FDA unveils guidelines for shift to universal leukoreduction
WASHINGTON, Jun 19 (Reuters Health) - In a policy shift on leukoreduction for blood products, the US Food and Drug Administration (FDA) has announced that the process should be performed at the pre-storage phase on all units of blood "whenever feasible."
The FDA unveiled its proposals for manufacturing controls, licensing and product use at a June 16 meeting of the Blood Products Advisory Committee as a regulatory first step toward making "universal" leukoreduction the industry standard of care.
Leukoreduction involves the separation of leukocytes from other blood components before transfusion to help decrease the likelihood of adverse reactions in patients.
The FDA has proposed a set of standards that it plans to incorporate into a guidance regarding leukoreduction. The guidance will stop short of specifically recommending universal leukoreduction, but will be worded to encourage the practice, the agency said.
The document is intended to serve as a springboard for eventually making the process mandatory for all blood centers and other healthcare facilities, Dr. Jong-Hoon Lee, chief of the blood and plasma branch of the FDA's Center for Biologics, said.
However, if the blood product industry formulates its own voluntary guidelines, the agency may be able to skip the formal rulemaking process and enforce leukoreduction standards through regular good manufacturing practices (GMP) regulation, Lee suggested.
Regarding manufacturing controls, the FDA is proposing that a facility's processing method be sufficient to reduce leukocytes in a given blood unit by 1.0 x 10 to the sixth power cells or fewer, while retaining at least 85% of the therapeutic product.
Further, the agency suggests that leukoreduction be performed within 24 hours of blood collection via a method that assures at a 95% confidence level that more than 95% of the units will meet specifications.
Lee said that blood centers will have to test about 60 consecutive blood unit samples to achieve a 95% confidence level of product quality and argued that the prevailing standards, which call for testing four units per month, are "grossly insufficient," yielding a comparatively low 59%
level of assurance.
American Red Cross spokeswoman Linda Chambers argued that the FDA's proposed 24-hour processing window fails to account for the time needed to transport donated blood from multiple, remote sites to the processing laboratory. In response, Lee noted that the agency is currently weighing an extension to 72 hours, depending on "center complexity."
Michael Fitzpatrick, deputy director of the Armed Services Blood Program Office, criticized the agency's proposed 85% standard for therapeutic product recovery, arguing that assessing the minimum levels of red cells' therapeutic benefit and then maintaining recovery within that range might prove to be a more feasible starting point
In addition, while the transition to leukoreduction as routine practice appears inevitable, questions remain regarding its value in ensuring benefits for all transfusion patients and about whether hospitals, already strapped for funds, can recoup their added costs through Medicare.
Some hospitals argue that they cannot afford the typical 2-year wait for reimbursement from Medicare, which would pick up the tab for the vast majority of transfusion patients' medical bills for the more costly leuko-reduced blood.
During Friday's meeting, Dr. Louis Katz, spokesman for the American Association of Blood Banks, noted that universal leukoreduction remains "very controversial" among the group's members and called on the FDA to expedite a formal rule or guidance so that blood centers can formulate clear timelines for leukoreduction management and budgeting.
Katz also stressed that the Health Care Financing Administration should draft specific guidelines on Medicare reimbursement before universal leukoreduction becomes mandatory. Resolution of the economic issues surrounding leukoreduction would effectively "mute" much of the scientifically based opposition to the practice, Katz commented. |
