english.prescrire.org > Positions > Regulatory issues > Risk management plans: far from reassuring

Theme: Regulatory issues

Drugs regulatory bodies ought to be the public’s principal defence against medicines that are useless, unproven or downright dangerous. Yet regulators increasingly depend upon financing from the pharmaceutical industry itself.  

Risk management plans: far from reassuring

Drug risk management plans lack transparency and contain ambiguities.

In recent years, numerous dispensations from drug licensing regulations have been granted in order to speed up the arrival of new drugs on the market. In return, regulatory agencies have ruled that there will be improved monitoring of drugs after the marketing authorisation comes into effect. It is in this context that pharmaceutical firms are developing "risk management systems" as part of their obligation to prevent or minimise the risks associated with their drugs.

There is actually very little information currently available concerning these increasingly widespread systems, which are almost totally lacking in transparency.

The pharmacovigilance actions provided for in these "risk minimisation activities" are the very minimum that can be expected. Some post-marketing studies are welcome. But risk minimisation activities for varenicline, for example, provide for an evaluation in those aged under 18, pregnant women and patients suffering from cardiovascular disease, whereas this drug, designed to help people stop smoking, is already on sale and the subject of a major advertising campaign. Furthermore, the provision of "patient education programmes" in some risk minimisation activities may lead to a blurring of roles between pharmaceutical companies and healthcare professionals.

Overall, for the moment, these systems are far from reassuring.

©Prescrire 2007

Source: ""Plans de gestion des risques" : pas rassurants du tout" Rev Prescrire 2007; 27 (282): 259-260.

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