FDA Sues Red Cross Over Blood Safety
Regulators allege ongoing lapses in quality control
FRIDAY, Dec. 14, 2001 (HealthDayNews) -- The Food and Drug Administration (FDA) has asked a federal court to hold the nation's largest blood supplier in contempt for what regulators are calling "persistent and serious violations of blood safety rules."
At issue is a 1993 consent decree -- which itself sprang from a 1988 voluntary policing agreement -- with the FDA in which the American Red Cross agreed to implement several safety measures to minimize the risk of contamination in the blood products it collects and distributes. But regulators say the Red Cross repeatedly has failed inspections at both its national headquarters and its branches.
The FDA took the action yesterday "to ensure that the American Red Cross takes much more seriously its role as guardian of the safety of the nation's blood supply, which is essential to the public health," said a statement by Dr. Bernard Schwetz, the agency's acting principal deputy commissioner.
"Unfortunately to date [the Red Cross] 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," Schwetz said.
Despite the lapses and FDA's action, however, Schwetz said Americans shouldn't be deterred from giving or receiving blood. "The risk of not receiving a needed transfusion far outweighs the risk of receiving blood," he said.
In a motion filed yesterday in U.S. District Court in Washington, D.C., the FDA said its inspections have turned up:
- Incorrect labeling and shipment of blood possibly contaminated with cytomegalovirus. While typically harmless in adults, the microbe can blind people with weakened immune systems and may be deadly to infants;
- Inadequate quarantine and inventory controls;
- Poor donor screening and failure to keep accurate lists of would-be donors deferred for having infection with syphilis and HIV. In one instance, FDA documents said a Red Cross center lost track of blood that had tested positive for the AIDS virus and, as of the court filing date, had not been able to locate the material;
- And distribution of blood that hasn't been fully screened for contamination.
The FDA also wants to hold the Red Cross "financially accountable for each unit of blood it fails to manage properly," Schwetz said.
Brad Stone, a spokesman for the agency, said the fines it's proposing could range from $10,000 for administrative slips to $50,000 per unit of blood for lapses that directly threaten a recipient. There would be no cap on the penalties, which easily could run into the millions of dollars.
While the FDA has pursued contempt judgments against individuals and companies, Stone said this is the first time the agency has taken such a step against a blood organization.
For its part, the Red Cross claimed the blood supply "has never been safer," and that it is "vigorously" contesting the FDA's contempt motion. The group said it has spent more than $280 million since 1993 to comply with the consent decree.
Larry Moore, the Red Cross' interim general counsel, in a statement today, called the FDA's motion and allegations "unwarranted" and "irresponsible."
"Given that the FDA has acknowledged that the blood supply is safe, we find the agency's unfair, inflammatory rhetoric regarding our blood program to border on reckless," Moore said.
However, in court documents filed by the FDA, the agency said that at an August 2000 meeting, Dr. Bernadine Healy, then president of the Red Cross, admitted that the headquarters' computer system occasionally "lost functionality," putting patients at potentially "grave" risk. Healy "also expressed surprise at the evident lack of concern for patients in some [Red Cross] employees," the documents said.
Dr. Sidney Wolfe of the consumer group Public Citizen called the FDA's move "long overdue" and said his organization asked for the contempt citation a year ago. "Although the FDA insists the blood supply is safe, these findings cause grave concern. If proper procedures are not followed, it is only a matter of time before someone is seriously harmed," Wolfe said in a statement.
It has been a difficult season for the blood organization. Earlier this fall, the Red Cross was roundly criticized for saying it planned to use money collected in the aftermath of the Sept. 11 terrorist attacks to help fund other operations. It ultimately backed away from that position.