Dark Cloud Has Finally Been Lifted Over Red Cross Blood Services

After about 22 years, the US Food and Drug Administration (FDA) has lifted the consent decree concerning to the safety of blood services operations of the American Red Cross, the largest supplier of blood products to the nation.

A consent decree in general is a legal arrangement in which the government becomes agree to drop charges against a defendant who, without admitting guilt, agrees not to do the certain activities. The Red Cross was not under the FDA consent decree dated December 4, 2015, according to an internal email from the Red Cross President and CEO Gail McGovern , in which McGovern called consent decree releasing an "unprecedented achievement" for the Red Cross.

In the message, McGovern described that in the last five years the American Red Cross has worked closely with the FDA to develop a more strong and world class system to assess and monitor the performance of [its] compliance functions , ultimately resulting in "sustainable compliance" period of 5 years that led to free the Red Cross from the consent decree by the FDA under which it had been operating since 1993.

Many observers criticized the operations of blood services of the American Red Cross in the past, and informed donors on at least two different occasions about its mismanagement of nearly half of the blood supply of the nation. Following the violation of blood safety standards, donors were made aware many times that the American Red Cross had paid at least $ 45 million in penalties and fines imposed by the FDA from 2003. In 2008, Red Cross was encouraged to more closely monitor the compliance of its blood services operations to avoid having to use donations to pay these unnecessary penalties. The Red Cross has, however, end up paying millions more in fines FDA after 2008.

Given that the American Red Cross controls much of the US blood supply, it is an important step that the Red Cross was finally able to reach the "sustained compliance" needed for its blood services operations by the FDA , now be flowing without consent decree.