Is there a place for children in the development of new drugs

In order to evaluate the adequacy of the new drugs authorized between 2002 and 2004 regarding their use in paediatrics, the Summaries of Drug’s Characteristics (SmPC) of these products were analyzed. 93 new drugs were marketed between 2002-2004. Among them 7.6% were exclusively developed for the adult and/or their use contra-indicated for children. 58% were not recommended due to a lack of information in children or paediatric safety data. Only 34.4% had a paediatric license including 5.4% without any age limitation or indication for use. This analysis demonstrated the lack of specific development of medicines for children which in turn results in a large number of off-label and unlicensed prescriptions in those young patients. A European regulation is therefore urgently needed to improve the development of drugs specifically adapted for children and evaluated in dedicated clinical trials.