Think FDA gets lots of flak from U.S. critics? Take a look at the blowback in France. Patients are suing and politicians are calling for public inquiry over the withdrawn diabetes drug Mediator. Critics say French regulators knew about the serious risks of Mediator as long as 12 years before finally taking action in November 2009. They waited to act even after the drug was withdrawn in Spain in 2003 and Italy in 2004, the critics say, and now the drug has been linked to some 500 deaths since 1976.
Opposition politicians are making hay out of the controversy, saying that the current government is too cozy with drugmakers and that it failed to protect patients. Politicians also are pressing regulators to explain why they didn't act sooner. As InPharm reports, health minister Xavier Bertrand told Le Figaro that there have been "serious failures" in the country's drug licensing system. Regulators will strengthen their safety monitoring, he promised.
Meanwhile, the fight has moved to court. In September, one court found that drugmaker Servier committed misconduct and levied €210,000 in damages to a patient who developed heart problems. Now, more patients and their families are suing Servier: Victims' association AVIM filed legal complaints on behalf of 116 Mediator patients yesterday. The association's lawyer said the organization plans to file a total of about 1,000 claims.