Novartis to pay millions in fines for off-label marketing of drug
Pharmaceuticals Corp. has agreed to pay $422.5 million in civil and criminal
fines for promoting drugs for uses that had not been approved by the Food
and Drug Administration, the U.S. Department of Justice announced Thursday
in Philadelphia. The corporation is the U.S. subsidiary of Novartis AG,
which is based in Switzerland.
the settlement, which requires approval by federal court in Philadelphia,
Novartis agreed to plead guilty and pay a criminal fine of $185 million
for off-label marketing of the antiepileptic drug Trileptal. It also will
pay $237.5 million in civil penalties for off-label marketing of that drug
and for offering financial inducements for doctors to prescribe Trileptal
and five other Novartis medicines - Diovan, Exforge, Tekturna, Zelnorm,
and Sandostatin. The "kickbacks" included payments for speaker
programs, advisory board memberships, entertainment, travel, and meals to
encourage doctors to prescribe the drugs.
news release, Novartis said it had disclosed earlier this year that it had
set aside money for the settlement. The company said it had agreed to five
years of additional federal monitoring, auditing, training, education, reporting,
will continue its commitment to high standards of ethical business conduct
and regulatory compliance in the sale and marketing of our products,"
Andy Wyss, president of Novartis Pharmaceuticals, said in the release.
David Memeger, the U.S. attorney for the Eastern District of Pennsylvania,
said Trileptal was approved for the treatment of epilepsy. After it was
launched in January 2000, sales were disappointing. Company employees then
began visiting doctors who would not normally treat epilepsy, such as psychiatrists
and pain specialists, to promote the drug as a treatment for bipolar disorder
and neuropathic pain, he said. It had not received FDA approval for those
said off-label promotion could "undermine the doctor-patient relationship."
are permitted to prescribe drugs off-label, he said, drug companies can
only legally promote approved uses. Memeger said Novartis made "hundreds
of millions of dollars" from the illegal marketing.
whistle-blowers will share $26.7 million from the settlement.
was prosecuted in this region because three of the four whistle-blower cases
were filed here.