The Pediatric Pharmacology Research Unit Network of the National Institute of Child Health and Human Development
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oO92-86 15/99 Copyright 0 1999 Drug Information Association Inc.
THE PEDIATRIC PHARMACOLOGY RESEARCH UNIT NETWORK OF THE NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT DUANEALEXANDER Director, National Institute of Child Health and Human Development, Bethesda, Maryland
The Pediatric Pharmacology Research Unit (PPRU) Network was established to help address a long-standing problem that was a barrier to optimal health and well-being of children: lack of testing in children of drugs used to treat children. The PPRU Network was developed in 1994 to address the industry concern that there was no satisfactory place to test drugs in children, to provide top quality data that would facilitate pediatric labeling, and to demonstrate that this could be done. The network accomplishes these goals by solicited cooperative agreement grants from leading pediatric pharmacology experts. The network’s developments, accomplishments to date. and plans for the 21st century are covered. Key Words: Pediatric Pharmacology Research Unit Network; Pediatrics; Pharmacology
THE NATIONAL INSTITUTE OF Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) is the world’s largest source of support for pediatric research. Established by Congress 35 years ago, it currently has a budget of $675 million, most of which is awarded competitively as research grants to scientists at medical schools and universities. Most grants are awarded to investigators who initiate proposals themselves, but some are awarded to scientists who respond to proposals initiated by the institute. The Pediatric Pharmacology Research Unit (PPRU) Network is an exam-
Presented at the DIA Workshop “Pediatric Drug Development: Successes and New Solutions,” April 20-21, 1998, Arlington, Virginia. Reprint address: Duane Alexander, Director, National Institute of Child Health and Human Development, 31 Center Drive, Bldg. 31, Rm. 2A03, MSC 2425, Bethesda, MD 20892-2524. E-mail: AlexanderD @exchange.nih.gov
ple of the latter. All the research is funded in furtherance of the NICHD mission: to help people have healthy children at the time they want them, and to help those children reach adulthood free of disease and disability and able to achieve their full potential. Clearly, having well tested, safe, and effective drugs to treat children is encompassed by that mission, and the PPRU Network was developed to help address a long-standing problem that was a barrier to optimal health and wellbeing of children.
DELINEATION OF THE PROBLEM Lack of testing in children of drugs used to treat children is a situation that goes back many years. It was Dr. Harry Shirkey, however, who focused broad attention on the issue. In a series of articles the wide use of the pediatric disclaimer clause after the 1962 drug amendments was noted, and the term “therapeutic orphan” was first coined to de-
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scribe the situation of children in 1964. The Food and Drug Administration (FDA) regulatory position was clearly defined in 1970 when the ag
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