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Glaxo Lawyer Indicted For Obstructing FDA Inquiry
Lauren Stevens, of Durham, North Carolina, was accused Tuesday of obstructing and making false statements during the investigation into unapproved uses of Glaxo’s antidepressant drug Wellbutrin SR. Stevens was a vice president and associate general counsel for London-based Glaxo.
Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
She learned in September 2003 that a Glaxo sales representative told the FDA about the off-label promotions and sent a copy of slides used by physicians to tout unapproved uses, according to the indictment.
Stevens wrote to the FDA in November 2003, sending the slide sets she knew the agency already had and saying that while she found “isolated deficiencies,” the evidence “clearly demonstrates” Glaxo didn’t engage in off-label promotions.
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