Dec. 1, 2000
The American Red Cross Is Jeopardizing the Safety of the U.S. Blood Supply, Should Be Held in Contempt of Court
The FDA Should Ask Court to Rule That the ARC Violated 1993 Consent Decree
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) should request that the American Red Cross (ARC) be held in contempt of court because of longstanding and dangerous practices that are jeopardizing the safety of the U.S. blood supply, Public Citizen said today.
“It appears that a strong case can be made by the FDA for requesting that the ARC be held in contempt of court,” Dr. Sidney M. Wolfe, director of Public Citizen’s Health Research Group wrote in a letter sent today to FDA Commissioner Jane Henney. “Unless the FDA exercises this legal responsibility, there is little evidence that the ARC will come into compliance with the terms of the 1993 Consent Decree or with U.S. laws and regulations concerning blood and blood products.”
The 1993 consent decree, which a federal court imposed because of repeated instances of dangerous blood-handling practices by ARC regional blood banks, required the ARC to better manage blood service operations and establish better quality control. However, according to court documents filed this week, the ARC has not complied. In Atlanta, FDA inspectors last year found blood products that tested positive for evidence of infection mingled with acceptable blood products. They also found inadequate management of blood products, including those that tested positive for infectious diseases. At the ARC’s Arlington, Va., headquarters this year, FDA inspectors learned that the ARC had improperly released blood products containing cytomegalovirus, a virus that can cause blindness in newborns. Inspectors also found that blood donors had incorrect histories and that staff failed to follow test kit instructions for HIV.
Even the ARC’s 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.
The ARC has “a legal obligation to ensure that … blood products are safe,” Wolfe wrote. “It is time for the FDA to stop playing dangerous, cooperative, polite games with the ARC.”