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 June 14, 2003
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FDA Slow to Move on Tissue Bank Regulations
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The U.S. Food and Drug Administration (FDA) received harsh criticism Wednesday for its failure to act on proposed regulations to govern the hundreds of tissue banks in the nation.

Investigations have revealed widespread problems in the industry, including at least one death caused by infected tissue, the Associated Press reports.

The chairwoman of the U.S. Senate Governmental Affairs Committee, Sen. Susan Collins, said she's made repeated attempts to get the FDA to act on proposed regulations to govern the tissue bank industry. Those rules have been pending for more than six years.

Collins charged that the FDA has failed to keep its commitment to address this public health risk and said that bureaucratic inertia has resulted in tragedy, the AP says.

The proposed regulations would force more thorough testing of tissue before it's given to patients and add tighter controls on the processing of human tissue.

An FDA spokesperson told the committee that there is no timetable for the regulations to be finalized but added that they are moving forward.

Collins said she would push for legislation to force the FDA to issue tissue transplant regulations within 90 days.


-- Scott Roberts and Robert Preidt

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