Former InterMune Inc. CEO W. Scott Harkonen was sentenced to three years of probation, with six months of home confinement, for making misleading statements about the results of a clinical trial of Actimmune (interferon gamma-1b).

On April 14, U.S. District Court Judge Marilyn Hall Patel sentenced Harkonen and ordered him to pay a $20,000 fine and to perform 200 hours of community service.

In 2009 a jury convicted Harkonen of wire fraud for disseminating a false and misleading press release about the efficacy of Actimmune as a treatment for idiopathic pulmonary fibrosis but acquitted him of a misbranding charge of promoting the drug for an unapproved use (Also see "Former KV Pharmaceutical CEO Sentenced To 30 Days In Jail" - Pink Sheet, 10 March, 2011.). The wire fraud charge carried a potential prison term of up to 20 years.

Three years earlier, InterMune agreed to enter into a deferred prosecution agreement and to pay $36.9 million to resolve criminal charges and civil liability related to the illegal promotion of Actimmune. The company also entered into a five-year corporate integrity agreement with HHS's Office of Inspector General (Also see "InterMune Settles Medicaid/Medicare Fraud Charges For $36.9 Mil." - Pink Sheet, 27 October, 2006.).

The prosecution of Harkonen was a rare instance in which the government has prosecuted an individual in a pharmaceutical health care fraud case. In the past year officials from the Department of Justice, FDA and the HHS Office of Inspector General have all publicly stated that their agencies intended to be more aggressive in going after individuals (Also see "How Broadly Will OIG Enforce Its Exclusion Powers? Possible Action Against Forest CEO Offers A Lesson" - Pink Sheet, 14 April, 2011.).

Stevens Reindicted On Same Charges

In one of the first cases arising from this new push, the DoJ charged former GlaxoSmithkline PLC attorney Lauren Stevens with obstructing an FDA investigation of GSK's off-label marketing of Wellbutrin SR (bupropion). A judge dismissed the charges last month on the grounds prosecutors gave improper instructions to the grand jury as to whether her advice of counsel defense was irrelevant to their finding of probable cause to indict her (Also see "Dismissal Of Indictment Against Former GSK Attorney May Bode Well For Pharma" - Pink Sheet, 24 March, 2011.). On April 14, the DoJ announced it had reindicted Stevens.

DoJ said she is charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency and four counts of making false statements to FDA. The department said these were essentially the same charges brought against Stevens in the original indictment.

- Brenda Sandburg (b.sandburg@elsevier.com)

Former InterMune CEO Sentenced To Probation, DoJ Reindicts Former GSK Attorney

More from Archive

More from Pink Sheet