FDA Asks Federal Judge to Hold Red Cross in Contempt, Impose Fines Over Blood-Collecting Practices
The FDA yesterday asked a federal judge to hold the American Red Cross in contempt of court and grant the agency the authority to fine the organization over "persistent and serious violations" of blood safety rules, the Los Angeles Times reports. The FDA's filing with U.S. District Judge John Garrett Penn in Washington, D.C., ended 16 months of "out-of-court negotiations" between the FDA and the Red Cross over the latter's alleged failure to meet the requirements of a 1993 consent decree in which the not-for-profit organization -- which supplies about 45% of the nation's blood -- agreed to improve the management and quality control of its blood collecting, testing and distribution processes (Ornstein, Los Angeles Times, 12/14). FDA officials emphasized that their action did not indicate that the blood supply was unsafe, adding that Americans should not hesitate to undergo transfusions. "The risk of not receiving a transfusion far outweighs the risk of receiving blood," Bernard Schwetz, the FDA's acting principal deputy commissioner, said in a statement (Gribbin, Washington Times, 12/14). But while "overlapping" safeguards are in place to prevent a single violation from becoming a health hazard, former Red Cross President Bernadine Healy acknowledged that some blood violations were "near misses" (AP/Milwaukee Journal Sentinel, 12/14). Schwetz said that the Red Cross "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," adding that "prospective penalties ... are necessary to ensure that the (Red Cross) is held financially accountable for each unit of blood it fails to manage properly" (Washington Times, 12/14).
The FDA said that its most recent inspections of Red Cross blood centers have found the release of blood "possibly tainted" with cytomegalovirus, which can kill, blind or cause brain damage in newborns; failure to turn away donors with syphilis; failure to update a national registry of unsuitable donors; and computer problems that could lead to the release of blood before it has finished all safety testing (AP/Milwaukee Journal Sentinel, 12/14). The FDA's request came just hours before a hearing between the two sides was scheduled to begin in Penn's court today. The agency, citing what it called the Red Cross' "cavalier disregard" for federal regulations, is seeking permission from Penn to impose $10,000 fines for each new violation by the Red Cross and fines of up to $50,000 for each pint of blood it must recall. The Washington Post reports that the filing "expressed the [FDA's] frustration that inspections and ongoing discussions with the Red Cross" have not led to significant improvements in its blood safety practices. Sidney Wolfe, director of Public Citizen's Health Research Group, said, "The situation is essentially that Red Cross keeps flouting the law and regulations and doesn't seem to have taken the consent decree very seriously. I think the FDA has every ground to ask for a contempt citation."
Red Cross Responds
The Red Cross issued a statement yesterday challenging the FDA's actions, saying it will "vigorously contest the ... motion and is confident that it will prevail." The organization said that it has spent $280 million and made significant progress in correcting problems in its blood program since the 1993 agreement with the government (Flaherty/Gaul, Washington Post, 12/14). Moreover, the Red Cross said that giving the FDA power to impose fines would "go beyond the authority granted the FDA by Congress and exceed what other blood banks face." The statement said, "The Red Cross remains committed to working cooperatively with the FDA to achieve the highest levels of blood safety" (Los Angeles Times, 12/14).