Understanding Pediatric Drug Lag Time: Review of Selected Drug Package Inserts

Abstract The wait for a pharmaceutical drug to become approved by the FDA for pediatrics lasts approximately 8 years longer than that for adults. One of the reasons given is the concern that simultaneous pediatric and adult trials may affect licensing in adults. We reviewed drug package inserts obtained from the FDA database for 5 selected agents for the years prior to and after being FDA approved for pediatric use. There were no new contraindications, warnings, or adverse events identified during pediatric clinical trials that would have put adult licensure at risk if approval was obtained in parallel for pediatric populations. The few changes in the package inserts in those years were due to ongoing adult clinical trials and post-marking experience in adults. The concern that pediatric trials might affect adult licensure does not appear to be justifiable.