Paxil Suit Shows Off-Label Prosecutions By States Can Be "More Dangerous" Than Federal Cases
This article was originally published in The Pink Sheet Daily
Former federal prosecutor Reed Stephens compares the implications of the Paxil lawsuit to those from the Neurontin case. Companies can "inoculate" themselves against federal anti-kickback cases, whereas state consumer protection cases are less predictable, Stephens says.
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The state attorney general alleges that GSK failed to publish information about the safety and efficacy of Paxil in children. The lawsuit seeks disgorgement of profits. GSK maintains that it has publicly communicated the data from its pediatric studies.
Corporate integrity agreement will be carefully studied in pharmaceutical industry given uncertainties surrounding off-label promotion rules. Pfizer agrees to establish clear policies and keep close tabs on off-label use – but the agreement does not define prohibited or permitted activities.
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