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GSK attorney charged with fraud

Former attorney for GSK, Lauren Stevens, is facing charges from the US Justice Department regarding the marketing of antidepressant Wellbutrin

A former attorney for GlaxoSmithKline (GSK) has been charged by the Justice Department with obstructing an official proceeding and making false statements to the US Food and Drug Administration (FDA) regarding marketing of the antidepressant Wellbutrin (buproprion). The retired attorney, Lauren Stevens, is also charged with concealing and falsifying documents to influence a federal agency.

GSK has not been charged with any illegal conduct in the matter, and the company was not indentified by name in the indictment.

The charges stem from Stevens' conduct after the FDA began an inquiry in October 2002 into whether GSK was promoting Wellbutrin for off-label uses, including weight-loss. The US marketing approval for the drug covers only depression, bipolar disorder and smoking cessation, although the compound has been shown in a number of clinical studies to be effective for weight-loss.

The Justice Department alleges that Stevens responded to the inquiry by issuing a series of intentionally misleading letters to the FDA. The letters Stevens wrote denied any off-label promotions, despite the fact that she knew that GSK had paid “numerous physicians” to give lectures to their peers that included promotions of unapproved uses, according to the Justice Department.

Stevens also failed to provide the FDA with slide sets used by the paid physicians to promote the drug, despite promising the agency that she would do so, according to the charges.

The lawyer's indictment is evidence of the Justice Department's strategy of pursuing individuals who break the law on behalf of the companies they work for.  "Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations," Tony West, assistant attorney general for the Civil Division of the Department of Justice, said in a statement announcing the charges against Stevens.

Each of the two obstruction charges that have been filed against Stevens could result in 20 years in prison, while each of four false statement charges filed against her could carry a penalty of five years in prison.    

The charges were filed in the District of Maryland. The case is being prosecuted by the Civil Division's Office of Consumer Litigation and US Attorney's Office for the District of Massachusetts and investigated by agents from the Office of Inspector General of the Department of Health and Human Services, the FBI, the FDA's Office of Criminal Investigations and the Defense Criminal Investigative Service.

12th November 2010

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