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FDA Fines Red Cross for $4.2 Million Blood Money

Red Cross Fined for Breaking Safety Laws

By THE ASSOCIATED PRESS

WASHINGTON (AP) -- The American Red Cross said money it makes selling blood will help cover the latest in a series of multimillion-dollar government fines. The Food and Drug Administration ordered the Red Cross on Friday to pay $4.2 million for violating blood-safety laws. The record fine is on top of $5.7 million the Red Cross already has been assessed by the FDA since a court settlement reached in 2003.

The latest fine is for violations that include failing to reject donors who had traveled to malarial areas and allowing blood and related products to be distributed without proper testing, said Margaret Glavin, the FDA's associate commissioner for regulatory affairs.

The FDA stressed it had no evidence of serious health consequences resulting from the violations and that the nation's blood supply remains safe.

The Red Cross provides nearly half the nation's blood supply, selling blood products to health facilities.

The fine stems from Red Cross recalls carried out between 2003 and 2005 that could have been prevented, the FDA said. The recalls involved about 12,000 units of blood and blood products. That number largely explains the size of the fine, Glavin said.

''FDA does not consider the current situation acceptable,'' Glavin said. ''We will continue to work to make sure that the quality system is improved in its design and in its implementation, so these types of problems do not continue to occur.''

In a statement, the American Red Cross said its senior management is committed to comply with the 2003 settlement and all applicable federal regulations. It planned to respond to the FDA within 20 days.

Red Cross spokesman Ryland Dodge said it will not use donated money to pay the fine, but instead will rely on operating funds, including revenue from the sale of blood products.

Source New York Times