guidance based on the evolution of the epidemic.
c. Impact on blood availability (Section II.C). The assertion made by FDA is incorrect and inappropriate. Deferral of 0.4% of donors equals deferral of 32,000 donors who donate 56,000 units a year. This is equivalent to the current deferrals for travel to malarial area. Estimates of the addition of Toronto are not available, but may be significant--particularly for blood centers that collect in areas with substantial traffic from Ontario. Since the ultimate spread of SARS is undetermined at this time, it is possible that geographical deferrals will make collections impossible in certain areas the US--creating a supply crisis. An alternative is to focus deferrals on individuals that have been classified as SARS contacts by Public Health Authorities.
d. Impact on the donor screening process. The guidance seriously complicates the donor screening process by imposing three additional donor questions that must be answered at several levels, requiring additional donor time, additional staff time and possibly additional staff, training, revision of donor forms, modification of computer systems, computer validation, etc.
e. Additional questions. The AABB Uniform Donor History Questionnaire task force was not involved in the development or analysis of any of the questions nor were, to our knowledge, any experts in interviewing. The new questions were not validated for comprehension. We believe that the additional questions could have a negative impact on blood safety, by making the donor history process more complex and confusing, and diverting the attention of donors from real issues like risk behavior. It is our experience that the more we ask, the less we learn. Interviewers and donors get tired. Very few people have a span of attention that can keep up with the over 40 questions dealing with over 70 issues that are posed by the interviewer.
f. CGMP aspects of emergency implementation. Implementation of these guidelines in the cGMP environment in less than 30 days is problematic. There are SOP revisions, training, validation, software revisions, software and systems validation issues, and we are not convinced the threat of SARS from transfusion justifies the priority it is given by FDA, especially in the face of our attempts to bring up WNV NAT, for a demonstrated risk. The alternative is a less controlled implementation of the SARS guidance and resulting defects in the trackability and traceability FDA demands.
g. First question. The first donor interview question (In the past 28 days, have you been ill with SARS or suspected SARS) is unacceptable because on the date of issuance of the guidance CDC reported 1 case per 8 million inhabitants in the US. It is inappropriate to clutter the donor history process with an irrelevant question. The only appropriate action would be for PHS to advise SARS patients not to donate blood for 28 days. Should the epidemic expand substantially in the US, this can be revisited. In addition, these people would have been covered by the travel or contact questions. We strongly recommend deletion of this question.
h. Close contacts. With the small number of cases in the US, there are few close contacts. We recommend that the question should be implemented only if the are more than a certain number of SARS cases in the US, and evidence of parenteral transmission is forthcoming.
i. Guidance approach to CDC Updates. The recommendation that collecting facilities consult the CDC website “routinely and periodically” for updates cannot be implemented in a cGMP environment. Changes in the list of countries of the definition of close contacts require changes in SOPs, changes in donor registration forms, changes in information provided to donors before donation, changes in documentation that the questions were asked and the answers were acceptable, training of staff, etc. The statement in the guidance implies that consultation of the CDC website must take place almost daily or, if taken to its extreme (like some FDA inspectors do) before each donor interview. For instance, the guidance was issued on Thursday, April 17 and CDC changed its case definition on Friday, April 18, 2003. We can think of only two alternatives. Either FDA waives documentation or FDA issues updates with time for implementation.
j. Case Reporting. The recommendation for reporting of SARS cases in donors or recipients to local health authorities is not reasonable. We believe that SARS cannot be diagnosed over the telephone by blood center collections staff or physicians. It is the obligation of the diagnosing physician to report the case to health authorities, not a collection facility with inadequate documentation. While the collection facility can initiate retrieval of products, it must not be required to assume the responsibility to notify public health authorities based on a telephone conversation with the donor. The same is true for a blood recipient who develops SARS. The responsibility is that of the diagnosing physician. Blood collecting facilities can and will collaborate with health authorities in the tracing of units, specimens and disposition of products from the index donation.
In summary, we are not convinced by the FDA that the threat of SARS to transfusion safety rises to the level of emergency and action required by the Guidance. While evidence on this issue is developed, and the epidemiology in the US is monitored, we propose that a deferral for 14 days for travel to CDC-listed destinations is an adequate initial step that will fit well with current operations and capture more than 90% of current cases in the US. The current guidance document should be rescinded and replaced by a more reasonable approach. Additionally, the FDA must convince CDC to add a proscription from blood donation to information already being provided to returnees from listed countries, as we have previously and repeatedly suggested as a simple, effective approach to prevent donation by at risk individuals.