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Lessons from the withdrawal of rofecoxib: France has policy for overall assessment of public health impact of new drugs

BMJ 2004; 329 doi: (Published 02 December 2004) Cite this as: BMJ 2004;329:1342
  1. Lucien Abenhaim (, professor of public health
  1. Faculty of Medicine, 24 rue du Faubourg St Jacques, Paris 75014, France

    EDITOR—In their editorial commenting on the withdrawal of rofecoxib, Dieppe et al advocate a series of measures before a drug can be licensed.1 Several experiences at the directorate general of the Health of France relating to this issue have led to the formulation of a new policy.

    Whenever a drug is likely to be used on a large scale, pharmaceutical companies must present a pre-reimbursement assessment and organise a postmarketing study of the public health impact of the drug. This impact assessment goes far beyond single end points, as is the case in trials and classic …

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