FDA Takes Heat Over Tissue Transplants

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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.

A top FDA official told the committee the regulations were moving forward but said there was no timetable for them to be finalized.

"They are complex rules. We want to do them right," said Dr. Jesse Goodman, director of the agency's Center for Biologics Evaluation and Research.

Goodman said that the FDA is able to provide some oversight of the industry under existing law but vowed to do "everything I can in my power to move this forward."

In 2001, 23-year-old Brian Lykins of Willmar, Minn., 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.

Lykins' father, Steve Lykins, told the committee that he was outraged to learn that the FDA still had not acted on the proposed regulations.

"How could a medical industry in the United States of America be allowed to operate like this?" he asked. "This industry has been allowed to operate like something out of the wild West for too long."

Two years ago, before the younger Lykins' death, the FDA told the committee that it would move ahead with its regulations. At that hearing, investigators reported widespread problems. Among them: operators who ran multiple tests on recovered tissue in hopes that a second test would find material healthy when the first did not; tissue banks that pooled material from several donors despite medical risk of one person's tissue contaminating another, and operators who mishandled cadavers after removing bone and skin.

Collins said Wednesday that she would press for legislation requiring the FDA to issue regulations covering tissue transplants within 90 days. "It is obvious me that without a statutory deadline FDA will continue to delay and delay," she said.

By Laura Meckler