WASHINGTON, D.C.—Senate Governmental Affairs Committee Chairman Susan Collins (R-ME) said that while the Food and Drug Administration’s (FDA) expansion of tissue bank registration requirements is a positive step, the agency still needs to move forward with two proposed regulations governing tissue bank standards and donor suitability. Senator Collins has been urging the FDA to act on these regulations for nearly three years.
“The FDA’s announcement that it is expanding registration requirements to apply to more tissue establishments is a minor but positive step,” said Senator Collins. “Far more important are the long-promised regulations imposing donor suitability criteria and good tissue practices. Until these regulations are finally issued, the safety of the nation’s tissue supply is threatened.”
In May 2001, following an investigation conducted by the Permanent Subcommittee on Investigations, then chaired by Collins, the FDA claimed at a committee hearing that it was “committed” to establishing a regulatory framework that would help ensure the safe use of human tissue for transplantation. Since that time, and after repeated requests from Collins for more information and a timeline for issuing the regulations, the FDA and the Department of Health and Human Services pledged that the regulations would be completed by the end of 2003. The two proposed regulations in question are “Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement” (66 Fed. Reg. 1508) and “Suitability Determination for Donors of Human Cellular and Tissue-Based Products” (64 Fed. Reg. 52696).
“I am frustrated by the delay in the implementation of these regulations and will not relent in my efforts to press the FDA to act until I see the final rules published in the Federal Register,” said Senator Collins.
In 1997, the FDA acknowledged the health risks involved with tissue transplants and the need for better federal oversight of the industry. Similar to blood transfusions and organ transplants, tissue transplants can transmit communicable diseases such as HIV and hepatitis. Unlike the government’s stringent oversight of the nation’s blood banks and organ donor programs, there are scant federal regulations governing how transplant tissues are processed and distributed.