By Corrine Fizer
Indivior, formerly known as Reckitt Benckiser Pharmaceuticals, has been accused of engaging in an illicit nationwide scheme to increase prescriptions of Suboxone Film, a drug used in the treatment of opioid addiction.
The company was criminally indicted in U.S. District Court in Abingdon, Virginia, after state Attorney General Mark Herring’s Medicaid Fraud Unit and federal authorities investigated Indivior and filed a civil lawsuit.
According to the indictment, Indivior “illegally obtained billions of dollars in revenue” from prescriptions by deceiving health care providers and benefit programs into believing that Suboxone Film was safer and less likely to be abused than similar opioid-addiction treatment drugs on the market.
The indictment said 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 primary ingredient in both Suboxone Film and tablets is buprenorphine, a highly potent opioid.
The British-owned company, headquartered in Richmond, marketed Suboxone Film as having a “lower risk of child exposure” and a “less divertible/abusable formulation,” the indictment said, “though there were no scientific studies to establish these claims.”
It said Indivior made false and misleading claims in marketing materials and through representations to physicians, pharmacists and health care benefit programs throughout the country.
The indictment also alleges that Indivior announced it was discontinuing its tablet form of Suboxone based on supposed “concerns regarding pediatric exposure to” tablets. In fact, government officials said, Indivior executives knew the primary reason for the discontinuance was to delay the Food and Drug Administration’s approval of generic tablet forms of the drug.
Indivior also allegedly increased its 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 “careless and clinically unwarranted manner.”
In the indictment, the government is seeking a monetary judgment of at least $3 billion.
Responding to the indictment, Indivior officials issued a statement denying any wrongdoing.
“We are extremely disappointed in this action by the Justice Department, which is wholly unsupported by either the facts or the law,” the company said.
“Key allegations made by the Justice Department are contradicted by the government’s own scientific agencies, they are almost exclusively based on years-old events from before Indivior became an independent company in 2014, and they are wrong.”
Herring and 35 other attorneys general previously filed a civil lawsuit against Indivior, accusing the company of keeping Suboxone prices high by “product hopping,” which refers to the pharmaceutical practice of switching patients from an older drug to a newer version of the same drug. The civil suit, which is ongoing, is separate from the criminal charges announced Tuesday.
“It’s incredibly frustrating that while we have been working to remove the stigma around medication-assisted treatment and make it more widely available, Indivior was allegedly conspiring to exploit patients, taxpayers and the expansion of MAT,” Herring said in a statement.
“My team and I are proud to have helped lead this investigation, and look forward to helping bring it to a just and fair conclusion.”
A federal grand jury indicted Indivior on charges of 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.