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HHS opposes pediatric legislation

This article was originally published in The Gray Sheet

Executive Summary

HHS Secretary Michael Leavitt is expressing "major concerns" about pediatric device language in the FDA Revitalization Act (S 1082), which cleared the Senate Health, Education, Labor and Pensions Committee April 18. In an April 17 letter to HELP Chairman Sen. Edward Kennedy, D-Mass., Leavitt writes that HHS opposes provisions that sanction government funding of research run by private consortia and allow firms to profit from devices approved under a humanitarian device exemption. The pediatric device section of the bill is intended to offer incentives to manufacturers to develop devices for children and adolescents (1"The Gray Sheet" April 2, 2007, p. 25). Amendments could be added to the legislation, which also includes provisions reauthorizing medical device and pharmaceutical user fee programs, before the full Senate votes on the measure...

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