Chesterfield pharma company enters $600M federal plea deal

Indivior Solutions Inc. settlement stems from false safety claims about opioid addiction treatment drug

Published July 24, 2020 by Sydney Lake

Less than one month after former Indivior PLC CEO Shaun Thaxter pleaded guilty in federal court in Abingdon to a misdemeanor criminal charge related to the marketing of the Chesterfield County-based company’s opioid addiction treatment drug Suboxone, the company announced Friday it has entered a $600 million plea deal with the U.S. Justice Department, the Federal Trade Commission and U.S. state attorneys general to resolve the issue.

“We are pleased to achieve this resolution and move forward in a way that provides certainty for our business in respect of this matter and allows us to continue focusing on our important work for patients suffering from opioid use disorder and mental health illnesses around the world,” Indivior CEO Mark Crossley said in a statement.

Thaxter stepped down in June as CEO of Indivior, a spinoff of British firm Reckitt Benckiser Group (RB Group), and was replaced by Crossley, the company’s former chief financial and operations officer and executive director. Last year, RB Group agreed to pay $1.4 billion to the federal government and various states to resolve its potential criminal and civil liability in the Suboxone investigation.

Suboxone contains a combination of buprenorphine, a potent opioid, and naloxone, an opioid overdose reversal drug. It is approved for use by people in recovery from opioid addictions to avoid or reduce withdrawal symptoms while receiving treatment for addiction. Thaxter had asked Indivior employees to devise a plan to get Massachusetts Medicaid agency MassHealth to use Suboxone Film instead of a competitor’s non-opiate treatment, according to a criminal complaint filed by the U.S. Attorney’s Office for the Western District of Virginia. 

“Certain Indivior employees subsequently shared false and misleading safety information with MassHealth officials about Suboxone Film’s risk of accidental pediatric exposure,” according to the Justice Department. “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.”

Under the terms of the agreement announced Friday, Indivior Solutions Inc., a wholly owned subsidiary of Indivior PLC, has pleaded guilty to one count of making a false statement regarding health care matters in 2012. Indivior will have seven years to pay the $600 million settlement, under which the Justice Department will move to dismiss the charges the grand jury returned in April 2019.

Indivior will make an initial $100 million payment the week the plea is finalized and approved by a judge, according to the company. Then, the company will pay six annual payments of $50 million every Jan. 15 through 2027. 

Indivior has also agreed to pay $10 million to settle Federal Trade Commission (FTC) charges that it violated antitrust laws. The $10 million from this settlement will be combined with an additional $50 million from the RB Group into a fund to provide payments to people who had purchased Suboxone Film.

“In the midst of the nation’s opioid crisis, a critical opioid-addiction treatment was about to become more affordable,” Gail Levine, a deputy director of the FTC’s Bureau of Competition, said in a statement. “But Indivior prevented that. It kept its drug prices high by unlawfully impeding generic manufacturers from competing effectively.”

Starting Friday, anyone who was prescribed Suboxone in the U.S. between March 1, 2013 and Feb. 28, 2019 can file a claim through the FTC to receive payments.

“The incident to which the agreement relates occurred well in the past and does not reflect the values Indivior has strived to demonstrate and uphold during our long history of partnering with health care providers, policymakers, and communities to fight the opioid crisis,” Crossley said in a statement.

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