Did Drug Company Lawyer Make False Statements to FDA?


When regulatory agencies ask major corporations to hand over documents to them as part of an ongoing investigation, there’s normally a pretty clear understanding of how things work: if the agency doesn’t receive the full set of documents it is asking for, it negotiates with the company, or ratchets up the urgency of the request, or goes to court to enforce a subpoena.

What it hardly ever does is ask the Justice Department to step in, years later, and seek an indictment of a high-ranking corporate in-house counsel for obstruction of a legal proceeding, making false statements, and concealment of documents.

But this may be changing. On November 9, 2010, the Justice Department announced the indictment of Lauren Stevens, a now-retired vice president and associate general counsel at GlaxoSmithKline, the British pharmaceutical giant, in connection with Stevens’ actions back in 2003 when the FDA was investigating GSK for allegedly promoting one of its drugs for unapproved uses.

The indictment says Stevens led a team of lawyers and paralegals responding to the FDA’s request for documents about GSK’s promotion of Wellbutrin, an anti-depressant, for weight loss and other uses that the FDA hadn’t approved. (Actually, the indictment doesn’t name the company or the drug, but many sources confirm their identity.)

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