FDA Asks Federal Court to Hold American Red Cross in Contempt of 1993 Consent Decree and Impose Prospective Fines for Violations

FOR IMMEDIATE RELEASE
P01-22
December 13, 2001

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FDA ASKS FEDERAL COURT TO HOLD AMERICAN RED CROSS IN CONTEMPT OF 1993 CONSENT DECREE AND IMPOSE PROSPECTIVE FINES FOR VIOLATIONS

The Food and Drug Administration today asked a Federal court to hold American Red Cross (ARC) in contempt of a 1993 consent decree covering ARC's blood program. FDA also asked the court for authority to levy prospective fines against ARC for future violations. ARC supplies approximately 45 percent of the nation's blood supply.

FDA's actions followed inspections of ARC facilities over the last 16 years that have shown continuing ARC violations. These inspections include one from February through April 2000 of ARC's national headquarters, which provides quality assurance oversight for all of ARC's regional and laboratory facilities, and an inspection of ARC's Salt Lake City facility from March through May, 2001. Despite ARC's agreement to make substantial improvements, as promised in a consent decree signed in May, 1993, these inspections revealed persistent and serious violations of blood safety rules.

"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, which is essential to the public health," said Bernard A. Schwetz, DVM, Ph.D., FDA's Acting Principal Deputy Commissioner. "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. In our view, these prospective penalties are necessary to ensure that ARC is held financially accountable for each unit of blood it fails to manage properly."

FDA laws and regulations establish overlapping safeguards designed to protect the blood supply. Because there is always some degree of risk, however small, in receiving blood products, each individual safeguard is considered critical to minimizing that risk. Although the failure of an individual safeguard, such as improper recordkeeping, does not automatically translate into the release of unsafe products, it may increase the potential risk. ARC's violations of the consent decree and blood safety regulations have decreased the margin of safety.

The need for strengthening ARC's motivation for compliance was particularly evident from the findings of FDA's sixth and most recent inspection of ARC's national headquarters in February-April 2000. This inspection revealed violative conduct, including the following:

incorrect labeling and release of blood potentially contaminated with cytomegalovirus;
lack of adequate quarantine and inventory controls;
inadequate donor registration controls and failure to maintain accurate and current lists of deferred donors; and
erroneous, premature release of computerized "holds" on blood donations.

FDA's March-May 2001 inspection of the Salt Lake City facility further demonstrated that ARC has not corrected these violations. Numerous violations were observed relating to quality assurance and ARC's continuing failure to monitor and exercise effective control over its regions. For example, possibly unsuitable donors were not deferred appropriately and quality assurance personnel did not investigate these deviations or attempt to correct them.

Dr. Schwetz emphasized that, as FDA works to improve blood safety, patients requiring blood transfusions should not hesitate to receive blood. "The risk of not receiving a needed transfusion far outweighs the risk of receiving blood," he said. ìI also want to encourage Americans to continue to donate blood. Giving blood is a safe and unselfish act. The health of millions depends on it," he added.

FDA's legal action consisted of a motion asking a federal court to issue an order requiring ARC to show cause why it should not be held in contempt of a 1993 consent decree and to impose on ARC prospective fines to encourage future compliance. The motion and supporting documents were filed in the United States District Court for the District of Columbia.

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