[Is pediatrics excluded from pharmaceutical innovation?].

OBJECTIVE

The development of therapeutic strategies for children depends unequivocally on the commercial launching of drugs with pediatric indications. New therapeutic drugs differ from one country to another, particularly considering children. The objective of this study was to compare access to new drugs by children in France (FR) and Canada (CA).

MATERIAL AND METHODS

Retrospective study comparing newly marketed drugs in FR and CA from 1 January to 31 December 2009. Data were collected through independent sources: (HAS, Thériaque, ANSM for FR and CEPMB, BDPP for CA).

RESULTS

Respectively, 37 and 30 new drugs were put on the market in 2009 in FR and CA. Among them, 38% (n=14) and 27% (n=8) had a pediatric indication. For 91% (FR) and 95% (CA) of the drugs not indicated for children, no clinical study has been planned to define pediatric indications. All the drugs (100%) with pediatric indications presented dosages based on age or weight, but it should be noted that two drugs had no form adapted to children. Fifty-seven percent of these drugs were first available on the French market and later on the Canadian market, with a median delay of 8.5months.

CONCLUSION

This study highlights the obvious lack of pediatric drugs contributing to large prescriptions of off-label drugs for children, with no dosage or adapted pharmaceutical form for this population.