The American Red Cross (ARC) was fined $4.2 million by the U.S. Food and Drug Administration (FDA) for failure to comply with requirements under federal laws and FDA regulations relating to the collection of blood products. The fines were assessed under an amended 2003 consent decree that calls for significant financial penalties when ARC fails to comply with FDA regulations and consent decree provisions designed to ensure the safety of the nation’s blood supply.
The ARC’s blood program, provider of 45 percent of the nation’s blood supply, has been under a consent decree in one form or another since 1993. Since entering into an updated decree in 2003 and prior to this action, FDA has issued the ARC seven similar letters and assessed $5.7 million in penalties.
“In accordance with established procedure, we will review the letter, prepare our plans to address the FDA’s concerns, and respond to the Agency within 20 days,” said Ryland Dodge, a spokesman for ARC’s biomedical division.
“While this ADL was expected, American Red Cross’s senior management takes it seriously and is committed to full compliance with the Amended Consent Decree and all applicable federal regulations. The 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,” he said.
An ARC official on background said, “The FDA and the Red Cross agree that the blood supply is as safe as it has ever been. We closely track adverse events associated with our blood product transfusions. The Red Cross is not aware of any adverse events associated with these products.”
Dodge said the ARC’s recall rate is “consistent with the rest of the industry,” although he could not provide numbers.
The fines stem from product recalls conducted and initiated by ARC between 2003 and 2005, according to the FDA. The federal agency found that while the recalls were initiated by ARC, that the events were preventable.
The violations include breaches of Good Manufacturing Practice (GMP), such as a failure to ask appropriate donor screening questions and failure to follow manufacturer test protocols.
Dodge stressed that recall was initiated by the ARC and that the fines will be paid from the biomedical services operating revenue, not from donated funds. Improvements in donor screening procedures and the use of a variety of new tests in the last few years have made the national blood supply safer from infectious diseases and other risks than it has been at any other time, according to an FDA statement.
“Although the failure of an individual safeguard does not automatically translate into the release of unsafe products, it may increase the potential for risk. It is the potential risk that FDA insists the Red Cross Board of Directors prioritize and support its new management’s ability to immediately address and work to improve its approach to quality,” according to the FDA statement.
In the original 1993 consent decree, ARC agreed to establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; to enhance training programs; and to improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions.
The revised consent decree included many of the same substantive provisions, updated to provide a series of clear deadlines for completing specific requirements of the decree and addressing additional types of violations observed since the original consent decree was signed in 1993. It also includes a comprehensive penalty scheme to address potential future violations. NPT