Indivior Solutions was sentenced to pay $289 million in criminal penalties in connection with a previous guilty plea related to the marketing of the opioid-addiction-treatment drug Suboxone, the Department of Justice announced today.
U.S. District Judge James P. Jones of the Western District of Virginia entered the sentence against Indivior Solutions pursuant to a plea agreement. Altogether, Indivior Solutions will pay $600 million to resolve its civil and criminal liability in this matter. In total, the payments made by Indivior Solutions and its parent companies, Indivior Inc. and Indivior plc, along with payments made under a 2019 resolution with Indivior’s former parent, Reckitt Benckiser Group plc, and criminal penalties paid pursuant to plea agreements with two former Indivior executives will exceed $2 billion. That amount represents the second-largest monetary resolution obtained by the Department of Justice in a case involving an opioid drug.
Suboxone, which contains the powerful opioid buprenorphine, is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment for opioid-use disorder. In connection with its guilty plea, Indivior Solutions admitted to making false statements to the Massachusetts Medicaid program (MassHealth) related to the relative safety of Suboxone Film, a version of Suboxone, around children.
“Combating the opioid epidemic is a top priority for the Department of Justice,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “We will hold drug manufacturers accountable when they make misrepresentations that could affect consumers’ access to opioid addiction treatments.”
Indivior Solutions, a subsidiary of Indivior Inc., pleaded guilty on July 24, 2020, to a one-count felony criminal information charging false statements relating to health care matters. Indivior Inc. agreed to terms complementing the Indivior Solutions guilty plea and agreed to implement prospective measures that include permanently disbanding Indivior Inc.’s Suboxone sales force and taking steps to prevent promoting Suboxone to health care providers at a high risk of inappropriate prescribing.
On June 30, 2020, Indivior’s former CEO, Shaun Thaxter, pleaded guilty to a one-count misdemeanor information related to Indivior’s false and misleading representations to MassHealth. On Oct. 22, 2020, the court sentenced Thaxter to a six-month term of incarceration and $600,000 in criminal fines and forfeiture.
On Aug. 26, 2020, Indivior’s former medical director, Tim Baxter, pleaded guilty to a one-count misdemeanor information related to Indivior’s false and misleading representations to MassHealth. Baxter’s sentencing hearing is scheduled for Dec. 17, 2020, before Judge Jones in Abingdon, Virginia.
“When a drug manufacturer claims to be part of the solution to the national opioid epidemic, we expect it to make honest representations to government officials, physicians and patients, who have to make crucial treatment decisions,” said Acting U.S. Attorney Daniel P. Bubar of the Western District of Virginia. “Instead, Indivior made false statements about Suboxone’s safety to increase its sales. I’m proud of the close relationship we have with our federal and state partners that led to today’s important result.”
“Pharmaceutical companies that falsely promote their drugs, intended to treat opioid addiction, as superior to other alternatives only worsens the opioid crisis that has touched far too many lives in the U.S. Such actions potentially narrow access to treatment for those who need it,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs, U.S. Food and Drug Administration. “We will continue to investigate and bring to justice those who devise and participate in these schemes to the detriment of the public health.”
In its guilty plea, Indivior Solutions, which employed marketing and sales personnel for the Indivior group of companies, admitted that in October 2012 it sought to convince MassHealth to expand Medicaid coverage of Suboxone Film in Massachusetts and sent MassHealth a misleading chart and false data indicating that Suboxone Film had the lowest rate of accidental pediatric exposure (i.e., children taking medication by accident) of all buprenorphine drugs in Massachusetts, when in fact it did not. Indivior Solutions further admitted that sending the false and misleading information occurred in the context of marketing and promotional efforts directed at MassHealth, which were overseen by top executives. MassHealth announced it would provide access to Suboxone Film for patients with children under the age of six shortly after Indivior provided the false and misleading information to agency officials.
The criminal case against Indivior was prosecuted by Randy Ramseyer of the U.S. Attorney’s Office for the Western District of Virginia; Albert P. Mayer and Carol Wallack of the Department of Justice Civil Division’s Commercial Litigation Branch; Charles J. Biro and Matthew J. Lash of the Department of Justice Civil Division’s Consumer Protection Branch; Kristin L. Gray, Joseph S. Hall and Janine M. Myatt of the Virginia Medicaid Fraud Control Unit of the Office of the Attorney General; and Garth W. Huston of the Federal Trade Commission. This matter was investigated by the Virginia Attorney General’s Medicaid Fraud Control Unit; FDA’s Office of Criminal Investigation; the United States Postal Service Office of Inspector General; and the Department of Health and Human Services Office of Inspector General.
The joint effort advances the goals of the department’s Prescription Interdiction & Litigation (PIL) Task Force to deploy all available criminal, civil, and regulatory tools to hold opioid manufacturers accountable for unlawful practices and to ensure that prescription opioid products are marketed truthfully.
For more information about the U.S. Attorney’s Office for the Western District of Virginia, visit its website at https://www.justice.gov/usao-wdva. Additional information about the Consumer Protection Branch and the Civil Fraud Section and their enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch and http://www. justice.gov/civil/fraud-section. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
originally published at Law - NORLY NEWS