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France proposes overhaul of drug regulatory system

BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d1829 (Published 23 March 2011) Cite this as: BMJ 2011;342:d1829
  1. Paul Benkimoun
  1. 1Paris

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The ministry launched a public investigation last year into how the drug, which was withdrawn in 2009 and has been linked to around 500 deaths, remained on the market for more than 30 years (BMJ 2010;341:c6882, doi:10.1136/bmj.c6882).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

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