US FDA Slammed Over Blood Products Regulation

The US Food and Drug Administration has failed to regulate the blood products industry effectively, according to a Congressional report adopted unanimously by the House Committee on Government Reform and Oversight. Despite some reforms, it says, the agency is not doing enough to protect Americans from tainted blood.

The report says the FDA does not move fast enough on product safety innovations, and 15 years after AIDS has emerged as a major world health problem, it has not yet developed an effective recall system.

The report recommends that a fund be set up for those who in future "suffer adverse consequences" from tainted blood- and plasma-based products, but does not deal with compensation for the 10,000 or so hemophiliacs and others who contracted HIV from blood-clotting drugs in the 1980s. The government should deal with the 300,000 people who do not realize they became infected with hepatitis C before screening tests became available in 1989, it adds. Both doctors and patients are ill-informed about the potential risks of blood products and alternatives to their use, says the report.