Suboxone maker Reckitt Benckiser to donate $ 1.4 billion of largest opioid regulation in US history

The manufacturer of Suboxone Reckitt Benckiser Group (RB Group) will pay the US government a record $ 1.4 billion to stop criminal and civil investigations into the commercialization of its drugs for the treatment of drug addiction. made the most important regulation relating to the opioid crisis in the history of the United States, authorities announced Thursday.

The settlement will cover multiple investigations of the company's subsidiary, Indivior (formerly known as Reckitt Benckiser Pharmaceuticals Inc.), as well as its alleged illegal marketing of its drug, announced the US Department of Justice (DOJ) .

"The removal of opioids is difficult, painful and sometimes dangerous, and people struggling to overcome drug addiction face challenges that can often seem insurmountable," said Deputy Attorney General Jody Hunt of the Civil Division of the Department of Justice. in a statement. "Manufacturers of drugs that sell products to help opioid addicts should do so in an honest and responsible manner."

Jason Alden / Bloomberg via Getty Images

Suboxone, which has been shown to be a drug that has sold tremendously for Indivior, is an addictive drug that also contains opioids. Indivior was split into a separate company from the RB Group in December 2014, but exposure, pending litigation and Suboxone investigations were still tied to the parent company.

On April 9, a federal grand jury in Virginia indicted Indivior for "allegedly being engaged in a nationwide illegal program aimed at increasing the prescriptions of Suboxone," according to the GM. The company has denied the charges and the trial is scheduled to open in May 2020.

Federal prosecutors have accused Indivior of marketing a version of Suboxone (film Suboxone) to health professionals, as it would create less dependency and be safer than other drugs containing its active ingredient, buprenorphine, an opioid, according to the statement. from the Ministry of Justice.

Prosecutors also accused Indivior of promoting the company's "Here to Help" web program and phone as a resource for drug-addicted patients, which they said was actually a way to connect these patients to doctors. which the company already knew that they already prescribed Suboxone and other opioids "to more patients than the federal law allows, in large doses and in a negligent and clinically unjustified way," the statement said of the MJ.

In addition, the government accused Indivior of announcing that he was going to stop taking Suboxone in tablet form "on the basis of" concerns about children's exposure "to tablets, while the Indivior leaders knew that the main reason for this judgment was to delay the publication of the report, approval of the generic tablet forms of the drug, "according to the statement of the DOJ.

In a statement, Invidior noted the settlement of its former parent company.

"The case of Indivior PLC with the United States Department of Justice (DOJ) is distinct from that of RB, and Indivior has no additional or new information about it," the statement said.

As part of the settlement on Thursday, the former parent company of Invidior, the RB Group, signed a non-suing agreement and thus confiscated $ 647 million of the proceeds received from Indivior. It also agreed not to manufacture, market or sell controlled substances in Tables I, II or III in the United States for three years and to cooperate with future investigations for Suboxone.

The trial against Invidior, a former subsidiary of the RB group, is scheduled to begin next May. Thursday's settlement concerned only the RB group and not Indivior.

In addition, the company has also agreed to pay $ 700 million in civil settlements to the federal and six states, as well as $ 50 million to the Federal Trade Commission.

The British company Reckitt Benckiser has issued a statement denying any wrongdoing.

"Although RB acted lawfully at all times and expressly denies all allegations of unlawful conduct, the RB Board of Directors, after careful consideration, determined that the agreement was in the best interests of the company and its shareholders, "the statement said. . The company had already set aside $ 400 million to settle claims related to the lawsuits of its previous subsidiary.

Experts said the settlement amount seemed right.

"Unlike private litigants seeking to get as much money as possible, DOJ lawyers are trying to find what they believe to be a fair settlement for all parties, including the public," said Barbara. , a long time American lawyer and professor at the Law School of the University of Michigan. McQuade told ABC News.

In 2007, the manufacturer of OxyContin, Purdue Pharma, disbursed $ 600 million to settle a marketing-related case with the Justice Department and three leaders pleaded guilty to bribery charges.