• Safety Concerns Assuaged, Birth Control Pill Back on the Market in France

    • 14 January 2014
    An acne drug also commonly used for birth control indications is slated to return to the market in France more than a year after French regulators first warned that the drug could be dangerous, prompting an EU-wide review of the drug and changes to its approved indications. Background The drug, known as Diane 35 (cyproterone acetage 2mg, ethinylestradiol 35µg), had been associated with an elevated risk of developing venous and arterial thromboembolisms (VTE/ATE), ...
  • Executives of Company Accused of Pulling Wool Over Eyes of EU Regulators Sentenced to Prison

    • 10 December 2013
    The former CEO of a now-disgraced manufacturer of breast implants that was accused of willfully misleading regulatory officials for years has been found guilty by a French court and sentenced to four years in Jail. Background Jean-Claude Mas, former CEO of the now-defunct manufacturer Poly Implant Prothese (PIP), was accused in 2010 of distributing hundreds of thousands of breast implant products made with deficient, industrial-grade silicone without the approval of reg...
  • French Regulators find Cardiology Manufacturer Non-Compliant with Regulations, Withdraw Devices

    • 15 May 2013
    French regulator ANSM has announced yet another problem-the second in as many weeks following a major scandal in 2012-this time with the Jarvik 2000 heart device due to violations of French laws and regulations by a manufacturer in the country. Background ANSM-Agence nationale de sécurité du médicament et des produits de santé, for those who prefer the full title-is a recent addition  to the world regulatory stage, having only been cr...
  • 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 ...
  • France: Reimbursement Review Launched for Spinal Neurostimulation Devices

    • 16 January 2013
    France's cost containment agency (HAS) is undertaking a health technology assessment review of all implantable spinal neurostimulation devices, whether rechargeable or not, that are intended for the treatment of chronic pain and are currently on the national List of Reimbursable Products and Services (PBDA).  The review is being done at the request of the Ministry of Health, it said. The review will result in an updated reimbursement list based on an assessment ...
  • France Releases Knee Joint Implant Reimbursement Recommendations

    France's National Commission for the Evaluation of Medical Devices and Technology Health (CNEDiMTS) has just released its opinion on the reimbursement status for the entire class of knee joint implants on the national list of reimbursable products and services (PBDA).  CNEDiMTS has retained most of the proposals of the Working Group on Classification concerning approved indications, prescribing methods and use, and technical specifications for each type of k...
  • 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...
  • France's ANSM Announces Launch of Nine Regulatory Pilot Projects

    • 29 October 2012
    French regulators have announced the results of an open call for regulatory projects aimed at improving the public health by improving how information is reported to patients and caregivers, how regulators investigate products with possible health risks to the public, and allowing patients to self-report adverse events to regulators. The projects are among the first for the recently-formed National Security Agency of Medicines and Health Products (ANSM), which was form...
  • France Clarifies Its Health Technology Assessment Process

    • 22 October 2012
    France's cost containment agency, the National Authority for Health (HAS), recently released guidance  on the methods that it uses when it conducts "economic evaluations" of medicines and medical devices.  The document explains the basic methodology that HAS uses in the economic evaluations that allow health interventions to be compared on the basis of their health effects and costs. The methodology used is the "reference case analysis" that is adaptable to t...
  • French Regulators Launch New Prescription Drug Paradigm Aimed at Limiting Off-Label Use

    • 08 October 2012
    In the wake of a drug safety scandal that brought down an entire regulatory agency, France's new healthcare product regulatory body, ANSM, is moving to fundamentally change the way it regulates the use and surveillance of off-label prescription drug products, reports the New England Journal of Medicine (NEJM) . France's previous regulatory agency, AFSSAPS, was reconstituted in May 2012 as the National Agency for the Safety of Medicines and Health Products (ANSM) after...