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FDA overwarning



One of the justifications for FDA preemption is the fear of overwarning; warning overload can be counterproductive, causing people to ignore important warnings. Thus, failure-to-warn litigation impedes safety. See "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," 71 Fed. Reg. 3922 (Jan. 24, 2006); Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2004).

Further evidence comes from a CNNMoney.com report (Aaron Smith, "Consumers tune out FDA warnings", Feb. 25) suggesting that the FDA's post-Vioxx caution has already caused the agency to be at the point of diminishing returns, as it is averaging 50% more safety alerts a year for 2005-2007 than it did in 2004, the year Vioxx was withdrawn from the market.

I discussed overwarning in other contexts on Overlawyered in Sep. 2006.

 

 


Rafael Mangual
Project Manager,
Legal Policy
rmangual@manhattan-institute.org

Katherine Lazarski
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.