December 14, 2001 WASHINGTON (AP) - The government asked a federal judge to hold the American Red Cross in contempt of court for repeated violations of blood safety regulations.
The Red Cross has committed "persistent and serious violations" of federal regulations over the past 16 years despite a 1993 court order mandating improvements, the Food and Drug Administration charged in a motion filed in U.S. District Court in Washington.
The FDA sought court permission to fine the Red Cross $10,000 a day for each new violation it discovers, fines that could add up to millions a year.
The court filing caps a year of sharply escalating tension between the FDA and Red Cross, which provides about 45 percent of the nation's blood supply.
The FDA insists the supply is safer than it ever has been. But the Red Cross violations mark what even former Red Cross President Bernadine Healy publicly acknowledged were "near misses."
FDA's most recent inspections of Red Cross facilities have found such violations as failure to quarantine blood possibly tainted with cytomegalovirus, which can kill or cause brain damage in newborns, and failure to properly defer donors at risk of carrying the AIDS virus.
The Red Cross has said it is making efforts to improve, and notes that FDA inspections have found fewer and fewer violations each year.
But FDA officials contend that despite repeated warnings, the organization continues to make the same mistakes, violating rules the government deems vital to ensuring that contaminated blood doesn't reach the public.
"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."
A Red Cross spokeswoman said she would comment later in the day. The motion filed Thursday asks U.S. District Judge John Garrett Penn to order the Red Cross to explain why it should not be held in contempt of a 1993 consent decree that required the organization to comply with FDA regulations in the collection, processing and distribution of blood.
Penn already had ordered the two sides into mediation last summer, when the FDA first attempted to levy fines, of up to $15 million a year, against the Red Cross. A hearing on how the mediation was progressing had been scheduled for Friday.
Copyright 2001 The Associated Press. All rights reserved.