Paediatric medication: the new European regulations
CESAMES INSERM, Université Paris Descartes Paris, France
The new European regulations in favour of paediatric medication, adopted in June 2006, used the same arguments as the Food and Drug Administration (FDA) in the 1990s, namely that imposing clinical trials to check the effects of medication on children makes it possible to improve the efficiency and safety of these paediatric products. In the USA, the FDA Modernization Act (1997) granted 6 months additional exclusive marketing rights to pharmaceutical companies which conducted FDA-approved paediatric studies. Since 2006, the same incentive has been granted, in Europe, to the pharmaceutical companies which conduct paediatric studies. To better understand the possible consequences of this incentive, we analyzed the American experience since they have already adopted this regulation a decade ago. At the end of the 1990s, clinical trials involving children increased substantially. At the same time, the broadening of the diagnostic criteria of numerous disorders, such as hyperactivity, bipolar syndrome, autism and phobia, was introduced in the new international classification of diseases. The new regulation and classification both contributed to increase the prescription of psychotropic drugs to children and adolescents in the USA after 1999. The number of drugs put on the market with new indications for the use on children's psychiatric disorders has grown enormously in the last decade. The 1997 Act led the industry to make a big profit thanks to the blockbusters, such as Prozac, but do not favour innovation. The FDA acknowledged that 76% of the new therapeutic agents are only slight innovation compared to the existing treatments whereas the mean price is twice as much. The results are disappointing: paediatric research for therapeutic agents which are no interest to the companies are conducted by the Foundation for Paediatric Research. At the same time, companies take advantage of the legislation and minimize the huge side effects of psychotropic drugs for children and adolescents. Furthermore, the conflicts of interest between the renowned psychiatrists who participate in redefining the mental pathologies and the pharmaceutical industry, have been given large media coverage, especially since the investigation carried out by the American Congress last summer.