USA: Generic Drug Investigation Sandoz to Pay 195 Million Dollars as Penalty in Antitrust Case
The three-year-long antitrust investigation into the U.S. generic drug industry has found that Sandoz was guilty of misconduct between 2013 and 2015 with regard to specific generic drugs sold in the United States. Now, the company will pay a hefty penalty and will also enter into a deferred prosecution agreement.
New Jersey/USA – Sandoz has reached a resolution with the U.S. Department of Justice (DOJ) Antitrust Division concerning the Department’s more than three-year-long antitrust investigation into the U.S. generic drug industry. The Sandoz resolution relates to instances of misconduct at the company between 2013 and 2015 with regard to certain generic drugs sold in the United States. As part of the resolution, Sandoz has agreed to pay 195 million dollars and will enter into a deferred prosecution agreement (DPA).
Sandoz is a global leader in generic pharmaceuticals and biosimilars with a broad portfolio of high-quality medicines covering all major therapeutic areas. In the U.S., during the period in question, the company provided patients with over 400 marketed generic medicines. As recognised by the DOJ, Sandoz cooperated with the government’s investigation. Individuals implicated in the underlying conduct are no longer employed by the company.
Under the terms of the agreement, Sandoz will continue to take steps to enhance its compliance programme, employee training, and monitoring. Sandoz will also continue to cooperate with the government’s ongoing investigation into the generic pharmaceutical industry.
Carol Lynch, President of Sandoz, said: “We take seriously our compliance with antitrust laws, and in reaching today’s resolution, we are not only resolving historical issues but also underscoring our commitment to continually improving our compliance and training programmes and evolving our controls. We are disappointed that this misconduct occurred in the face of our clear antitrust compliance policies and multiple trainings – and in full contravention of the company’s values.”
In addition, the company is also in settlement negotiations with the DOJ Civil Division to resolve potential related claims and is taking a provision of 185 million dollars for this purpose.