What role has the FDA approval process played in the Vioxx problems?
The director for Science and Medicine at the Office of Drug Safety, David Graham, delivered a scathing assessment of FDA drug approval policy. He blamed the 55,000 or more Vioxx deaths on the FDA’s decision in 1999 to approve Merck & Co.’s sale of the drug, despite data that suggested the arthritis medication was linked to increased risks of heart attack and stroke. “Unless the FDA establishes an independent division to monitor the safety of drugs once they’re on the market, Graham said, more Vioxx-like disasters are likely.
