The US Food and Drug Administration (FDA) has asked the US District Court for the District of Columbia for authority to impose fines on the American Red Cross for blood product safety violations. In December, the FDA released a statement saying that the Red Cross had failed to improve its safety record despite signing a 1993 court document promising to do so.
In early 2000, the FDA reported violations at Red Cross headquarters in Washington, including incorrect labeling and release of blood potentially contaminated with cytomegalovirus. The agency also cited inadequate quarantine and premature release of blood.
However, FDA Acting Commissioner Bernard Schwetz, DVM, PhD, said despite violations, the risk of not receiving a needed transfusion "far outweighs the risk of receiving blood."
The Red Cross, which supplies about 45% of the nation's blood, responded by saying that the action will lead to burdensome record-keeping. "The American Red . . . [Full Text of this Article]