U.S. FDA TO EXAMINE REGULATION OF HUMAN TISSUES

The U.S. FDA has formed a multidisciplinary task force on human cell and tissue safety. The FDA Human Tissue Task Force, which will be led by senior FDA officials from within the Center for Biologics Evaluation and Research and the Office of Regulatory Affairs, 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 the task force will be to assess the effectiveness 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.

While the agency believes most firms involved in tissue manufacturing comply with the new regulations, the 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.