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The French drug regulatory agency:
unacceptable delays

The French drug regulatory agency denies dragging its feet and favouring the interests of pharmaceutical companies. And yet its slowness in making decisions benefits drug companies rather than public health.

Decisions by the French drug regulatory agency (AFSSAPS) are often long in coming, and it is questionable whether this agency is there primarily to serve patients or pharmaceutical companies. The Director of AFSSAPS has written a letter to defend his Agency in a number of recent cases. The Director of the AFSSAPS would be in a better position vis-à-vis his critics if his arguments and decisions were based not on confidential opinions, but on solid, verifiable facts, made public, and above all took into account a drug's benefit-harm balance. Beyond the few cases in which AFSSAPS has attempted to defend itself, this agency's slowness is endemic, as is borne out by yet more new examples.

©Prescrire November 2005

Source: "L'agence française des produits de santé est-elle avant tout au service des patients ou au service des firmes pharmaceutiques ?" Rev Prescrire 2005 ; 25 (266) : 793-796.

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