"The Food and Drug Administration has made virtually no progress in strengthening its regulatory requirements for the tissue transplant industry, despite the clear evidence that these regulations are desperately needed to protect public health," said Senator Collins. "The delay is inexplicable. The FDA has made promise after promise that it would adopt final regulations, but it has failed to act. This is bureaucratic inertia."
In 1997, the FDA acknowledged that the use of infected tissue poses a serious public health threat and that better federal oversight of the industry is needed. Despite this, reports of infections from tainted tissue are rising, and, in 2001, tainted bone tissue caused the death of 23-year old Brian Lykins who received the tissue during elective knee surgery. 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.
Two years ago, the Permanent Subcommittee on Investigations, which Collins chaired, found that despite the health risks to unsuspecting transplant recipients, FDA regulation of the tissue bank industry was woefully inadequate. Then, only months after the subcommittee's hearing on tissue banks, Lykins died. An investigation later found that Brian's tissue donor had been dead for 19 hours and the corpse had not been refrigerated during that time. At today's hearing, Brian Lykins' parents spoke publicly for the first time since their son's death on November 11, 2001.
"Unfortunately, the FDA has not kept its commitment to minimizing the public health risk through effective regulation," said Collins.