PHILADELPHIA (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 settlement agreement.
The drug maker illegally marketed Trileptal as a treatment
for bipolar disorder and nerve pain, 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 Food and
Drug Administration, Memeger said.
“That legal obligation takes priority over generating
profits,” he said.
Federal prosecutors 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, according to the company.
The government also alleges Novartis paid kickbacks to induce
doctors to prescribe Trileptal as well as Diovan, Exforge, Tekturna, Zelnorm
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.
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 Novartis AG, the world’s third-biggest drug
maker by revenue.