The former CEO of an international drug corporation pleaded guilty in an Abingdon, Virginia, courtroom Tuesday to a federal charge related to the misbranding of Suboxone film, authorities said Tuesday.
Shaun Thaxter, who led Indivior PLC, a Great Britain-based company, pleaded guilty to one count of causing the introduction into interstate commerce of the opioid drug Suboxone, which was misbranded in violation of the Federal Food, Drug and Cosmetic Act, according to the U.S. Attorney’s Office.
Thaxter had served as Indivior’s top executive since 2009 and stepped down Monday. Indivior announced that Mark Crossley has been appointed as CEO to replace Thaxter. Company leaders lauded Thaxter in the announcement.
“Finally, I would like to take a moment to thank Shaun for his leadership at Indivior and significant contributions within the addiction treatment community,” Crossley said in the announcement.
Thaxter stated that “we have truly been pioneers in developing new treatments and helping to change patients’ lives.”
Federal prosecutors in Abingdon — who have a history of prosecuting companies in the pharmaceutical industry and their executives — said Thaxter was charged in connection with Indivior’s “misrepresentations” to a state Medicaid program in Massachusetts regarding the safety of Suboxone film.
Suboxone film is a drug 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, prosecutors said.
“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.”
Daniel P. Bubar, the first assistant U.S. Attorney in western Virginia, said Thaxter violated the public’s trust.
In 2012, Thaxter oversaw and encouraged Indivior’s efforts to secure formulary coverage for Suboxone film from the Massachusetts Medicaid agency called MassHealth, according to court records. Thaxter asked Indivior employees under his direction to devise a strategy to win preferred drug status for Suboxone film and counteract a nonopioid competitor MassHealth was considering for opioid-addiction treatment, records state.
Certain Indivior employees subsequently shared false and misleading safety information with MassHealth officials about Suboxone film’s risk of accidental pediatric exposure, records state. 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 6.
Thaxter has agreed to pay $600,000 in fines and faces up to one year in prison. He’ll be sentenced in Abingdon on Sept. 29.
The case is part of a larger Indivior investigation, according to Brian McGinn, a spokesman for the U.S. Attorney’s Office. The Abingdon division previously prosecuted Purdue Pharma, Abbott Labs and Animal Health International, McGinn said.