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A former general counsel has found herself on the other side of the law for an alleged FDA cover up, thanks to a Department of Justice indictment. Former Vice President and G.C. for pharmaceutical giant GlaxoSmithKline, Lauren Stevens, is facing one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the FDA. The charges relate to the anti-depressant Wellbutrin and whether GSK promoted its off-label use for weight loss, a treatment which has not been approved by the FDA.
The FDA asked GSK for information in 2002 regarding the company's promotion of Wellbutrin as a weight loss treatment, reports ABC News. The indictment alleges that Stevens' response was that the company did not do any off-label promotion for the drug. The evidence, says the DOJ, shows that they did.
The numbers clearly show GSK promoted Wellbutrin for weight loss, according to the indictment. For example, the DOJ alleges Lauren Stevens sent letters to 550 of 2,700 paid speakers for GSK who gave presentations about Wellbutrin, asking to review the slides used in their talks. ABC reports that 28 speakers complied and Stevens determined that they were promoting the drug for off-label uses. Some speakers gave their talks hundreds of times.
Promoting a drug for a use that it has not been approved for is a charge that the Department of Justice often pursues. Other drug companies have been hit with suits over this behavior and some have had to settle for millions, or even billions of dollars. In just one example, Pfizer agreed in 2009 to a record-breaking $2.3 billion in fines to settle criminal and civil charges stemming from its off-label promotion of the drug Bextra.
The indictment further claims that Stevens made notes regarding the risks and benefits of turning over the speakers' slides to the FDA, reports ABC. Stevens' lawyers strongly refute the allegations. "Lauren Stevens is an utterly decent and honorable woman. She is not guilty of obstruction or of making false statements. Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer specifically because of its experience in working with [the] FDA," Stevens' attorney Brien T. O'Connor said in a statement.
GlaxoSmithKline, as a company, has not been charged with a crime.