(Reuters) – The U.S. Justice Department on Tuesday announced the indictment of Indivior Plc and a subsidiary on charges they engaged in an illegal scheme to boost prescriptions of the film version of its opioid addiction treatment Suboxone.
An indictment filed in federal court in Abingdon, Virginia, alleged Indivior made billions of dollars by deceiving doctors and health care benefit programs into believing the film version of Suboxone was safer and less susceptible to abuse than similar drugs.
The case marked the first time the Justice Department had brought criminal charges against a publicly traded drugmaker related to the U.S. opioid addiction epidemic, which has killed tens of thousands of people each year.
The indictment charged Indivior and its subsidiary Indivior Inc with conspiracy, health care fraud, mail fraud and wire fraud.
Slough, England-based Indivior in a statement said it was “extremely disappointed” by the department’s decision to charge it. Indivior called the indictment “wholly unsupported by either the facts or the law.”
Prior to the indictment, Indivior had been in settlement talks with the department. It had set aside $438 million to cover legal matters, most of which related to the probe.
“The department has apparently decided it would rather pursue self-serving headlines on a matter of national significance than achieve an appropriate resolution,” Indivior said.
Suboxone film is a U.S. Food and Drug Administration-approved opioid used by people recovering from opioid dependency. The indictment said Indivior’s scheme led to thousands of opioid-addicted patients using the film version.
The indictment said the scheme began when Indivior Inc was owned by Reckitt Benckiser Group PLC. The indictment referred to Reckitt, which spun out Indivior in 2014, as “Company A.”
Reckitt, which was not charged, did not respond to a request for comment.
The indictment said Indivior Inc developed the film version of Suboxone as a period of marketing exclusivity granted by the FDA for the tablet form of the drug was coming to an end, opening it up to generic competition.
The indictment said Indivior, then called Reckitt Benckiser Pharmaceuticals Inc, promoted the film version as safer and less able to be diverted for improper purposes than its tablet form despite a lack of scientific evidence supporting those claims.
The department said Indivior also sought to boost profits using a program called “Here to Help” that connected patients addicted to opioids to doctors Indivior knew were prescribing painkillers at high rates and in “suspect” circumstances.
The case is U.S. v. Indivior Inc, et al, U.S. District Court, Western District of Virginia, No. 19-cr-00016.
Reporting by Eric Beech; Editing by David Alexander and James Dalgleish