January 29, 2013 — According to a 2012 filling with the Securities and Exchange Commission (SEC), Swiss drug-maker Novartis AG is facing a federal investigation into the company’s marketing of Tekturna (aliskiren) and its combination products. The investigators are requesting documents dating back to 2005, including documents detailing payments made to doctors. Novartis reported that the investigation is “civil and criminal in nature” and they are cooperating fully.
According to Novartis’s report describing the investigation:
The U.S. Attorney’s Office for the Western District of Kentucky is “requesting the production of documents relating to marketing practices, including renumeration of healthcare providers, in connection with certain NPC products (including Tekturna and its combination products).”
Investigations into “off-label” marketing and illicit payments to doctors are nothing new for the company. In 2010, Novartis agreed to plead guilty to similar charges related to marketing of the anti-epileptic drug Trileptal. They paid more than $420 million in civil and criminal fines to the U.S. Department of Justice, which resolved allegations that they paid kickbacks to doctors who prescribed Trileptal and illegally marketed it “off-label” for unapproved purposes.