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Tuesday, June 30, 2020

Opioid Manufacturer Indivior’s Chief Executive Officer Pleads Guilty In Connection With Drug Safety Claims

The chief executive officer of Indivior PLC, Shaun Thaxter, pleaded guilty today in federal court in Abingdon, Virginia to a one-count information charging him with causing the introduction into interstate commerce of the opioid drug Suboxone Film, which was misbranded in violation of the Federal Food, Drug, and Cosmetic Act. 

Thaxter served as Indivior’s top executive since 2009 (including the time period prior to December 2014 when Indivior was known as Reckitt Benckiser Pharmaceuticals).  Indivior announced yesterday that Thaxter is stepping down as chief executive officer.  When Indivior was known as Reckitt Benckiser Pharmaceuticals it was  a subsidiary of British conglomerate Reckitt Benckiser Group (RB Group).  RB Group paid $1.4 billion in 2019 to resolve its liability to the United States and various states related to the marketing of Suboxone.

Suboxone Film 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.  Thaxter was charged in connection with  Indivior’s misrepresentations to a state Medicaid program regarding the safety of Suboxone Film. 

“Our nation is confronting the deadliest drug crisis in American history. Opioid withdrawal is dangerous, difficult, and painful, and the people struggling to overcome addiction face challenges that can often seem insurmountable,” said Deputy Assistant Attorney General Michael D. Granston of the Department of Justice’s Civil Division.  “Opioid manufacturers, and the individuals charged with managing them, are obligated to ensure the opioid drugs they sell are marketed and distributed honestly, responsibly, and in compliance with the law.”

“The public must be able to trust pharmaceutical manufacturers and their executives—particularly when they are marketing powerful opioids,” said First Assistant U.S. Attorney Daniel P. Bubar of the Western District of Virginia.  “While he was the top executive of Indivior, Shaun Thaxter violated that trust, and must be held accountable.  I am very proud of the continued partnership between our office and the Virginia Medicaid Fraud Control Unit, FDA, HHS, and the U.S. Postal Service.”

According to the criminal information filed in court today, Thaxter had authority over Indivior’s marketing and sales of Suboxone Film which, along with other Suboxone products, generated substantially all of the company’s revenue.  In 2012, Thaxter oversaw and encouraged Indivior’s efforts to secure formulary coverage for Suboxone Film from the Massachusetts Medicaid agency called MassHealth.  Thaxter asked Indivior employees under his direction to devise a strategy to win preferred drug status for Suboxone Film and counteract a non-opioid competitor MassHealth was considering for opioid-addiction treatment.  Certain Indivior employees subsequently shared false and misleading safety information with MassHealth officials about Suboxone Film’s risk of accidental pediatric exposure.  Two months after receiving that false and misleading information, MassHealth announced it would provide access to Suboxone Film for Medicaid patients with children under the age of six.

Thaxter pleaded guilty to a misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act by causing the distribution of misbranded Suboxone Film in interstate commerce.  Under the terms of the plea agreement filed today, Thaxter has agreed to pay $600,000 in fines and forfeiture and faces up to one year in prison.  Thaxter will be sentenced on Sept. 29, 2020,  by U.S. District Court Judge James P. Jones in Abingdon, Virginia.

“Opioid addiction and abuse is an immense public health crisis and taking steps to address it is one of the FDA’s highest priorities,” said FDA Commissioner Stephen M. Hahn, M.D. “Providing misleading information about relative product benefits could undermine efforts to provide affordable treatment to those suffering from this crisis.  We will continue to work with the Department of Justice to investigate and hold accountable those who devise and participate in schemes to the detriment of the public health.”

On April 9, 2019, a federal grand jury sitting in Abingdon, Virginia, indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone.  The United States’ criminal trial against Indivior is scheduled to begin on September 28, 2020, in the U.S. District Court in Abingdon, Virginia.  Indivior is presumed innocent until proven guilty.

The criminal cases against Thaxter and Indivior are being prosecuted by attorneys from the U.S. Attorney’s Office for the Western District of Virginia and the Department of Justice’s Civil Division, including Albert P. Mayer, Randy Ramseyer, Kristin L. Gray, Joseph S. Hall, Janine M. Myatt, Garth W. Huston, Carol Wallack, Charles J. Biro, and Matthew J. Lash.  The criminal investigation of Thaxter was handled by the FDA’s Office of Criminal Investigations; the Virginia Medicaid Fraud Control Unit; the United States Postal Service - Office of Inspector General; and the U.S. Department of Health and Human Services - Office of Inspector General.  Assistance was provided by representatives of the FDA’s Office of Chief Counsel.

Consumer Protection
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Updated July 1, 2020