FDA Accuses Red Cross of ‘Serious Problems’ with Blood Supply

In a U.S. District Court filing last week, the FDA cited inspections of the Red Cross blood supply that indicated "serious problems," and asked the court for the right to "impose financial penalties to spur the organization to faster action," the Washington Post reports (Kaufman, Washington Post, 12/2). According to the FDA, the Red Cross has been unsuccessful in ensuring the safety of its blood supply since it failed inspection in 1985, and has since received numerous warnings from the agency. In 1988, the Red Cross agreed to implement a plan to meet FDA standards, but as problems continued, the FDA in 1993 negotiated a court decree requiring "better controls and a quality assurance program." And since 1993, the FDA has sent 10 letters to Red Cross warning of noncompliance (Recer, Associated Press, 12/2). The most recent inspections have detected problems "including contaminated blood being stored with blood for distribution ... and the actual improper distribution of some blood with cytomegalovirus," which is harmless to most people, but potentially harmful to infants and those with impaired immune systems, such as those with AIDS (Kaufman, Washington Post, 12/2). In addition, the blood supplier failed to "follow procedures in a second HIV test of blood that had been rejected because it tested positive for the AIDS virus in an initial test." The Red Cross said that the "HIV-suspected" blood was not distributed and the blood tainted with cytomegalovirus was not used by patients. Previous inspections in July uncovered a total of 25 violations in an Atlanta Red Cross Center and 63 violations at the Red Cross Headquarters in Washington, D.C.

Red Cross Response
Hoping to prevent multimillion-dollar penalties, the not-for-profit blood supplier appealed for a federal mediator and filed court papers to block the fines in U.S. District Court this week (Associated Press, 12/2). Red Cross President Bernadine Healy said that the organization had "no choice but to oppose" the financial penalties. "We have zero operating profit. We couldn't accept a situation where money for our programs might go to pay penalties rather than to improve those programs," she said. However, Healy has agreed with the FDA's assessment, noting that the blood supplier has begun "the process of borrowing $100 million to address some of the problems." Healy said, "Yes, there have been some near misses that should never have occurred, and we weren't moving as fast as we should have. But nobody was harmed, and the public should know that the blood supply is safe." Jay Epstein, director of the FDA's office of blood research and review, agreed that the blood supply is "safe," but added that "it can and should be made safer, and in particular the system to assure safety must be improved. ... The FDA believes that existing violations are serious because they present a real potential for harm." Healy said she was "stunned" by the FDA's inspection reports, given that the blood supplier's improvements have been "widely proclaimed" by former FDA commissioner David Kessler and HHS Secretary Donna Shalala.

Public Citizen Gets Involved
The FDA's court filings were made public by the not-for-profit watchdog group Public Citizen, which had sent a letter to the FDA urging "tough action" against the Red Cross. Public Citizen Director Sidney Wolfe wrote, "It is time for the FDA to stop playing dangerous, cooperative, polite games with the (Red Cross) and ask that the organization be held in contempt of court from recklessly disregarding the 1993 consent decree. Otherwise, it will only be 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 documented in many FDA inspections" (Washington Post, 12/2). A copy of Public Citizen's letter to the FDA is available at www.citizen.org/hrg/PUBLICATIONS/redcrosscontempt.htm (Public Citizen release, 12/1).