Having investigated and prosecuted, sometimes unsuccessfully, pharmaceutical and biotech companies and their executives for years, the government this week has turned its might on a pharmaceutical company’s associate general counsel. Lauren Stevens, a former in-house attorney for GlaxoSmithKline, was charged with 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 Food and Drug Administration (FDA), for arguably doing her job. Her indictment spotlights the importance of being extremely cautious when responding to governmental inquiries and investigations and the need for “gatekeepers”—those deemed to be responsible for ensuring that a company acts legally—to be especially careful. Every statement to the government must now be evaluated with this in mind.
According to the indictment, Stevens coordinated the company’s response to an FDA investigation into whether the company had engaged in or encouraged off-label promotion of its anti-depressant drug, Wellbutrin. In the course of the company’s internal investigation, Stevens allegedly obtained materials used by speakers hired by the company. Those materials allegedly indicated that the speakers had engaged in off-label promotion of the drug.
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