Addressing the Barriers to Pediatric Drug Development: by Development, and Translation Forum on Drug Discovery,

By Development, and Translation Forum on Drug Discovery, Institute of Medicine

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Hassall provided presentations on the barriers to pediatric drug development from the perspective of the industry, echoThis section is based on the presentations of Ms. Natasha Jarrett, Director of Regulatory Affairs, Hoffmann-LaRoche, and Mr. Thomas Hassall, Senior Director of Global Scientific, Medical, and Regulatory Affairs, Abbott Laboratories. CHALLENGES IN DEVELOPING AND PRESCRIBING DRUGS FOR CHILDREN 25 ing many of the points made by previous speakers. Ms. Jarrett noted a shift away from protecting pediatric patients against experimentation and toward protecting them through the generation of data from drug trials.

Ireland cautioned that reauthorization of BPCA will require Congress to address new cost issues because of the recent changes resulting from the Medicare prescription drug benefit. The benefit is likely to increase costs to the government, so cost–benefit considerations will be central to the reauthorization debate. Dr. Snodgrass responded that the cost of not conducting pediatric studies should also be examined. Training and Research Several participants expressed the need for more physician training.

Gorman, the number of pediatric pharmacologists is declining. Therapeutics is no longer, or rarely, taught in medical schools. In addition, too few physician scientists are able to conduct research that bridges the gap between basic science and clinical practice. Pediatric clinical research units are rare, and pediatric expertise on IRBs is limited, with the exception of children’s hospitals. Significant technical barriers to pediatric drug testing also exist. Dr. Gorman cited limited baseline information on frequency of disease and treatments of choice.

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