Firm will pay $35m over allegations it failed to report suspicious orders of controlled substances
Generic drugmaker Mallinckrodt has agreed to pay $35 million to settle a lawsuit brought by the US Department of Justice over opioid painkillers. The company has not admitted any fault, but is accused of failing to properly detect and notify the US Drug Enforcement Agency of suspicious orders of controlled substances such as oxycodone. The settlement also covers problems with the company’s manufacturing batch records at its plant in Hobart, US.
The case is part of the US government’s ongoing efforts to curb the high levels of opioid abuse across the country. Earlier this year, the Food and Drug Administration (FDA) took the unusual step of requesting Endo Pharmaceuticals remove Opana ER – a slow-release formulation of oxymorphone – from the market, owing to concerns that its benefits do not outweigh the risks. The company has now acceded to that request, and will work with the FDA, distributors and doctors to coordinate the withdrawal.