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EMA adverse event probe, with teeth, may threaten Roche drugs worth $28bn

This article was originally published in Scrip

Executive Summary

The European Medicines Agency announced on 23 October that it will begin to investigate Roche’s alleged non-compliance with pharmacovigilance obligations concerning 19 of its most prominent drugs. Some 80,000 adverse events, including over 15,000 deaths reported following the use of Roche drugs in the US have allegedly neither been analysed by Roche to assess whether they need to be reported to European authorities, nor reported to the European authorities. The EMA is concerned that analysis of these events could shift the balance of risk-benefit of drugs approved in the market.

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