The makers of the opioid addiction treatment Suboxone have agreed to pay $300 million to settle allegations raised by several states, claiming Indivior falsely advertised the drug as safer and less prone to abuse than it actually is.
Last year, Indivior reached a $600 million settlement with the federal government over charges of aggressive and deceptive marketing. On Tuesday, the manufacturer agreed to pay another $300 million in a state settlement (PDF), which will be split among all 50 states and the District of Columbia, according to a press release by California Attorney General Rob Bonta.
The states’ attorneys general alleged that Indivior improperly used Medicaid funds, due to its advertising techniques, which deceived regulators and the medical community about Suboxone’s safety.
Suboxone (buprenorphine and naloxone) is a drug approved to treat recovering opioid addicts; helping them avoid withdrawal symptoms while they undergo therapy to help them break their addiction. However, the federal government and the states say Indivior, formerly known as Reckitt Benckiser Group, PLC, promoted the sale of Suboxone to doctors they knew lacked legitimate medical use for the drug, and prescribed it to patients without other accompanying treatment, like counseling.
One of the active ingredients, buprenorphine, is a powerful opioid in its own right, making Suboxone a vector of abuse by opioid addicts.
The allegations also indicate Indivior falsely claimed the Suboxone Sublingual Film, the typical way the drug is distributed, was more resistant to abuse and less likely to be accidentally exposed to children than the drug in its pill form. The film is placed under the tongue to dissolve, which critics say is just as easy, if not easier, to abuse and be accidentally ingested by children.
The states and federal government also claim the manufacturer submitted a fraudulent petition to the FDA in September 2012, which claimed the Suboxone Tablet had to be discontinued due to safety concerns. However, they say that, in actuality, the manufacturer sought to control supply and improperly inflate Suboxone pricing, including what state Medicaid programs paid for it.
“Doctors and the public should be able to trust that what a company says their product can do is the truth, especially when the company claims it can be used during the treatment of something as serious as opioid addiction,” Attorney General Bonta said in the press release. “Today’s settlement should send a message that false marketing and improper use of California’s Medicaid dollars will have costly consequences.”
In 2019, Reckitt Benckiser Pharmaceuticals reached a $700 million settlement with the federal government and states over Suboxone Medicaid fraud allegations. Indivior spun off from the company shortly afterwards and reached the $600 million agreement with the Justice Department last year.
In a statement released in response to Attorney General Bonta’s press release, Indivior notes that the $300 million is coming from that $600 million agreement it made with the Justice Department last year, and does not constitute a commitment to pay additional money to resolve that settlement.
“The various state settlement agreements being announced this week are administrative in nature, and simply formalize the individual state settlements which were previously agreed to in principle as part of the July 2020 criminal and civil resolution between Indivior and the states (and the federal government). As such, there is no new financial or legal obligation that has arisen,” the company’s statement reads. “The Company was pleased to put those issues behind it in 2020 and remains focused on realizing its patient-focused Vision and fulfilling its compliance commitments.”
The company said it will have no further comments on the settlement agreement.