Thursday, March 20, 2008
According to the Indictment, the accused, a medical doctor in California is accused of marketing the drug Actimmune beyond what it had been approved for with the FDA. The former CEO of InterMune Inc. was indicted in Count One with "Wire Fraud, Aiding and Abetting," and Count Two with "Doing Acts, With Intent to Defraud and Mislead, Resulting in Drugs Being Misbranded While Held for Sale Following Shipment in Interstate Commerce." The website of InterMune states that the company "is a biopharmaceutical company focused on developing and commercializing innovative therapies in pulmonology and hepatology." The company entered into a deferred prosecution agreement in 2006. (see here)(although the link to the press release on the government's deferred prosecution agreement no longer works). The company now issued a press release letting people know that the former CEO hasn't been with the company for over four years. The company press release also states:
"In 2006, InterMune settled all government claims related to that conduct, without criminal sanctions against the company. At the time, the government acknowledged that InterMune fully cooperated with its investigation and had instituted numerous and comprehensive compliance changes before the investigation even began. Today's government action does not affect the Company's settlement in any way.
'In today's action, the government is bringing charges against a former employee, not against InterMune, its current employees or its Directors."
Dan Levine (The Recorder) initially wrote about this matter here (subscription required) and now writes here in an article on Law.com titled Biotech Executive Indicted for Off-Label Claims. In reading the latter article, it looks like there are some facts in dispute between the prosecution and defense.
Indictment - Download harkonen_indictment.pdf
(esp) (w/ a Stetson hat tip for assistance from librarian Whitney Curtis).