Reckitt Benckiser to pay $1.4bn over opioid treatment sales
Reckitt Benckiser has agreed to pay a $1.4 billion fine to settle a US investigation into the sales and marketing of opioid addiction treatment Suboxone film (buprenorphine and naloxone) by its former prescriptions business.
Yesterday, July 11, the UK-based company said it had reached agreements with the US Department of Justice (DOJ) and the Federal Trade Commission (FTC) to resolve the long-running investigation.
The resolution is the largest recovery by the US in a case concerning an opioid drug and includes the forfeiture of proceeds totalling $647 million, civil settlements with the federal government and the states totalling $700 million, and an FTC settlement.
Reckitt agreed to pay $50 million to settle FTC charges that it violated the antitrust laws through a deceptive scheme to thwart lower-priced generic competition to Suboxone.
Suboxone, which was introduced in 2002, quickly became a mainstay of opioid addiction treatment, according to the FTC.
But, in 2009, Reckitt’s regulatory exclusivity for Suboxone was set to expire, and it expected to face competition from lower-cost generics.
Before the generic versions became available, Reckitt and its former subsidiary developed a dissolvable oral film version of Suboxone and worked to shift prescriptions to this patent-protected film, according to the FCT complaint.
The FTC added: “Worried that doctors and patients would not want to switch to Suboxone Film, Reckitt allegedly employed a ‘product hopping’ scheme where the company misrepresented that the film version of Suboxone was safer than Suboxone tablets because children are less likely to be accidentally exposed to the film product.”
Reckitt then allegedly filed a citizen petition with the Food and Drug Administration (FDA) reciting the unsupported safety claims and requesting that the agency reject any generic tablet application.
According to the FTC, this petition was intended to delay the approval of generic competitors while the FDA reviewed it.
Gail Levine, a deputy director of the FTC’s Bureau of Competition, said: “Buprenorphine products are approved for use in the treatment of Americans struggling to overcome opioid addiction, and, in the middle of the nation’s opioid crisis, Reckitt allegedly sought to deny those consumers a lower-cost generic alternative to maintain its lucrative monopoly on the branded drug.”
The FTC settlement is part of the broader government settlement with Reckitt, which resolves criminal and civil fraud claims by the US Department of Justice (DoJ).
In April 2019, a grand jury sitting in Virginia, indicted Reckitt’s former subsidiary Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone. The criminal trial against Indivior is scheduled to begin on May 11, 2020.
According to the indictment of Indivior, the subsidiary promoted the film version of Suboxone Film across the country as less-divertible and less-abusable and safer around children, families, and communities than other buprenorphine drugs.
It also allegedly referred patients to doctors it knew were “prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in a careless and clinically unwarranted manner”.
To resolve its potential criminal liability, Reckitt has executed a non-prosecution agreement that requires it to forfeit $647 million of proceeds it received from Indivior.
Under the civil settlement, Reckitt has agreed to pay a total of $700 million to resolve claims that the marketing of Suboxone caused false claims to be submitted to government health care programmes.
Reckitt said that it had acted lawfully at all times and expressly denied all allegations that it engaged in any wrongful conduct, but that after consideration determined that the agreement was in the best interests of the company and its shareholders.
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