The Food and Drug Administration asked a federal judge Thursday to hold the American Red Cross in contempt of court for "persistent and serious violations" of blood safety rules, escalating a years-long dispute between the FDA and the nation's largest blood supplier.
The Red Cross "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," Bernard Schwetz, FDA's acting principal deputy commissioner, said in a statement.
The Red Cross provides about 45 percent of the nation's blood supply.
The court filing in Washington, D.C., ends 16 months of out-of-court negotiations between the Red Cross and the federal regulators about how to guarantee the safety of the blood supply. In 1993, the FDA and Red Cross agreed on a court order requiring the charity to improve management and quality control. The FDA says the Red Cross has not met its obligations under that agreement.
FDA officials cited numerous violations of the court order, including inadequate procedures to ensure that bad blood stays out of circulation. Potentially, the errors could have endangered people who got blood transfusions, although the FDA says there is no proof of actual harm.
Other serious problems include: poor donor screening, release of mislabeled blood, collecting blood from disqualified donors, and flawed procedures aimed at keeping unsuitable blood in quarantine.