Dark Cloud Over Red Cross Blood Services Has Finally Been Lifted
After about 22 years, the U.S. Food and Drug Administration (FDA) has lifted its Consent Decree pertaining to the safety of the blood services operations of the American Red Cross, the nation’s largest supplier of blood products. A consent decree, in general, is a legal arrangement in which the government agrees to drop charges against an accused party who, without admitting guilt, agrees to refrain from certain activities. The Red Cross was no longer under the FDA Consent Decree as of December 4, 2015, according to an internal email message from Red Cross President and CEO, Gail McGovern (obtained by ProPublica), in which McGovern calls the Consent Decree release an “unprecedented accomplishment” for the Red Cross. In the message, McGovern describes that the Red Cross “has worked closely with the FDA over the last five years to develop a more robust, world-class system to evaluate and monitor the performance of [its] compliance functions” ultimately resulting in a five-year period of “sustained compliance” that led to the FDA releasing the Red Cross from the Consent Decree, under which it had been operating since 1993.
CharityWatch has been critical of the Red Cross’ blood services operations in the past, alerting donors on at least two different occasions about its mismanagement of nearly one-half of the nation’s blood supply. As a result of violating blood safety standards, CharityWatch made donors aware that the Red Cross had paid at least $45 million in penalties and fines levied by the FDA dating back to 2003. In a 2008 article, CharityWatch encouraged the Red Cross to more closely monitor the compliance of its blood services operations in order to avoid having to use donations to pay such wasteful penalties; the Red Cross did, however, end up paying millions more in FDA fines after 2008. Given that the Red Cross controls a major portion of the U.S. blood supply, it is an important step forward that the Red Cross has finally been able to achieve the period of “sustained compliance” required by the FDA for its blood services operations to now be flowing Consent Decree-free.