FDA News

FDA Releases Human Tissue Task Force Report

(June 12, 2007)-- The U.S. Food and Drug Administration (FDA) released a report that concludes there are no significant industrywide problems in the recovery of human tissues used for transplantation. The report was issued by FDA’s Human Tissue Task Force (HTTF), an intra-agency group assembled in August 2006 to evaluate the effectiveness of FDA’s tissue regulations.

The HTTF recommended targeted inspections or a "blitz" of U.S. companies that recover human tissues – including tendons, ligaments, bone and other musculoskeletal tissues. One goal of the blitz was to look for more widespread problems in tissue recovery after FDA ordered two companies to cease manufacturing in 2006. FDA had found that these companies were not following procedures intended to prevent infectious disease transmission.

Investigators from FDA’s Office of Regulatory Affairs (ORA) inspected 153 major human tissue recovery firms from October 2006 through March 2007. While some deviations from the regulations were identified, no major inaccuracies or deficiencies were found that could put tissue recipients at risk.

Based on data from the blitz, HTTF reported that nearly all recovery firms were in substantial compliance with FDA’s comprehensive risk-based tissue regulations that went into effect in May 2005.

The task force report also made several recommendations on how to enhance FDA’s tissue safety activities. FDA will use the information to better understand and oversee industry practices and to develop or revise guidance documents, regulations and future inspection strategies.

"The results, particularly of the blitz, show that FDA’s new tissue regulations help keep human tissue safe," said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research (CBER). "The work of the HTTF and FDA has provided valuable information about tissue recovery firms, our status on tissue safety, and important additional steps that should be taken to enhance the safeguards already in place."

The overall risk of disease transmission through tissue transplantation is believed to be very low, according to Goodman. While 1.5 million musculoskeletal tissue transplants are performed annually, reports of disease transmission are rare.

However, any instance of disease transmission can be serious, and up to 100 recipients may receive tissue from a single donor. In addition, the industry is growing in size, scope and complexity, further underscoring the need for strong process control by manufacturers and effective federal oversight.

"The recommendations of the task force will help us provide greater assurance of tissue safety," said ORA Associate Commissioner Margaret O’K. Glavin. "The collaboration between CBER and the Office of Regulatory Affairs through the HTTF is a model that served us particularly well and will be continued."

There are more than 2,000 active cell and tissue establishments registered with FDA. In fiscal year 2007, FDA intends to conduct 484 inspections. The task force recommends that all tissue establishments performing manufacturing steps considered to represent the highest potential risk for disease transmission be inspected every two years. It recommends that all others be inspected every three years.

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