The American Red Cross agreed to significant revisions to a decade-old consent decree with the Food and Drug Administration that set clear deadlines for addressing problems at the nation's largest blood supplier and stiff fines for failure to comply, according to the FDA. Besides continuing provisions dating to 1993, the revised decree addresses more recent safety violations largely identified in a 2000 inspection of Red Cross headquarters, the FDA said. Complaining of a "chronic recurrence of problems" at the charity's biomedical division, the FDA sought more enforcement tools. Failure to comply with the revised decree could cost the Red Cross up to 1% of its biomedical division's $1.9 billion in gross annual revenue the first year the decree is in effect, 2% in the second year, 3% in the third year and 4% thereafter. The Red Cross fiercely resisted financial penalties when the FDA first moved to hold the charity in civil contempt in December 2001. In a statement on the revised decree, Red Cross officials said, "This agreement is welcomed and marks a new era of cooperation." -- by Cinda Becker
Red Cross agrees to fines under new decree
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