Off-Label Marketing Puts Novartis AG in Hot Water

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Novartis Pharmaceuticals must face claims that it promoted the use on infants of a drug that U.S. regulators have deemed harmful, a federal judge ruled. While working as a senior sales consultant for Basel, Switzerland-based Novartis in its dermatology and respiratory division, from 2001 through 2006, Donald Galmines marketed and sold the atopic dermatitis drug, Elidel. The Food and Drug Administration had authorized the marketing of Elidel as a second-line treatment for patients aged 2 and older after it found that the drug posed safety risks to infants in December 2000. Though regulators refused to approve the drug for patients older than 3 months of age, Galmines said Novartis soon began marketing Elidel as safe for children under the age of 2 and as a first-line treatment. This marketing allegedly continued even after the FDA revealed in 2005 that the drug increased the risk of cancer in animals and respiratory infections in children younger than 2.

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