Red Cross Asks for Mediation in FDA Dispute
The American Red Cross filed a motion Thursday in U.S. District Court in Washington, D.C. asking for a mediator to resolve a dispute between it and the FDA over whether the not-for-profit organization has failed to comply with federal regulations over the last 15 years, the AP/Las Vegas Sun reports (AP/Las Vegas Sun, 12/7). In November, the FDA had filed suit in the same court, alleging that it uncovered "serious problems" in an inspection of the Red Cross and asked for the right to "impose financial penalties to spur the organization to faster action." Since 1993, the Red Cross has been under a court decree to comply with FDA regulations in collecting, processing and distributing donated blood. But the FDA maintains that the Red Cross has not complied with "current good manufacturing practices" since 1985 and in a recent "effort to force compliance," the agency met with Red Cross officials to discuss a plan to fine the organization up to $15 million per year for continued violations, the AP/Las Vegas Sun reports.
According to the FDA, those violations include failing to follow instructions for "viral marker testing of blood;" to maintain controls to assure adequate expiration dating; to maintain and calibrate equipment; to assure proper training; and to maintain accurate, complete records of the manufacturing process. The FDA also alleges that Red Cross employed "inadequate procedures to prevent distribution of unsuitable products." Last week, Red Cross President and CEO Dr. Bernadine Healy said that while the organization had not released any dangerous blood, "there have been near misses." She added that the organization is "jumping on" the problems. A court hearing is to be set on the mediation request (AP/Las Vegas Sun, 12/7).
In other blood safety news, FDA advisers, concerned about "mad cow disease" are scheduled to meet on Jan. 18 to discuss whether the United States should impose new restrictions on blood donors who have traveled to Europe. The disease, also called Creutzfeldt-Jakob Disease, is a fatal, "brain-wasting" human disease believed to be transmitted by eating infected animals. While there is no evidence that the disease has been passed between humans through a blood transfusion, studies in sheep have found that a new variant known as bovine spongiform encephalopath (BSE) can be transmitted by transfusions. Spanish officials said yesterday that another cow had died of BSE and two German cattle were found to have the disease last month. Already, individuals who have spent six months or more in the United Kingdom between 1980 and 1996 are not permitted to donate blood in the United States (Lueck/Regalado, Wall Street Journal, 12/8).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.