Are Americans more resistant to the risks and more likely to benefit from certain drugs than Europeans? Or is the European Medicines Agency (EMA) more resistant than the U.S. Food and Drug Administration (FDA) to the drug industry’s desire to get approval for drugs with unique risks but without compensating benefits?
Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group, explores the question in his latest column in the British Medical Journal. This is Wolfe’s second column as a regular contributor.
This question arises because the FDA has recently approved two diet drugs, heralded by the agency as “the first drugs for long-term weight management that FDA has approved in 13 years” but rejected by the EMA. In both cases FDA advisory committees earlier rejected approval but later supported the FDA’s and the companies’ desire for approval. Similarly, the FDA has also failed to ban the diabetes drug rosiglitazone (Avandia), banned three years ago by the EMA.