FDA Again Fines Red Cross Over Blood Collection Practices

No one has been harmed by tainted blood, the agency stressed

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By Steven Reinberg
HealthDay Reporter

FRIDAY, Sept. 8, 2006 (HealthDay News) -- Levying the largest fine to date, the U.S. Food and Drug Administration has slapped the American Red Cross once again for failure to comply with safe blood collection techniques.

The Red Cross (ARC), which gathers 45 percent of the nation's blood supply, has been under government mandate since 1993 to improve its quality control system and ensure the safety of its blood supply.

The latest fine, of $4.2 million, brings the total amount levied against the ARC for failure to comply with government requirements to $9.9 million since 2003. It came as a result of a recently completed FDA review of ARC blood recalls between 2003 and 2005, a review that found the recalls were preventable. The agency's violations include breaches of Good Manufacturing Practices, such as failure to ask appropriate donor screening questions and failure to follow manufacturer test protocols.

"The safety of the blood supply is extremely important," Margaret Glavin, the FDA's associate commissioner for regulatory affairs, said during a press conference late Friday.

"The safety of the blood supply requires a rigorous quality control system at all points along the supply chain," she added.

She noted the announcement of the fine was not a public health advisory, and there was no evidence that anyone had been harmed by any recalled blood.

But in light of these new problems, she said, the FDA is requiring the ARC to review its quality-assurance system and its implementation.

"FDA does not consider the current situation acceptable," Glavin said. "It is not acceptable that the quality system has failed in this way. We will continue to work to make sure that the quality system is improved in its design and in its implementation so that these kinds of problems do not continue to occur."

FDA officials did say that some of the blood designated for recall was released, but there appeared to be no adverse consequences.

"We are not aware of any actual contaminations or any actual health consequences from and of the released units," said Dr. Jay Epstein, the FDA's director of the Office of Blood Research and Review and the Center for Biologics Evaluation and Research.

According to the New York Times, which cited court papers unsealed earlier this year in the U.S. District Court in Washington D.C., a former Red Cross quality-control manager has accused the charity of releasing 607 pints of contaminated blood in New Jersey, even though charity officials knew that the blood had been improperly collected and exposed to air.

FDA Commissioner Dr. Mark B. McClellan added in a prepared statement, "I am hopeful that the acceptance of this agreement by ARC's new leadership reflects a new willingness to implement a management culture that expects and achieves good blood safety practices."

In response to the latest FDA action, the ARC said in a statement released Friday: "In accordance with established procedure, we will review the letter, prepare our plans to address the FDA's concerns, and respond to the agency within 20 days. The American Red Cross senior management takes it seriously and is committed to full compliance with the Amended Consent Decree and all applicable federal regulations."

More information

The FDA can tell you more about blood collection.

SOURCES: Sept. 8, 2006, teleconference with Margaret Glavin, associate commissioner, regulatory affairs, and Jay Epstein, M.D., director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Washington, D.C.; Sept. 8, 2006, statement, The American Red Cross; Sept. 8, 2006, New York Times

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