Shaun Thaxter, the former head of pharma group Indivior (INDV), has pleaded guilty to a US Department of Justice criminal charge pertaining to the marketing of the opioid addiction treatment Suboxone. Mr Thaxter had stepped down from his role as chief executive of Indivior at the end of June, and was replaced by Mark Crossley - formerly chief financial and operations officer.
An announcement from the DoJ said that Mr Thaxter pleaded guilty on Tuesday 30 June to a misdemeanour count of violating the Federal Food, Drug and Cosmetic Act by causing the introduction of the “misbranded” treatment Suboxone Film into interstate commerce. Before his sudden departure from the group, Mr Thaxter had served as leader of Indivior since 2009 – including the period prior to 2014, when Indivior was known as Reckitt Benckiser Pharmaceuticals. Reckitt Benckiser (RB.) paid $1.4bn (£1.1bn) last summer to fully resolve all federal investigations into it in connection with the long-running probe into the sales and marketing of Suboxone Film. Indivior is entirely demerged from Reckitt.
The DoJ said that in 2012, Mr Thaxter “oversaw and encouraged” Indivior’s efforts to secure coverage for Suboxone Film from a Massachusetts medical agency called MassHealth. The department noted that Mr Thaxter asked Indivior employees under his direction to try to win preferred drug status for Suboxone Film, counteracting a non-opioid competitor that the respective agency 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 paediatric exposure”. Subsequently, MassHealth revealed that it would provide access to Suboxone Film for Medicaid patients with children under the age of six.
Mr Thaxter’s attorney Wick Sollers commented that “it should be made clear, which the DOJ press release intentionally omitted, that the plea was to a strict liability, non-intent misdemeanor under the Responsible Corporate Officer Doctrine." He added, "Mr Thaxter was unaware of the alleged misstatements when they were made and he authorised disclosure to the government as soon as he was informed of the issue."
Under the terms of the plea agreement, Mr Thaxter has agreed to pay $600,000 in fines and forfeitures and could face up to one year in prison. He will be sentenced at the end of September. “Opioid addiction and abuse is an immense public health crisis and taking steps to address it is one of the FDA’s [Food and Drug Administration’s] highest priorities,” commented FDA Commissioner Stephen Hahn.
Indivior stated that the plea deal is in Mr Thaxter’s “personal capacity and not on behalf of the group”. It added that it continues to attempt to resolve its own outstanding litigations “as expeditiously as possible”. The group said in May that it had lifted its provision for investigative litigation matters from $438m to $621m; no small number, when you consider that revenue for 2019 landed at $785m. At the time, Indivior noted that the DoJ was seeking to recover $3bn in relation to allegations of fraud around the Suboxone medication. It added that it believed it had strong defences and would vigorously defend itself.