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January 25, 2006

Support for FDA Drug-Labelling Rule Preemption

An editorial in The Washington Times by Peter J. Pitts, a former associate commissioner of the FDA, supports the position taken by the FDA in its recent rulemaking that FDA-approved prescription drug labels should preempt state law tort claims for inadequate warnings.  The editorial concludes by saying that the FDA "has the authority, the ability, the means, the mission and the mandate to manage the health-care risks and benefits inherent in the products it regulates on behalf of the American public." 

It does not address the question of what should happen if there is a failure in the FDA regulatory program.  Time, and the inevitable court challenges, will tell us whether the FDA does indeed have the authority to preempt state law through this new regulation.


January 25, 2006 | Permalink


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