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Wednesday, March 19, 2008

Take two aspirin and call a criminal defense lawyer in the morning.

Scott Harkonen, the former CEO of California biotech firm InterMune Inc., was indicted yesterday for alleged “off-label” marketing of the company's drug Actimmune. The drug was FDA-approved only to treat of a rare form of osteoporosis; prosecutors accuse Harkonen of writing a press release in 2002 claiming the drug could be used to treat idiopathic pulmonary fibrosis. While doctors may prescribe drugs for whatever use they wish, the DOJ has taken the position that it is illegal for companies to promote such off-label use.

The DOJ, FBI, and other governmental agencies have been pursuing investigations of pharma companies and their senior management, and even employees, for alleged off-label marketing of drugs, and there have been some notable settlements. But no company has challenged the government's position at trial, even though the theory of criminal liability in this situation seems to me strained and tortured, and wide open to challenge. CR

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