Reckitt Benckiser denied any wrongdoing in a statement but decided that taking the deal was its best option.
Suboxone manufacturer and distributor Reckitt Benckiser (RB) Group will pay a total of $1.4 billion to the U.S. government after taking a settlement offer by the Department of Justice. This will end civil and criminal probes into the multinational company and is so far the largest opioid-related settlement in U.S. history.
RB was under investigation due to alleged misconduct by its former subsidiary company, Indivior. The subsidiary is still under investigation and is set to go to trial over the allegations in May 2020.
Indivior has been accused of making misleading claims in its marketing materials and of running a program that was supposed to be a resource for people with opioid use disorder but was allegedly used to connect people with doctors who were known to prescribe Suboxone.
According to a statement by the Department of Justice, these doctors were prescribing the addiction treatment drug and other opioid-based medications “to more patients than allowed by federal law, at high doses, and in a careless and clinically unwarranted manner.”
Suboxone contains both buprenorphine, a low-intensity opioid that can treat or prevent opioid withdrawal symptoms without getting a patient high, and naloxone, which blocks opioid receptors in the brain and is commonly used to treat opioid overdoses. The naloxone in Suboxone is only activated if the tablets are crushed or dissolved for snorting or injecting the drug, which is meant to prevent its abuse.
In spite of this precaution, Suboxone still contains an opioid and can be abused, so it remains a controlled substance under the U.S. government.
Although Indivior is no longer a part of RB, the former parent company agreed to hand over $647 million in proceeds received from Indivior as well as paying $700 million in civil settlements across six states and to the federal government, plus an additional $50 million to the Federal Trade Commission.
Under the terms of the settlement, they will also refrain from manufacturing, marketing, or selling Schedule I, II, or III controlled substances in the U.S. for three years.
RB denied any wrongdoing in a statement but decided that taking the deal was the best option.
“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 reads.
Officials of states participating in the lawsuit are pleased by this result.
“This is a landmark moment in our fight to hold drug companies responsible for their role in the opioid crisis,” said Virginia Attorney General Mark Herring. “We will not allow anyone to put profits over people, or to exacerbate or exploit the opioid crisis for their own benefit.”