Workshop participants seconded Dr. Rodriguez’s view that the current legislation is having a positive impact on the development of therapies for children. Dr. Dianne Murphy, Director, Office of Pediatric Therapeutics, FDA, and several other participants suggested that in the new iterations of BPCA and PREA, a requirement be included that product labels provide information on results of pediatric trials regardless of the product’s approval status and the process. For off-patent, older agents, FNIH lacks sufficient resources to conduct the needed pediatric studies. Dr. Wayne Snodgrass, Chairman of the Committee on Drugs, American Academy of Pediatrics, cited morphine as an example. Information is lacking on the optimal use of morphine, or even on the drug’s basic kinetics, in various age groups and with different disease processes.

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