Glaxo Lawyer Indicted For Obstructing FDA Inquiry

A former in-house attorney of the pharma giant GlaxoSmithKline has been indicted for trying to impede a Food and Drug Administration inquiry into the marketing of a prescription drug.

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.

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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.

Stevens knew the company “had held what was likely more than 1,000 programs that were led by speakers whose presentation materials included off-label information” about the drug and so were not “isolated deficiencies,” the indictment said.

The lawyer is charged with one count of obstructing an official proceeding, one count of falsifying and concealing documents and four counts of making false statements. The first two charges carry maximum terms of 20 years, and the others carry terms of five years.

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“Lauren Stevens is an utterly decent and honorable woman,” her lawyer, Brien T. O’Connor of Ropes & Gray LLP, said in an e-mailed statement. “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 FDA.”

A Glaxo spokesman confirmed Stevens did work for the company. "She is now retired," the spokeswoman said.

Source-Medindia