Red Cross is fined $4.2 million

0 Comments | Deseret News (Salt Lake City), Sep 10, 2006 | by Gardiner Harris New York Times News Service

WASHINGTON -- The Food and Drug Administration announced a $4.2 million fine against the American Red Cross on Friday because it had repeatedly failed to handle and collect blood supplies properly.

The penalty is the culmination of a 20-year effort by federal regulators to force the Red Cross to improve its oversight of its giant blood business. It comes on top of $5.7 million in fines the agency has imposed since 2003.

In a news conference, drug agency officials said that the blood supply remained safe and that they had no evidence that contaminated or recalled blood sickened anyone. Instead, the problems "indicated a decreased assurance of safety," said Dr. Jay Epstein, director of the Office of Blood Research and Review at the agency.

In a statement, the Red Cross said its senior management took the fine "seriously" and was "committed to full compliance" with the rules. It said it would officially respond in 20 days.

"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," the statement said.

FDA officials acknowl- edged in a news briefing on Friday that fully complying with the agency's regulations was "very difficult."

The associate commissioner for regulatory affairs, Margaret O'K. Glavin, said, "FDA does not consider the current situation acceptable."

The violations include failing to ask the right donor-screening questions and failing to follow other procedures that led to blood recalls from 2003 to last year. The recalls could have been prevented if the Red Cross had followed its own procedures, the agency said.

The Red Cross provides 45 percent of the nation's blood supply. In 2003, in an accord with the FDA and a federal judge, it promised to pay fines if it failed to follow proper blood procedures. The repeated violations of that agreement led to the nearly $10 million in fines.