Former InterMune CEO indicted on off-label marketing charges

Share this article:
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.
Share this article:
close

Next Article in News

Email Newsletters

More in News

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.

GSK second-quarter sales disappoint

GSK second-quarter sales disappoint

Executives urge analysts to focus on the company's long-term potential.

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union