FDA Asked To Reconsider Rule
on Contaminated Blood Products

The rare but occasional transplantation of contaminated cellular products was the topic of a meeting last month between FDA representatives and leaders of cellular therapy organizations, including ASBMT.

Ever since the implementation of the FDA Current Good Tissue Practice (cGTP) rule in May last year, there has been concern about a proscription against the transplantation of hematopoietic progenitor cell products that have positive sterility cultures.

According to a strict interpretation of section 1271.265, distribution or infusion of a blood product with a positive microbial culture is a violation of the cGTP rule.  Some centers have been reporting the transplant of positive-culture products as a deviation under an urgent medical need exemption.  The FDA, however, has maintained that permitted deviations apply only to donor eligibility and not to the transplant of manufactured products that have failed a sterility test.

Transplantation of a culture-positive autologous or allogeneic peripheral blood cell or donor lymphocyte product is an unusual occurrence, according to data in a recent survey of members of the International Society for Cellular Therapy (ISCT), presented at the meeting with the FDA.  However, in some situations it is accepted clinical practice to proceed with the infusion, according to the survey.

The staff representing the FDA Center for Biologics Evaluation and Research (CBER) acknowledged the apparent disparity between clinical practice and the cGTP rule and said that the information presented at the meeting would be evaluated to determine whether a guidance document or adjustment in the cGTP rule may be needed.