FDA Delays Regulating Tissue Transplants May
-- The Food and Drug Administration was criticized Wednesday
for failing to issue regulations governing hundreds of tissue
banks despite at least one death linked to infected tissue
and investigations that have found widespread problems.
Sen. Susan Collins, chairwoman of the Senate Governmental
Affairs Committee, said she has repeatedly pressed the FDA
to issue rules regulating the industry that have been pending
for more than six years.
"The FDA still has not kept its commitment to addressing
this public health risk," said Collins, R-Maine. "The
result of bureaucratic inertia has been tragedy."
The regulations that have been proposed, but not finalized,
would require more stringent testing of tissue before it is
given to patients and would add controls for the processing
of human tissue.
In prepared testimony submitted to the committee, Dr. Jesse
Goodman, a top FDA official, said the agency was working to
oversee the industry and was still reviewing comments on the
"FDA is committed to protecting public health by promoting
greater safety of tissues used in transplantation," said
Goodman, director of the agency's Center for Biologics Evaluation
In 2001, 23-year-old Brian Lykins of Willmar, Minnesota,
died after routine surgery, where bone tissue from a cadaver
was grafted into his knee. The tissue apparently was infected
with a deadly bacteria.
The Centers for Disease Control and Prevention investigated
Lykins' death, and said Wednesday that it has reports of 62
infections associated with soft-tissue grafts.