Statement of the American Red Cross On the Announcement of Consent Decree Penalties

American Red Cross
Thursday, 21 August 2003

The American Red Cross is committed to full compliance with the Food and Drug Administration (FDA) amended Consent Decree and all other federal regulations. Significant resources have been expended to meet this goal, with the Red Cross successfully meeting several Consent Decree milestones.

However, on July 22, the FDA notified the American Red Cross that the Standard Operating Procedures (SOPs) submitted in June were not in line with FDA expectations. The SOPs are a complex system of procedures designed to detect, investigate, correct and monitor problems, trends and system problems. The FDA also announced its intention to assess fines under the terms of the amended Consent Decree. The scope of these fines is discretionary to the FDA, and the Red Cross will be in discussions with the agency on this matter.

The Red Cross acknowledges the important role the FDA plays in helping to ensure the safest possible blood supply. We share this commitment to safety and are taking swift actions to implement solutions to meet FDA requirements and to assist in assuring the safety of the nation's blood supply.

While the Red Cross included the possibility of fines in budgetary planning, we intend to reach full compliance. The Red Cross is prepared to pay these and future penalties from Biomedical Services operating funds. None of the public's generous monetary donations will be used to pay any penalties associated with the Consent Decree. The American Red Cross remains dedicated to its mission and to the millions of Americans who rely on us to provide lifesaving blood and blood components each year. Giving blood is safe and those who need blood should not hesitate to receive it.

For more information, or to contact American Red Cross, see their website at: www.redcross.org