The U.S. Food and Drug Administration (FDA) is imposing a fine of $16 million on the American Red Cross (ARC) for failures to comply with federal laws and regulations regarding the collection and manufacture of blood products.

No evidence was found that these violations caused harm or potential harm to any patients, and the blood supply is "believed to be safe," according to the FDA. But the violations threaten the safety of future blood supplies.

The ARC has violated the Federal Food, Drug and Cosmetic Act, FDA regulations and the consent decree - a 1993 legal document, which in 2003 was amended to allow the FDA to impose significant fines for failure to comply with FDA regulations and provisions.

The fines total $16.18 million - $9.79 million for violations related to mismanagement of certain blood products, including shipping products at the wrong temperature, and $6.39 million for good manufacturing practice violations. Blood products include red cells, plasma and platelets.

Last October, the FDA notified the ARC regarding the 2008 and 2009 inspections that revealed not only the violations but the failure to "adequately investigate identified problems."

Due to new leadership at both FDA and ARC, the regulatory agency wanted to "thoroughly evaluate before taking action," Mary Malarkey, director of compliance for the FDA's center of biologics, told DOTmed News.

The ARC is "disappointed that the FDA believed it necessary to fine us for prior violations dating back several years," ARC's Stephanie Millian said. "The FDA also acknowledged no evidence that the Red Cross violations endangered any patients."

In fact, Malarkey said the blood supply is "safer than it's ever been," and she encourages volunteers to donate.

Because of ARC's consent decree with the FDA, routine inspections occur annually, unlike other organizations, which undergo inspection every two years, said Malarkey. The violations, including shipping blood products at the wrong temperature, were revealed during a routine inspection.

Both FDA and ARC acknowledged that the emergency response organization has taken steps to make improvements, including addressing the quality issue and increasing oversight of the organization, said Malarkey.

"It's important to note that they have made progress in addressing the quality issues...but they need to make swift additional progress on all of these issues the FDA has identified," said Malarkey.

ARC noted that "it's important to understand that many of the incidents cited by the FDA in the October 2009 notification occurred prior to the improvement made by the Red Cross. In fact, 98 percent of the events identified by the FDA took place in 2008 and before."

The FDA previously sent 12 similar letters to ARC, imposing more than $21 million in fines under terms of the amended 2003 consent decree. That $21 million has been paid and is separate from the $16 million announced last week.

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