| Comment Record|
Dr. Celso Bianco ||
2002-07-08 15:03:27 |
America's Blood Centers |
| Comments for FDA General |
1. General Comments
America's Blood Centers
725 15th Street, N.W., Suite 700
Washington, DC 20005
July 8, 2002
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Draft Guidance: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components for Transfusion to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV, Docket No. 02D–0096
Dear Docket Officer:
America’s Blood Centers appreciates the opportunity to comment on the Center for Biologics Evaluation and Research’s draft guidance issued following the licensure of the first nucleic acid test (NAT) for screening blood donors for HIV-1 and hepatitis C virus (HCV). For your information, ABC is a national network of locally-controlled, non-profit community blood centers that collect almost half of the US blood supply from volunteer donors. Collectively, we operate in 45 states and serve patients at more than half of the nation’s 6,000 hospitals. ABC’s total blood collections exceeded 7 million pints in 2001.
ABC member centers are very pleased with this guidance and agree that nucleic acid tests make a great contribution to the safety of the blood supply.
We have the following specific comments on the draft guidance:
The Draft Guidance applies to Whole Blood and Blood Components, as defined in CFR Title 21, Part 640.1. ABC member centers request that FDA provide a clearer definition of the scope of the guidance.
We recommend that the final document include references to autologous donations of whole blood, red blood cells, platelets and plasma collected by apheresis, hematopoietic progenitor cells and the soon to be regulated component Recovered Plasma.
Despite the detail presented on the package insert of the licensed NAT, there is insufficient guidance regarding product retrieval, supplemental testing, donor notification, donor counseling and lookback. We understand that FDA plans to issue a specific guidance focused on the management of donors with positive test results on nucleic acid testing.
ABC members request the issuance of this complementary draft guidance as soon as feasible. The guidance needs to address algorithms for either resolution of positive NAT results on initial testing in pools or individual samples, including positive pools in which resolution by individual testing fails to identify a positive sample. The guidance also needs to address reentry algorithms for false positive test results. In addition, members that have discontinued or plan to discontinue HIV-1 p24 Ag testing hope that the guidance will address reentry of individuals with false positive results without the need to consider prior results or repeat this outdated screening assay. Members are aware of the fact that these issues have been discussed and voted on by the Blood Products Advisory Committee and are eager to implement the recommendations.
We applaud FDA for recognizing that the licensed technology is not universally available and that a substantial number of licensed establishments continue to perform nucleic acid testing under IND and need time to implement licensed systems.
ABC members request that FDA coordinate issuance of the final guidance with the licensure of at least one additional test. ABC members are concerned about the potential dependence of the entire US blood supply on a single manufacturer. In addition, we request sufficient forewarning about issuance of the final guidance to allow a smooth transition from the IND to the licensed test. Six months is too short a time, particularly for licensed establishments that may need to change manufacturers. A change in manufacturers requires reconstruction of facilities, new SOPs, personnel training and validation of the new assay—without affecting the availability of blood and blood products to the patients they serve.
IV.A. Reporting requirements
ABC members feel that the reporting requirements are reasonable.
However, we recommend that FDA create a table summarizing these requirements to make them clearer and easier to follow. In addition, ABC members request that FDA clearly state that facilities that currently send samples to a contract laboratory that is still performing NAT under IND may report the change by the contract laboratory from IND to licensed assay in their Annual Report.
IV.B. Labeling requirements
The draft guidance states that labels and the Circular of Information should indicate whether testing was performed on pooled or individual samples. Seventy-four of the 75 ABC members believe that this requirement is burdensome and has limited public health benefit. However, the Oklahoma Blood Institute (OBI) believes that the guidance and the label should distinguish NAT performed in pools from NAT performed on individual samples. OBI has indicated to us that it will file its specific comments.
There are multiple reasons for the request for changes in the wording of labels and the Circular of Information by the majority of ABC members. First, current software used by licensed facilities to manage NAT maintains all data and records indicating the mode of testing, test results, repeats, discrimination, etc. However, only unit IDs and test results are communicated to the labeling system contained within the 510(k) approved blood management software. At the time of labeling, the systems check the results table and verify whether all requirements were met (deferral files, test results, blood type, etc.) to allow application of a label for transfusion of a component. If a unit is repeatedly reactive for any test, or there is another issue such as a deferral match, the unit is labeled as biohazard, the reason identified, and the unit is separated from acceptable units.
None of the approved computer systems used by ABC member centers is able to provide pool or single testing information at the time of labeling. Distinction between pools and individual tests would require changes in the interface between the NAT management software and the main system, and the creation of specific fields in the main system. This demands a substantial investment in time for development and validation, delaying the use of the labels for many months or a year.
The only immediate solution would be the creation of a manual system for communicating test results from the NAT laboratory to the components laboratory and manual application of labels. However, this would be prone to errors that can extend beyond the NAT results and violate the quality principles we have applied to our blood processing systems.
Second, the majority of ABC members are concerned about the potential public perception that could result when components with different labels are side by side on the shelf of a hospital blood bank. There is a potential for a hospital to demand only individually-tested units, despite the minimal difference in the risks of HCV or HIV transmission between pool-tested and individually-tested components. Furthermore, individual NAT is performed on rare occasions, when there are insufficient numbers of specimens to fill a run, when there is an emergency, or for the resolution of positive pools. Thus, the discriminatory labels may create serious problems for the availability of components.
We request that the final guidance recommend labeling that does not distinguish between pool sample and individual sample testing.
Thank you for the opportunity to comment. I shall be pleased to answer any questions that you may have about our recommendations.
Celso Bianco, M.D.
Executive Vice President