Former InterMune CEO charged in off-label marketing scheme
Pharma Compliance Alert, March 26, 2008
Scott Harkonen, the former CEO of InterMune, was indicted last week for alleged fraudulent marketing of InterMune's osteoporosis drug Actimmune, according to a Department of Justice (DOJ) press release.
The DOJ alleges Harkonen created a 2002 press release falsely claiming Actimmune could treat idiopathic pulmonary fibrosis (IPF), a fatal lung disease. A clinical trial failed, but a press release claimed Actimmune helped patients with IPF live longer.
Harkonen allegedly created a plan to convince doctors to prescribe Actimmune to treat IPF. As part of this plan, Harkonen led specialty pharmacies to distribute the misleading information which, resulted in more than 2,000 pulmonologists perscribing the drug, the DOJ alleges.
In October 2006, InterMune entered into a deferred prosecution agreement and paid more than $36 million to resolve criminal charges and civil liability in connection with the illegal promotion and marketing of Actimmune. InterMune also entered into a five-year corporate integrity agreement.
The charges include a felony violation of the Food, Drug, and Cosmetic Act and wire fraud.
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