Endo Health Solutions, currently in bankruptcy, has reached a settlement with the federal government to resolve criminal and civil allegations regarding the sales and marketing of its opioid drug Opana ER, according to the U.S. Justice Department.
The drug, which had been pulled from the market in 2017, was initially approved in 2006 for the management of moderate-to-severe pain requiring a continuous, around-the-clock opioid analgesic over an extended period.
In 2012, the company introduced a new formula designed to render the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. But in March 2017, an independent FDA advisory committee convened to evaluate the abuse patterns and other safety concerns associated with Opana ER and voted 18-8 that the benefits of the reformulated drug no longer outweighed its risks.
The recent settlement includes a criminal plea, where Endo will plead guilty to misbranding drugs, incurring penalties over $1.5 billion, marking one of the largest financial penalties in the pharmaceutical industry. Additionally, Endo will settle civil liabilities for $475.6 million, addressing claims under the False Claims Act related to federal health care program losses.
This agreement also encompasses a bankruptcy case settlement, ensuring the U.S. government receives up to $464.9 million over the next decade for various claims, including criminal, civil, tax and health care-related issues. The company's settlement with opioid claimants involves significant restrictions on opioid marketing and sales and mandates the disclosure of millions of documents to public archives, shedding light on its part in the crisis.