Complexity of pediatric studies sees costs rise substantially

The average cost in the USA to complete pediatric research on already-marketed prescription drugs, in response to a request from the Food and Drug Administration, increased nearly eight times between 2000 and 2006, according to findings released by the Tufts Center for the Study of Drug Development. The rise, in nominal dollars, from $3.93 million in 2000 to $30.82 million in 2006, is consistent with the general increase in costs, length and complexity for developing new drugs, the Tufts CSDD said.

The analysis also found that, during the first 10 years of an FDA program which seeks to encourage pediatric research, such studies have been undertaken on more than 100 diseases and conditions and have led to new labeling for 120 new or already approved drugs for use in children.

Act for children "doing its job"