Insys Therapeutics has agreed to pay $225 million to resolve civil and criminal actions brought by the U.S. Department of Justice over alleged kickbacks and marketing of its opioid painkiller.

Under the deal, announced Wednesday, Insys agreed to pay $195 million to settle allegations in five separate whistleblower lawsuits that it violated the False Claims Act. Its operating subsidiary also will plead guilty to five counts of mail fraud and pay a $2 million fine and $28 million in forfeiture. Both parts of the settlement center on Subsys, a fentanyl spray that Insys manufactured and that the U.S. Food and Drug Administration approved in 2012 for the treatment of chronic pain in cancer patients.

“The opioid epidemic has devastated communities and ravaged families across this country,” said Assistant Attorney General Jody Hunt of the Department of Justice's Civil Division, which prosecuted the case along with the U.S. attorney's offices in Massachusetts and the Central District of California, as well as the U.S. Department of Health and Human Services' Office of Inspector General. “The Department of Justice is committed to using the legal tools at our disposal to combat the illegal marketing and distribution of opioids, including fentanyl. Today's settlement sends a strong message to pharmaceutical manufacturers that the kinds of illegal conduct that we have alleged in this case will not be tolerated. I want to assure the families and communities ravaged by this epidemic that the Department of Justice will hold opioid manufacturers accountable for their actions.”

The agreement excludes cases brought by several cities, counties and attorneys general against Insys, one of several opioid manufacturers.

The deal comes after Insys disclosed last month that it might file for bankruptcy protection and could not afford the legal costs related to a Department of Justice's investigation.

Under a charging document, prosecutors said Insys and its operating subsidiary began paying bribes and kickbacks to medical professionals, under the guise of being “speaking programs,” to increase marketing of Subsys from August 2012 to June 2015. The deferred prosecution agreement, expected to last five years, comes after five former Insys executives, including billionaire founder John Kapoor, were convicted last month of charges relating to the marketing of Subsys.

The civil portion of the agreement resolves lawsuits in which the United States had intervened alleging Insys violated the False Claims Act by paying kickbacks to physicians and nurse practitioners to prescribe Subsys to their patients.

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Opioid maker Insys to pay $225M to settle kickback allegations

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