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Albany Law Journal of Science and Technology
Promotion of Off-Label Use: In Favor of a Regulatory Retreat
19.0000000000000 ALB. L.J. SCI. & TECH. 609 (2009)
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.