Accusing the company of engaging in an illicit nationwide scheme to increase prescriptions for profits, a federal grand jury in Abingdon, Virginia, has indicted Indivior, the manufacturer of Suboxone film, an opioid used to treat opioid addiction.
The U.S. Department of Justice said Tuesday the grand jury indicted Indivior Inc., formerly known as Reckitt Benckiser Pharmaceuticals, a company that had sales of about $1 billion in 2018, primarily from Suboxone film.
The indictment charges Indivior with conspiracy to commit wire fraud, mail fraud and health care fraud. In addition, the indictment charges the company with one count of health care fraud, four counts of mail fraud and 22 counts of wire fraud.
According to the indictment, Indivior obtained revenue from the Suboxone film prescriptions by deceiving health care providers and health care benefit programs into believing they are safer, less divertible and less abusable than other opioid-addiction treatment drugs.
The indictment also claims the company sought to boost profits by using a “Here to Help” program to connect opioid-addicted patients to doctors the company knew were prescribing opioids at high rates and in a clinically unwarranted manner.
“We are extremely disappointed in this action by the Justice Department, which is wholly unsupported by either the facts or the law,” the company, which is currently based in the U.K., said Tuesday.
Indivior said key allegations made by the Department of Justice are contradicted by the government’s own scientific agencies, based on years-old events from before Indivior became an independent company in 2014, and “they are wrong.”
The company said it will contest the case vigorously and looks forward to the full facts coming out in court.
The deadly opioid epidemic continues to devastate communities and families across the country, said Principal Deputy Associated Attorney General Jesse Panuccio with the Department of Justice.
“The Department of Justice intends to hold accountable those who are in position to know the harm opioid abuse inflicts but instead choose to profit illegally from the pain of others,” Panuccio said. “Manufacturers, distributors, pharmacies and doctors should all be on notice that they must follow the law and act responsibly.”
Rather than marketing the opioid-addiction drug responsibly, Assistant Attorney General Jody Hunt said the company “promoted it with a disregard for the truth about its safety and despite known risks of diversion and abuse.”
Indivior developed Suboxone film around 2007 as a patent-protected alternative to the tablet form of Suboxone, which was then about to face generic drug competition, the indictment states. The indictment says buprenorphine, a highly potent opioid, is the primary ingredient in the film and tablets.
The company promoted the film as a safer alternative to the tablet form, “even though the company lacked any scientific evidence to support those claims,” the indictment states. The company made the claims in marketing materials and through representations to physicians, pharmacists and health care benefit programs throughout the country, the indictment adds.
The indictment also claims that the company’s “Here to Help” program connected individuals with doctors who were issuing prescriptions “in a careless and clinically unwarranted manner.”
The scheme, the indictment claims, converted thousands of patients over to Suboxone film and caused state Medicaid programs to expand and maintain coverage at substantial costs to the government.
Recently, Indivior lost in court when it tried to stop companies from producing and selling generic Suboxone film.
“As this case makes clear, our office will aggressively prosecute health care fraud cases and particularly those that target people struggling with opioid addiction,” said First Assistant U.S. Attorney Daniel P. Bubar of the Western District of Virginia.
A number of state and federal agencies, including the Food and Drug Administration, have investigated.
Virginia Attorney General Mark Herring said the indictment alleges a “truly shameful scheme to put profits over the health and well-being of patients.”