Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 12 December 2012
The eponymous head of the French pharmaceutical manufacturing group Servier, Jacques Servier, has been charged by a French court with manslaughter and causing injury in a case related to the company's now-discredited diabetes drug Mediator, reports The New York Times and Reuters.
Servier, 90, was charged along with six of the Servier Group's companies over claims that the company knowingly and improperly marketed Mediator (benefluorex) without adequately disclosing its risks to patients. The drug had been available since 1974, but many countries started to withdraw the medications during the past decade over concerns that it could be harboring dangerous risks to certain patients.
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.
The Times reports Servier was ordered to pay nearly $100,000 in bail, and the other six companies more than five times as much each. Reuters explained that the court's investigation of Servier could possibly-but not definitely-lead to a trial.
Tags: ANSM, Servier, AFSSAPS, France, French
Regulatory Focus newsletters
All the biggest regulatory news and happenings.