UK-incorporated specialty pharma firm Mallinckrodt (NYSE: MNK) has reached an agreement in principle with the US Drug Enforcement Administration (DEA) and the US Attorneys' Offices (USAOs) for the Eastern District of Michigan and the Northern District of New York, respectively, to settle previously disclosed investigations relating to the company's monitoring program, reporting, record keeping and security measures related to manufacturing and distribution of controlled substances, notably its oxycodone product.
As part of the agreement, the company will pay $35 million to resolve all potential claims. The agreement in principle is subject to additional review and approval by the Department of Justice and DEA. Mallinckrodt says it has been and is a leader in developing and sharing best practices related to its innovative suspicious order monitoring program that exceeds DEA requirements.
But denies government allegations
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