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November 18, 2004

SENATOR COLLINS COMMENTS ON FDA’S NEW RULES FOR SAFER HANDLING OF HUMAN TISSUE USED FOR TRANSPLANTS

Collins Held Hearings, Urged FDA to Issue Regulations to Protect Patients from Tainted Tissue

WASHINGTON, DC—Following years of requests from Senate Governmental Affairs Committee Chairman Susan Collins, the Food and Drug Administration today released a long-overdue regulation to govern good tissue practices for donations of human tissue used for transplants.

“This rule is a major step toward ensuring that tissue contaminated with life-threatening diseases is not transplanted into unsuspecting patients. FDA regulation of ‘good tissue practice’ is long overdue, and is necessary to address concerns about the proper handling, storage, and processing of tissue,” said Senator Collins.

As the Chairman of the Senate Governmental Affairs Committee and as the former Chairman of the Permanent Subcommittee on Investigations, Senator Collins has held several series of hearings to examine the need for federal regulation of the tissue bank industry. These included a hearing that highlighted the case of Brian Lykins, a healthy 25-year-old who died in 2001 after routine knee surgery as a result of a tissue transplant contaminated with a fatal bacterium. For years, Senator Collins repeatedly requested that the FDA stick to its timeline for issuing the regulations, and for more information when it failed to do so. The FDA eventually issued rules requiring tissue banks to be federally registered and regulating donor suitability, but it continued to delay implementing rules for good tissue practice.

In 1997, the FDA first 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 have been scant federal regulations governing how transplant tissues are processed and distributed. The Centers for Disease Control have identified more than 60 cases of individuals sickened as a result of transplants of contaminated tissue.

The regulations issued today requires manufacturers to recover, process, store, label, package and distribute human cells, tissues and cellular and tissue-based products in a way that prevents the introduction, transmission, or spread of communicable diseases. The regulations apply to a broad range of these products including musculoskeletal tissue, corneas, human heart valves, dura mater (lining of the brain) and cellular therapies.