Harmonising regulatory approval for antibiotics in children

Abstract

Antimicrobial resistance represents a substantial threat to the Sustainable Development Goals (SDGs), with a large impact on the health of children worldwide. 1 Alfvén T Dahlstrand J Humphreys D et al. Placing children and adolescents at the centre of the Sustainable Development Goals will deliver for current and future generations. Glob Health Action. 2019; 121670015 Crossref PubMed Scopus (11) Google Scholar , 2 Laxminarayan R Bhutta ZA Antimicrobial resistance—a threat to neonate survival. Lancet Glob Health. 2016; 4: e676-e677 Summary Full Text Full Text PDF PubMed Scopus (29) Google Scholar However, very few paediatric trials for new antibiotics have been done to inform the optimal treatment of multidrug-resistant infections in children. The current drug regulatory framework has evolved from a system that rightly aimed to protect children, yet remains governed by interpretation of laws established in response to historical incidents involving agents that caused harm. 3 National Institute of Medicine (US)Forum on Drug Discovery, Development, and Translation. Addressing the Barriers to Pediatric Drug Development: Workshop Summary. Regulatory Framework, Washington, DC2008 Google Scholar This approach, particularly for medicines from well established classes with a long experience of safe use in children (such as β-lactam penicillins), now unnecessarily complicates the process of paediatric antibiotic development, and is one of the many barriers to children with multidrug-resistant infections being appropriately treated with licensed drugs. Regulatory approval for anti-infectives in childrenWe recognise the challenges in doing clinical trials for anti-infectives in children and thank Phoebe Williams and colleagues1 for highlighting some of these challenges. We have provided clarifications to address some points raised by the authors. Full-Text PDF