Novartis under U.S. scrutiny for Gilenya marketing tactics

Novartis ($NVS) is up against another marketing investigation. A U.S. Attorney's Office in New York has demanded documents and information about its Gilenya promotions, adding to a list of other government probes.

According to the company's quarterly filing with the Securities and Exchange Commission, investigators requested documents related to its marketing of the multiple sclerosis treatment, including any payments to doctors. In other words, another kickbacks probe.

Obviously, the disclosure is brief, but if the Justice Department is investigating Novartis' financial ties to doctors, it wouldn't be the first time. In January, the company said a U.S. Attorney's Office in Kentucky had issued a subpoena for documents about its Tekturna marketing, including payments to physicians.

It's also not the first time Novartis has faced inquiries about its Gilenya marketing. In April, the Justice Department intervened in a whistleblower suit, which claims that Novartis used kickbacks--disguised as discounts and "bonus" rebates--to persuade specialty pharmacies to boost use of its transplant drug Myfortic. As part of their specialty-pharmacy probe, investigators are checking out rebates and discounts for other products, including Gilenya.

Meanwhile, the company has been investigating employees in India for padding invoices and using the proceeds to buy Galvus, the company's own diabetes drug, to meet their sales targets. Some workers have already been fired, the company told FiercePharma in June. 

In announcing the Myfortic suit in April, U.S. Attorney Preet Bharara called Novartis a "repeat offender," suggesting that the company may have violated the corporate integrity agreement it signed as part of a $422 million off-label marketing settlement in 2010. The Justice Department doesn't like that. When Pfizer made its $2.3 billion off-label marketing deal with prosecutors, they said the company's record criminal fine was so large because the company had overstepped its promise to behave after a previous settlement of Neurontin marketing tactics.

- see the Law360 brief (sub. req.)
- check out the SEC disclosure

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