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European drug regulator is being investigated by fraud agency

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d7283 (Published 08 November 2011) Cite this as: BMJ 2011;343:d7283
  1. Zosia Kmietowicz
  1. 1London

The agency responsible for regulating drugs across the European Union is being investigated for alleged conflicts of interest by the European Commission’s Anti-Fraud Office.

The European Medicines Agency, which is based in London, confirmed that the office has started an investigation but said that it had received no “further communication with regard to the scope and timeframe of the investigation.”

The investigation was triggered by the scandal over the French antidiabetes drug benfluorex, marketed as Mediator by the French drug company Servier. The drug, which was mainly used as an appetite suppressant in people with type 2 diabetes, was banned in France in 2009, 12 years after compounds belonging to the fenfluramine group, of which benfluorex is one, were withdrawn from the world market because of links with pulmonary hypertension and heart valve disease (BMJ 2010;341:c6882, doi:10.1136/bmj.c6882). It is estimated that the drug may have caused 500 deaths in France and many more in other countries.

In January the French health ministry published a damning report on the conduct of Servier and of the French drug agency Afssaps (Agence Française de Sécurité Sanitaire des Produits de Santé) over the drug (BMJ 2011;342:d360, doi:10.1136/bmj.d360). It said that Servier concealed the true nature of benfluorex for 35 years, selling it as an antidiabetes drug while it acted as an appetite suppressant. It was also highly critical of Afssaps for missing several opportunities to take benfluorex off the market.

The French agency has since been overhauled and renamed as the National Agency for the Safety of Medicines (Agence Nationale de Securité du Médicament), with proposed new powers, including imposing fines and penalties on those in the health sector who fail to declare any conflicts of interest (BMJ 2011;343:d4979, doi:10.1136/bmj.d4979).

Andrew Herxheimer, emeritus fellow at the UK Cochrane Centre, said that it would be legitimate for the European Medicines Agency to raise questions about the conduct of a national drug agency and that, in the case of the Mediator scandal, “it does raise the question of whether the agency should have raised questions.”

The European Anti-Fraud Office has said that its investigation into the agency opened on 22 July but that for “reasons of judicial secrecy and to protect the individual rights” it was unable to comment further. It could not say when it would be reporting on the case and that it would be up to national authorities to act on any recommendations it made in its report.

Notes

Cite this as: BMJ 2011;343:d7283

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