Novartis Settles Trileptal Marketing Allegations

Novartis AG, a Swiss pharmaceutical giant, announced that its offices in the United States have reached a plea agreement with federal investigators, reported the Wall Street Journal. Allegations include criminal charges concerning how Novartis marketed its epilepsy drug <"http://www.yourlawyer.com/topics/overview/trileptal">Trileptal, added the Journal. Novartis will pay a $185 million fine, according to the agreement.

Both civil and criminal investigations have been conducted over how Novartis promoted Trileptal and its marketing of the drug for uses not approved by the U.S. Food and Drug Administration (FDA), said the Journal. Such off-label marketing is illegal. “Payments made to health-care providers in connection with this medicine,” were also reviewed, Novartis said, quoted the Journal. Novartis previously revealed an investigation was underway, said the Journal, which noted that the probe is being conducted by the U.S. Attorney’s Office for the Eastern District of Pennsylvania.

The guilty plea and payment are meant to resolve criminal allegations of a violation of the U.S. Food, Drug and Cosmetic Act; the agreement is “contingent on court approval,” Novartis said, quoted the Journal.

The drug maker is also negotiating with the same investigators “to resolve civil claims relating to Trileptal,” it said, reported the Journal. Experts believe a settlement could be nearing and Novartis said it increased its financial reserves for Trileptal investigations by $318 million in 2009’s fourth quarter, for a total of $397 million; it is not known if this reserve amount includes the $185 million fine, noted the Journal.

Last year, we wrote that federal regulators approved new suicide warnings for more than two-dozen epilepsy drugs, including Novartis’ Trileptal. The FDA ordered the label update when it issued a public-health advisory regarding the association between epilepsy drugs and suicidal thoughts and behavior. The warnings resulted from the FDA’s review of 199 clinical trials of 11 antiepileptic drugs which showed patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent).

Novartis also said the investigative team is looking into “potential off-label marketing,” quoted the Journal, as well as health care provider payments for five other Novartis drugs: Diovan, Exforge, Sandostatin, Tekturna, and Zelnorm.

“Novartis is unable to assess with reasonable certainty the outcome of the investigation related to these five products or the amounts, which could be material, that it might be required to pay to resolve this investigation,” it said in its statement, said the Journal.

The Journal pointed out that other drug companies, such as Pfizer Inc. and Eli Lilly & Co., have also agreed to large settlements with U.S. investigators regarding the pharmaceutical companies marketing practices. In September, AstraZeneca reached an early agreement to pay out $520 million to settle issues concerning how it marketed Seroquel, a drug prescribed for schizophrenia.

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