In an extremely important and long awaited decision, the Second Circuit Court of Appeals recently overturned the conviction of Alfred Caronia, a pharmaceutical sales representative who had been charged with off-label promotion. In doing so, the court raised serious questions concerning the constitutionality of FDA’s restrictions on off-label speech under the First Amendment. This webinar will examine the scope and extent of the court’s ruling, and discuss the implications of the court’s First Amendment analysis for both government enforcement matters and FDA regulation.
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