The Washington Brief

When EMA and FDA decisions conflict: differences in patients or in regulation?

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5140 (Published 22 August 2013)
Cite this as: BMJ 2013;347:f5140

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  1. Sidney M Wolfe, founder and senior adviser
  1. 1Health Research Group, Public Citizen, Washington, DC
  1. Swolfe{at}citizen.org

In his new regular column Sid Wolfe asks why the two regulatory bodies have arrived at different decisions on the same diet drugs

Are Americans more resistant to the risks and more likely to benefit from certain drugs than Europeans or, on the contrary, is the European Medicines Agency (EMA) more resistant than the US Food and Drug Administration (FDA) to the drug industry’s desire to get approval for drugs with unique risks but without compensating benefits?

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”1 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.2

In June 2012 the FDA approved lorcaserin (marketed in the United States as Belviq). The weight loss drugs dexfenfluramine and fenfluramine were banned in 1997 because of many post-approval cases of heart valve damage, attributed to adverse effects on the 2B serotonin heart receptor.3 Lorcaserin has minimal 2B serotonin receptor activity, but the FDA approved …

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