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January is National Volunteer Blood Donor Month. It is also the month in which a federal judge has set a trial schedule in a long-running battle between the American Red Cross and the U.S. Food and Drug Administration (FDA) over alleged violations of federal blood safety rules. The FDA recently asked a federal court to hold the Red Cross in contempt of a 1993 consent decree covering the organization’s blood supply program and to impose fines of $10,000 for each future violation. U.S. v. American National Red Cross, No. 93-0949. In its contempt motion, the FDA says that inspections of Red Cross facilities over the past 16 years show “persistent and serious” violations of blood safety rules despite the organization’s 1993 promise to make substantial improvements. “Unfortunately to date, ARC has exhibited a corporate culture that 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,” said Bernard A. Schwetz, the FDA’s acting principal deputy commissioner. “In our view, these prospective penalties are necessary to ensure that ARC is held financially accountable for each unit of blood it fails to manage properly.” The FDA contends, for example, that an inspection in 2000 of a Red Cross facility found violations — still uncorrected — such as incorrect labeling and release of blood potentially contaminated with cytomegalovirus, lack of adequate quarantine and inventory controls, inadequate donor registration controls and failure to maintain accurate and current lists of deferred donors. Red Cross interim General Counsel Larry Moore called the contempt motion “not only unwarranted but irresponsible.” The Red Cross, he said, has improved significantly the blood program and recognizes there is more to be done. “But we cannot, and will not, agree to bureaucratic, ineffective and unauthorized requirements imposed by the staff of the FDA,” he said. The FDA, he said, is imposing unnecessary requirements that “go beyond the legal authority granted by Congress to the FDA and that go beyond anything required of the rest of the blood banking community.” A court-ordered mediator has been working with the FDA and the Red Cross since August to resolve the dispute. But with no resolution, U.S. District Judge John Garrett Penn of the District of Columbia gave the parties a litigation schedule on Jan. 11. “We will be submitting our response to the FDA’s contempt motion within the next several weeks,” said Red Cross spokesman Blythe Kubina.

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