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From: TSS ()
CJD WATCH MESSAGE BOARD The U.S. Food and Drug Administration (FDA) announced today that the American Red Cross (ARC) is being fined $4.2 million for failure to comply with requirements under Federal laws and FDA regulations relating to the collection of blood products. These 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 fines stem from a recently completed FDA review of recalls conducted by ARC between 2003 and 2005 that found these events were preventable by ARC. 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. We have no evidence that these violations resulted in serious health consequences. Because receiving blood products always carries a degree of risk, it is important that the blood industry complies with the full set of safeguards in Federal laws and FDA regulations to minimize that risk. However, any particular breach of the safeguards does not necessarily translate into unsafe blood products, because the safeguards designed to protect the blood supply are to some extent overlapping. The FDA continues to advise care providers and consumers that rigorous protections are in place and that the blood supply is safe. Patients in need of a transfusion should continue to follow the advice of their physicians. The risks of receiving a transfusion are far less than the risk of failing to receive a transfusion when blood treatment is indicated. 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. However, because there is always some degree of risk in receiving blood products, each individual safeguard is considered critical to minimizing that risk. 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. The amended consent decree requires ARC to: Establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; While achieving a blood supply with zero risk of transmitting infectious disease is the ultimate objective, we recognize based on the available science that this may not be realistic. Therefore, the FDA requires blood processors to adopt and strictly follow a multi-layered safety program to protect and enhance the safety of blood products at each stage of their manufacture. At the blood collection stage, these measures generally include: Accurate and complete educational material for donors so that they can assess their risk and decline to donate if that is appropriate; Blood donations are critically needed every day to save lives, and blood donation is a safe procedure. FDA encourages persons who are in good health to donate blood and to become regular blood donors. #### http://www.fda.gov/cber/talkpapers.htm#arc Red Cross fined $4.2 mln over blood safety By Lisa Richwine WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2 million for failing to ask blood donors proper screening questions and skipping other steps meant to keep the blood supply safe, officials said on Friday. The fine, the largest ever levied by the Food and Drug Administration for a blood safety violation, follows a multiyear battle between the FDA and the Red Cross, which collects about 45 percent of the blood donated in the United States each year for transfusions. The agency said it had no evidence that any blood collected by the Red Cross harmed people who got transfusions. "It is not acceptable that the quality systems failed in this way," Margaret O'K. Glavin, FDA associate commissioner for regulatory affairs, told reporters. The FDA said its investigation found that several Red Cross recalls of blood between 2003 and 2005 could have been prevented if it had taken a series of mandatory steps to ensure donations are free of HIV or other infectious agents. One way the Red Cross erred was by failing to ask donors about travel history that could increase the chances of having malaria or the human version of mad cow disease, FDA officials said. The problems involved 12,000 units of blood and blood components, FDA officials said. None of the units was found to be contaminated after they were recalled. The latest fine was issued as part of a legally binding consent decree reached in 2003 in which the Red Cross promised to improve its blood safety system. Previously, the FDA had fined the organization a total of $5.7 million. The 2003 deal revised a 1993 agreement that allowed the FDA to fine the Red Cross for blood collection lapses. The Red Cross said it would review the FDA's letter outlining its new concerns and respond within 20 days. "American Red Cross's senior management takes (the letter) seriously and is committed to full compliance with the amended consent decree and all applicable federal regulations," the organization said in a statement. http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML http://today.reuters.co.uk/news/articlenews.aspx?type=healthNews&storyID=2006-09-08T224834Z_01_N08403053_RTRIDST_0_HEALTH-REDCROSS-DC.XML&pageNumber=1&imageid=&cap=&sz=13&WTModLoc=NewsArt-C1-ArticlePage1 TSS ----- Original Message ----- PRODUCT ______________________________ ______________________________ ______________________________ http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html these usa mad cow blood for humans are a dime a dozen, the come out just http://disc.server.com/discussion.cgi?disc=167318;article=2971;title=CJD%20WATCH http://disc.server.com/discussion.cgi?disc=167318;article=2972;title=CJD%20WATCH TSS
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