Think off-label marketing isn't a big deal? Tell that to InterMune's ex-CEO, who was indicted for trumping up the efficacy of his lung-disease product Actimmune and marketing it for an unapproved use. Prosecutors allege Dr. W. Scott Harkonen lied in a press release, saying that Actimmune extended the lives of patients with a fatal lung disease known as IPF. By touting Actimmune as an IPF remedy, they say, he was violating FDA rules against off-label marketing.
Harkonen's lawyer says there is data showing that Actimmune helps IPF patients. "By this indictment, the government is trying to criminalize an important potentially life-saving scientific debate," Brosnahan said. InterMune already paid $37 million to settle off-label marketing claims. Plus, the company said in a statement, Harkonen has left the building; he's now CEO of CoMentis, which says it's standing by its leader.
- read the San Jose Mercury News report