Legal, Opioids

In combat mode, Indivior hunkers down for a war with DoJ over multibillion-dollar fraud charges

In the latest legal saga surrounding the US opioid epidemic, Indivior and the Department of Justice have exchanged their first round of shots on allegations that the UK drugmaker pocketed billions through fraudulent marketing of its opioid addiction treatment.

Howard Pien

The grand jury indictment, accompanied by a strongly worded statement, eviscerated its stock price on the London Stock Exchange (£36.4 at last check, down 65%). Having lost millions in market value — and facing $3 billion in demanded fines — Indivior has not conceded an inch, calling the DoJ “fundamentally wrong” and vowing to “contest charges vigorously.”

At the core of the indictment is an alleged scheme in which Indivior deceived healthcare providers about the effects of the Suboxone film on one hand, and lured patients into getting prescriptions for the drug on the other. The indictment states that Indivior promoted Suboxone Film as safer and less abusable than its tablet form, “even though the company lacked any scientific evidence to support those claims”; used a “Here to Help” hotline to direct patients to doctors that it knew were prescribing Suboxone Film in a “careless and clinically unwarranted manner;” and even announced it would discontinue the Suboxone tablet with the purported purpose of delaying generic entry.

“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,” principal deputy associate attorney general Jesse Panuccio said in the statement.

Indivior began its four-page defense by distancing itself from pain pill makers, which it subtly points to as the real contributors to the opioid crisis. Board chairman Howard Pien also cited CDC research that it says demonstrate Suboxone Film did reduce pediatric exposure, as well as cases where company representatives educated doctors and reported risky prescribers to the authorities.

In short:

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. The department has apparently decided it would rather pursue self-serving headlines on a matter of national significance than achieve an appropriate resolution, but we will contest this case vigorously and we look forward to the full facts coming out in court.

Indivior was spun out of Reckitt Benckiser in 2014 and has spent much of the last five years battling generic rivals encircling Suboxone. The FDA has recently approved what the company hopes will be a blockbuster replacement: Sublocade, a once-monthly injection of buprenorphine.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
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Atlas Venture Cambridge, MA

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