Life Science Compliance Update

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August 31, 2016

Misleading Survival Data Leads to FCA Liability in Recent Genentech Case

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The DOJ and FDA are starting to back off prosecuting cases involving just off-label claims, after making several unsuccessful attempts. However, the recent Genentech settlement may illuminate a path to success for the DOJ utilizing the False Claims Act. This article outlines the Genentech case, why it is different from other off-label cases, and what compliance officers can do to prevent their company from experiencing the same fate.

The Department of Justice (DOJ) recently announced that pharmaceutical companies Genentech and OSI Pharmaceuticals, LLC, will pay $67 million to resolve allegations that they made misleading statements about the effectiveness of the drug Tarceva to treat lung cancer. Genentech and OSI worked together to co- promote Tarceva.

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