How often do accusations of over-touting a drug land a pharma CEO in criminal court? Not often. No wonder, then, that so many eyes are turned to a San Francisco court this week where the ex-chief of InterMune faces federal prosecution. W. Scott Harkonen is under fire for a press release InterMune issued about the efficacy of its leading drug Actimmune, at a time when the company was trying to get FDA approval for a new indication.
Prosecutors say that the release overstated Actimmune's effectiveness at treating idiopathic pulmonary fibrosis, the new use InterMune wanted from the FDA. Sent out to announce the results of a clinical study, the release not only misrepresented the trial data but also directly contradicted guidance the company had received from the FDA, the prosecution contends. Harkonen's attorney, however, says that the press release was true.
Harkonen faces charges of wire fraud and felony misbranding of a drug. And this despite the fact that he left InterMune in 2003 and that InterMune itself entered into a deferred prosecution agreement with the Justice Department in 2006. Oh, and by the way, InterMune never did get that new indication for Actimmune; it discontinued a trial in 2007 because the drug wasn't making enough headway.
- read the story from The Recorder