Red Cross Ordered to Resume Mediation with FDA over Safety of Blood Program
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. 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. 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 (Flaherty, 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).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.