U.S. indicts Indivior over Suboxone opioid treatment marketing

[April 10, 2019]  By Nate Raymond

(Reuters) - The U.S. Justice Department announced on Tuesday 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 healthcare benefit programs into believing the film version of Suboxone was safer and less susceptible to abuse than similar drugs.

The department brought the case amid the U.S. opioid addiction epidemic, which has killed tens of thousands of people annually.

The indictment charged Indivior and its subsidiary Indivior Inc with conspiracy, health care fraud, mail fraud and wire fraud. If Indivior is convicted, the government will seek to have it forfeit at least $3 billion, the indictment said.

Slough, England-based Indivior said in a statement 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."

Indivior had before the indictment 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 drug.
 

The indictment said the scheme began before Indivior spun out of Reckitt Benckiser in 2014. Reckitt, which was not charged and was referred to as "Company A," did not respond to requests for comment.

The indictment said Indivior Inc, then called Reckitt Benckiser Pharmaceuticals 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 after the FDA approved the film version in 2010, Indivior promoted it 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 Nate Raymond in Boston; Additional reporting by Eric Beech in Washington; Editing by James Dalgleish and Peter Cooney)

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