U.K. consumer goods company Reckitt Benckiser (RB) has agreed to pay $1.4 billion to end federal investigations into how it marketed an opioid addiction treatment drug by its former prescription pharmaceuticals business Indivior.
In an announcement, RB has reached agreements with the U.S. Department of Justice and the Federal Trade Commission to resolve the long-running investigation into the sales and marketing of Suboxone Film by Indivior. Indivior was charged by the U.S. Department of Justice with fraudulently claiming Suboxone Film was better and safer than similar drugs when it was not. Indivior was removed from the RB Group in 2014.
Suboxone Film, an opioid addiction treatment drug that dissolves under the tongue, is touted as an alternative to methadone injections.
Developed by RB Pharmaceuticals at the request of the National Institute on Drug Abuse, the drug was given expedited approvals by the FDA in recognition of its importance in the U.S. healthcare system, awarded orphan drug status, and launched in 2002.
This settlement will “fully resolve all federal investigations into RB in connection with the subject matter of the Indivior indictment and claims relating to state Medicaid programs for those states choosing to participate in the settlement,” according to an RB press release.
“Suboxone and its related products have helped millions of people return to a normal life,” according to RB reports. “Prior to Individor’s separation from RB, 5 million people were treated in the U.S. between 2003 and 2014 for opioid dependence.”
The resolution will also protect the RB Group’s participation in all U.S. government programs.
“While RB has acted lawfully at all times and expressly denies all allegations that it engaged in any wrongful conduct, the board of RB determined that the agreement is in the best interests of the company and its shareholders,” the press release said. “This is a non-criminal resolution and is on the basis that there is no admission of any violation of law or any wrongdoing by RB or any RB Group employee.”
Further, the hefty settlement, “avoids the costs, uncertainty, and distraction associated with continued investigations, litigation, and the potential for an indictment at a time of significant transformation under RB 2.0 and during CEO transition.”
New RB CEO Laxman Narasimhan, former PepsiCo chief commercial officer, will be appointed to the RB Board on July 16. He will succeed outgoing RB CEO Rakesh Kapoor.
The issue is of growing concern with national reports estimating that more than 55,000 Americans die each year from drug overdose, and this is the leading cause of death of people under age 50.
RB’s settlement is the largest by a drug company to date, followed by the $600 million paid in 2007 by Purdue Pharma, the maker of the opioid drug OxyContin.
Currently, there are numerous multi-million-dollar federal lawsuits pending against wholesale distributors and manufacturers of opioids.
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