Federal prosecutors late Tuesday charged British drugmaker Indivior with felony fraud and conspiracy for its marketing of opioid products including Suboxone. The company allegedly created a "nationwide scheme" in the U.S. designed to convince doctors and government insurance providers that Indivior's patented opioid medications are safer and less prone to abuse than cheaper generic alternatives.
"The indictment alleges that, rather than marketing its opioid-addiction drug responsibly, Indivior promoted it with a disregard for the truth about its safety and despite known risks of diversion and abuse," said Assistant Attorney General Jody Hunt in a statement.
Federal prosecutors claim Indivior bilked Medicare, Medicaid and other health care providers out of billions of dollars as they paid for a more expensive version of the drug, believing it to be safer. The criminal charges, filed in the western district of Virginia, stem from a joint investigation that included the U.S. Food and Drug Administration, Virginia's state attorney general office, and other agencies.
The company issued a statement denying any wrongdoing. "Key allegations made by the Justice Department are contradicted by the government's own scientific agencies," Indivior said on Tuesday, adding that the firm "will contest this case vigorously and we look forward to the full facts coming out in court."
At the heart of the 28-count indictment is Indivior's effort, beginning in 2007, to popularize a new method of delivering its Suboxone medication, which is used to treat patients suffering from opioid dependency. With a cheaper generic tablet form of the drug expected to go on sale, the company developed a dissolvable film that could be placed under the tongue, describing the new delivery system as "less abusable" with a "lower risk."
Prosecutors now say the company knew the dissolvable film version of Suboxone was potentially more dangerous, more susceptible to abuse, and included a higher risk that children might be exposed to the drug. The firm also developed a program that allegedly connected opioid-dependent patients with doctors who prescribed Suboxone "in high doses and in suspect circumstances."
Federal prosecutors say if Indivior is found guilty, the company should forfeit at least $3 billion in penalties. In its response, Indivior said the company acted responsibly and has played a crucial role responding to the deadly opioid epidemic. The firm also says it tried to negotiate a settlement before the charges were filed.
"We are extremely disappointed in this action by the Justice Department, which is wholly unsupported by either the facts or the law," Indivior's statement said.
This indictment marks an escalation in what has already emerged as a dangerous year for major drugmakers and distributors entangled in the opioid crisis. According to the U.S. Centers for Disease Control and Prevention, prescription opioid overdoses have killed more than 200,000 Americans over the last 20 years.
Companies including Purdue Pharma, Johnson & Johnson and CVS face a wave of civil lawsuits in state courts around the country. They stem from claims that Big Pharma accelerated the opioid crisis by aggressively marketing prescription painkillers and other opioid medications. The next major trial is set to begin next month in Oklahoma.
Federal prosecutors have successfully pursued criminal charges against opioid manufacturers in the past. In 2007, Purdue Pharma and three of its executives pleaded guilty and paid more than $600 million in fines and other charges after the company falsely claimed its Oxycontin medication was less addictive than other opioid painkillers.