European Drug Agency Faces Scrutiny

Europe’s anti-fraud office has launched an investigation into potential conflicts of interest at the EU’s drug approval agency.

By | August 4, 2011

Benfluorex 3-D structureWIKIMEDIA COMMONS, TOTOTS

The EU’s anti-fraud watchdog organization, OLAF, has launched an investigation into whether potential conflicts of interest at the European Medicines Agency (EMA), the European counterpart to the US Food and Drug Administration, are hindering its regulatory role.

The scrutiny comes in the wake of a scandal over the diabetes drug benfluorex, brand name Mediator, which was withdrawn from the French market in 2009. Mediator, produced by the French pharma company Servier, was prescribed off-label as a weight-loss aid for 33 years, despite worrying signs that it could cause deadly heart valve problems. Italy and Spain pulled benfluorex from the market in 1998, but the EMA dragged its heels for a decade. The EMA even provided Mediator an exemption to a ban on appetite-suppressant drugs in 1999. Anywhere from 500 to 2,000 people may have died as a result of medicine. The EMA finally recommended withdrawing benfluorex completely from the market in November 2009 and the European commission agreed in 2010.

One reason EMA may have a tough time being independent is that 80 percent of the EMA’s funding comes from pharmaceutical companies, European Parliamentarian Michele Rivasi told ScienceInsider. The investigation will determine whether such financial ties create a conflict of interest that could potentially bias the agency’s regulatory decisions.

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