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With New Law, France Revamps Drug Approval

PARIS— Triggered by the scandal over the diabetes drug Mediator, a law to reform how drugs are approved and regulated in France was adopted by the parliament here yesterday. Because of concerns over side effects, Mediator, or benfluorex, was withdrawn from France in November 2009 after 33 years on the market; several studies suggest it may have caused between 500 and 2000 deaths in France, mainly from heart valve damage. Under the new law, the French Health Products Safety Agency (AFSSAPS), which came under fire for its role in keeping Mediator on the market, is being overhauled and renamed the National Agency for the Safety of Medicines and Health Products (ANSM). Potential new drugs now have to be compared with existing approved ones, instead of just with placebos, if they are to be reimbursed under the public health insurance system, and pharmaceutical companies applying for a drug's approval must declare any links they have with outside organizations, physicians, and researchers or face criminal sanctions for failure to comply.

The new law has some critics. The socialist opposition voted against the final bill because its flaws outweighed the improvements to the initial draft, says Catherine Lemorton, a socialist parliamentarian from Toulouse in southern France. She welcomes that all approved medicines in France will be reviewed every 5 years even if they appear problem-free, and that all ANSM discussions on drugs will be videotaped and accessible online. The new law also contains a sales tax on medical drugs that should generate an estimated €150 million for government-directed physician training, but Lemorton regrets that drug makers don't have to pay more and will still be able to themselves sponsor medical educational classes at increasingly financially-strapped universities. And she is particularly angry that vaccine manufacturers will still be in charge of immunization campaigns. "I was outraged at a recent advertisement in the gossip magazine Voici, which showed a 14-year-old girl saying she had her uterus and would therefore be vaccinated against cervical* cancer," she told ScienceInsider. "It is up to the state to promote these campaigns."

Meanwhile, the Cour de Cassation, France's highest criminal and civil court of appeal, has rejected a request from Servier, Mediator's manufacturer, to group all the lawsuits brought by alleged victims into a single trial. This means that the first trial will open in the Paris suburb of Nanterre 6 February and that a verdict could be handed down by the end of 2012, says François Honnorat, a lawyer for 50 of the people suing Servier. So far a total of 200 people have filed suit, but more could follow. Up to 1.5 million people in France may have taken Mediator between 1995 and its withdrawal in November 2009, Honnorat notes. At that time, 250,000 were taking it.

Those filing the lawsuits have accused the manufacturer's founder, Jacques Servier, of aggravated deception for marketing the drug to overweight diabetic patients rather than as a straightforward appetite suppressant. Servier risks a maximum prison sentence of 4 years, but "could be liable for huge damages to the victims, and the company could lose its operating license," says Honnorat.

*The type of cancer Lemorton noted in her quote has been corrected.