April 16, 2007
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
RE Docket 2006D-0514, 17 January 2007, “Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies”
Via electronic submission: www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA
Dear FDA Dockets Manager:
AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, developing and delivering programs and services to optimize patient and donor care and safety.
AABB fully supports comments submitted to the docket by a work group consisting of AABB, the International Society for Cellular Therapies and the National Marrow Donor Program. In addition AABB has the following comments.
The draft guidance does an excellent job describing testing and specifying expected results of these tests, in order for a facility to license a cord blood product. However, there are thousands of products that are in the current inventory which are acceptable but may not have had the recommended tests performed. Data from the National Marrow Donor Program presented at the Cellular, Tissue and Gene Therapies Advisory Council meeting on March 30, 2007, suggests that 80% of the current public cord blood inventory was collected prior to May 25, 2005. As the Food and Drug Administration (FDA) is aware, retesting of these products may be an issue since test kits currently in use do not list umbilical cord blood as an appropriate sample for testing, thus the quandary – what methodology should be utilized in order to test these samples? Additionally, the draft guidance does not adequately address products that are imported from Europe. Approximately 20% of the cord blood products that are transplanted in the United States originate from Europe. Products that are collected in Europe may not have had the required and recommended tests performed and the products may not be licensed by the FDA.
There is a strong possibility that European facilities will not want to pursue FDA licensure for the products. FDA should provide guidance on how transplant facilities could continue the use of imported products, in this situation.
In an effort to preserve the products already in inventory, AABB request consideration of the following approaches to qualifying previously manufactured HPC-Cs.
- Some products will not meet the current release criteria for infectious disease testing.
- Appropriately label the products with the infectious disease marker(s) that were not performed and the appropriate warning statement.
- Inform the transplanting physician of the infectious disease testing that has not been performed.
- Obtain written consent from the physician/facility that they will accept the product.
- Label as appropriate including biohazard labeling, where applicable.
- Some products will lack documentation of GMP compliance.
- Conduct an audit or otherwise document that there were processes and procedures in place at the time of manufacture to demonstrate that the products were manufactured in a controlled manner For example, a facility might have had an SOP in place at the time of manufacture describing equipment cleaning and schedules for cleaning even if there was no requirement to document this with each product or equipment use, and may not have qualified their cleaning agents to the extent that is currently performed.
- When there are no other options to qualify previously manufactured products, a determination that the manufacturer successfully maintained accreditation by a recognized standard setting organization (AABB or equivalent) at the time of manufacture would indicate the products meet best practices at the time.
- These standards evolve over time but generally meet a higher level of industry practice and provide additional assurance that a voluntary peer review program was in place which provided confirmation of adherence to such standards.
AABB believes that the approaches described above would assist facilities in assessing the acceptability of their previously manufactured HPC-Cs. If the products are acceptable, then they could be released for transplantation under guidance set forth by the FDA. This approach might also be applicable for products that are imported from Europe
AABB strongly supports initiatives that improve the safety of patients and donors and stand ready to interact with FDA as necessary. AABB requests that FDA carefully consider product availability and patient safety issues when evaluating the recommendations put forth in this guidance document.
Questions concerning these comments may be directed to Joseph L. Giglio, Deputy Director, Regulatory Affairs, AABB jgiglio@aabb.org
Sincerely,
M. Allene Carr-Greer, MT(ASCP)SBB
Director, Regulatory Affairs
AABB