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

doi:10.1136/bmj.329.7478.1342-a

From trainee to consultant, BMJ Group offers doctors around the world tailored information, special events, learning resources and recruitment services at every step along their career path.

... by doctors, for doctors, for patients
We are open for entries!

Online learning

BMJ Learning

High-quality CME / CPD for doctors and other healthcare professionals. BMJ Learning features hundreds of accredited, peer-reviewed learning modules in text, video, and audio formats. Find out more

Courses and Qualifications

BMJ Masterclasses

BMJ Masterclasses, led by experts, help clinicians to use the latest evidence and recent guidelines in practice and meet their CPD/CME requirements. Find out more

Exam Preparation

The leading provider of online exam preparation, helping over 167,000 healthcare professionals to pass their exams. Find out more

onExamination

Search all BMJ comment articles:

From

Limit by

Access to the full text of this article requires a subscription or payment. Please log in or subscribe below.

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 …