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Insys Therapeutics to pay millions to resolve allegations surrounding promotion of opioid painkiller

Federal Court

By Carrie Bradon | Jul 16, 2019

Medical malpractice 04

WASHINGTON (Legal Newsline) – Insys Therapeutics agreed to a resolution to settle the government's separate criminal and civil investigations regarding the promotion of opioid painkiller Subsys, the U.S. Department of Justice announced on June 5.

Insys, an opioid manufacturer, will enter into a deferred prosecution agreement with the government in which Insys' operating subsidiary has agreed to plead guilty to five counts of mail fraud. 

Insys will pay $2 million in fines and $28 million in forfeiture, as well as $195 million to settle allegations it violated the False Claims Act. Criminal and civil investigations of Insys came from the alleged unlawful marketing practices in association with its drug Subsys, a sublingual fentanyl spray that is highly addictive.

In 2012, Subsys was approved by the Food and Drug Administration for the treatment of persistent pain in adult cancer patients who were already receiving opioid therapy.

Insys is alleged to have used speaker programs to increase product awareness of Subsys, but the Department of Justice alleges these programs were a vehicle to pay bribes and kickbacks to practitioners in exchange for the increased prescriptions of Subsys.

The Department of Justice is committed to taking steps to address the opioid epidemic,” said Principal Deputy Associate Attorney General Claire Murray in a press release. “Illegal conduct by pharmaceutical manufacturers, especially in the midst of the opioid crisis, will not be tolerated. We will continue to investigate and vigorously prosecute these types of allegations and hold opioid manufacturers accountable under the law."

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