Inspections, Compliance, Enforcement, and Criminal Investigations
April 14, 2011: Former InterMune CEO Sentenced for False and Misleading Statements Related to Pulmonary Fibrosis Drug's Clinical Tests
SAN FRANCISCO—W. Scott Harkonen, M.D., the former chief executive office (CEO) of InterMune Inc., was sentenced Wednesday before U.S. District Court Judge Marilyn Hall Patel for wire fraud relating to the dissemination of false and misleading statements about the results of a clinical trial of InterMune's drug Actimmune. Judge Patel sentenced Harkonen to three years' probation, with six months of home confinement. He was ordered to pay a $20,000 fine and to perform 200 hours of community service. In September 2009, after a seven-week trial, a jury convicted Harkonen of wire fraud for the creation and dissemination of false and misleading information about the efficacy of Actimmune (Interferon gamma-1b) as a treatment for idiopathic pulmonary fibrosis (IPF).
Evidence at trial showed that Harkonen was the CEO of InterMune from February 1998 through June 30, 2003 and a member of InterMune's board of directors. Under Harkonen's direction, InterMune marketed and sold Actimmune to treat the fatal disease IPF despite the fact that Actimmune was not approved by the Food and Drug Administration (FDA) as a safe and effective treatment. The cost of Actimmune for one IPF patient for one year was approximately $50,000 and the vast majority of the sales of Actimmune were for the unapproved, off-label use of treating IPF.
Evidence at trial further showed that Harkonen caused InterMune to issue a false and misleading press release publicly announcing the results of a clinical trial of Actimmune for the treatment of IPF on Aug. 28, 2002. Although the clinical trial had failed, InterMune's press release falsely stated that the results of the clinical trial established that Actimmune helped IPF patients live longer. The headline of the press release read, "InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF," with the subheading "Reduces Mortality by 70 percent in Patients With Mild to Moderate Disease."
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 five-year Corporate Integrity Agreement with the Office of Inspector General for the Department of Health and Human Services.
"The Department of Justice is firmly committed to holding accountable corporate executives who promote drugs using false or fraudulent information," said Acting Deputy Assistant Attorney General for the Office of Consumer Protection Litigation, Maame Ewusi-Mensah Frimpong. "Executives like Dr. Harkonen, who—without regard for patient health or safety—engage in criminal conduct on behalf of their companies, will not be permitted to carry out this conduct with impunity."
This case is being prosecuted by Assistant U.S. Attorney Kyle Waldinger of the Northern District of California and Trial Attorney Allan Gordus of the Office of Consumer Protection Litigation with the Department of Justice in Washington, D.C. The prosecution is the result of a multi-year investigation by the FBI; the FDA's Office of Criminal Investigations; the U.S. Department of Veterans Affairs, Office of Inspector General; and the Office of Personnel Management, Office of the Inspector General.