Access to Pediatric-Friendly Formulations at the Time of Pediatric Labeling and After Marketing

None of the legislative and regulatory advances shaping pediatric drug development explicitly mandate the marketing of pediatric formulations. This study explores the availability of commercial products at the time of, and after, pediatric labeling.

Orally administered drugs with new pediatric labeling between 1998 and 2024 were evaluated for formulations marketed at the time of labeling, current marketing status, and generic availability.

Six hundred eleven labeling changes representing 425 drugs available as 567 marketed formulations were reviewed. One hundred eighty-eight (44%) drugs were marketed with pediatric-friendly (PF) formulations; the remainder were available only as solid dosage forms. The rate of change in pediatric labeling significantly outpaced the rate of PF formulation development. For 329 (54%) labeling changes, the only marketed formulation was a solid dosage, although this varied by age group. Standalone PF formulations were discontinued at rates comparable to adult formulations (28% vs 30%) but were 2 to 3 times more likely to have no available generic alternative. Where both an adult and PF formulation were marketed, discontinuation rates for PF formulations were 4 times more likely than discontinuation of the adult formulations when PF forms were still marketed (13% vs 3%) and PF formulations were 2 to 5 times more likely to have no generic alternative. Where PF formulations were not marketed, only 56% of labels provided guidance on manipulation of the adult formulation.

Inadequate PF formulation development and lack of sustained accessibility represent barriers to safe and appropriate pharmacotherapy for children. Key stakeholders should collaborate to improve medication options for pediatric patients.