Intended for healthcare professionals


French health minister announces reform of drug regulation

BMJ 2011; 342 doi: (Published 20 January 2011) Cite this as: BMJ 2011;342:d360
  1. Paul Benkimoun
  1. 1Paris

The 88 year old founder of France’s second largest drug company, Laboratoires Servier, has been subpoenaed by lawyers acting for six patients who experienced serious cardiovascular side effects after being treated with the diabetes drug benfluorex (Mediator).

The drug, which was mainly prescribed as an appetite suppressant in patients with type 2 diabetes, has been linked to around 500 deaths (BMJ 2010;341:c6882; doi: 10.1136/bmj.c6882). The delay in banning the drug in France is set to be one of the biggest medical scandals of recent years.

French health minister Xavier Bertrand has announced that he will radically reform the way that drugs are regulated in France.

He said he favoured granting a marketing authorisation only to drugs which showed they are “at least equivalent to …

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