Reckitt Benckiser Settles Suboxone Marketing Cases for $1.4 Billion
The Virginia U.S. Attorney says Reckitt Benckiser has agreed to pay $1.4 billion to resolve potential civil and criminal liability relating to marketing of its opioid addiction treatment drug Suboxone. A news release says the resolution is the largest recovery by the federal government in an opioid drug case.
The release says that until 12/2014, Reckitt Benckiser’s Indivior subsidiary (then known as Reckitt Benckiser Pharmaceuticals) marketed and sold Suboxone throughout the U.S. Indivior was spun off by Benckiser 12/2014. Earlier this year, a Virginia federal grand jury indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase Suboxone prescriptions. A criminal trial against Indivior was due to open 5/11/20.
To resolve the potential criminal liability stemming from the conduct alleged in the indictment of Indivior, the release says, Reckitt Benckiser has executed a non-prosecution agreement that requires the company to forfeit $647 million of proceeds it received from Indivior and not to manufacture, market, or sell Schedule 1, 2, or 3 controlled substances in the U.S. for three years. The parent company also has agreed to cooperate fully with all investigations and prosecution by the Justice Department related in any way to Suboxone.
Under a related civil settlement, Benckiser has agreed to pay $700 million to resolve claims that the marketing of Suboxone caused false claims to be submitted to government healthcare programs. Of the $700 million, $500 million will go to the federal government and up to $200 million to states that opt to participate in the agreement. The government has alleged that the company knowingly (1) promoted the sale and use of Suboxone to doctors who were writing prescriptions without any counseling or psychosocial support and for uses that were unsafe, ineffective, and medically unnecessary and that were often diverted for uses that lacked a legitimate medical purpose; (2) promoted the sale or use of Suboxone film to doctors and state Medicaid agencies using false and misleading claims that it was less susceptible to diversion and abuse than other buprenorphine products and was less susceptible to accidental pediatric exposure than tablets; and (3) submitted a 9/25/12 petition to FDA claiming that Suboxone tablet had been discontinued due to safety concerns about the tablet formulation of the drug and took other steps to delay the entry of generic competition for Suboxone to improperly control the drug’s pricing, including pricing to federal healthcare programs. The civil settlement resolves six whistleblower suits pending in Virginia and New Jersey federal courts.
Under a separate agreement with the Federal Trade Commission, Benckiser will pay $50 million to resolve claims that it engaged in unfair methods of competition to impede competition from generic forms of Suboxone.