cGMPs

Do Recent Diet Drug Approvals 'Put the FDA to Shame?'

Source: PharmaManufacturing.com

Aug 28, 2013

bmj.com

Drug industry's longtime critic, Dr Sidney Wolfe, founder and senior adviser to the Health Research Group at Public Citizen, questions the US FDA's decision to approve two diet drugs that were rejected as too dangerous by the European Medicines Agency (EMA).

In his new regular British Medical Journal column, Dr. Wolfe asks why the two regulatory bodies have arrived at different decisions on the same diet drugs.

Belviq (lorcaserin) and Qsymia (phentermine plus topiramate) are available as anti-obesity drugs in the US. In Europe, on the other hand, the diet drugs have been deemed too harmful for any weight-loss benefits to be worthwhile - the ratio of their risks to benefits is too high, according to the European Medicines Agency.