Suboxone maker Reckitt Benckiser Group (RB Group) will pay the U.S. government a record $1.4 billion to end criminal and civil probes into the marketing of its addiction treatment medication, making it the largest settlement related to the opioid crisis in U.S. history, authorities said on Thursday.
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The settlement will cover multiple investigations into the company's subsidiary, Indivior (formerly known as Reckitt Benckiser Pharmaceuticals Inc.), and its alleged illegal marketing of its drug, the U.S. Department of Justice (DOJ) said.
"Opioid withdrawal is difficult, painful, and sometimes dangerous; people struggling to overcome addiction face challenges that can often seem insurmountable," the Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division said in a statement. "Drug manufacturers marketing products to help opioid addicts are expected to do so honestly and responsibly."
Suboxone, which proved to be a blockbuster-selling drug for Indivior, is an addiction-fighting medication that also contains opioids. Indivior was spun off into a separate company from the RB Group in December 2014, but the exposure and looming litigation and probes related to Suboxone were still attached to the parent company.
On April 9, a federal grand jury in Virginia indicted Indivior for "allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone," according to the DOJ. The company denied the charges and trial is scheduled to start in May 2020.
Federal prosecutors charged that Indivior allegedly marketed a version of Suboxone (Suboxone Film) to medical professionals as less addictive and safer than other drugs containing its active ingredient, the opioid buprenorphine, according to the DOJ statement.
Prosecutors also charged that Indivior promoted the company's "Here to Help" web and phone program as a resource for opioid-addiction patients, which they alleged was actually a method of connecting those patients to doctors the company knew were already prescribing Suboxone and other opioids "to more patients than allowed by federal law, at high doses, and in a careless and clinically unwarranted manner," the DOJ statement said.
In addition, the government charged that Indivior announced it would discontinue its tablet form of Suboxone "based on supposed 'concerns regarding pediatric exposure' to tablets, despite Indivior executives’ knowledge that the primary reason for the discontinuance was to delay the Food and Drug Administration’s approval of generic tablet forms of the drug," according to the DOJ statement.
In a statement, Invidior noted its former parent company's settlement.
"Indivior PLC’s case with the US Department of Justice (DOJ) is separate from that of RB, and Indivior has no additional or new information related to this matter," the statement read.
As part of the settlement on Thursday, Invidior's former parent company RB Group agreed to a non-prosecution agreement and to forfeit $647 million of proceeds it received from Indivior. It also agreed to not manufacture, market, or sell Schedule I, II, or III controlled substances in the U.S. for three years and to cooperate with future investigations related to Suboxone.
The trial against the RB Group's former subsidiary Invidior is still slated to start next May. Thursday's settlement was only with RB Group, and not Indivior.
In addition, the company also agreed to pay $700 million in civil settlements to the federal government and six states, as well as $50 million to the Federal Trade Commission.
Britain-based Reckitt Benckiser issued a statement denying any wrongdoing.
"While RB acted lawfully at all times and expressly denies all allegations that it has engaged in any wrongful conduct, after careful consideration, the board of RB determined that the agreement is in the best interests of the company and its shareholders," the statement said. The company had previously set aside $400 million to settle claims related to its former subsidiary's lawsuits.
Experts said the settlement amount sounded fair.
"Unlike private litigants who are trying to get as much money as possible, DOJ lawyers are trying to come up with what they believe to be a fair settlement for all parties including the public," longtime U.S. attorney and University of Michigan Law School professor Barbara McQuade told ABC News.
In 2007, OxyContin maker Purdue Pharma paid $600 million to settle a case with the Justice Department over its marketing claims and three executives pleaded guilty to criminal misbranding.