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Off-Label Use “Predictions” May Be Scrutinized, Prosecutor Sheehan Says

Executive Summary

Companies may include predictions of off-label use in their business plans but should be careful not to cross the line into encouraging off-label promotion, Philadelphia Associate U.S. Attorney James Sheehan suggested at a Food and Drug Law Institute advertising conference in Washington, D.C

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Sheehan joins Spitzer

James Sheehan is nominated to serve as New York State Medicaid Inspector General, Governor Eliot Spitzer announces April 11, where he will oversee the fraud and abuse enforcement activities of New York's $50 billion Medicaid program. Sheehan, who currently serves as the Associate U.S. Attorney for Civil Programs in the Eastern District of Pennsylvania, has been involved in a number of pharmaceutical industry-related cases (1"The Pink Sheet" Sept. 20, 2006, p. 6). As New York attorney general, Spitzer was similarly active in cases involving the pharmaceutical industry. [Editor's Note: "The Pink Sheet" now publishes a monthly round-up employment changes, professional awards, and other news about people in the pharma industry. Please submit announcements to [email protected]]....

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