Nature Medicine | Spoonful of Medicine

As pediatric trials go global, some worry who really benefits

kidglobe.jpgBy Monica Heger

Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only a small fraction of approved medicines is ever tested in pediatric clinical trials. To encourage more safety and efficacy studies of drugs in children, in 1997 the US Food and Drug Administration (FDA) created a special provision that grants six-month patent extensions to medicines screened in children.

Dubbed the Pediatric Exclusivity Provision, the licensing status has led to more than 150 drugs now being approved for specific use in children. But with an increasing number of pediatric trials being conducted in countries where the resulting medicines often aren’t even available, some critics say the provision pads the pockets of ‘big pharma’ more than it benefits youngsters. (Click here to continue reading)

Image by woodleywonderworks via Flickr Creative Commons

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