Life Science Compliance Update

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July 07, 2016

History Repeating – Is Insys a Warner Chilcott Clone?

Recent arrests have once again left the pharmaceutical world wondering how many times do the same lessons have to be learned? With the arrests of ex- Insys employees, the old days of sham educational events and lunches have once again resurfaced. This article outlines the arrests, how they are similar to previous arrests, and what can (and should) be done to stop activities like this from happening.

According to George Santayana, "those who fail to learn from history are doomed to repeat it". For the pharmaceutical industry, this appears to be true. Recently, the Department of Justice and the Federal Bureau of Investigation announced the arrest of two former employees of Insys Therapeutics for allegedly violating the Anti- Kickback Statute (AKS), as part of a scheme to pay doctors thousands of dollars to participate in sham educational programs. The purpose of the payments allegedly was to induce those physicians to prescribe millions of dollars' worth of fentanyl spray.

The fentanyl spray at issue was approved by the United States Food and Drug Administration ("FDA") around January 2012, solely for the management of breakthrough pain in cancer patients who are already receiving, and are tolerant, to opioid therapy for their underlying persistent pain. The spray created approximately $330 million of revenue for Insys in 2015 alone.

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