Attorney General Curtis Hill announced last week that Indiana and other states have reached an agreement with the pharmaceutical distributor Reckitt Benckiser Group (“Reckitt”) to settle allegations that the company improperly marketed or otherwise promoted the drug Suboxone. The company’s actions allegedly resulted in improper expenditures of state Medicaid funds.
Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids.
Reckitt is an English public limited company headquartered in Slough, England, in the United Kingdom. Until Dec. 23, 2014, Reckitt’s wholly-owned subsidiary Indivior Inc. distributed, marketed and sold Suboxone Sublingual Tablets and Suboxone Sublingual Film in the United States. At that time, Indivior Inc. was known as Reckitt Benckiser Pharmaceuticals Inc. In December of 2014, Reckitt spun off Indivior Inc.
The settlement described in this statement is with Reckitt alone. Reckitt has paid $700 million to resolve various civil fraud allegations impacting Medicaid and other government healthcare programs, of which more than $400 million will go to Medicaid programs. As part of the settlement, Indiana Medicaid will receive $9,524,657.87 in restitution and other recovery.
The civil settlement resolves allegations that, from 2010 through 2014, Reckitt, directly or through its subsidiaries, knowingly:
- promoted the sale and use of Suboxone to physicians who were writing prescriptions: 1) to patients without any counseling or psychosocial support, such that the prescriptions were not for a medically accepted indication and 2) for uses that were unsafe, ineffective, and medically unnecessary and that were often diverted for uses that lacked a legitimate medical purpose;
- promoted the sale or use of Suboxone Sublingual Film based on false and misleading claims that Suboxone Sublingual Film was less subject to diversion and abuse than other buprenorphine products and that Suboxone Sublingual Film was less susceptible to accidental pediatric exposure than Suboxone Sublingual Tablets;
- submitted a petition to the U.S. Food and Drug Administration on Sept. 25, 2012, fraudulently claiming that it had discontinued manufacturing and selling Suboxone Sublingual Tablets “due to safety concerns” about the tablet formulation of the drug; and
- took other steps to fraudulently delay the entry of generic competition for various forms of Suboxone in order to improperly control pricing of Suboxone, including pricing to federal healthcare programs.
The civil settlement resolves the claims against Reckitt brought in six qui tam lawsuits pending in federal courts in the Western District of Virginia and the District of New Jersey. To resolve its potential criminal liability stemming from conduct alleged in the indictment of Indivior, Inc., Reckitt has entered into a separate non-prosecution agreement.
“When companies engage in unfair, abusive and deceptive practices that cause harm to Hoosiers, we must hold them accountable for their misconduct,” Attorney General Hill said. “Settlements such as this one are aimed at doing just that.”
A National Association of Medicaid Fraud Control Units (“NAMFCU”) team participated in the investigation and in settlement negotiations. The team included representatives from the offices of the attorneys general for the states of California, Indiana, New York, Ohio, Virginia and Washington.