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
TrackBack URL for this entry:
Listed below are links to weblogs that reference Proposed FDA Rule Attempts to Preempt State Law: