Red Cross, FDA Ordered to Resume Mediation Over ‘Long-Standing’ Blood Program Dispute
A federal judge in Washington, D.C., last Friday ordered the American Red Cross and the FDA to return to mediation to resolve a "long-standing dispute" over the safety of the group's blood program, the Washington Post reports. U.S. District Court Judge John Garrett Penn said that mediation would serve as the "best way" to resolve an issue important to the "confidence of the American public." However, Penn also scheduled a Jan. 11 court date to hear arguments on contempt charges and other issues "if mediation fails and the case proceeds in court." The FDA last Thursday asked Penn to hold the Red Cross in contempt of court and renewed a request to allow the agency to fine the group for "repeated" violations of blood safety rules (Flaherty, Washington Post, 12/15). In 1993, the FDA entered into "a court-supervised consent decree," in which the Red Cross promised to "make major improvements in its testing, handling and tracking of blood supplies" or face contempt of court charges (Kaiser Daily HIV/AIDS Report, 12/10). The FDA and the Red Cross entered mediation in August to determine whether the agency could impose fines on the group for "continuing failures" in the blood program. Both the FDA and the Red Cross said last Friday that mediation has not led to agreement on the issue. The Red Cross, questioning the legal authority of the FDA to impose fines on the group, said that it will fight "vigorously" against any fines and "will not agree to bureaucratic, ineffective and unauthorized requirements imposed" by the agency (Washington Post, 12/15). In a statement, Red Cross officials said that the group has spent more than $280 million to improve blood safety and meet FDA regulations and that "the nation's blood supply has never been safer than it is today" (Schmid, AP/Philadelphia Inquirer, 12/15). Although FDA officials agreed that the nation's blood supply "has become safer" in the past few years, they said that they hoped to "eliminate unnecessary risks" in the group's blood program "that are correctable" (Washington Post, 12/15).
Sept. 11 Fallout
Meanwhile, the Washington Post reports that the American Red Cross, in its "first public accounting of the post-Sept. 11 blood drive," stated that it had to destroy blood donated by about 50,000 individuals because it "was not needed." The Red Cross received 928,293 pints of donated blood between Sept. 10 and Oct. 14 -- about 287,000 more pints than the group received during the same period last year -- at its 36 blood centers around the nation. The Red Cross was forced to destroy 49,860 of those pints, "about twice what it normally loses." U.S. blood groups have criticized the Red Cross for "continuing to solicit donations after it was clear that most of the victims in the Sept. 11 attacks on the World Trade Center and the Pentagon were dead." Brian Rhoa, vice president of finance and planning for Red Cross blood services, said, "We [made] our best guess and came within 5% of using it all," adding, "Am I satisfied with this? No, I would like the number to be zero. But that isn't realistic" (Gaul/Flaherty, Washington Post, 12/16).