January 29, 2013 — The Swiss drug company Novartis AG has been subpoenaed by American federal prosecutors who are investigating the company’s marketing practices behind Tekturna (aliskiren) and other drugs. In the company’s 2012 report to the Securities and Exchange Commission, the company reported that a U.S. attorney’s office in the Western District of Kentucky launched an investigation that was “civil and criminal in nature.”
According to Novartis’s SEC report:
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).”
The investigation of “off-label” marketing practices and payments hearkens back to a criminal and civil lawsuit involving the anti-epileptic drug Trileptal. In 2010, Novartis agreed to pay more than $420 million after pleading guilty to charges from the U.S. Department of Justice that they illegally marketed Trileptal for “off-label” purposes. Although doctors are allowed to prescribe medications for uses that are not approved by the FDA, drug companies are not allowed to market medications for “off-label” purposes. The payment resolved allegations that Novartis paid “kickbacks” to healthcare professionals to induce them to prescribe Trileptal.
Recently, experts have raised concerns about the safety of Tekturna. In 2011, Novartis canceled a clinical study and suspended promotion of the drug after finding an increased risk of stroke, kidney problems, dangerously high potassium, and high blood pressure in patients with type-2 diabetes.
In 2012, the U.S. Food and Drug Administration (FDA) published a Safety Communication to warn doctors not to prescribe Tekturna in combination with common high blood-pressure medications (ACE inhibitors and ARBs) to patients with diabetes or kidney problems.