Sandoz resolves legacy federal government civil investigation regarding generic drugs
Sandoz, a U.S. subsidiary of Novartis, has entered a settlement agreement with the Civil Division of the U.S. Department of Justice concerning the Department’s years-long pricing investigation into the U.S. generic drug industry.
This settlement is an expected outcome of the resolution the company reached in March 2020 with the DOJ Antitrust division regarding the same investigation and underlying conduct.
Sandoz said that today’s settlement contains no new factual allegations against Sandoz, and the company fully provisioned for this settlement and disclosed the agreement in principle as part of the March 2020 resolution.
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As recognized by the DOJ, Sandoz cooperated with the government’s investigation. The conduct at issue here occurred at Sandoz from March 2013 through December 2015 in direct contravention of the company’s values, policies and trainings in place at the time. The individuals implicated in the underlying conduct are no longer employed by the company.
As part of the agreement, Sandoz will pay $185 million, plus interest from the date of the agreement in principle to settle, and has agreed to corporate integrity obligations with the Office of Inspector General of the Department of Health and Human Services through 2026.
Keren Haruvi, Sandoz president, said: “Today’s settlement bookends the March 2020 resolution and resolves all outstanding federal government matters concerning the DOJ’s investigation into our historical conduct. The agreement is consistent with our commitment to resolve legacy compliance matters and continuously improve our compliance and training programs and evolve our controls. We’re moving forward and remain focused on pioneering new ways to help people around the world access high-quality medicines.”
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Sandoz noted that since the time of the referenced conduct, Sandoz has further evolved its compliance program in the spirit of continuous improvement. Given that this resolution includes a Corporate Integrity Agreement, Sandoz will be implementing controls designed to ensure compliance with the terms of this settlement. Sandoz strives to operate at the highest levels of sound governance as it reinforces its global leadership in generic pharmaceuticals and biosimilars covering all major therapeutic areas, the company said.