To resolve potential criminal liability stemming from conduct alleged in the indictment of a former subsidiary in the United States, RB Group will forfeit nearly one billion in proceeds and pay a further billion in settlements
Global consumer goods conglomerate Reckitt Benckiser Group (RB Group) has agreed to pay US$1.4 billion (AUD$2.06 billion) to resolve its potential criminal and civil liability related to a federal investigation of the marketing of the opioid addiction treatment drug Suboxone in the United States.
The resolution – the largest recovery by the US in a case concerning an opioid drug – includes the forfeiture of proceeds totalling US$647 million (AUD$954 million), civil settlements with the federal government and the states totalling $700 million (AUD$1.032 billion), and an administrative resolution with the Federal Trade Commission for $50 million (AUD$74 million).
Until December 2014, RB Group’s wholly owned subsidiary, Indivior (then known as Reckitt Benckiser Pharmaceuticals) marketed and sold Suboxone throughout the US, according to the US Department of Justice.
Suboxone is a drug product approved for use by people recovering from opioid addiction to avoid or reduce withdrawal symptoms while they undergo treatment.
In December 2014, RB Group “spun off” Indivior and the two companies are no longer affiliated.
On 9 April 2019, a federal grand jury indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone.
According to the indictment, Indivior—including during the time when it was a subsidiary of RB Group—promoted the film version of Suboxone (Suboxone Film) to pharmacists, doctors, Medicaid administrators and others across the US as less divertible, less abusable and safer around children, families and communities than other buprenorphine drugs, although such claims have never been established.
The indictment alleges that Indivior used its “Here to Help” internet and telephone program, a resource for opioid-addicted patients, in part to connect 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”.
It alleges that Indivior announced a “discontinuance” of its tablet form of Suboxone based on supposed “concerns regarding paediatric exposure” to tablets, despite Indivior executives’ knowledge that the primary reason for the discontinuance was to delay the Food and Drug Administration’s approval of generic tablet forms of the drug.
The indictment further alleges that Indivior’s scheme fraudulently converted thousands of opioid-addicted patients over to Suboxone Film, causing state Medicaid programs to expand and maintain coverage of Suboxone Film at substantial cost to the government.
Indivior is presumed innocent until proven guilty, the US Department of Justice emphasised.
The criminal trial is scheduled to begin on 11 May 2020, in the United States District Court in Abingdon, Virginia.
“We are confronting the deadliest drug crisis in our nation’s history. Opioid withdrawal is difficult, painful, and sometimes dangerous; people struggling to overcome addiction face challenges that can often seem insurmountable,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division.
“Drug manufacturers marketing products to help opioid addicts are expected to do so honestly and responsibly.”
To resolve its potential criminal liability stemming from the conduct alleged in the indictment of Indivior, RB Group has executed a non-prosecution agreement that requires the company to forfeit US$647 million (AUD$954 million) of proceeds it received from Indivior and not to manufacture, market, or sell Schedule I, II, or III controlled substances in the US for three years.
In addition, RB Group has agreed to cooperate fully with all investigations and prosecutions by the Department of Justice related in any way to Suboxone.
Under the civil settlement, RB Group has agreed to pay a total of US$700 million (AUD$1.032 billion) to resolve claims that the marketing of Suboxone caused false claims to be submitted to government health care programs.
The claims settled by the civil agreement are allegations only and there has been no determination of liability.
Under a separate agreement with the Federal Trade Commission (FTC), RB Group has agreed to pay US$50 million (AUD$74 million) to resolve claims that it engaged in unfair methods of competition in violation of the Federal Trade Commission Act.
The FTC is filing a complaint in the US District Court for the Western District of Virginia alleging anti-competitive activities by RB Group designed to impede competition from generic equivalents of Suboxone.
“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, RB Group allegedly sought to deny those consumers a lower-cost generic alternative to maintain its lucrative monopoly on the branded drug,” said Gail Levine, a Deputy Director of the FTC’s Bureau of Competition.