FDA forms task force on human tissue safety

Aug 30 2006

The Food and Drug Administration (FDA) today announced the formation of a multidisciplinary FDA task force on human cell and tissue safety.

The FDA Human Tissue Task Force (HTTF), which will be led by senior FDA officials from within the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA), was established as part of the agency’s efforts to strengthen its comprehensive, risk-based system for regulating human cells and tissue.

The main priority of HTTF will be to assess the effectiveness of the implementation of the new tissue regulations, which went into effect in 2005. Of particular interest will be a review of recently reported findings that some tissue recovery establishments are not following federal requirements for tissue recovery.

“The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products,” said Jesse Goodman, MD, MPH, director of CBER. “The creation of this task force is part of the agency's overall plan to ensure that all human cells and tissues are as safe as possible.”

While the agency believes most firms involved in tissue manufacturing comply with the new regulations, FDA wants to explore where additional steps could help strengthen its approach to making sure firms follow required practices to prevent the transmission of communicable diseases. The agency continues to work diligently to identify and, where appropriate, take action against establishments and individuals that violate the rules. These actions may include both administrative and criminal proceedings.

“FDA is committed to rapidly identifying and stopping those establishments and individuals that risk endangering the public health by not complying with the regulations,” said Margaret O’K Glavin, Associate Commissioner of the Office of Regulatory Affairs. “We also will continue to work with professional and trade associations to support their ongoing efforts to assure quality oversight of manufacturing operations and product safety.”

“The creation of this task force underscores FDA’s recognition that compliance with the rules in place to ensure recipient safety is our highest priority,” Dr. Goodman said.

Within the next three months, the task force will develop an action plan, and where necessary, propose changes to existing policies, as well as generate a set of recommendations, identify what resources are needed to support these actions and report on how the agency can immediately implement its action plan.