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3 Current Challenges in Developing and Prescribing Drugs for Children
Pages 20-28

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From page 20...
... 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.
From page 21...
... Although children cannot consent to participate in research studies, there is broad international agreement on three core ethical principles that should guide pediatric research: • Children should not be enrolled in research unless necessary to answer an important scientific question about the health and welfare of children. • Research involving children must be characterized by a balance of risks and potential benefits comparable to that of available alternatives.
From page 22...
... Nelson's presentation, Dr. Alan Fleischman, a member of the audience from the New York Academy of Medicine, noted that several major reviews of Subpart D definitions have been performed in the past 5 years by the National Human Research Protections Advisory Committee, two Institute of Medicine (IOM)
From page 23...
... In addition, testing of drugs in pediatric populations is considered to be high risk, with little expected return on investment. When adverse events occur in a trial, sponsors face product liability risks, as well as the risk of having to add a warning to the product label.
From page 24...
... Gorman's presentation, Dr. Robert Califf of the Duke University Medical Center and a member of the IOM Forum on Drug Discovery, Development, and Translation identified an issue that he believes is critical and needs to be discussed more openly: the pharmaceutical industry routinely seeks scientists outside of the United States to conduct studies because the nation's pediatric clinical research capability is not adequate for the purpose.
From page 25...
... She discussed the industry's ethical incentives to conduct research in pediatric populations, including the responsibility to share pharmaceutical knowledge with the community and to protect pediatric patients and further their treatment through provision of the data generated by industry trials. Current regulations, in particular those associated with the Pediatric Research Equity Act (PREA)
From page 26...
... In addition, the Prescription Drug User Fee Act (PDUFA) used to exempt pediatric applications from user fees; however, this is no longer the case�� .
From page 27...
... In addition, there are major gaps in knowledge regarding different drug delivery systems. The recently launched Pediatric Formulations Initiative has several aims: • To identify on- and off-patent drugs for which no suitable formulations are available • To determine scientific and technical barriers to the development of pediatric formulations • To summarize current knowledge on drug palatability, taste masking, bitterness reduction, and pediatric taste studies, and to identify gaps in knowledge in these areas • To determine current knowledge of the toxicity of flavorings, dyes, sweeteners, and preservatives • To identify current practices for dispensing drugs without appropriate pediatric formulations and to determine the suitability of different methods for oral administration • To identify regulatory issues that affect the development and approval of pediatric formulations • To create a forum for information exchange To carry out this initiative, four working groups composed of representatives from industry, academia, the FDA, and NIH were formed.
From page 28...
... He also cited studies that have revealed ethnic variations in the distribution of certain enzymes that cause faster or slower metabolism of drugs. Moving from dose guessing to informed prescribing will require additional studies of the pharmacokinetics, safety, and efficacy of new drugs and older, off-patent drugs.


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