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Indivior Must Disband Suboxone Sales Force, Implement Executive Pay Recoupment Program

 
• By Brenda Sandburg

$600m settlement with DOJ over Suboxone marketing includes corporate integrity agreement and exclusion of subsidiary from government health programs. Indivior also agrees to pay $10m to FTC and be enjoined from future antitrust violations.

WASHINGTON, DC - MARCH 2018: Headquarters of the U.S. Justice Department. Art Deco aluminum torcheres at doorway. Renamed the Robert F. Kennedy Department of Justice Building in 2001.
DOJ inks second settlement over Suboxone marketing • Source: Shutterstock

A year after Indivior plc's former parent Reckitt Benckiser Group PLC reached a $1.4bn settlement with the US Department of Justice, Indivior has agreed to pay $600m more to resolve additional criminal and civil liability over the marketing of its opioid addiction treatment drug Suboxone Film (buprenorphine/naloxone).

This time the company agreed to disband its Suboxone sales force and entered into a corporate integrity agreement (CIA) requiring it to implement numerous accountability and auditing provisions.

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Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
• By Sue Sutter

The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

More from Compliance

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
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Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.