Confirming recent statements by Department of Justice (“DOJ”) and Food & Drug Administration (“FDA”) officials that the government will increasingly target individual executives for criminal prosecution, DOJ has indicted a former Associate General Counsel for pharmaceutical giant GlaxoSmithKline (“GSK”) on two counts of obstruction of justice and four counts of making false statements during an FDA investigation.
The indictment – filed on November 9, 2010 in the District of Maryland, where the FDA’s main offices are located, but brought by the United States Attorney’s Office for the District of Massachusetts – alleges that the in-house lawyer obstructed an FDA investigation into whether GSK promoted its anti-depressant Wellbutrin for off-label purposes. While the indictment does not specifically name GSK or the drug, a GSK spokesperson confirmed that the in-house lawyer, Lauren Stevens, was a former employee. According to the indictment, Stevens authored several letters during the investigation denying that GSK promoted Wellbutrin for off-label purposes, despite allegedly knowing that the company had sponsored events at which Wellbutrin was improperly marketed. The indictment further alleges that Stevens failed to provide the FDA with slides used by physicians to promote Wellbutrin, despite committing to produce them. Instead, Stevens allegedly concluded that the slides were “incriminating” and informed the FDA that GSK’s production was “final” and “complete.”
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