Shaun Thaxter charged with misbranding Suboxone Film.
The chief executive officer of Indivior PLC, Shaun Thaxter, has pleaded guilty in federal court in Abingdon, Virginia to a charge of “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.” He was tried in connection with Indivior’s misrepresentations to a state Medicaid program concerning the safety of Suboxone Film. Indivior announced that Thaxter will be stepping down as CEO.
The company was once known as Reckitt Benckiser Pharmaceuticals and existed as a subsidiary of Reckitt Benckiser Group (RB Group). RB Group paid $1.4 billion in 2019 to resolve its liability to the United States regarding deceptive marketing of Suboxone Film, used in the medication-assisted treatment of heroin addiction. The drug’s active ingredient, buprenorphine, is a powerful and addictive opioid.
“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.”
Investigators discovered, in 2012, the executive 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.” In order to fulfill his mission, some employees “shared false and misleading safety information with MassHealth officials about Suboxone Film’s risk of accidental pediatric exposure.” After receiving this falsified information, MassHealth said it would allow access to Suboxone Film for Medicaid patients with children under six years of age.
“By valuing profits over patients, Thaxter’s directions endangered numerous Medicaid beneficiaries and their families, especially young children, with accidental opioid exposure. When treatment medications are used, it is essential they be prescribed carefully, legally, and based on accurate information, to protect the health and safety of patients in federal healthcare programs,” said Elton Malone, Assistant Inspector General for Investigations with the Office of Inspector General of the U.S. Department of Health and Human Services. “Protecting the health and safety of those served by Federal Healthcare Programs is of the utmost importance to OIG. Along with our federal and state law enforcement partners we will continue working to protect beneficiaries from harm as a top priority.”