DOJ Accuses Indivior Of Illegally Marketing Suboxone Film

By Paul Gaita 04/15/19

The drug company is accused of promoting its sublingual film strips as safer and less abusable than other opioid treatment drugs.

Indivior execs discussing suboxone film

A British pharmaceutical company was indicted by the U.S. Department of Justice (DOJ) on charges of fraud involving its Suboxone film medication, which is used to treat opioid dependency.

The DOJ alleged that Indivior reaped "billions of dollars in revenue" by engaging in an "illicit nationwide scheme" to promote its sublingual film strips as safer and less abusable than other opioid treatment drugs, and further sought to boost profits with a helpline for prospective patients that allegedly diverted them to physicians that prescribed Suboxone. 

Indivior refuted the charges in an eight-page rebuttal, but were unable to stop their stock from dropping by 71% after the DOJ issued its indictment on April 9.

Indivior developed its Suboxone film strips in 2007 as an alternative to the tablet form of the drug, which was facing competition from generic products. Both the tablet and the film strips contain buprenorphine, an opioid used in medication-assisted treatment (MAT) for opioid dependency, and itself a highly addictive drug.

The DOJ alleged that Indivior marketed its Suboxone film as safer and less-divertable than the tablet modality, and "aggressively marketed" the film as having a "lower risk of child exposure," despite lacking any scientific evidence to support those claims. 

Prosecutors found that the film strips could actually be more hazardous to children, due to their fast dissolution when placed under the tongue and formulation that made them "taste better." The DOJ also claimed that Indivior lied when it announced the end of production for Suboxone tablets in 2012 due to "concerns regarding pediatric exposure," when, as the indictment noted, the real reason was to delay the Food and Drug Administration's approval of generic forms of Suboxone.

Additionally, the indictment alleged that Indivior diverted more patients to its film strips through an internet and telephone resource program. The "Here to Help" line connected opioid-dependent patients to doctors that it knew were prescribing Suboxone and other opioids at an amount and dosage greater than allowed by federal law, and in some cases, under suspect circumstances.

The alleged scheme proved successful for Indivior, which saw sales of Suboxone Film strips jump from $83 million in 2010 to $843 million in 2014, according to the DOJ indictment.

Thousands of patients reportedly switched prescriptions to Suboxone film as a result of the company's allegedly fraudulent promotion, and state Medicaid programs expanded and maintained coverage of Suboxone film at a "substantial" cost to the U.S. government.

The DOJ indictment charged Indivior with one count of health care fraud, four counts of mail fraud and 22 counts of wire fraud, as well as conspiracy to commit all three aforementioned charges. The indictment is only an allegation, and all defendants are presumed innocent until proven guilty beyond a reasonable doubt.

In a statement, Indivior chairman wrote that his company "conducts more research into opioid addiction than any other company, and the products it has brought to market have helped millions of people struggling with opioid addiction." He added that he was surprised that the DOJ would indict a company for claims that "the government's own researchers believe are true." 

The news of the indictment sent Indivior's stock price sliding from $100 a share to approximately $30 a share on April 10.

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, and The Los Angeles Beat, among many other publications and websites.