Child tests will raise US drug bill "under 1%"

The US Food and Drug Administration has estimated that the pediatricexclusivity provision, which was included in the 1997 FDA Modernization Act to incentivize pharmaceutical manufacturers to test their prescription drugs on children, will raise the US drugs bill by less than 1% a year.

This increase reflects the provision's effect of keeping generic competitors off the market for the length of the six months' marketing exclusivity granted under the FDAMA, the FDA comments in its report to Congress on how the provision has worked since it was introduced three years ago. During that time, over 58 pediatric studies have been conducted and 25 prescription drugs have received the exclusivity provision, the report says, noting that this incentive has done more to generate clinical studies and useful prescribing information for the pediatric population than any other regulatory or legislative process to date.

Not working for older and low-volume drugs, or producing data in newborns