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Rasi At The EMA: Redefining Benefit/Risk As Staggered Approvals Rise

 
• By Faraz Kermani

The Executive Director of the European Medicines Agency Guido Rasi’s dual goals of increasing safety and overall accountability undoubtedly will benefit patients and industry alike, but a grueling task lies ahead.

When Professor Guido Rasi finally was appointed officially to the post of Executive Director of the European Medicines Agency in October 2011, there was a sense that the EMA was entering a new era of openness and accountability. The introduction of new pharmacovigilance legislation and the increasing demands from an ever-more powerful European Parliament already are ratcheting up the pressure on Rasi to come up with innovative solutions and fast. The signs so far are encouraging, but there is still some way to go.

Against the backdrop of the scandal involving Servier SA’s diabetes drug Mediator (benfluorex), the concept of benefit/risk is undergoing...

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