British drugmaker Indivior has been charged with felony fraud and conspiracy after marketing its opioid product as “less prone to abuse.” The allegations against the company included its drug Suboxone.
According to claims, Indivior created a “nationwide scheme” which was perpetrated against US consumers, as well as doctors and government insurance programs. The company worked to convince the medical and healthcare community that its opioid mediations were safer and less prone to abuse than any of the generic (less expensive) alternatives available.
According to federal prosecutors, the company cheated Medicare, Medicaid, and other health insurance providers out of billions of dollars by claiming its products were safer and more effective. It is also accused of failing to promote the drug accurately and implying it was safe despite being aware of risks.
The charges against Indivior stem from a joint investigation by the US Food and Drug Administration, Virginia’s state attorney general office, and several other agencies.
Indivior issued a statement calling the allegations against it contradictory to the government’s scientific agencies and denied any wrongdoing. It also stated it will continue to contest the 28 claims against it.
New Method of Delivery of Drug Marketed as Less Addictive
According to reports, Indivior began in 2007 to promote a new method of delivering Suboxone, its own a medication used to treat patients with opioid dependency. The promotion began just before sales of a generic version of the drug were set to begin.
The new method of delivery was a dissolvable film that would be placed under the tongue. Indivior billed it as “less abuse-able” and told the medical community it had fewer risks.
According to claims filed against Indivior, the company knew the new method of delivery it had developed was potentially more dangerous and more likely to be abused. It also knew there was a bigger risk for children to be exposed to the drug when used in this manner.
Additionally, the company also developed a program that connected people addicted to opioids with doctors who were known to prescribe Suboxone “in high doses” and under “suspect circumstances.”
Indivior claims it acted responsibly and believes itself to be a crucial component in the war against opioid addiction. It called the claims made by the Justice Department “wholly unsupported by either facts or the law.” Indivior attempted to negotiate a settlement prior to the DOJ filing charges.
If the company is found guilty they could face the forfeiture of at least $3 billion in penalties.
Drug Manufacturers Targeted for their Role in the Country’s Opioid Crisis
The charges against Indivior come at a time when more drug makers than ever are receiving attention for their role in the country’s opioid addiction epidemic. Other companies facing multiple civil lawsuits include Johnson & Johnson, Purdue Pharma, and CVS. All are linked to the assertion that the companies played a role in creating the opioid epidemic through their marketing or prescription painkillers and other similar medications.
Already, in 2007, Purdue Pharma and two of its execs pleaded guilty to charges and paid more than $600 million in fines after claims they marketed Oxycontin as less addictive than other drugs.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.