FDA may seek fines against Red Cross for blood safety violations

By Advocate.com Editors

Originally published on Advocate.com August 27 2003 12:00 AM ET

The government is threatening the American Red Cross with thousands of dollars in fines for allegedly violating a court settlement that was supposed to end continuing disputes over blood safety rules. In April, the Food and Drug Administration reached an agreement to settle charges that the Red Cross had committed "persistent and serious violations" of federal blood safety rules dating back 17 years. The FDA in 2000 found that the Red Cross couldn't track donations, wasn't labeling them properly, and hadn't kept accurate records of donors who have been deferred from giving blood because of health risks, including sexually active gay men, who are barred from donating blood in the United States. The Red Cross also was reported to have lost blood samples that tested positive for communicable diseases, including HIV. The settlement spelled out changes the Red Cross must make to comply with FDA rules--such as ensuring that no patient receives potentially unsafe blood and rejecting donations from improper donors.

On June 3, the Red Cross submitted its plans to make some of the required changes--those dealing with how officials would investigate and correct quality-assurance problems that might arise. But in a warning letter dated July 22 but released by the FDA late last week, the government told the Red Cross that its plans do not fully comply with the court settlement because they leave out some specifically ordered changes. As a result, the FDA said it intends to fine the Red Cross up to $10,000 a day for every day it was in violation of the agreement--counting from June 3 through August 6, when the Red Cross responded to the government's complaints.

The Red Cross said it had already met several of the settlement's requirements but was working to rectify this problem. "We are taking swift actions to implement solutions to meet FDA requirements and to assist in assuring the safety of the nation's blood supply," Red Cross vice president Ramesh Thadani said in a statement.