ABINGDON, Va. — Federal authorities on Thursday announced a $1.4 billion settlement with the former marketers of Suboxone, a powerful opioid treatment drug.
Reckitt Benckiser Group, also known as RB Group, agreed to pay $1.4 billion to resolve its potential criminal and civil liability related to a federal investigation into the marketing of the opioid addiction treatment drug, according to a news release.
The resolution — the largest recovery in a case concerning an opioid drug — includes the forfeiture of $647 million of proceeds, civil settlements with the federal government and the states totaling $700 million and a $50 million administrative resolution with the Federal Trade Commission.
Suboxone is a drug approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids.
“The opioid epidemic continues to be a serious crisis for our nation, and I’m proud of the work the Department of Justice and our partners are doing to address this epidemic,” Principal Deputy Associate Attorney General Claire Murray said in the statement.
Until December 2014, RB Group’s wholly owned subsidiary, Indivior Inc. [then known as Reckitt Benckiser Pharmaceuticals Inc.] marketed and sold Suboxone. In December 2014, RB Group spun off Indivior Inc., and the two companies are no longer affiliated.
The criminal trial against Indivior is scheduled to begin on May 11, 2020, in U.S. District Court in Abingdon. On April 9, a federal grand jury in Abingdon indicted Indivior on charges of engaging in an illicit nationwide scheme to increase prescriptions of Suboxone.
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 $647 million it received from Indivior and not to manufacture, market or sell Schedule I, II, or III controlled substances in the U.S. 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, according to the statement.
According to the indictment, Indivior — including during the time when it was a subsidiary of RB Group — promoted the film version of Suboxone to physicians, pharmacists, Medicaid administrators and others across the country as less-divertible, less likely to be abused and safer around children and families than other buprenorphine drugs, even though such claims have never been established.
The indictment further accuses Indivior of touting its “Here to Help” internet and telephone program as a resource for opioid-addicted patients. Instead, Indivior used the program, 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.
The indictment states that Indivior’s scheme was highly successful, fraudulently converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programs to expand and maintain coverage of Suboxone Film, at substantial cost to the government.
“This is a landmark moment in our fight to hold drug companies responsible for their role in the opioid crisis,” Virginia Attorney General Herring said in a separate statement. “We will not allow anyone to put profits over people or to exacerbate or exploit the opioid crisis for their own benefit.”
Herring’s Medicaid Fraud Control Unit led a complex, multi-year investigation into allegations of illegal marketing of Suboxone, according to the statement.
Under the civil settlement, RB Group agreed to pay $700 million to resolve claims that Suboxone marketing caused false claims to be submitted to government health care programs. The $700 million settlement includes $500 million to the federal government and up to $200 million to states that opt to participate in the agreement. The claims settled by the civil agreement are allegations only and there has been no determination of liability.
The civil settlement addresses allegations that RB Group promoted the sale and use of Suboxone to physicians who were writing prescriptions without any counseling or psychosocial support and for uses that were unsafe, ineffective and medically unnecessary and were often diverted for uses lacking a legitimate medical purpose, according to the statement.
The civil settlement also resolves the claims against RB Group in six lawsuits pending in federal court in the Western District of Virginia and the District of New Jersey under the whistleblower provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the U.S. and share in any recovery.
Under a separate agreement with the Federal Trade Commission, RB Group agreed to pay $50 million to resolve claims that it engaged in unfair methods of competition. The FTC is filing a complaint in U.S. District Court for the Western District of Virginia claiming that anticompetitive activities by RB Group designed to impede competition from generic equivalents of Suboxone. RB Group no longer manufactures or markets drug products, the release states.