Feds reach $35M settlement with oxycodone maker
Detroit – One of the largest manufacturers of the generic opioid painkiller oxycodone has agreed to pay $35 million to settle allegations it violated federal drug laws, the U.S. Attorney’s Office said.
The settlement, announced Tuesday with United Kingdom-based Mallinckrodt LLC, is unprecedented in scope and settles claims the pharmaceutical company did not satisfy obligations to detect and notify the U.S. Drug Enforcement Administration of suspicious oxycodone orders.
The powerful opioid is helping fuel a public health crisis and leading to a spike in overdose deaths nationwide.
From 2008 to 2011, the government alleged Mallinckrodt supplied increasingly excessive quantities of oxycodone pills without notifying the DEA of the suspicious orders. The company supplied the pills to distributors who funneled the drug to pharmacies and pain clinics.
The settlement includes protections against the illegal diversion of controlled substances like oxycodone, according to the U.S. Attorney’s Office. Manufacturers will be required to monitor and report future suspicious orders at the next level of the supply chain – from distributors to independent and small chain pharmacies and pain clinic customers.
“This settlement continues our fight against the opioid epidemic by requiring all in the supply chain not to participate in suspicious orders: physicians, pharmacies, distributors and now – manufacturers,” acting U.S. Attorney Daniel Lemisch said in a statement.
The company also violated record-keeping requirements at its manufacturing facility in upstate New York, the government alleged.
“This settlement reflects DEA’s commitment to the public health and safety by holding DEA-registered manufacturers accountable and requiring them to do their due diligence by knowing the downstream customer,” said Tim Plancon, special agent in charge of the DEA’s Detroit field office.
Mallinckrodt denied violating federal drug laws and admitted no liability.
“While Mallinckrodt disagreed with the U.S. government’s allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers,” General Counsel Michael-Bryant Hicks said in a statement.