BEST PHARMACEUTICALS FOR CHILDREN ACT - DATA COORDINATING CENTER

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The Best Pharmaceuticals for Children Act provides a mechanism for studying on- and offpatent drugs in children. The original BPCA of 2002 directed the Secretary of the Department of Health and Human Services (DHHS), acting through the Director of the National Institutes of Health (NIH), to establish a program for pediatric drug development. The Director of the NIH delegated to the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) the authority and responsibility for establishment and conduct of a pediatric drug development programThe BPCA legislation authorizes the NICHD, in consultation with the Food and Drug Administration (FDA) and with experts in pediatric research, to identify therapeutic gaps in pediatric diseases, disorders or conditions in which more complete knowledge of treatment strategies, including drugs and biologics, may be beneficial to the pediatric population. The NICHD, specifically the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OTTPB), administers the research program (hence forth termed the “BPCA Program”) and works cooperatively with other NIH Institutes and Centers (ICs) with significant pediatric research portfolios in order to fulfill the mandate to improve pediatric therapeutics. The NICHD develops a priority list of drugs needing further study in pediatric practice and sponsors the clinical trials of those prioritized therapeutics. Since the inception of the BPCA in 2002, the NICHD has awarded approximately 35 individual projects for the purpose of gathering information to improve labeling of drugs that are used in children. The NICHD currently maintains an infrastructure of contracts to provide support for various BPCA activities. This infrastructure requires a high level of interaction with the NICHD and the other responsible parties hence forth termed Contractors. This structure, henceforth termed “the Consortium”, work together to construct, implement, monitor and audit pre-clinical and clinical activities, in order to improve the knowledge and labeling of drugs, biologics and devices used in children. Below are the responsible parties