A dispute between the U.S. Food and Drug Administration and the American Red Cross wound up in court this week, with the FDA trying to levy multimillion-dollar fines against the nonprofit organization for failing to comply with safe blood-handling practices.

The court fight has its roots in a consent decree filed by the FDA in 1993, after the federal agency found allegedly dangerous blood-handling practices in regional Red Cross centers, the Reuters news service reports.

Problems identified by FDA inspectors included distribution of cytomegalovirus-contaminated blood, and storage of contaminated blood with blood already cleared for public use. Cytomegalovirus is a common herpes virus that doesn't harm most people, but can cause serious illness in those with suppressed immune systems and in newborns.

Since the 1993 decree, the FDA and Red Cross have been negotiating enforcement details, an FDA official told Reuters. The decree requires the Red Cross to establish a quality-control program and better management over blood service operations. Reuters cited an FDA statement that the Red Cross's current system is "inadequate ... for preventing the release of potentially harmful blood products."

The nonprofit Public Citizen, an organization that advocates for public health issues, is asking that the Red Cross be held in contempt of court.

Dr. Bernadine Healy, the Red Cross's president and chief executive officer, said the group is in agreement with the FDA regarding updates to the consent decree, including making improvements to computer systems, personnel training, inventory control, quality systems and reporting.

But she said the organization won't give the FDA permission to levy fines against it, and she is disappointed the FDA refused to mediate the case.

Healy told Reuters the Red Cross doesn’t have the money to pay the proposed fines. She added that the organization wanted to make changes beyond those requested by the FDA, such as filtering out immune system cells to eliminate viruses such as AIDS from all donated blood, and that the Red Cross was preparing to borrow $100 million to make some of the requested improvements.

Dr. Sidney Wolfe, director of Public Citizen’s health research group, wrote a letter to the FDA claiming "...it will be only a matter of time before, if it has not happened already, patients receiving blood or blood products will be needlessly infected because of sloppy procedures."

Jay Epstein, director of the FDA's office of blood research and review, stated that while the agency found problems that "present a real potential for harm," the U.S. blood supply is safe and can be made even safer, the Washington Post reports.

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