FDA Takes Court Action Against Alleged Red Cross Violations
The FDA has filed court papers stating that the Red Cross should be fined and held in contempt of court for "repeated and uncorrected" safety violations in collecting, testing and distributing blood, the Newark Star-Ledger reports. The papers, filed late last month following a recent investigation, claim that the Red Cross "jeopardize[ed] the public health" and operated with "chronic inattention and callous indifference to its blood collection and processing responsibilities" (Cohen, Newark Star-Ledger, 9/16). The charges stem from the agency's eight-week inspection of the Baltimore-based Greater Chesapeake & Potomac Blood Service that found workers allowed people with low blood pressure to donate blood without a physician's approval, raising their risk of heart attack, stroke and shock. The center also did not report several "severe reactions" in which people who donated blood had to be taken to the emergency room, the FDA investigation revealed (Gaul/Flaherty, Washington Post, 9/16). In addition, the FDA inspection revealed that the Red Cross accepted donors who did not answer required questions about their HIV/AIDS history, used equipment that does not "reliably perform" to determine donor eligibility and maintained inadequate inventory controls, which resulted in the loss of blood products. These violations "pose serious and potentially fatal threats to blood donors and recipients," Leslie Holness, an FDA blood division official, said (Newark Star-Ledger, 9/16). Further, the Red Cross has "failed to follow up" on these and other repeated safety violations, according to court documents. Lawyers for the Red Cross argued that the FDA "overstated" and "misstated" the findings of the inspection, the Washington Post reports (Washington Post, 9/16). The lawyers said the charges are "inaccurate ... and incomplete," noting that the Red Cross has "poured enormous amounts of money and manpower" into improving its blood collection facilities since it entered into a consent decree in 1993 with the FDA and promised to make major changes. FDA officials will appear before a federal judge later this month to demand the Red Cross be fined for the alleged violations (Newark Star-Ledger, 9/16).
Combined with a General Accounting Office report released last week that found that the Red Cross discarded more than 200,000 units of blood in the weeks following Sept. 11, the FDA's allegations are creating a "backlash" against the agency, which is "struggl[ing] to hold onto donors and counter apathy" toward blood donation, the Post reports. The Red Cross's supply of blood has dwindled to a "critical level" of two days; the optimum reserve level is seven to 10 days (Washington Post, 9/16). The Star-Ledger reports that the Red Cross's reputation as "one of the nation's most respected charities is being threatened" by the recent allegations (Newark Star-Ledger, 9/16). FDA and Red Cross officials are expected to appear in court to answer questions later this month (Washington Post, 9/16).