France's medicines watchdog, the National Security Agency of Medicines and Health Products (ANSM), is facing criminal charges of manslaughter and unintentional injuries over its alleged negligence surrounding Servier's diabetes drug Mediator, which may be responsible for as many as 2,000 deaths.
Mediator (benfluorex), which was also prescribed as an appetite suppressant off-label, was withdrawn in France in November 2009 after reports it had caused 500-2,000 deaths in the 30-odd years it had been on the market.
However, the drug, which was linked to heart valve damage, was pulled from the French market ten years later than in several European countries and the USA, and the ANSM (formerly Afssaps*) is now under investigation for failing to act on Mediator's safety issues.
Lawyer Jean-Christophe Courbis, who is representing hundreds of patients who say their health suffered from taking Mediator as well as relatives of those claimed to have died from it, reportedly told national newspaper 20 Minutes: “Since the start we have highlighted the failures of this agency, and with it [health safety agency] Afssaps, which allowed laboratories such as those of Mr Servier to prosper.”
ANSM "had been complicit" in allowing Servier to continue selling the drug, he said, according to French publication The Connexion.
Jacques Servier, founder of the drug's manufacturer, was put under investigation on suspicion of dishonest practices, deception over the quality of Mediator, and of falsely obtaining authorisation to sell the drug back in 2011, and is also reportedly facing manslaughter charges.
*The French government dissolved Afssaps and replaced it with the ANSM in May last year to help tighten up the safety of medicines.