Clinical Therapeutics/Volume 30, Number 11, 2008 Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: Selected Reports from Working Groups George P. Giacoia, MD; Perdita Taylor-Zapata, MD; and Donald Mattison, MD Obstetric and Pediatric Pharmacology Branch, Center for Research for Mothers and Children, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland ABSTRACT Background: The Pediatric Formulation Initiative (PFI) is a project of the Eunice Kennedy Shriuer National Institute of Child Health and Human Development (NICHD). The PFI was established to address the issue of the lack of appropriate formula- tions in children and to use this activity as a means to improve pediatric formulations, as mandated by the Best Pharmaceuticals for Children Act of 2002 and 2007. The PFI began in 2005 with the formation of 3 working groups-Scientific, Economics, and Taste and Flavor. These groups began the process of identi- fying issues, gathering needed information, and con- sidering possible ways to overcome barriers to the development of pediatric drug formulations. Objective: The purpose of this supplement was to provide details of the working groups' activities through presentation of full-length articles. Also pre- sented is an article that discusses the 2007 European Union (EU) regulation on medicinal products for pe- diatric use. Methods: Information for this article was gathered from the proceedings of a PFI workshop, sponsored by the NICHD, that was held in Bethesda, Maryland, on December 6 and 7,2005, as well as postworkshop discussions of the different working groups. Results: The increased awareness that the majority of medications used today have not been labeled for use in children, and have not been tested to define safety, efficacy, and appropriate dosing, has led to the passage of legislation in the United States and in the EU to create incentives to stimulate the testing of drugs in this special population. It is imperative that the problems associated with the compounding and use of extemporaneous formulations as described in this supplement be addressed. Regulatory barriers to November 2008 the availability of commercially developed pediatric formulations in different countries will need to be minimized or removed. New drug delivery systems will need to be tested and made available to pediatric patients. Further research in the mediators of bitter taste and study of taste blockers, as well as newer methods for taste testing in pediatrics, should be en- couraged. An overarching goal for the future is ad- dressing the economic barriers to develop appropriate pediatric dosage forms for drugs with limited market penetration. The lack of appropriate formulations is part of a larger problem that includes limited develop- ment and manufacture of medicines tailored for pedi- atric patients (particularly those affected by neglected diseases), insufficient investment in drug trials, and limited research on drug disposition in various pediat- ric populations worldwide. Conclusion: The solution to these issues will re- quire alignment of vision and commitment as a global priority of policy makers, regulators, scientists, phar- maceutical sponsors, academic institutions, govern- ments, and research foundations. (Clin Ther. 2008; 30:2097-2101) © 2008 Excerpta Medica Inc. Key words: National Institute of Child Health and Human Development, Pediatric Formulation Initia- tive, pediatrics, extemporaneous, compounding. INTRODUCTION The Pediatric Formulation Initiative (PFI) is a project of the Eunice Kennedy Shriuer National Institute of Accepted for publicatIOn August 28,2008 dOl:1 0.1 016/J.cIinthera.2008.11.017 0149-2918/$32.00 © 2008 Excerpta Medica Inc. All nghts reserved. 2097