The U.S. Food and Drug Administration (FDA) has issued a massive $16 million fine to the American Red Cross for its prior failures to comply with Federal laws and regulations related to the collection and manufacture of blood products. The LA Times described the failures as â€œslipshod practices in the collection and manufacture of <"http://www.yourlawyer.com/practice_areas/medical_malpractice">blood products,â€ noting that this is just â€œthe latest in a string of multi-million dollar penalties for failure to meet blood safety standards.â€
Although compliance failures were found, the FDA said that it did not find evidence that the Red Cross violations endangered any patients; the blood supply is believed to be safe. Multiple layers of safeguards are in place to protect and enhance the safety of blood products; however, these types of violations decrease the assurance that blood products manufactured by American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply, said the FDA.
In November we wrote that the FDA discovered what it described as â€œwidespread and persistent problems with the storage and distributionâ€ of blood supplied by the Red Cross. Based on agency investigation, which took place the prior year, a significant violations were found, including over 200 violations discovered at 12 Red Cross facilities nationwide. The FDA noted that from 2003 through 2008 the Red Cross had to recall 7,363 â€œunsuitableâ€ blood components, said Dow Jones last year.
The FDA assessed fines totaling $16.18 million: $9.79 million for violations related to mismanagement of certain blood products and $6.39 million for Good Manufacturing Practice violations. Blood products include red cells, plasma, and platelets, said the FDA. The fines were assessed under an amended 2003 consent decree that outlines requirements for the American Red Cross to ensure safety of the nationâ€™s blood supply. The original 1993 decree was amended in 2003 to allow the FDA to impose such fines for failure to comply with agency regulations and provisions designed to ensure the nationâ€™s blood supply safety.
The LA Times pointed out that these recent fines bring the total fines assessed against the Red Cross to $37 million for â€œsubstandard blood handling proceduresâ€ and go back to 2003, when the consent decree was imposed.
Meanwhile, in October 2009, the agency notified the American Red Cross that FDA inspections conducted during fiscal years 2008 and 2009 revealed violations that included failure to identify problems that occur during manufacturing and failure to adequately investigate identified problems. Since 2003, the American Red Cross has made progress addressing some of its quality issues, including standardizing procedures, upgrading its National Testing Laboratories, and increasing oversight of the organization; however, to fully comply with federal regulations and consent decree provisions, the American Red Cross must make swift, additional progress on all of the issues the FDA has identified. The FDA previously sent 12 similar letters to the American Red Cross, imposing a total of more than $21 million in fines under terms of the amended 2003 consent decree.