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GSK’s $750 Mil. DoJ Settlement: When GMP Violations Equal Healthcare Fraud

Executive Summary

GlaxoSmithKline’s $750 million settlement with the Department of Justice raises a worrisome question for industry: will violations of current good manufacturing practices become a target for whistleblower suits?

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Former prosecutors say there are cases pending under seal, but it is uncertain whether the government will intervene. They note the difficulty in proving the allegations and say FDA’s regulatory regime may be a better route for handling GMP issues.

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