Red Cross Agrees to Closer FDA Oversight

The Food and Drug Administration said Friday that it had settled a long-standing battle with the American Red Cross over its management of much of the nation’s blood supply, with the Red Cross agreeing to submit to closer FDA oversight.

The FDA said the charity, which manages 45% of the blood collected and distributed in the United States, had agreed to a revised and tougher version of a 1993 court document that allows the FDA to fine the Red Cross for lapses.

“I am hopeful that the acceptance of this agreement by [the Red Cross’] new leadership reflects a new willingness ... to ensure ... our nation’s blood supply,” said FDA Commissioner Mark B. McClellan.

“We are aiming to help or improve its management culture, to promote safe blood practices. If there is a recurrent theme through all of this, it is that we need and hope to see more extensive oversight in the senior management of [the Red Cross] in each ... of their blood centers.”

The Red Cross issued a statement saying that it welcomed the agreement as marking “a new era of cooperation” with the FDA and that it recognized the need to strengthen its procedures and was starting an aggressive quality program.

In 2001, the FDA asked a federal court to hold the Red Cross in contempt for failing to meet terms of a 1993 consent decree in which the organization agreed to improve its blood safety system.

The court told the FDA and the Red Cross to work out an agreement; McClellan said the consent decree was the result of those negotiations.

The agreement allows the FDA to fine the charity up to $10,000 per event, and $10,000 a day, for any violation of standard operating procedures, the law, or consent decree requirements.

The fines go up to $50,000 for each unit of blood the Red Cross releases if the FDA has found it to be unsafe. Among several other fines, the FDA can also penalize the Red Cross $10,000 for each donor it omits from the National Donor Deferral Registry, a list of all unsuitable donors.

McClellan said the FDA has repeatedly found problems at the Red Cross. In December, FDA inspectors said the Red Cross, among other things, took blood from people who should have been ineligible to donate, and it failed to ensure that it kept accurate records of people banned from giving blood.

The FDA has also cited the Red Cross for poor labeling of blood and blood products and for falsifying records, McClellan said. Many problems were brought to light by Red Cross workers.

McClellan said the FDA could not act on reports that three Red Cross employees had been fired after calling a hotline set up by the FDA to report such offenses, but he said the agency was following up on the accusations made by the employees.