The consumer group Public Citizen wants the Food and Drug Administration (FDA) to impose a nearly $10 million fine on the American Red Cross because of hundreds of violations the agency found in a 2010 inspection of a donor support center in Philadelphia.
An FDA fall 2010 inspection of this national Red Cross center in Philadelphia, which was obtained by Public Citizen via a Freedom of Information request, documented hundreds of violations of a 2003 agreement between the FDA and the American Red Cross intended to ensure the safety of the nation’s blood supply, the organization said.
Public Citizen said it separately learned that months ago, the FDA decided to impose a financial penalty of nearly $10 million for those violations, but this has been held up for inexplicable reasons.
Failing to notify
The violations included:
- failing to notify health departments when a blood donor has been determined to have infectious diseases, such as HIV, Hepatitis B or C, West Nile Virus or syphilis;
- failing to review donors whose blood donations needed to be quarantined in the past;
- failing to promptly add people with known problems such as infections to the national list of deferred donors; and
- delays in logging problems with donations more than five days after their discovery.
“Since the FDA and American Red Cross’s 2003 agreement, the Red Cross has been previously fined $37 million, but the substandard performance of critical Red Cross blood handling functions continues,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The longer HHS delays in imposing the financial penalties, the more opportunity it will afford for the Red Cross to claim that things are much better now, even if they are not.
"Too many lives are at risk if the Red Cross continues violating the important 2003 Consent Decree it agreed to abide by,” Wolfe said.