Indivior, the maker of an anti-addiction drug, has agreed to pay $600m to settle criminal and civil investigations and plead guilty to a felony charge, as part of the US Department of Justice’s largest ever resolution involving an opioid.
The drugmaker — spun off from Reckitt Benckiser in 2014 — pleaded guilty to making false statements relating to healthcare matters, as it sought to promote Suboxone Film by claiming it was safer than other drugs containing the same active ingredient, buprenorphine.
Suboxone is used by patients suffering from opioid-use disorder to reduce withdrawal symptoms.
The settlement comes after Reckitt Benckiser agreed to pay $1.4bn last year in an effort to draw a line under the episode. The $2bn total is much higher than any other settlement related to the opioid epidemic so far.
Michael Granston, deputy assistant attorney-general for the justice department’s civil decision, called the opioid crisis a “public health emergency”.
“Prevention and access to effective treatments for opioid addiction are critical to fighting this epidemic,” he said. “When a drug manufacturer claims to be part of the solution for opioid addicts, we expect honesty and candour to government officials, as well as to the physicians and patients making important treatment decisions based on those representations.”
Mark Crossley, Indivior chief executive, said he was pleased to reach a settlement. “The incident to which the agreement relates occurred well in the past and does not reflect the values Indivior has strived to demonstrate and uphold during our long history of partnering with healthcare providers, policymakers, and communities to fight the opioid crisis,” he said.
The settlement comes as many opioid makers face a number of lawsuits from counties and states paying for damage wrought by the crisis, which has seen 2m Americans addicted to opioids and hundreds of thousands of overdoses since the late 1990s.
Opioid makers including Johnson & Johnson and Teva are trying to negotiate a global settlement. Together with four state attorneys-general last year they proposed a $48bn deal, including some cash and some in-kind donations. But they have not yet got enough other states to sign up to the agreement.
Purdue Pharma, the maker of OxyContin, owned by members of the Sackler family, went into bankruptcy last year. The company, which paid a $600m fine in 2007, is still trying to settle the cases against it, after offering $10bn to $12bn in September last year.
As part of the settlement, Indivior must disband its salesforce for Suboxone and remove healthcare providers at risk of inappropriate prescribing from its programme.
Shaun Thaxter, Indivior’s former chief executive, pleaded guilty last month to charges associated with the drug safety claims. As part of the settlement announced on Friday, Mr Crossley must personally testify that the company did not commit healthcare fraud every year, under penalty of perjury.