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January 15, 2006

Proposed FDA Rule Attempts to Preempt State Law

According to the Wall Street Journal, the Food and Drug Administration is proposing to include in the preamble of a new drug-labelling rule a declaration that federally-approved drug labels preempt state products liability law.  So long as a drug was labelled in compliance with the FDA-approved label, the proposed rule would declare, the drug manufacturer is shielded from state law failure to warn and other claims.  This proposal mirrors a position taken in the past by the FDA in briefs filed in a number of cases arguing that agency labelling guidelines preempt state law.  Those arguments have met with a mixed reception in the courts and the courts could also reject the FDA's position if included in a rule preamble.  This proposal is part of the on-going clash between federal and state officials over their respective authorities to regulate product safety, a clash heightened in recent years by the Bush Administration's focus on tort reform.  Also see Kaiser Network story.


January 15, 2006 | Permalink


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