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Former InterMune CEO W. Scott Harkonen Indicted for Wire Fraud and FDA Violations
Date:3/18/2008

falsely stated that, "InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF," with the subheading "Reduces Mortality by 70% in Patients With Mild to Moderate Disease."

According to the indictment, it was part of the scheme to defraud that the information in the press release be conveyed to pharmacies that sold Actimmune and to patients and doctors. In furtherance of this scheme, defendant Harkonen caused a specialty pharmacy to distribute the misleading information in the press release to more than 2,000 pulmonologists and to patients taking Actimmune.

In October 2006, InterMune agreed to enter into a deferred prosecution agreement and to pay nearly $37 million to resolve criminal charges and civil liability in connection with the illegal promotion and marketing of its drug Actimmune. InterMune also entered into a 5-year Corporate Integrity Agreement with the Office of Inspector General for the Department of Health and Human Services.

"When corporate executives provide false and misleading information about pharmaceuticals, they jeopardize the public health and welfare," said Jeffrey S. Bucholtz, acting Assistant Attorney General for the Civil Division. "The Department of Justice is committed to ensuring that patients and their doctors receive truthful information about medical products and will hold accountable those individuals who are responsible for sending the public deceptive information."

"The U.S. Attorney's Office for the Northern District of California is committed to protecting the public against health care fraud," said Brian J. Stretch, acting U.S. Attorney. "Those who unlawfully violate the trust that exists among the biotechnology industry, the FDA, doctors and patients will be prosecuted."

The maximum statutory penalty for wire fraud is 20 years in prison, a $250,000 fine, three years supervised release, and $100 mandatory special assessment. The maximum statutory penalty fo
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SOURCE U.S. Department of Justice
Copyright©2008 PR Newswire.
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