Children benefit from FDA pharmaceutical research program

The average cost to conduct pediatric research on already-marketed prescription drugs increased nearly eight times between 2000 and 2006, according to findings by the Tufts Center for the Study of Drug Development.

“The Best Pharmaceuticals for Children Act seems to be doing its job,” says a researcher from the Tufts Center for the Study of Drug Development. © BARBARA LAING

The increase, in nominal dollars, from $3.93 million in 2000 to $30.82 million in 2006, is consistent with the general increase in cost, length and complexity for developing new drugs, according to the Tufts study.

The analysis also found that during the first 10 years of a Food and Drug Administration program that 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.

To improve labeling of prescription drugs for children, the FDA since 1998 has managed a program in which it asks pharmaceutical companies to conduct pediatric studies on marketed products in exchange for six additional months of market protection, known as pediatric exclusivity, for all products that contain the active ingredient being studied. The Best Pharmaceuticals for Children Act, which authorizes this program, is due for renewal in October.

“While the cost to complete pediatric studies has soared, drug companies are not letting that get in their way,” said Christopher Milne, associate director of the Center for the Study of Drug Development (CSDD). “The Best Pharmaceuticals for Children Act seems to be doing its job, which is to generate more pediatric studies. The bottom line is that better prescribing information and more formulations are being developed for children,” he said.

Since the pediatric exclusivity program began, the FDA reports that it has issued 336 requests for 782 studies involving 46,000 children. During the same time, the cumulative number of pediatric studies completed and subsequently accepted by the FDA rose from 58 in 2000 to an estimated 568 in 2006, according to Tufts CSDD.

The study was reported in the March/April issue of the Tufts CSDD Impact Report.

This story ran in the Tufts Journal in April 2007.