Food‐Drug Effects and Pediatric Drug Development Studies Submitted to the US Food and Drug Administration, 2012‐2022

Abstract Food effect (FE) studies characterize food‐drug interactions that may alter the efficacy or safety of a drug, but these studies are not conducted in pediatric patients. Pediatric patients have substantial physiologic, anatomic, and dietary differences from adults, which may result in differences in their FE considerations. Therefore, the objective of this study was to identify oral drug products approved for use in pediatric patients aged <6 years with an FE observed in adults. Additional objectives were to summarize the therapeutic areas, pharmacokinetic effects, and labeling instructions that resulted from these studies. Publicly available data were searched for products studied in pediatric patients and approved for use by the United States Food and Drug Administration (FDA) from 2012 to 2022. Of the 102 oral drug products approved for use in patients aged <6 years, 43 recommended the consideration of food intake in the drug labeling. These included drug products recommended to be taken with food (n = 21, 49%) or without food (n = 14, 33%). Each of the 14 drug products recommended to be taken without food are approved for use in pediatric patients aged <2 years. The products approved for use in pediatric patients aged <2 years comprised the highest proportion with area under the plasma concentration‐time curve extrapolated to infinity (AUC inf , n = 35, 75%) and maximum serum concentration (C max , n = 45, 80%) affected by food. Close monitoring is warranted during the postapproval period for products identified as having a significant FE in adults and that are approved for use in pediatric patients aged <6 years. Promising tools for predicting pediatric FE may include physiologically based pharmacokinetic absorption modeling.