BMJ  2004;329:1342 (4 December), doi:10.1136/bmj.329.7478.1342-a

Letter

Lessons from the withdrawal of rofecoxib

France has policy for overall assessment of public health impact of new drugs

The first 150 words of the full text of this article appear below.

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 epidemiological (aetiological) research. It currently works within the framework of a formal agreement signed in May 2003 between the health product economic committee (CEPS) and the association of drug enterprises (LEEM).

Large scale epidemiological evaluations are needed to measure the potential shifts in disease related morbidity and mortality in populations, and risk . . . [Full text of this article]

Lucien Abenhaim, professor of public health

Faculty of Medicine, 24 rue du Faubourg St Jacques, Paris 75014, France lucien.abebhaim@wanadoo.fr


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Relevant Article

Lessons from the withdrawal of rofecoxib
Paul A Dieppe, Shah Ebrahim, Richard M Martin, and Peter Jüni
BMJ 2004 329: 867-868. [Extract] [Full Text] [PDF]

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