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Although the company has not yet been charged, an ex-Vice President and General Counsel for GlaxoSmithKline is facing charges today over the off-label promotion of the anti-depressant Wellbutrin. Lauren Stevens has been indicted by the Department of Justice for failing to tell the FDA that the company was indeed promoting the use of Wellbutrin for weight loss. The drug has not been approved by the FDA for treating weight issues.
Lauren Stevens is accused of not providing the FDA with the true facts regarding GSK's off-label promotion of Wellbutrin, reports The New York Times. The DOJ charges that Stevens sent letters to the FDA saying the company did not promote Wellbutrin for any off-label use. The FDA asserts that Stevens made false statements that obstructed their investigation.
Several major drug companies have been the focus of off-label investigations for some of their best selling drugs. During the FDA approval process, careful examination is made of both the safety and efficacy of a drug for its intended use. A drug company may not attempt to influence doctors to prescribe that drug for a use it has not been approved for.
Some recent off-label cases include Allergan's promotion of Botox and Johnson & Johnson's alleged promotion of Risperdal, a drug approved to treat severe mental illness, for use in treating dementia in nursing home patients.
GlaxoSmithKline itself has not yet been charged with a crime related to its promotion of the drug, reports The Times. However, the company has announced that it has reserved $400 million to pay for an expected settlement.
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