Dr. W. Scott Harkonen was indicted Tuesday on charges that he fraudulently promoted the drug Actimmune for a fatal lung disease while he was the chief executive for the drug's manufacturer, Intermune Inc. of Brisbane.
Harkonen, who is now chief executive of the South San Francisco biomedical company CoMentis Inc., was accused by a federal grand jury in San Francisco in a two-count felony indictment for wire fraud and marketing violations.
The former Intermune CEO is accused of creating a market for Actimmune that reached $141 million in 2003 by falsely claiming through news releases and sales campaigns that the drug substantially reduced the death rate for patients with idiopathic pulmonary fibrosis, a progressive scarring of the lungs. The drug, which cost $50,000 a year, had actually failed to show such benefits in clinical trials, according to federal prosecutors.
The criminal case is part of a drive in recent years by both state and federal prosecutors to crack down on company promotion of their drugs for off-label uses - that is, for diseases not indicated on a drug's FDA-approved label. Actimmune is approved for two rare diseases afflicting children, but the Food and Drug Administration never approved it for idiopathic pulmonary fibrosis. In general, companies have been forbidden to market medicines for unapproved uses, though doctors are legally free to prescribe drugs off-label if they think scientific evidence warrants it.
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One quote:
"Pharmaceutical executives who promote drugs using false and misleading information should not be allowed to hide behind a corporate shield," said Kim Rice, Special Agent in Charge of FDA's Office of Criminal Investigations, Washington Field Office. "Pharmaceutical companies do not run themselves, and those who engage in criminal conduct will be held personally accountable."
Insider's view: It's a start. When will the FDA go after the Big Pharma execs rather than the little fish?
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