EMA Investigates French Drug Company

A French pharma company faces questions from Europe's regulatory agency about the safety of its osteoporosis drug.

Edyta Zielinska
Sep 12, 2011

WIKIMEDIA COMMONS, INFROGMATION

The European Medicines Agency (EMA) announced that it is further investigating the embroiled French pharmaceutical company Servier, this time over the safety of its osteoporosis drug.  The company had come under fire in late July for its diabetes drug Mediator, whose wide off-label use as a weight loss drug was connected with an estimated 2,000 deaths.

In 2007, the EMA issued warnings regarding Servier's osteoporosis drug Protelos regarding a skin condition that sometimes occurred as a side-effect, and cited the company for flaws in its adverse event tracking-system, the French newspaper Libération reported last week. As a result of a 2009 follow-up, France's regulatory agency (AFSSAPS) found major problems with the company's manufacturing practices that raised concerns about all of Servier's drugs. While the EMA allowed Servier to continue producing drugs, it ordered an additional follow-up report, due to be released later this month, according to Science...

The scandal surrounding Servier is causing wide-reaching effects, with concern over whether the diabetes drug Mediator, which was pulled from the market in Italy and Spain in 2003, was properly handled by the French regulatory agency as well as by the EMA. Earlier this summer, the European Union's antifraud office (OLAF) launched an investigation of the EMA itself, over whether the agency's industry ties create a conflict of interest that puts the public at risk.

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