FDA alleges Red Cross violates blood safety regulations

By Associated Press, 12/14/2001

ASHINGTON - The government asked a federal judge yesterday to hold the American Red Cross in contempt of court for repeated violations of blood safety regulations, including shipment of contaminated blood.

The Food and Drug Administration's unprecedented action charges the Red Cross with ''a cavalier disregard'' for blood quality standards. Despite the court fight, the FDA insisted any risk from blood transfusions today is low.

The FDA motion cited ''persistent and serious violations'' dating back 16 years and continuing despite a 1993 federal court order mandating improvements.

''FDA is acting today to ensure that the American Red Cross takes much more seriously its role as guardian of the safety of the nation's blood supply,'' said the FDA acting commissioner, Bernard Schwetz.

''Unfortunately, to date ARC has exhibited a corporate culture that has been willing to tolerate an unacceptably low level of quality assurance and a lack of concern for the public it is supposed to serve,'' he said.

The Red Cross said it will fight the health agency, issuing a statement saying the motion ''asks the court to take action beyond the legal authority granted by Congress to the FDA.''

The Red Cross has invested more than $280 million to upgrade its blood operations and believes ''the nation's blood supply has never been safer than it is today,'' the statement said.

A court hearing was scheduled for today.