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  • Promotion of Off-Label Use: In Favor of a Regulatory Retreat

    The title of my talk is Promotion of Off-Label Use: In Favor of a Regulatory Retreat, and by that I mean that the FDA’s background prohibition on off-label promotion should recede and just go away. In the gap should step in the tort claims that co-panelist Eric Chaffin has today been talking about: fraud, negligence, and duty to warn. And those tort claims sh ould step in only where that promotion is either fraudulent or careless in some way.

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