FDA Action on Red Cross Long Overdue

Dec. 13, 2001

FDA Action on Red Cross Long Overdue

Statement of Dr. Sidney M. Wolfe, Director, Public Citizen?s Health Research Group

A year ago, Public Citizen requested the U.S. Food and Drug Administration (FDA) to ask that the American Red Cross (ARC) be held in contempt of court because of longstanding, dangerous practices that are jeopardizing the safety of the U.S. blood supply. On Thursday, the FDA finally made that request.

While we are pleased the government took action, it is long overdue, and we urge the court to act swiftly. Records indicate that the Red Cross has not come into compliance with a 1993 consent decree or with U.S. laws and regulations concerning blood and blood products.

The importance of having a safe blood supply cannot be overstated. The American public relies heavily on the Red Cross blood supply, and patients should know that when they receive blood, it will not be tainted. Records indicate that the ARC has improperly released blood products containing cytomegalovirus, a virus that can cause blindness in newborns. Also, FDA inspectors found that blood donors had incorrect histories and that Red Cross staff failed to follow test kit instructions for HIV.

Although the FDA insists the blood supply is safe, these findings cause grave concern. If proper procedures are not followed, it is only a matter of time before someone is seriously harmed. That would be inexcusable, particularly given the fact that the government has known about the Red Cross? violations for well over a decade. Even the ARC?s former president, Dr. Bernadine Healy, said in an Aug. 14, 2000, meeting that she found the FDA?s findings “alarming” and that the severity of the situation held the potential for “grave impact” to patients, court records show.

We strongly support the efforts to hold the Red Cross in contempt of the consent decree. Unfortunately, given the lengthy history of this case, the fines that would accompany a contempt of court citation appear to be the only way the Red Cross will respond.

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Click here to read Public Citizen’s December 2000 letter to the FDA.