Former CEO of biotech firm InterMune, W. Scott Harkonen, has been indicted on federal wire fraud and felony charges for his alleged role in the off-label marketing of InterMune's drug Actimmune (Interferon gamma-1b).
The indictment handed down by the US Department of Justice (DOJ) this week alleges that, under Harkonen's direction, Intermune marketed and sold Actimmune to treat IPF, a fatal disease, despite the fact that drug was not approved by the FDA for this use.
The FDA approved Actimmune years ago to treat a bone disorder and a condition that makes people prone to infections. Authorities charge that InterMune also promoted the drug in 2002 and 2003 as a treatment for patients with idiopathic pulmonary fibrosis, or IPF, a potentially fatal lung disease, for which the drug wasn't approved.
The DOJ charges that Harkonen allegedly devised a scheme to induce doctors to prescribe, and patients to take, Actimmune to treat IPF. As part of the alleged scheme, InterMune issued a press release in Aug. 2002 publicly announcing positive results of a clinical trial of Actimmune as a treatment for IPF, even though the clinical trial failed.
Harkonen also was accused of having sales reps discuss Actimmune's use in treating IPF to doctors and had T-shirts printed with the message that IPF patients could “feel better and live longer” by taking the drug.
InterMune issued a statement saying that none of its current employees was charged with a crime.
“Since 2004, InterMune has been a transformed company with a new management team, a rigorous compliance program and a promising pipeline focused on serious pulmonary and hepatic diseases," it said.