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FDA's New Labeling Rule

By Beth L. Kaufman and David Black
May 30, 2006

On Jan. 18, 2006, the U.S. Food and Drug Administration (FDA) issued a final rule to revise the required format of prescription drug labels so as to enable physicians to find the information they need more readily. New features include a section called 'Highlights' and a Table of Contents. According to the FDA's press release, this is the first time in 25 years that the labeling requirements have undergone a major revision.

One of the most important parts of the new rule is an 11-page statement proclaiming that FDA labeling requirements should pre-empt most state product liability claims. Courts across the country will now have to decide how much deference to give the FDA's statement in determining whether certain state product liability claims against pharmaceutical companies, such as failure to warn claims, are barred because labeling approved by the FDA is deemed to have provided all the necessary warnings. The new rule amends 21 CFR Parts 201, 314 and 601 and is titled 'Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.' The rule takes effect on June 30.

FDA's Pre-emption Statement in the New Rule

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