Indivior’s Former Medical Director Convicted Concerning Drug Safety Claims

Indivior’s Former Medical Director Convicted Concerning Drug Safety Claims

Abingdon, Virginia – On 17th December 2020, Timothy Baxter, the former Indivior PLC medical director, was convicted in a federal court in Abingdon, Virginia, to six months home confinement, 100 hours of community service, and a 100,000 U.S. dollars criminal fine in relation to the firm’s marketing of opioid medication.

In August 2020, Timothy Baxter admitted guilty to a one-charge misdemeanor Information associated with Indivior’s misleading and false representation to the Massachusetts Medicaid program concerning Suboxone, a medication approved for recovering addicts of an opioid to reduce or avoid withdrawal symptoms. In association with his plea of guilty to triggering the introduction into interstate commerce of misbranded drugs under the FDA (Federal Food, Drug, and Cosmetic Act), Timothy Baxter confessed that he failed to prevent Indivior from submitting false and fraudulent information to the Massachusetts Medicaid program to the Suboxone Film’s relative safety, a version of Suboxone, around kids.

Jeffrey A. Rosen, Deputy Attorney General, stated that in this administration, the Justice Department had augmented its important and in progress drug enforcement efforts with a series of new initiatives directed at unlawful conduct involving opioid drugs prescription.  Deputy Attorney General Rosen further added that the Department’s multi-pronged trial of Indivior’s illicit Suboxone marketing is a prime example of how to prevent this crisis via diverse strategies. The net outcome of the Department’s Indivior-linked cases would support the current efforts to punish criminal behavior in the opioid space, prevent further criminal behavior among opioid markers and their top executives, and contribute notably to the Department’s objective to stop the tides of this crisis.

Daniel P. Bubar, Acting United States Attorney, stated that after Timothy Baxter failed to make sure Indivior offered accurate and honest information to a state Medicaid program concerning Suboxone, it led to overstated safety submissions and criminal behavior. Acting United States Attorney Bubar further stated that Timothy Baxter’s failure was mostly egregious, give his position and role in the firm as global medical director. The 17th December 2020 sentence should deter other pharmaceutical directors against offering anything less than truthful information concerning their products. Acting U.S. Attorney Bubar concluded his statement by stating that they could not have done this matter without the cooperation with and hard work of the Office of the Virginia Attorney General and their federal law enforcement partners, for which they are remarkably grateful.

As per the court documents, Timothy Baxter assisted the global Indivior’s efforts in 2012 to get formulary insurance for Suboxone Film from the Massachusetts Medicaid program. Indivior workers conceived a strategy to win preferred medication status for Suboxone Film and impede a non-opioid competitor Massachusetts Medicaid program was considering for the treatment of opioid addiction. A specific Indivior worker later shared misleading and false safety information with Massachusetts Medicaid program officials concerning Suboxone Film’s risk of unintentional pediatric exposure. Timothy Baxter failed to combat this course of behavior performed by a worker under his instruction. Two months after obtaining fraudulent and false information, the Massachusetts Medicaid program reported it would give access to Suboxone Film for Medicaid patients with kids under six years.

Shaun Thaxter, Indivior’s previous Chief Executive Officer, was convicted in October 2020 to half a year in federal prison and 600,000 U.S. dollars criminal fine and forfeiture after he admitted guilt to the same indictment. James P. Jones, United States District Court Judge of Virginia’s Western District, imposed the convictions for both Shaun Thaxter and Timothy Baxter. The matter follows civil and corporate criminal settlements reported by the Department earlier this year (2020). Cumulatively, reimbursements made by Indivior Solutions and its parent firms, Indivior plc, and Indivior Inc., together with reimbursements made under a 2019 settlement with Reckitt Benckiser Group plc, Indivior’s previous parent, will exceed 2 billion U.S. dollars.

Mark Herring, Attorney General, stated that sadly, they persistently continue to endure the damaging effects of the opioid pandemic in societies across the Commonwealth. Attorney General Herring further noted that opioid makers and their leadership should be held answerable for their role in hatching and prolonging this opioid crisis by placing profits over people. Attorney General Herring concluded the statement by publicly acknowledging the Medicaid Fraud Control Unit, as well as its federal, state, and local law enforcement partners for all of their determination, hard work, and partnership in this crucial case.

Assistant Commissioner Catherine Hermsen of the FDA’s Criminal Investigations Office stated that opioid addiction is a severe public health pandemic in the United States, and FDA is continuing to take measures to prevent and address this important case. When firms and their leadership give false and misleading information concerning their products’ benefits, it threatens efforts to give affordable treatment, mostly to those suffering from opioid addiction. Assistant Commissioner Hermsen assured that they would continue to investigate and work to protect against those individuals whose conspiracies threaten public health and places Americans at risk.

United States Postal Service – Office of Inspector General Special Agent Kenneth Cleevely in Charge, Eastern Area Field Office stated that the United States Postal Service uses billions of U.S. dollars yearly in employees’ compensation or health care linked expenses, most of which are legitimate. However, once medical providers, corporations, pharmacies, and other organizations decide to breach the rules and profit illicitly, special agents with the United States Postal Service – Office of Inspector General will persistently work with its law enforcement associates to hold them accountable. Special Agent Cleevely informed the Americans to report fraud or other criminal activities involving the United States Postal Service by contacting its special agents.

Assistant Inspector General Elton Malone for Investigations with the Inspector General’s Office of the United States Health and Human Services Department noted that Timothy Baxter knowing misleading and false Suboxone representation is no small issue, mostly at a period when the nation fights the ongoing opioid pandemic. Assistant Inspector General Elton Malone further said that these Indivior prosecutions must send a stern warning and message to pharmaceutical firms who fail to uphold the integrity and duties expected of them. Malone assured that they would persistently continue to collaborate with its law enforcement partners to hold accountable corporations and their executive directors.

Attorneys from the Office of the U.S. Attorney for Virginia’s Western District, Virginia Attorney General – Medicaid Fraud Control Unit, Department of Justice – Civil Division, and Federal Trade Commission such as Randy Ramseyer, Albert P. Mayer, Kristin L. Gray, Janine M. Myatt, Joseph S. Hall, Garth W. Huston, Charles J. Biro, Carol Wallack, and Matthew J. Lash, prosecuted the case against Shaun Thaxter, Timothy Baxter, and Indivior. The FDA – Office of Criminal Investigations, United States Postal Service – Office of Inspector General, Virginia Medicaid Fraud Control Unit, and U.S. Department of Health and Human Services – Office of Inspector General, investigated the case.

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