FDA fines American Red Cross $4.2M for violating blood collection laws

[JURIST] The US Food and Drug Administration (FDA) [official website] announced Friday that it was fining the American Red Cross [NGO website] $4.2 million [press release] for "failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products" that had prompted the recall of 12,000 units of blood between 2003 and 2005. Margaret Glavin, FDA associate commissioner for regulatory affairs, said the Red Cross allowed individuals who had visited areas with known cases of malaria to donate blood which was then distributed without appropriate testing. Glavin said the blood supply in the US remains safe and the Red Cross said it plans to comply with the penalty [press release], set under the terms of an amended 2003 consent decree.

The fine is the largest ever levied by the FDA following the 2003 court settlement, which empowered the government to impose heavy fines on the Red Cross if FDA rules were found to have been violated. Red Cross officials say they plan to reply to the FDA within the next 20 days. In 2005, the Canadian Red Cross pleaded guilty and publicly apologized [transcript] for allowing the distribution of blood and blood products contaminated with HIV and hepatitis C to thousands of Canadians in the 1980s. Responsibility for blood collection and distribution in Canada has been shifted to a new Canadian Blood Services [NGO website] organization. AP has more.



 

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