Thursday, August 29, 2002

fda takes on the red cross

I wasn't aware of the ongoing litigation between the Food and Drug Administration and the Red Cross. A ten-year-old Federal District Court suit in Washington State sees its next action on September 24th, when a motion filed by the FDA will be argued. The government agency is asking that the Red Cross be held in civil contempt for failing to honor a consent decree from 1993. They are also asking for authority to levy fines in the future for violations that may arise. A brief filed last week indicated numerous violations in the nearby Chesapeake region, which includes Pennsylvania, Maryland, Virginia, and the District of Columbia. The list of charges against the organization that collects half the nation's blood supply states that the Red Cross:
-- "Continues to accept donors who have not completed the health history questionnaire, including those who leave unanswered the question designed to detect those at high risk for HIV/AIDS."

-- Accepts blood from donors with very low blood pressure and those who have given within the past eight weeks, putting them at risk of adverse reactions including anemia.

-- Has "lax inventory control," including "losing blood products" and "distributing unsuitable blood products."
I'm wondering that, if not for the press reporting about the lawsuit, would we have heard anything about these ongoing troubles between the FDA and the Red Cross.

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