[Most innovative drugs labelled during the last years in paediatrics: does the paediatrician have the tools for their identification?].
When a new drug is labelled, before deciding its integration in the therapeutic strategy, the doctor has to know the degree of innovation of the drug, i.e. its actual benefit and the improvement of actual benefit, also called added value over other available drugs. For each new medicine in France, after drug approval by the French Drug Agency, the French National Authority for Health thought its "Commission de transparence" (Transparency Commission) issues an opinion about the degree of innovation of the drug, which is independent of the marketing authorization. The added value over other available drugs is quantified by five levels of improvement: level I, major progress to level V, no progress. The complete opinion of the Transparency Commission and its synthesis (one page) is online http://www.has-sante.fr/. Between 2006 and 2008, no paediatric drug has obtained a level I of improvement (major progress), ten have obtained a level II (significant progress), 11 a level III (moderate progress), 12 a level IV (minor progress) and for 38 drugs, no progress has been retained. The need to know and to follow therapeutic recommendations is the evidence based medicine. The opinions of the Transparency Commission are one of those recommendations.
Autret-Leca
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Service de pharmacologie clinique, centre régional de pharmacovigilance et d'information sur le médicament, CHRU de Tours, 2, boulevard Tonnellé, 37044 Tours cedex 9, France. autret-leca@med.univ-tours.fr
D002648:Child; D004345:Drug Industry / Q000592:standards*; D004348:Drug Labeling / Q000592:standards; D005602:France; D006801:Humans; D040541:Marketing / Q000592:standards; D010372:Pediatrics / Q000592:standards; D010820:Physicians / Q000592:standards