The American Red Cross will have to pay $16.18 million in federal fines because of a failure to comply with safe practices dealing with collection and manufacturing of blood products, including red cells, plasma, and platelets, the U.S. Food and Drug Administration announced late yesterday.
While there is no evidence the practices that resulted in the fines have endangered any patients who received blood products, the FDA said these regulatory violations "decrease the assurance that blood products manufactured by the American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply."
The fines include $9.79 million for mismanagement of certain blood products and $6.39 million for violations of Good Manufacturing Practice standards. The American Red Cross processes 43% of the nation's blood supply, or about 6.5 million units, which are turned into 9.5 million blood products used by patients each year.
"The FDA is hopeful these fines will encourage the Red Cross to act more quickly to take the actions necessary to address and correct the issues that have contributed to these violations," the agency said in a statement.
In a response posted on its website last night, the America Red Cross said it is "disappointed that the FDA believed it necessary to fine us for prior violations dating back several years. The FDA also acknowledged no evidence that the Red Cross violations endangered any patients."
The statement continued, "The Red Cross is fully committed to meeting all FDA standards, and we have made significant progress over the past two years in improving our regulatory compliance by our implementation of system-wide changes to our operations.
"The fines announced today relate to Adverse Determination Letters sent by the FDA to the Red Cross in October. It's important to understand that many of the incidents cited by the FDA in the October 2009 notification occurred prior to the improvements made by the Red Cross. In fact, 98% of the events identified by the FDA took place in 2008 and before. The recalls cited represent 0.0775 percent of our blood products, which is less than one-tenth of one percent of our total number of blood products produced," the American Red Cross statement said.
In the FDA's statement, the agency said that FDA officials notified the ARC last October that federal inspections in 2008 and 2009 discovered violations, such as failure to identify manufacturing problems and failure to adequately investigate those problems.
The current $16 million fine is the latest in a string of safety issues and problems with the American Red Cross stemming back to 1993, when federal officials entered into a consent decree with the blood collection, testing and distribution organization. That decree called for significant improvements in safeguarding the blood supply.
In 2003, the consent decree was amended to allow the FDA to impose fines for failure to comply with agency regulations. The amended decree outlines requirements for the American Red Cross to implement a variety of safeguards to ensure the safety of the supply, the agency said.
Since 2003, the American Red Cross has made progress to address its quality issues, such as standardizing procedures, upgrading national testing laboratories and increasing oversight, the FDA said.
"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 agency said.
The FDA said it has sent 12 similar letters to the American Red Cross and imposed more than $21 million in fines under terms of the amended decree.
"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 agency said.