Dana-Farber Cancer Institute - Comment

There are serious concerns that the overseas cord blood banks, which currently supply 30-50% of the cord blood units transplanted in the United States, may not want or be able to hold an IND to distribute their units to patients at US transplant centers. That would create barriers to obtaining these units for US transplant patients as their physicians would have to obtain an IND themselves to procure these units. This process is time consuming and requires additional documentation and expense, and could delay or prevent patients from accessing Non-US cord blood units for transplantation. Since most transplants are not investigational, adding an IND to routine procedures burdens both the BMT center and the FDA. The FDA should not restrict use of publically banked cord blood units that are the best donor for a particular patient because they are not licensed or non-conforming. The FDA should not interfere with current medical practice as it relates to donor selection. The physician ultimately selects the best donor to use for their patient's transplant based on multiple factors. The FDA should not create cumbersome or duplicative reporting systems for patient transplant outcomes. All US transplant centers report outcomes to the CIBMTR which holds the contract for the SCTOD (Stem Cell Transplant Outcomes Database). This data should be shared with the FDA if needed, in lieu of requiring additional reporting. Donor screening tests used in overseas cord blood banks are of high quality are approved by the regulatory agencies in their respective countries. The US FDA does not recognize these tests and considers these units non-conforming. However, the tests are medically valid and accurate and should be given deemed status. Moreover, the same testing is performed on adult volunteer donations with no apparent problems.