Suboxone film drugmaker settles federal probe finding it misrepresented the drug’s benefits.
Indivior has agreed to pay $600 million to settle criminal and civil probes conducted by the U.S. Department of Justice, pleading guilty to a felony charge of making false statements promoting Suboxone Film by claiming it was safer than other drugs containing buprenorphine. Suboxone has been widely used by patients to calm symptoms of opioid use withdrawal.
Mark Crossley, Indivior chief executive, said, “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 healthcare providers, policymakers, and communities to fight the opioid crisis.”
As part of the settlement, Indivior must disband its salesforce for Suboxone and Crossley must personally testify the company did not commit healthcare fraud every year, under penalty of perjury. Shaun Thaxter, Indivior’s former chief executive, pleaded guilty in June to charges related to the safety of Suboxone.
“During the nationwide opioid epidemic, Indivior Solutions made false statements about Suboxone’s safety to increase its sales. In doing so, Indivior Solutions misled government health care officials and is being held accountable today for its felonious conduct,” said First Assistant U.S. Attorney Daniel P. Bubar of the Western District of Virginia. “This resolution is the culmination of years of work by prosecutors and agents and demonstrates that we will continue to work tirelessly to hold pharmaceutical manufacturers responsible for illegal conduct.”
“The opioid crisis is a public health emergency. Prevention and access to effective treatments for opioid addiction are critical to fighting this epidemic,” explained Deputy Assistant Attorney General Michael D. Granston for the Justice Department’s Civil Division. “When a drug manufacturer claims to be part of a solution for opioid addicts, we expect honesty and candor to government officials, as well as to the physicians and patients making important treatment decisions based on those representations.”
“Opioid addiction and abuse is an immense public health crisis and taking steps to address it is one of the FDA’s highest priorities,” said FDA Commissioner Stephen M. Hahn, M.D. “Medication-assisted treatments incorporating drugs like Indivior’s Suboxone, in combination with counseling and behavioral therapy, are an important tool in combating opioid use disorder but can quickly become part of the problem if not used responsibly. When companies encourage the use of powerful drugs where not medically necessary and provide misleading information about relative product benefits, they can ultimately risk more misuse, abuse, diversion, and accidental exposure to opioid drugs as well as make treatment more difficult to obtain for those suffering from this crisis. We will continue to work with the Department of Justice to investigate and hold accountable those who devise and participate in schemes to the detriment of the public health.”
Opioid makers including Johnson & Johnson and Teva are in the middle of attempting to negotiate a global settlement over their alleged roles in the opioid crisis. Purdue Pharma, the maker of OxyContin, went into bankruptcy last year and offered $10 to $12 billion to settle all cases against it. The case is also still pending.