Novartis has agreed to pay $19.9 million to the state of Texas to settle allegations that it marketed a prescription eczema cream, Elidel, for off-label uses. According to the whistleblower, a former marketing representative for Novartis, the company marketed Elidel for use in children under 2 years of age. Such off-label use was not proven safe or effective and in 2005 the company added a warning to its product labeling that such use is associated with cancer in infants.

The whistleblower’s suit is pending in Pennsylvania federal court on behalf of the federal government and several states, including California, Massachusetts, Virginia, Illinois, and Michigan. The federal government has declined to intervene.

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