US Government Spending on New Drugs with Incomplete and Postponed Mandatory Pediatric Trials

Among new drugs approved between 2015 and 2022 that were required to conduct pediatric studies under the Pediatric Research Equity Act (PREA), 38% had their pediatric trials delayed by more than a year, with the US government spending $27 billion on these products through Medicare and Medicaid in the interim. Current enforcement mechanisms to improve compliance with PREA requirements are weak and stricter financial penalties should be used to encourage timely completion of studies.