Pediatric Exclusivity-Associated Revenues and Labeling Changes, 2013-2023

The Best Pharmaceuticals for Children Act (BPCA) provides a 6-month exclusivity for manufacturers that conduct additional pediatric studies of their products. 97% of pediatric exclusivities granted over a 10-year period resulted in new pediatric efficacy data added to the drug label. However, this data was often generated a decade after market entry, generating a median excess revenue of $134 million per exclusivity, suggesting optimization of BPCA requirements may be necessary to facilitate timely evidence generation.