Resolution Reached between American Red Cross and Food and Drug Administration

WASHINGTON, April 11, 2003 — The top priority of the American Red Cross is the safety, security and availability of nearly half of the nation's blood supply.
The Red Cross and the Food and Drug Administration (FDA) have reached agreement on terms of a new Consent Decree, which provides legal guidance on the handling of donated blood. Both organizations have agreed to work collaboratively to further enhance the safety of America's blood supply under this new agreement.

This agreement is welcomed and marks a new era of cooperation between the Red Cross and the FDA, allowing focus and forward progress to enhance operations. The Red Cross and the FDA agree that the nation's blood supply is safer today that it has ever been. We are determined to keep it as safe as possible and organizationally to be accountable to the highest standards set by regulators and the American public we serve.

There is a recognized need to further strengthen our procedures and processes. The Red Cross has implemented a comprehensive and aggressive quality program that will result in an even safer blood supply.

The new Consent Decree provides greater specifics on how the Red Cross will manage, monitor and resolve problems if they arise. It formalizes management of issues and provides timelines for their resolution. It calls for fines if the Red Cross fails to meet compliance standards. If that occurs, no public financial donations will be used to pay for these assessments. Previously debated issues between both organizations have been resolved with no further action being taken.

The American Red Cross remains dedicated to its mission and to the millions of Americans each year who rely on us to provide lifesaving blood and blood components. We want the American people to understand that giving blood is safe and, if they need blood, they should not hesitate to receive it.

For more information, visit Red Cross Biomedical safety site.