• Regulatory NewsRegulatory News

    ANSM Committee Delves Into Nitty-Gritty of Fatal French Phase I Trial

    France’s National Agency for Medicines and Health Products Safety (ANSM) released a report this week outlining how its Temporary Specialist Scientific Committee (TSSC) evaluated what went wrong with a first-in-man clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January. ANSM launched its investigation into the Phase I trial in January, which the contract research organization (CRO) running t...
  • Regulatory NewsRegulatory News

    French Regulators Suspend Catalent Manufacturing Site

    France’s health product regulator, l’Agence National de Sécurité du Médicament et des produits de santé (ANSM), suspended production at contract manufacturer Catalent’s softgel capsule manufacturing facility in Beinheim, France, on Friday. The suspension of the site, which the company says it’s unable to predict the duration of, came because of “out-of-place softgel capsules in several product batches that were detected during quality control procedures and removed prior...
  • French Regulator Back in Spotlight as Another Device is Alleged to Have Evaded Controls

    • 03 May 2013
    French regulator ANSM is once again finding itself in position it is all too familiar with: The spotlight. After enduring several scandals over the last two years, most notably those related to pharmaceutical manufacturer Servier and implant manufacturer Poly Implant Prothese (PIP), the regulator is again facing uncomfortable questions after it was revealed that device manufacturer Ceraver had marketed hip implants that did not meet EU standards. Background ANSM-Agence ...
  • French Regulator Charged with Manslaughter for Role in Diabetes Drug Scandal

    • 22 March 2013
    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. Background 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 ...
  • CEO Charged with Manslaughter after Drug's Risks Brought to Light

    • 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 disc...
  • French Executive Released from Prison to Await Trial over Regulatory Fraud

    • 30 October 2012
    The former executive of a French medical device company accused of manufacturing and selling breast implant products manufactured with sub-standard industrial-grade silicone has been released from jail to await charges of causing involuntary bodily harm and aggravated fraud, reports Reuters . Jean-Claude Mas, the former head of the now-defunct implant manufacturer Poly Implant Prothese (PIP), was among several executives arrested earlier in the year after regulato...
  • New French Regulatory Agency Announces Transition of Leadership

    • 03 May 2012
    France's newly-formed National Agency for the Safety of Medicines and Health Products (MSNA), which will ostensibly replace Afssaps, announced 5 May that it will retain its existing leader, Dominique Maraninchi, for the new agency. Maraninchi will lead the new agency, established 1 May by decree, after only having been at Afssaps since February 2011. The agency has been under fire for a number of scandals, including the revelations that the agency allowed Servier's diab...
  • France: New Agency to Soon Replace AFSSAPS

    France has created a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), to replace its current regulatory agency, Afssaps. The move was announced 29 April in France's Official Journal, which noted the new agency remains under development and the change will be effective in a few months. MSNA will have a broader regulatory authority for monitoring and evaluation of health products, such as the development of independent rese...
  • FDA In Process of Translating Many Publications, Guidances

    The US Food and Drug Administration's (FDA) Associate Commissioner for International Programs, Mary Lou Valdez, said in a statement the agency is working to translate many publications into different languages in order to help its foreign regulatory counterparts. In FDA's 11 April statement, Valdez notes the Office of International Programs (OIP) is "committed to supporting the agency's efforts to become a regulatory agency with a truly global reach." As a result, OIP i...
  • EC Investigation of PIP Implants Inconclusive, Calls for Further Study

    A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP's breast implant products. The study, released 2 February 2012, calls for additional investigation, surveillance of the products and stress tests on the products. The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) conducted the stud...
  • Reuters: French Regulatory Authority, Executives Searched In Mediator Probe

    • 03 February 2012
    The offices of French regulatory authority Afssaps were searched by French investigators on 2 February as part of an investigation in to deaths associated with Servier's anti-diabetes drug Mediator, according to Reuters . Mediator has been blamed for over 500 deaths in France, and was on the market for more than 30 years. After its introduction to the market in 1976, it was prescribed to nearly 5 million French citizens before it was recalled from the market in late 200...
  • PIP Executive Arrested in France, Could be Charged With Manslaughter

    • 26 January 2012
    Two former executives of the French company Poly Implant Prothese (PIP) were arrested on 24 January by French investigators, who may charge at least one of them with manslaughter for their role in a burgeoning scandal involving the manufacture and sale of allegedly substandard breast implant products. The executives, former chief executive officer Jean-Claude Mas and former chief financial officer Claude Couty, were arrested following reports that PIP used industrial g...