Pharmaceutical distributor Reckitt pays $9.5 million to settle allegations

(Photo Supplied/Indiana Attorney General)

INDIANAPOLIS, Ind. (WOWO) – Indiana Attorney General Curtis Hill announced that Indiana and other states reached an agreement with pharmaceutical distributor Reckitt Benckiser Group to settle allegations of improper marketing of the drug Suboxone by the company.

Suboxone is a drug that has been approved to use for recovering opioid addicts to help reduce withdrawal symptoms while undergoing treatment.  However, Suboxone and its active ingredient, buprenorphine, are also powerful and addictive opioids.

The English public limited company is headquartered in Slough, England.  Reckitt’s wholly-owned subsidiary Indivior Inc. distributed, marketed and sold Suboxone Sublingual Tablets and Suboxone Sublingual Film in the United States until December 23, 2014.  Indivior Inc. was known as Reckitt Benckiser Pharmaceuticvals Inc. at that time. Reckitt spun off Indivior Inc. in December of 2014.

The settlement is just with Reckitt.  Reckitt has paid $700 million to resolve several civil fraud allegations that impact Medicaid and other government healthcare programs.  More than $400 million of that money will go to Medicaid programs.  Indiana Medicaid will receive $9,524,657.87 of that money for restitution and other recovery.

The civil settlement resolves allegations that, from 2010 through 2014, Reckitt, directly or through its subsidiaries, knowingly:

  • Promoted the use and sale of Suboxone to physicians who were writing prescriptions to patients without any counseling or psychosocial support, such that the prescriptions were not for a medically accepted reason. Also for uses that were ineffective, unsafe, and medically unnecessary and were many times were diverted for uses that were not for a legitimate medical purpose.
  • Promoted the use or sale of Suboxone Sublingual Film based on false and misleading claims that Suboxone Sublingual Film was less subject to diversion and abuse that 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 September 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.
  • Took other steps to fraudulently delay the entry of generic competition for various forms of Suboxone in order to improperly control the pricing of Suboxone, including pricing to federal healthcare programs.

This 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.  Reckitt has entered into a separate non-prosecution agreement to resolve its potential criminal liability stemming from the conduct alleged in the indictment of Indivior, Inc.

Attorney General Curtis Hill said “When companies engage in unfair, abusive and deceptive practices that cause harm to Hoosiers, we must hold them accountable for their misconduct.  Settlements such as this one are aimed at doing just that.”

A team from the National Association of Medicaid Fraud Control Units participated in the investigation and in the settlement negotiations.  Representatives from the offices of the attorneys general for the states of California, Indiana, New York, Ohio, Virginia, and Washington were included in the team.

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