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Federal Pre-emption Defense Under Fire In Draft House Bills

This article was originally published in The Tan Sheet

Executive Summary

A one-sentence provision tucked into draft House legislation renewing FDA's drug user fee program seeks to weaken manufacturers' ability to use FDA approval as a defense in state product liability lawsuits

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A proposal apparently circulated by House Democratic leaders to renew user fee programs for three months while negotiations on FDA reform legislation continue is "not an option," Sen. Michael Enzi, R-Wyo., ranking member of the Health, Education, Labor and Pensions Committee, has declared

Phantom Stopgap PDUFA Renewal Might Prompt Faster FDARA Action

A proposal apparently circulated by House Democratic leaders to renew user fee programs for three months while negotiations on FDA reform legislation continue is "not an option," Sen. Michael Enzi, R-Wyo., ranking member of the Health, Education, Labor and Pensions Committee, has declared

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A proposal apparently circulated by House Democratic leaders to renew user fee programs for three months while negotiations on FDA reform legislation continue is "not an option," Sen. Michael Enzi, R-Wyo., ranking member of the Health, Education, Labor and Pensions Committee, has declared

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