EMA resources stretched by Mediator scandal

pharmafile | October 18, 2011 | News story | Research and Development, Sales and Marketing EMA, Mediator 

The European Medicines Agency has been forced to use ‘considerable resources’ to deal with a flood of enquiries over Mediator after safety concerns caused it to be withdrawn from the French market in November 2009.

Mediator (benfluorex) was developed by French firm Servier as a diabetes treatment, but millions of people used it to help them lose weight. 

New research suggests it is linked to at least 500 deaths in France between 1976 and November 2009, but it remained on the French market despite evidence suggesting its serious risks.

The EMA said it has had deal with a barrage of enquiries about the drug, even though the drug was not authorised centrally but by the French regulator.

In its half-year report the Agency said: “Considerable resources were allocated to address queries from interested parties and media, to respond to access to documents requests, to organise visits by the French Parliament and Senate […] to discuss the responsibilities of the EMA in the Mediator proceedings.”

This cost and interest and is expected to be ongoing, the Agency said, as the European anti-fraud body OLAF will conduct an investigation at the EMA over Mediator.

Change at the top for EMA

The Agency’s report also confirms a change in leadership at the top of the Agency.

Guido Rasi, currently head of the Italian medicines agency, will take up the role of Executive Director from 16 November.

He will replace the interim head Andreas Pott, who has been in charge since January when its former leader Thomas Lonngren controversially left to join the NDA consultancy group.

There will also be a new chair of the management board as Sir Kent Woods, currently the chief executive of the UK’s MHRA, will replace Pat O’Mahony.

Ben Adams

 

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