The average cost to complete paediatric research on already marketed prescription drugs, in response to a request from the US 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 increase, from $3.93 million in 2000 to $30.82 million in 2006, is consistent with the general rise in cost, length, and complexity for developing new drugs, Tufts CSDD said. The analysis also found that during the first 10 years of an FDA programme that seeks to encourage paediatric research, such studies have been undertaken on more than 100 diseases and conditions and have led to new labelling for 120 new or already approved drugs for use in children.
"While the cost to complete paediatric studies has soared, drug companies are not letting that get in their way," said Tufts CSDD associate director Christopher Milne. "The Best Pharmaceuticals for Children Act seems to be doing its job, which is to generate more paediatric studies. The bottom line is that better prescribing information and more formulations are being developed for children."
Since 1998, the FDA has managed a programme in which it asks pharmaceutical companies to conduct paediatric studies on products in exchange for six additional months of market protection, or ‘paediatric exclusivity,’ for all of its drugs that contain the active ingredient being studied.
Since the paediatric exclusivity programme 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 paediatric studies completed and subsequently accepted by the agency rose from 58 in 2000 to an estimated 568 in 2006.
The study also found that:
– efficacy/safety studies now account for 40% of all paediatric studies conducted, up from 25% in 2000.
– the time required to complete a study and submit a final report nearly doubled since 2000; and
– the mean number of patients required for studies in response to an FDA request was up 178% between 2000 and 2006, and the mean number of studies per request rose 60%.