Pediatric Drug Studies: Protecting Pint-Sized Patients... -
[Cached Version]
Published on: 1/30/2004
Last Visited: 6/26/2005
"That was the voluntary effort, and we weren't making much headway," says Rosemary Roberts, M.D., chair of the pediatric subcommittee in FDA's Center for Drug Evaluation and Research."Most manufacturers just went back to saying that safety and effectiveness had not been established for children."
Without pediatric data about a drug, Roberts says, doctors are sometimes reluctant to treat a child with it."Some physicians won't even try a drug in a child if they don't have enough information," she says.
...
"It can be a real guessing game as to whether we're treating a child effectively," Roberts says.