Novartis fined $422.5M in marketing, kickback case

Sep 30, 2010 By KATHY MATHESON , Associated Press Writer
U.S. Attorney Zane David Memeger, from left, speaks as Nicholas DiGiulio from the Department of Health and Human Services and Thomas Doyle from the Food and Drug Administration look on during a news conference about Novartis Pharmaceuticals Corp., Thursday, Sept. 30, 2010, in Philadelphia. The U.S. Justice Department says the pharmaceutical maker has agreed to pay $422.5 million stemming from illegal marketing of the anti-epileptic drug Trileptal and five other drugs. (AP Photo/Matt Slocum)

(AP) -- Novartis Pharmaceuticals Corp. will pay $422.5 million in penalties for marketing an epilepsy medicine for unapproved uses and for paying kickbacks to doctors to prescribe it and five other drugs, federal officials announced Thursday.

The company agreed to plead guilty to distribution of a misbranded drug, a misdemeanor, and pay a criminal fine and forfeiture totaling $185 million in the case involving Trileptal, U.S. Attorney Zane Memeger said at news conference in Philadelphia.

"Every day in this country, patients rely on sound advice from their doctors," Memeger said. "Off-label marketing ... can undermine the doctor-patient relationship."

Novartis will also pay $237.5 million to resolve civil liabilities over the kickbacks and the off-label marketing of Trileptal, an anti-epileptic medicine, according to a .

The drug maker illegally marketed Trileptal as a treatment for bipolar disorder and , sending its sales force to the offices of neurologists, psychiatrists and pain specialists, Memeger said.

While doctors are permitted to prescribe medications for off-label uses based on their medical experience, pharmaceutical companies are not allowed to market or promote drugs for uses not approved by the , Memeger said.

"That legal obligation takes priority over generating profits," he said.

do not allege any patients were harmed by the off-label marketing.

"NPC is pleased to have this matter behind us, and will continue to work with the government and other organizations to improve health care for all Americans," the company said in a statement. "We are committed to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products."

The criminal information filed Thursday in Philadelphia alleges that Novartis sought FDA approval in 1995 to sell Trileptal as a treatment for mania - a component of bipolar disorder - but that it was not effective in clinical trials.

After beginning sales of Trileptal as an anti-epileptic drug in January 2000, the company was disappointed by poor sales and sought new ways to promote it. Novartis trained and rewarded sales reps for off-label marketing, the information said.

Prosecutors allege Novartis marketed the drug off-label from July 2000 through at least June 2004.

Recent sales figures for Trileptal are not reported because it is no longer a top 20 product, Novartis spokeswoman Julie Masow said.

The government also alleges Novartis paid kickbacks to induce doctors to prescribe Trileptal as well as Diovan, Exforge, Tekturna, Zelnorm and Sandostatin.

The announcement Thursday resolves four whistle-blower lawsuits filed by former Novartis employees who reported the off-label marketing. They will share $25.6 million of the penalty money.

Novartis became aware of the government's investigation five years ago and had set aside $397 million by the end of 2009 in anticipation of a resolution, according to a quarterly financial report the company filed Jan. 26.

The drug maker, which cooperated with the probe, has entered into a corporate integrity agreement with the government that will subject the company to strict monitoring.

Novartis Pharmaceuticals, based in East Hanover, N.J., is a subsidiary of Swiss company AG, the world's third-biggest drug maker by revenue.

Explore further: US approves new, hard-to-abuse hydrocodone pill (Update)

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

Patient privacy focus of Amgen suit

Jan 09, 2008

Two former employees with the California biotech company Amgen Inc. allege the company persuaded sales people to access patient records to boost sales.

Botox maker to pay $600M to resolve investigation

Sep 02, 2010

(AP) -- Allergan Inc., the maker of wrinkle-smoothing Botox, has agreed to pay $600 million to settle a yearslong federal investigation into its marketing of the top-selling, botulin-based drug.

Novartis says on track to deliver US vaccine order

Oct 29, 2009

(AP) -- Swiss drugmaker Novartis AG said Thursday it is on track to meet its U.S. government order for swine flu vaccine, seeking to calm fears in recent weeks that shipments and vaccination programs may be delayed.

Off-label use of stents investigated

Mar 07, 2007

A federal committee is investigating the off label use of drug-coated heart stents by U.S. doctors, The Wall Street Journal reported Tuesday.

Recommended for you

US approves new, hard-to-abuse hydrocodone pill (Update)

8 hours ago

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

12 hours ago

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

Only half of patients take their medications as prescribed

22 hours ago

The cost of patients not taking their medications as prescribed can be substantial in terms of their health. Although a large amount of research evidence has tried to address this problem, there are no well-established ...

Interpol call for roadmap to tackle fake drugs

Nov 19, 2014

Interpol on Wednesday called for a greater global response to pharmaceutical crime as it warned criminal gangs were capitalising on weaknesses in legislation and border controls.

Empagliflozin in type 2 diabetes: Added benefit not proven

Nov 19, 2014

Empagliflozin (trade name Jardiance) has been approved since May 2014 for adults with type 2 diabetes mellitus in whom diet and exercise alone do not provide adequate glycaemic control. The German Institute for Quality and ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.