PARIS- say he hopes to avoid a repeat of the scandal Mediator, the French Health Minister Xavier Bertrand today unveiled what he described as the biggest overhaul to the drug regulatory system ever undertaken in the country. Bertrand was referring to benfluorex, a drug against diabetes who stayed on the market here for 33 years *, long after other countries had rejected or withdrawn it. The drug is estimated by various studies have caused 500 to 2,000 deaths in France, mainly against damage of the heart valve. The oral drug, marketed as a mediator by Servier Laboratories, was taken by some 5 million people in France and was often prescribed for weight loss until it was removed by France in November 09 the new research has revealed the extent of valvular problem.
The drug regulatory reform will focus on the prevention of conflicts of interest at all levels of the health service of the Ministry down, increasing transparency in drug approvals, ensuring that all drugs offer real benefits, improved training for taking professional decisions of health, and better information for professionals and the public. The measures include a "Sunshine Act" French where pharmaceutical companies will be fined if they do not declare all agreements with outside groups, stricter controls on prescription drugs for unauthorized uses, changes in methods drug marketing, and a ban on the funding of student medical services by pharmaceutical companies. New drugs are compared to those that already exist, not just placebos. The Agency for the Safety of Health Products (AFSSAPS), the regulator which was severely criticized in his role in the affair Mediator will also renamed the National Agency for the Safety of Medicines (ANSM).
Bertrand said he expects a bill will be adopted by the Cabinet before the end of July and presented to parliament in the autumn. The whole package will be reviewed two years after its entry into force, when "there will be [more] heading changes," said Bertrand. Without waiting for the law, work will begin on the 19,000 currently reassessing medicines authorized in France, including 12 000 are on the market. "Many of them will be abandoned," predicts Bertrand. "A drug must show that it is at least as effective as other available if they are to be repaid." The French system, he added, must be able to react as quickly as the Food and Drug Administration of the United States, citing an example in which the FDA added a cons-indication to another drug against diabetes, pioglitazone (Actos), 48 hours after being suspended from the French market.
Although Bertrand acknowledged "serious shortcomings in the functioning of our drug system," he said he was "no question" that France and its taxpayers, rather than the drug manufacturer Servier would compensate the victims. Maraninchi Dominique, who replaced Jean Marimbert as head AFSSAPS in February, called Bertrand reform plan "fantastic" but says Science Insider that the newly appointed agency would need an increase of 20% of its € 115m annual budget to implement "the first step."
the case generated a series Picks reports in what did not, and others are yet to come. All have criticized the drug system present in France, with varying degrees of virulence, and offered an avalanche of proposals to remedy the situation , many in the prescribing Bertrand. "This is a major reform [and comes] only a year after the publication of (pulmonologist) Book Irene Frachon Mediator 150 mg: How many deaths " Socialist parliamentarian said and cardiologist Gérard Bapt, which was a leading activist for change in the drug system and led the ad hoc committee of the national Assembly on the mediator.
the drug scandal has captivated the media here for months and raised questions about the proximity of the French pharmaceutical industry in the political and regulatory agencies. Almost every week there seems to be a new twist in the saga, including a large number of trial, raids on offices Servier and home of the founder and owner Jacques Servier. ultimately, it is up to the courts to answer crucial questions, said Jean-Pierre Door, a member of the national Assembly and the parliamentary ruling UMP. These include whether the benfluorex was actually an amphetamine; why the drug was withdrawn from Italy, Spain and Switzerland years before France; why 17 of side effects warnings were ignored; and why the European Medicines Agency itself has taken no action until December 09, when it recommended the withdrawal of the drug.
Fixed :. The drug was on the market in France for 33 years, and not 35 as originally reported
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