By Development, and Translation Forum on Drug Discovery, Institute of Medicine
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Extra info for Addressing the Barriers to Pediatric Drug Development: Workshop Summary
Dr. Spielberg encouraged the development of more networks of primary care pediatricians to participate in such efforts under the proper auspices and ethics. Finally, Ms. Ireland agreed with others who stated that off-patent studies are not optimally conducted through the Foundation for the National Institutes of Health (FNIH), which relies on charitable contributions for the necessary support. Dr. Mathis acknowledged that the National Institutes of Health (NIH) also has had difficulty in securing funding for offpatent studies.
Participants also described several challenges in using drugs to treat children— problems with formulations and issues of dosing, bioavailability, and drug response. Barriers to pediatric drug Development Barriers to pediatric drug development identified by workshop participants include ethical concerns, economic barriers, and logistical and technical issues. Delays in pediatric drug testing that result from these barriers have led to unnecessary exposure to ineffective drugs or ineffective dosing of effective drugs, both of which prevent patients from receiving appropriate therapies.
Mathis, L. 2006. Growth and development of pediatric drug development at the FDA. Speaker presentation at the Institute of Medicine Workshop on Addressing the Barriers to Pediatric Drug Development, June 13, 2006, Washington, DC. McKinney, R. E. 2003. Congress, the FDA, and the fair development of new medications for children. Pediatrics 112:669–670. , W. Rodriguez, D. Murphy, and T. Crescenzi. 2003. Pediatric drug labeling: Improving the safety and efficacy of pediatric therapies. Journal of the American Medical Association 290(7):905–911.
Addressing the Barriers to Pediatric Drug Development: Workshop Summary by Development, and Translation Forum on Drug Discovery, Institute of Medicine