The Food and Drug Administration asked a federal court to hold the American Red Cross in contempt for continued safety violations in its huge blood supply program despite a 1993 consent decree ordering the program to clean up its practices.
The motion, filed in U.S. District Court for the District of Columbia, also asked for authority to levy fines of $10,000 per day for each violation until corrected. Federal Judge John Garrett Penn scheduled a hearing for Jan. 11 on the FDA's request, but he also encouraged the two sides to continue to try to settle their dispute.
The FDA's action compounds the public relations disaster that has embroiled the nation's largest charity since Sept. 11. The Red Cross' blood services division collects about 6.5 million units of blood annually-about 45% of the nation's supply and a $1.8 billion annual business.
The FDA said inspections of Red Cross facilities have turned up chronic violations. The most recent inspections, including one at the group's national headquarters in Washington in 2000 and another at the Salt Lake City facility from March through May of this year, revealed "persistent and serious violations" of blood safety rules, the FDA said.
The inspection of the national headquarters revealed the incorrect labeling and the release of blood potentially contaminated with cytomegalovirus, which can harm or even kill newborns; inadequate quarantine and inventory controls; inadequate donor registration controls; and erroneous, premature releases of "holds" on blood donations, the FDA said. The Salt Lake City inspection demonstrated that the violations had not been corrected, the agency said.
In a written statement, the Red Cross said it would vigorously contest the motion, asserting that it overreaches the FDA's legal authority and goes "beyond anything required of the rest of the blood banking community." The nation's blood supply has never been safer, Red Cross officials said, and they insisted the charity has "been working cooperatively with the FDA" to comply with the consent decree. Since 1993 the Red Cross has invested more than $280 million to meet the decree's requirements, the officials said. "We find their current motion to be not only unwarranted, but irresponsible," they concluded.