Navigation Links
Former InterMune CEO W. Scott Harkonen Indicted for Wire Fraud and FDA Violations
Date:3/18/2008

SAN FRANCISCO, March 18 /PRNewswire-USNewswire/ -- W. Scott Harkonen, M.D., the former CEO of InterMune Inc., was indicted on wire fraud and felony Food, Drug and Cosmetic Act charges for his role in the creation and dissemination of false and misleading information about the efficacy of InterMune's drug Actimmune (Interferon gamma-1b) as a treatment for idiopathic pulmonary fibrosis (IPF), the Justice Department announced today.

The indictment alleges that Harkonen, a medical doctor, was the chief executive officer of InterMune from February 1998 through June 30, 2003, and a member of InterMune's board of directors from February 1998 through September 2003. Under Harkonen's direction, InterMune marketed and sold Actimmune to treat IPF, a fatal disease, despite the fact that the drug was not approved by the Food and Drug Administration (FDA) as a safe and effective treatment.

According to the indictment, Harkonen promoted and caused the promotion by InterMune of Actimmune as a safe and effective treatment for IPF, despite the lack of FDA approval, in order to sell more Actimmune and to generate revenues and profits from sales of the pharmaceutical for InterMune. The cost of Actimmune for one IPF patient for one year was approximately $50,000 and the vast majority of the company's sales of Actimmune were for the unapproved, off-label use of treating IPF.

The indictment further states that Harkonen devised a scheme to induce doctors to prescribe, and patients to take, Actimmune to treat IPF. As part of that scheme to defraud, on Aug. 28, 2002, InterMune issued a press release publicly announcing the results of a clinical trial of Actimmune for the treatment of IPF. Although the clinical trial in fact failed, Harkonen caused the issuance and distribution of a false and misleading press release to portray that the results of the trial established that Actimmune helped IPF patients live longer. Specifically, the press release's headline falsely stated that, "InterMune Announces Phase III Data Demonstrating Survival Benefit of Actimmune in IPF," with the subheading "Reduces Mortality by 70% in Patients With Mild to Moderate Disease."

According to the indictment, it was part of the scheme to defraud that the information in the press release be conveyed to pharmacies that sold Actimmune and to patients and doctors. In furtherance of this scheme, defendant Harkonen caused a specialty pharmacy to distribute the misleading information in the press release to more than 2,000 pulmonologists and to patients taking Actimmune.

In October 2006, InterMune agreed to enter into a deferred prosecution agreement and to pay nearly $37 million to resolve criminal charges and civil liability in connection with the illegal promotion and marketing of its drug Actimmune. InterMune also entered into a 5-year Corporate Integrity Agreement with the Office of Inspector General for the Department of Health and Human Services.

"When corporate executives provide false and misleading information about pharmaceuticals, they jeopardize the public health and welfare," said Jeffrey S. Bucholtz, acting Assistant Attorney General for the Civil Division. "The Department of Justice is committed to ensuring that patients and their doctors receive truthful information about medical products and will hold accountable those individuals who are responsible for sending the public deceptive information."

"The U.S. Attorney's Office for the Northern District of California is committed to protecting the public against health care fraud," said Brian J. Stretch, acting U.S. Attorney. "Those who unlawfully violate the trust that exists among the biotechnology industry, the FDA, doctors and patients will be prosecuted."

The maximum statutory penalty for wire fraud is 20 years in prison, a $250,000 fine, three years supervised release, and $100 mandatory special assessment. The maximum statutory penalty for acting with intent to defraud and mislead, resulting in drugs being misbranded while held for sale after shipment in interstate commerce, is three years in prison, a $250,000 fine, one year supervised release, and $100 mandatory special assessment. However, any sentence following conviction would be imposed by the court after consideration of the U.S. Sentencing Guidelines and the federal statute governing the imposition of a sentence. Harkonen is scheduled to be arraigned on Friday, March 28, 2008, at 9:30 a.m. before the Hon. Magistrate Judge Joseph C. Spero.

"Pharmaceutical executives who promote drugs using false and misleading information should not be allowed to hide behind a corporate shield," said Kim Rice, Special Agent in Charge of FDA's Office of Criminal Investigations, Washington Field Office. "Pharmaceutical companies do not run themselves, and those who engage in criminal conduct will be held personally accountable."

"We have an obligation to pursue and bring to justice those who prey on the vulnerable and place profits before public health," said FBI Special Agent in Charge Charlene B. Thornton. "This four-year investigation reflects the seriousness with which the FBI takes violations of the law by those entrusted to safeguard the health of the public."

"The results of this criminal investigation show our commitment to protect the Veteran Administration's healthcare system from deceptive and fraudulent practices by pharmaceutical companies," said Special Agent in Charge Douglas J. Carver of the U.S. Department of Veterans Affairs, Office of Inspector General. These charges are the result of a multi-year investigation by the Federal Bureau of Investigation; the Food and Drug Administration's Office of Criminal Investigations; the Department of Veterans' Affairs' Office of Investigations; and the Office of Personnel Management's Office of Investigations.

This case is being prosecuted by Assistant U.S. Attorney Ioana Petrou of the Northern District of California and trial Attorneys Sondra Mills and Allan Gordus of the Office of Consumer Litigation in the Civil Division in Washington with the assistance of Associate Chief Counsel Anne Walsh of the FDA Office of General Counsel, Paralegal Specialists Maryam Beros and Matthew McCrobie, and Legal Technician Ana Guerra.

An indictment contains only allegations against an individual and, as with all defendants, the defendant in this case must be presumed innocent unless and until proven guilty.


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Cardinal Health Names Former Acting Deputy U.S. Attorney General Craig S. Morford to Chief Compliance Officer Post
2. Former Federal Reserve Chairman Paul Volcker To Join Board of Directors of Still River Systems
3. Thomas Farina, Former Pharmaceutical Company District Manager, Charged With Obstruction of Justice
4. Former Blue Cross/Blue Shield Account Manager Sentenced for Health Care Fraud Scheme, Tax Evasion
5. Lilly and Partners In Health, Brigham and Womens Hospital Team Up to Fight MDR-TB in Former Soviet Republics
6. Former Biolase CEO & EVP Launch Technology4Medicine
7. Nyer Medical Group Completes Acquisition of Minority Interest in Pharmacy Chain Subsidiary; Former Minority Shareholders Invest in Nyer Medical Group and Sign 3-Year Employment Agreements
8. OrthoSynetics(TM) Applauds SEC Suit Against Former Company Management
9. Local VA Performers Hold February 15 Benefit to Reduce $10,000 in Medical Bills for Former VCU Student Kellie Brown
10. Herley Industries Announces the Passing of Its Former President
11. Former Navy Surgeon General Is Among Three New Accomplished TriWest Advisory Board Members
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... ... January 19, 2017 , ... ... of Proctology) announced today the opening of 3 medical offices specializing specifically ... Hemorrhoids Center of Los Angeles (Beverly Hills), Hemorrhoids Center of Newport Beach, ...
(Date:1/18/2017)... ... , ... A recent video posting of a new fidget product gathered online ... to relieve stress and anxiety. No one was more surprised than Think Ink ... completed a successful Kickstarter campaign raising $67,000 on the popular crowdfunding platform. “We’ve ...
(Date:1/18/2017)... ... January 18, 2017 , ... From a health perspective, 2017 ... daily linking gut health to chronic disease, mental health and general physical well-being. The ... an important resolution to consider. , For one Charlottesville restaurant, good gut health is ...
(Date:1/18/2017)... ... January 18, 2017 , ... The VA Maryland Health ... on a research project focused on multiple sclerosis (MS). Led by Christopher M. ... to control the disease without compromising normal immune function that often occurs during ...
(Date:1/18/2017)... ... January 18, 2017 , ... ... among specialty pharmacists and pharmacy professionals, has teamed up with Ochsner Health ... program, announced Brian Haug, president of Pharmacy Healthcare Communications, LLC, publishers of ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... , January 19, 2017 According to ... for cryotherapy is set to witness a CAGR of 6.5% during ... America will continue to be the leading market for ... ... Suppliers are emphasizing on ensuring affordable and adequate supply of gas ...
(Date:1/19/2017)... 2017 Accuray Incorporated (Nasdaq: ARAY ... continue to set the bar for excellence in customer ... user satisfaction rating among radiation treatment delivery systems in ... Market Intelligence Briefing™. The most recent ratings trend also ... industry peers for 11 of the past 12 quarters. ...
(Date:1/19/2017)... Calif. , Jan. 19, 2017  Abaxis, Inc. ... manufacturing point-of-care blood analysis instruments and consumables for the ... call to discuss its financial results for the third ... call will be at 4:15 p.m. ET on Thursday, ... for the third quarter fiscal year 2017 after the ...
Breaking Medicine Technology: