The FDA's plans for pediatric therapeutics

By Dr Nicola Davies

The development of pediatric therapies faces numerous obstacles in the pharmaceutical industry. Among these obstacles are reluctance to expose children to potential harm from experimental therapies, fear of increased liability from pediatric studies, and lack of incentive because of the small market share represented by several pediatric medicines.1

Fortunately, various legislative initiatives enable the US Food and Drug Administration to promote pediatric studies of drugs that are approved or under review for adults. For example, as per the Pediatric Research Equity Act (PREA), sponsors are required to conduct pediatric assessment of certain therapeutics that are approved or, in the case of anti-cancer drugs, under review for certain indications.2,3 As a result of these initiatives, in 2021, 11 approved drugs were expanded for new pediatric populations.4