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- Lucien Abenhaim (lucien.abebhaim@wanadoo.fr), professor of public health
- 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 …
Log in
Log in using your username and password
Log in through your institution
Subscribe from £173 *
Subscribe and get access to all BMJ articles, and much more.
* For online subscription
Access this article for 1 day for:
£38 / $45 / €42 (excludes VAT)
You can download a PDF version for your personal record.