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InterMune settles off-label charges for $37 million

Pharma Compliance Alert, November 1, 2006

InterMune will pay $36.9 million and enter a corporate integrity agreement with the government to settle charges related to off-label promotion of Actimmune (interferon gamma-1b) by former employees during a period that ended in June of 2003.

Actimmune is FDA-approved to treat an immune disorder called chronic granulomatous disease (CGD) and a bone disorder called osteopetrosis. However, between August 2002 and January 2003, most of InterMune's Actimmune sales were for idiopathic pulmonary fibrosis (IPF), according to the government .

According to The Associated Press, the company disseminated and promoted a study of InterMune to treat IPF, claiming that the study showed the drug reduced mortality 70% in patients with mild or moderate IPF.

According to the government, the study showed the drug was not associated with a statistically significant improvement in progression of IPF or patient survival.

The company will pay $36.9 million plus 5% interest over five years. The first annual installment is $5 million and will be paid this year, according to InterMune.

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