STATEMENT: FDA Issues Adverse Determination Letter

WASHINGTON, Wednesday, November 22, 2006 — The American Red Cross has received an Adverse Determination Letter (ADL) from the U.S. Food and Drug Administration (FDA) following an inspection of its New York-Penn Blood Services Region in the fall of 2005. The ADL assesses penalties of $5.7 million. The FDA investigators identified concerns associated with the New York-Penn Blood Region’s implementation of the Red Cross’s problem management system, a comprehensive system of procedures designed to monitor, identify, correct, and prevent problems. Since these procedures were implemented in 2004, the Red Cross has continually taken steps to improve the problem management process. Recently, the Red Cross has taken additional steps to enhance the skills and training of staff performing these procedures.

The Red Cross will review the ADL and prepare a plan of action to address the FDA’s concerns within 20 days of receipt of the letter. The Red Cross pays all imposed fines from Biomedical Services operating funds; no monetary donations to any part of the Red Cross from the generous American people will be used to pay these fines.

To ensure the Red Cross implements the highest quality blood program possible, the Red Cross Board of Governors has requested that an independent and comprehensive assessment be conducted of the Red Cross’s compliance with all FDA regulatory requirements. The Red Cross management team has welcomed this initiative and is fully committed to correcting all identified deficiencies. The Red Cross acknowledges the important role of the FDA and will continue to enhance our systems to provide lifesaving blood and blood components to millions of Americans each year.

The top priority of the Red Cross is the safety and availability of the nation’s blood supply, of which the Red Cross provides over 40 percent. The Red Cross has many layers of safety in place to protect the blood supply, from collection through distribution. The FDA and the Red Cross agree the blood supply today is safe and that blood donation is a safe procedure.

The American Red Cross helps people prevent, prepare for and respond to emergencies. Last year, almost a million volunteers and 35,000 employees helped victims of almost 75,000 disasters; taught lifesaving skills to millions; and helped U.S. service members separated from their families stay connected. Almost 4 million people gave blood through the Red Cross, the largest supplier of blood and blood products in the United States. The American Red Cross is part of the International Red Cross and Red Crescent Movement. An average of 91 cents of every dollar the Red Cross spends is invested in humanitarian services and programs. The Red Cross is not a government agency; it relies on donations of time, money, and blood to do its work.