FDA fines Red Cross $4.2 million

September 09, 2006|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON -- The American Red Cross was fined $4.2 million yesterday by the Food and Drug Administration, which voiced concern about the charity's quality controls for its blood supply.

An FDA official, Dr. Jay Epstein, said testing of recalled blood didn't reveal contamination. He said there was no indication that the blood had been released or that anyone was harmed.

The penalty is the largest blood-related fine levied by the FDA. It follows the Red Cross' recall of 12,000 pints of blood collected improperly, agency officials said.

The Red Cross supplies nearly half of the country's blood. Over the years, the charity has drawn a total of $9.9 million in fines, and much scrutiny, over its blood supply practices.

Since 2003, it has been operating under a consent agreement with the FDA. The FDA imposes fines when the Red Cross doesn't follow the quality-control procedures required by agency regulations and outlined in the decree.

Stephanie Millian, a Red Cross spokeswoman, said the charity voluntarily recalled the blood between April 2004 and April 2005 and notified the FDA.

The FDA review found that the recalls were preventable. "It doesn't mean the Red Cross' blood supply isn't safe. The blood supply is safer today than it ever was," Millian said.

After the recalls, the Red Cross took steps to prevent problems from recurring, and it is planning added safeguards, Millian said.

The charity samples and tests donated blood at five laboratories around the country. Recently, the Red Cross acquired new blood-screening equipment for the labs, but Millian said there was no connection to the FDA's announcement.

FDA officials said the problems prompting the recalls ranged from Red Cross offices not asking donors whether they had traveled in a malaria zone to failing to test the blood for hepatitis B.

The agency did not publicize the fines it previously imposed. While FDA officials wouldn't go so far as to express frustration, they criticized the need to take repeat action.

Susan Bro, an FDA spokeswoman, referred to the Red Cross's history of "ineffectiveness." Margaret O'K. Glavin, associate FDA commissioner for regulatory affairs, said, "FDA does not consider the current situation acceptable."

jonathan.rockoff@baltsun.com

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