The US government has requested documents from Novartis as it investigates allegations that the company held ‘sham’ events that were a front for providing kickbacks to prescribers.
The US Attorney’s Office in Manhattan, New York, wants information on some 79,000 events – held over a 10-year period – which it says may have been intended to induce doctors to prescribe its drugs.
Novartis maintains they were all legitimate events intended to educate physicians about their products and has filed a legal request that it does not have to supply the enormous amount of information requested.
The origins of the case date back to 2013, when the Department of Justice (DoJ) filed two separate lawsuits claiming the kickbacks had resulted in hundreds of millions of dollars-worth of unwarranted reimbursement payments by federal healthcare programmes.
The original complaint related to immunosuppressant product Myfortic (mycophenolate), antihypertensives Lotrel (amlodipine and benazepril) and Valturna (aliskiren and valsartan), and the diabetes treatment Starlix (nateglinide).
Novartis says the latest action means that the government has “suddenly exploded” the number of events from a few hundred detailed in its earlier complaint, according to a Bloomberg report.
Last November, the company settled civil claims related to allegations of kickbacks involving specialty pharmacy prescribing of Myfortic and thalassaemia treatment Exjade (deferasirox), without admitting any liability.
The US government contends that some of the venues used for the events would not have allowed presentations to be made – citing examples such as Hooters and Nobu restaurants and fishing trips.
It has also highlighted some incidents where the price tag for speaker meals was excessive – for example $3,000 for two people and more than $2,000 for three people – and suggested some doctors repeatedly attended events. Some did not take place at all, it alleges.
Novartis also agreed to pay $422m in 2010 to settle civil and criminal charges that it engaged in off-label marketing and financial kickbacks to doctors for a number of its drugs, including the epilepsy treatment Trileptal (oxcarbazepine).