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Jan. 6, 2012 

Public Citizen Calls on FDA to Impose a New $10 Million Fine on the American Red Cross

The Red Cross Previously Racked Up Tens of Millions in Fines for Violations in Adequately Protecting the Nation’s Blood Supply

WASHINGTON, D.C. –The Food and Drug Administration (FDA) should immediately impose a nearly $10 million fine on the American Red Cross because of hundreds of violations the agency found in a 2010 inspection of a donor support center in Philadelphia, Public Citizen said in a letter sent today to Health and Human Services Secretary Kathleen Sebelius.

An FDA fall 2010 inspection of this national Red Cross center in Philadelphia, which was obtained this week by Public Citizen via a Freedom of Information request, documented hundreds of violations of a 2003 agreement between the FDA and the American Red Cross intended to ensure the safety of the nation’s blood supply. Public Citizen separately learned that months ago, the FDA decided to impose a financial penalty of nearly $10 million for those violations, but this has been held up for inexplicable reasons.

Public Citizen calls on HHS to immediately impose the fine.

The violations included failing to notify health departments when a blood donor has been determined to have infectious diseases, such as HIV, Hepatitis B or C, West Nile Virus or syphilis; failing to review donors whose blood donations needed to be quarantined in the past; failing to promptly add people with known problems such as infections to the national list of deferred donors and delays in logging problems with donations more than five days after their discovery.

“Since the FDA and American Red Cross’s 2003 agreement, the Red Cross has been previously fined $37 million, but the substandard performance of critical Red Cross blood handling functions continues,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The longer HHS delays in imposing the financial penalties, the more opportunity it will afford for the Red Cross to claim that things are much better now, even if they are not. Too many lives are at risk if the Red Cross continues violating the important 2003 Consent Decree it agreed to abide by.”

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