Benchmarking the Interval Between Adult and Pediatric Drug Labeling

BACKGROUND Despite decades of efforts to improve pediatric drug development, delays persist between adult approval and pediatric labeling for the same indication. During this interval, medications are frequently prescribed to children without labeled guidance. The magnitude and distribution of these delays have not been quantified. METHODS We conducted a retrospective, time-to-event analysis of pediatric labeling changes approved by the US Food and Drug Administration between March 2010 and March 2025. Time from adult approval to pediatric labeling was summarized using medians and IQRs. Kaplan-Meier methods estimated the probability of remaining without pediatric labeling over time, and Cox proportional hazards models assessed differences by pediatric age cohort and temporal trends. We report 95% CIs for hazard ratios. RESULTS Among 456 pediatric labeling changes in which a gap between the adult and pediatric labeling existed, the median time from adult approval to pediatric labeling was 7.2 years (IQR, 4.2–10.9 years). The probability of remaining without pediatric labeling was 88% at 3 years, 70% at 5 years, and 33% at 10 years after adult approval. No statistically significant change in timelines was observed. CONCLUSIONS Among indications in which a gap between adult and pediatric labeling existed, the interval between adult drug approval and pediatric labeling remains long, with no statistically significant change over 15 years. These findings establish benchmarks that can inform future efforts to improve timeliness of pediatric labeling.