Ex-GlaxoSmithKline Executive, Lauren Stevens, alleged in drug fraud

Ex-GlaxoSmithKline Executive, Lauren Stevens, alleged in drug fraud

On Tuesday, the Justice Department declared that it had charged a former vice president and top lawyer for the British drug giant GlaxoSmithKline with making false statements and hindering a federal investigation into illegal marketing of the antidepressant Wellbutrin' for weight loss.

This news grabbed eyeballs of pharmaceutical executives as well as lawyers. "This is absolutely precedent-setting this is really going to set people's hair on fire," said Douglas B. Farquhar, a Washington lawyer. Recently, he presided at a panel on law enforcement during a drug industry conference. "This is indicative of the F.D.A. and Justice strategy to go after the very top-ranking managing officials at regulated companies."

The accused, Lauren C. Stevens, has been charged with lying to the Food and Drug Administration in 2003. They claim that she has been writing letters, as associate general counsel, denying that doctors speaking at company events had promoted Wellbutrin for uses not approved by the agency. Ms. Stevens "made false statements and withheld documents she recognized as incriminating," FDA statement indicated.

"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 said.

Ms. Stevens has assembled a high-powered legal defense team. "She's pleading not guilty," Brien T. O'Connor, a lawyer with Ropes & Gray added, "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 F.D.A."

Ms. Lauren Stevens, 60, has been unavailable for comment. The court's decision is likely to create waves in the healthcare industry. If the case turns in favor of Ms. Lauren Stevens, then concerns are likely to be raised about parameters the FDA uses to hurl accusations.

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