The Food and Drug Administration (FDA) today announced the formation of a multidisciplinary FDA task force on human cell and tissue safety.
“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.”
This move comes in response to the public health concern which has been generated as a result of the discovery of at least 2 human tissue harvesting companies have supplied tissue to companies that process the tissue without adequately screening the tissue to eliminate the risk that the tissue is infected or diseased. The processing and distributing companies have likewise turned a blind eye to the screening requirements based upon the desperate need for tissue, which has become a billion dollar industry. We now know of at least 1300 bodies between the two companies which have been improperly and in some cases illegally harvested for tissue. Multiple lots of tissue can be taken from each body and at least 13,000 tissue lots distributed to hospitals have been recalled, albeit much of that tissue has already been implanted in unsuspecting surgical patients.
The FDA’s moves means that there are surely more disclosures of unscreened and dangerous tissue that remains out there and surely there will be more recalls of tissue to come.
“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.”