Healthy Skepticism Library item: 19409

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Benkimoun P
France proposes overhaul of drug regulatory system
MJA 2011 Mar 23; 342:
http://www.bmj.com/content/342/bmj.d1829.extract

Abstract:

The French Ministry of Health has initiated a national consultation to overhaul the regulation of prescription drugs, after the very critical first report by the national drug agency into the appetite suppressant benfluorex (marketed in France as Mediator).

The ministry launched a public investigation last year into how the drug, which was withdrawn in 2009 and has been linked to around 500 deaths, remained on the market for more than 30 years ( BMJ 2010;341:c6882, doi: 10.1136/bmj.c6882 ).

The consultation, which will continue until the end of May, includes six working groups representing different stakeholders. Participants are expected to make proposals on the assessment, monitoring, use, and promotion of drugs.

At the same time the independent drug review journal Prescrire has published 57 recommendations on how to improve the …