A federal grand jury has indicted a former attorney for GlaxoSmithKline for allegedly obstructing a Food and Drug Administration inquiry into off-label marketing.
Grand jury indicts former GSK attorney
Lauren Stevens, of Durham, N.C., is charged with one count of concealing and falsifying documents and four counts of making false statements as vice president and associate general counsel for the company, which is not named in the indictment.
Stevens allegedly was responsible for responding to a 2002 letter from the FDA seeking materials such as slides used in presentations by physicians paid by the company to promote the antidepressant Wellbutrin, referred to in the indictment as “W-Drug.” The government had received information indicating Wellbutrin was being promoted for unapproved use as a weight-loss drug.
Prosecutors allege Stevens learned that many physicians on the company's speaker rolls had given “likely more than 1,000” presentations endorsing the drug for unapproved uses, but then withheld handouts and slides she identified as incriminating.
GlaxoSmithKline did not respond to a request for comment before deadline. The company previously disclosed that the government was investigating its response to the FDA's 2002 Wellbutrin inquiry and that the Justice Department has been investigating its marketing practices since 2004. The company took a $400 million charge to its fourth-quarter results in 2008 anticipating a settlement, but no resolution to the matter has been announced.
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