By Randolph E. Schmid
Associated Press
WASHINGTON – Frustrated by years of trying to get the American Red Cross to correct violations of blood safety rules, the government is asking a federal judge for authority to levy fines that could total millions of dollars.
The Food and Drug Administration insisted the nation’s blood supply is safe. But it asked a federal judge to hold the Red Cross in contempt of court, charging the charity with “a cavalier disregard” for federal regulations that dates back 16 years.
“Persistent and serious violations” continue despite a 1993 federal court order mandating improvements, the FDA said in an unprecedented motion filed Thursday in U.S. District Court in Washington.
U.S. District Court Judge John Garrett Penn directed the FDA and the Red Cross to continue trying to resolve their dispute with a mediator, and set a Jan. 11 date for them to return to court to proceed on the order being sought by the FDA.
“This is an important case,” Penn said. “It’s important to the confidence of the American people that it be resolved.”
The Red Cross, which provides about 45 percent of the nation’s blood supply, said it will fight the health agency. In a statement, the Red Cross said the FDA wants to take action “beyond the legal authority granted by Congress.”
The agency’s most recent inspections of Red Cross facilities have found:
_Release of blood possibly tainted with cytomegalovirus, which can kill, blind or cause brain damage in newborns.
_Failure to properly defer certain donors with syphilis, and failure to properly update and check a national registry of unsuitable donors.
_Computer errors that could cause the release of blood before it has finished all safety testing.
The Red Cross has invested more than $280 million to upgrade its blood operations to meet FDA requirements, and believes “the nation’s blood supply has never been safer than it is today,” the statement said.
In its filing, the FDA sought permission to fine the Red Cross $10,000 a day for each new violation it discovers. If blood has to be recalled, fines could climb to $50,000 per unit of recalled blood.
Those fines could add up to millions of dollars a year.
“FDA is acting today to ensure that the American Red Cross takes much more seriously its role as guardian of the safety of the nation’s blood supply,” said the FDA acting commissioner, Bernard Schwetz.
“Unfortunately, to date ARC has exhibited a corporate culture that has been willing to tolerate an unacceptably low level of quality assurance and a lack of concern for the public it is supposed to serve,” he said.
The violation of a single rule doesn’t necessarily mean a health hazard, the FDA said, because regulations set overlapping safeguards of the blood supply.
“The risk of not receiving a needed transfusion far outweighs the risk of receiving blood,” Schwetz said.
Even so, former Red Cross President Bernadine Healy publicly acknowledged some violations were “near misses.”
The FDA action is the latest in a series of recent public problems for the Red Cross. It came under sharp criticism and had to backtrack from a plan to divert some of the half-billion dollars donated to help the terrorist victims to other uses. Healy resigned amid the controversy.
At the same time, the Red Cross provoked tension with other blood banks by seeking massive blood donations following Sept. 11, even after it became clear supplies were sufficient. It wound up discarding some 6 percent of donated red cells.
A consumer advocate who pushed FDA to force better Red Cross compliance called the court filing overdue.
While no one knows of infections due to Red Cross lapses and “most blood is safe, that’s not good enough,” said Dr. Sidney Wolfe of Public Citizen. The Red Cross seems “incapable of reorganizing themselves, of getting the kind of leadership necessary to clean up the blood supply.”
Copyright ©2001 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Talk to us
> Give us your news tips.
> Send us a letter to the editor.
> More Herald contact information.