France's Servier is under renewed scrutiny from European regulators. The company, which came under fire over off-label use of its Mediator diabetes drug, has seen repeated inspections from European drug watchdogs since 2007. The latest inspection report is due this month, the French newspaper Libération says.
As ScienceInsider reports, back in 2007, the Servier osteoporosis drug Protelos was linked to a severe and potential fatal skin reaction, and the European Medicines Agency at the time ordered the company to correct "flaws" found in its adverse event tracking. In December 2009, in the wake of the Mediator scandal, the EMA asked the French drug regulator AFSSAPS to check back with Servier to make sure the flaws had been fixed. But that inspection found problems with Servier's manufacturing processes.
Those manufacturing questions were eventually cleared up, at least enough for the EMA to allow Servier to continue turning out its products. AFSSAPS confirms it conducted another follow-up inspection in July. The report from that inspection will appear later this month, ScienceInsider says.
Meanwhile, European regulators are themselves under scrutiny as a result of the Mediator snafu. The drug had been linked with 2,000 deaths by the time it was finally pulled from the market in France in late 2009, and as TheScientist now notes, the EU's antifraud office has been investigating the EMA about potential conflicts of interest.
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