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Dodd Aims For Quick Passage Of Pediatric Device Legislation

This article was originally published in The Gray Sheet

Executive Summary

Sen. Christopher Dodd, D-Conn., is pushing for quick action on legislation to provide incentives for the development of pediatric medical devices

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HHS opposes pediatric legislation

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...

HHS opposes pediatric legislation

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...

PDUFA bill carries device language

Prescription Drug User Fee Act reauthorization legislation, set for markup April 18 in the Senate Health, Education, Labor & Pensions Committee, would establish a publicly accessible database of all postmarket surveillances and studies of PMA-approved and 510(k)-cleared medical devices. The legislative language comes after CDRH has already voluntarily launched a public 1Web site tracking postmarket study progress (2"The Gray Sheet" April 2, 2007, p. 26). The bill also includes language, originally introduced by Senator Chris Dodd, D-Conn., last month, that would link pediatric device innovators with funding sources, allow profit for humanitarian-device-exempted devices and mandate postmarket surveillance studies for pediatric devices (3"The Gray Sheet" April 2, 2007, p. 25). In addition, the legislation formally encourages reauthorization of the Medical Device User Fee and Modernization Act of 2002, which, like the drug user fee program, needs to be reauthorized before Sept. 30 when it is set to expire...

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