Consumer advocates asked Congress to step in to spur improvements in the American Red Cross' violation-pocked blood safety record.
Public Citizen, a Washington-based advocacy group, called on Congress to launch an inquiry after obtaining documents filed by the Food and Drug Administration in U.S. District Court in Washington late last year to support the FDA's motion to hold the blood supplier in contempt and levy millions in fines for its continuing violations (Dec. 17, 2001, p. 10).
In a letter sent to Senate Majority Leader Tom Daschle (D-S.D.) and Sen. Ted Kennedy (D-Mass.), the consumer group asked lawmakers to force the Red Cross to improve its "public-health-threatening record."
The beleaguered blood supplier, which collects and distributes about 45% of the nation's blood needs, already is enmeshed in a federal court battle with the FDA over safety violations that date back to a 1993 consent decree ordering it to clean up its practices.
Public Citizen charged that the court documents showed that recalls of unsuitable blood products increased almost 18-fold-to 641 from 36-from 1988 to 2000.
"The disclosures in the pending litigation raise serious questions about the ability of the American Red Cross to assure the safety of its blood supply," Kennedy responded in a written statement. "Congress needs to deal with these questions, too, and take whatever steps are necessary to guarantee the safety of the blood supply."
Red Cross officials insisted that the blood supply is safer than it has ever been in history.
"It is unfortunate that Public Citizen is creating unnecessary fear and alarm about the safety of the blood supply," Larry Moore, the Red Cross' interim general counsel, said in a written statement.
The court battle promises to drag on for months. Earlier this month, FDA and Red Cross officials reached an agreement on a schedule for the litigation, said Blythe Kubina, a Red Cross spokeswoman. The Red Cross will be submitting its response to the FDA filing within the next several weeks, she added.