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

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7478.1342-a (Published 02 December 2004) Cite this as: BMJ 2004;329:1342
  1. Lucien Abenhaim (lucien.abebhaim@wanadoo.fr), 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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