French regulators have announced that judicial authorities have indicted the agency for its role in the regulation of the anti-diabetes drug Mediator, once manufactured by Servier and since blamed in the deaths of hundreds of French citizens.
Mediator has been a drug plagued by scandal in recent years.
A 2007 review of the medication by the European Medicines Agency found that the use of the drug was dangerous in patients with high blood levels of triglycerides. A subsequent 2009 review by French regulatory authorities, responding to reports of cardiac valvulopathy, found the drug dangerous enough to suspend its marketing authorization entirely.
In 2010, EMA's Committee for Medicinal Products for Human Use (CHMP) recommended that doctors stop prescribing the drug, and that the drug's marketing authorization be revoked.
That revelation came too late for many patients, however. Mediator has been blamed for hundreds-and possibly thousands-of deaths and thousands of serious injuries, and the ensuing scandal has been a key part in the overhaul of France's healthcare products regulatory agency, now known as the Agence nationale de sécurité du medicament et des produits de santé (ANSM). The company has vigorously denied reports of fatalities, saying it is only aware of a small handful of cases where its drug might have caused problems.
The problem was especially bad in France, where the drug was widely prescribed outside its normal indications as an appetite suppressant, reportedly subsidized by the French government. That tacit approval of the drug's off-label uses has since led to the resignation of the head of both the French regulatory agency, then known as Afssaps, and CHMP Chair Eric Abadie, who also served as a scientific advisor at Afssaps.
Since the drug's risks have come to light, French authorities and legislators have been on something of a manhunt. In February 2012, investigators raided Afssaps' offices as part of a probe into their regulatory oversight of the drug.
By most accounts, the drug was on the market nearly a decade longer than it ought to have been. Most EU member states revoked the drug's marketing authorization in the early 2000s.
Shortly after its offices were raided, Afssaps announced it would cease to exist, and that it was being re-founded as the ANSM, complete with expanded authority to conduct postmarketing pharmacovigilance activities and a much larger budget for regulatory enforcement. It has since launched new restrictions on off-label prescriptions, seen as a response to the off-label promotion of Mediator.
Then, in December 2012, Jacques Servier, the eponymous head of Servier, was charged with manslaughter as the result of the company's alleged promotion of Mediator. Six other executives were charged as well.
The agency itself has been charged with manslaughter. The publication The Connexion said it "is thought to be the first time a government agency has faced criminal charges."
In a statement, ANSM said it is cooperating with legal authorities to "shed light" on its contributions to the scandal, and that it intends to make a help make sure victims, families and users of the drug can get the justice to which they are entitled.
The agency also said it has taken pains to make changes in the ensuing months since the investigation began, noting that it is no longer the same agency that it was when the investigation first began. "Justice will tell the extent of the responsibility of the Agency in the case of Mediator," it said, according to a translated statement.
Regulators added that they will continue to work toward restoring confidence in the agency.