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Law360 publishes “5 Tips For In-House Counsel Handling Gov’t Inquiries” by Jonathan Kotlier

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08.30.2013 | Article

Jonathan L. Kotlier, chair of the firm’s Government Investigations and White Collar Defense practice group, published “5 Tips For In-House Counsel Handling Gov’t Inquiries” in Law 360’s “Expert Analysis” sections for White Collar, Securities, Life Sciences, and Corporate. The article discusses the case of Lauren Stevens, former vice president and associate general counsel of GlaxoSmithKline PLC, who was indicted in 2010 on charges of misleading the U.S. Food and Drug Administration about the company’s off-label promotion of its anti-depression drug Wellbutrin. Although government prosecution was terminated, the Stevens case illustrates the dangers to in-house counsel when responding to inquiries by government agencies.

Jonathan offers five “best practices” that in-house counsel, and regulatory affairs people, should consider when interacting with and responding to inquiries from the government. These include: evaluating the nature of the inquiry; consulting with/hiring outside counsel; need to be candid; don’t play games with production of documents; and document everything. He notes that had Stevens been more cautious in her approach to the FDA’s initial inquiry, she may have avoided prosecution with all its attendant professional and personal costs.

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