Contact: Jeannine Guttman
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May 20, 2004

Senator Collins Welcomes FDA’s Long-Overdue Decision to Implement Tissue Donor Rules

Held Hearings, Urged FDA to Issue Rule & Protect Patients From Tainted Tissue

WASHINGTON, DC—Following years of requests from Senate Governmental Affairs Committee Chairman Susan Collins (R-ME), the Food and Drug Administration (FDA) today released a long-overdue regulation to expand current screening and testing requirements for donations of human tissue used for transplants.

“This rule is a major step toward ensuring that tissue contaminated with life-threatening pathogens is not transplanted into unsuspecting patients. This is a serious problem that my Committee’s investigations found occurring far too often,” said Senator Collins.

“While I welcome this new rule, I remain perplexed by the FDA’s repeated and unacceptable delays in implementing this rule. I am concerned that this delay may have put lives at risk,” said Senator Collins.

Senator Collins explained that approximately 1 million tissue transplants occur every year; therefore, this is a crucial matter affecting public health.

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.

In May 2001, following an investigation conducted by the Permanent Subcommittee on Investigations, then chaired by Senator 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. After repeated requests from Senator Collins for more information and a timeline for issuing the regulations, the FDA issued a rule requiring tissue banks to be federally registered and today issued the regulation on donor suitability.

In addition, in May 2003, Senator Collins chaired a hearing on the issue and 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.

Brian’s parents testified before the Governmental Affairs Committee about the tragic case and appealed for greater oversight by the FDA of tissue banks.

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 help ensure the safety of donated tissue through donor screening, lab tests, and proper labeling to avoid improper use of unsafe specimens.

The rule requires that tissue may not be transplanted until the donor has been determined to be eligible according to specific donor screening and testing requirements. Manufacturers will be required to ship tissue-based products with documentation of the donor eligibility determination. Tissue from ineligible donors must be properly labeled and physically separated from tissue from eligible donors.

“There is still one more step that the FDA must take -- issuing a rule governing current good tissue practices,” said Senator Collins. “It is vital that the FDA finalize that rule as quickly as possible, since it will address concerns about the proper handling, storage, and processing of tissue. I will continue to press for adoption of this final component of the regulation of tissue banks.”