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On May 2, at the conclusion of an all too rare criminal prosecution of pharmaceutical company executives, a federal jury in Boston found John Kapoor — the billionaire founder of Insys Therapeutics, the drug company that markets fentanyl sublingual spray (SUBSYS) — and four other former company executives guilty of criminal racketeering charges.[1] Kapoor and his codefendants had been charged in October 2017 with “leading a nationwide conspiracy” to profit by bribing doctors to...
On May 2, at the conclusion of an all too rare criminal prosecution of pharmaceutical company executives, a federal jury in Boston found John Kapoor — the billionaire founder of Insys Therapeutics, the drug company that markets fentanyl sublingual spray (SUBSYS) — and four other former company executives guilty of criminal racketeering charges.[1] Kapoor and his codefendants had been charged in October 2017 with “leading a nationwide conspiracy” to profit by bribing doctors to inappropriately prescribe the company’s fentanyl spray product and by defrauding health insurers.[2]
Subsys, the first of two drugs marketed by Insys,[3] is a rapid-acting, highly addictive, dangerous opioid that is sprayed under the tongue. It is more than 100 times more potent than morphine. The Food and Drug Administration approved the drug in 2012 only for treating breakthrough pain in adult cancer patients who are not responding adequately to other opioids.[4]
Under the brazenly illegal scheme orchestrated by Kapoor and his coconspirators, company employees paid bribes and kickbacks to health care practitioners in multiple states to entice them to prescribe Subsys to large numbers of patients, most of whom were not diagnosed with cancer.[5] Pharmaceutical company marketing of drugs for such unapproved — also known as “off-label” — uses is illegal.
The government also had charged the Insys executives with conspiring to mislead and defraud health insurance companies that resisted approving payment for Subsys when it was prescribed to non-cancer patients.[6] To that end, they established a “reimbursement unit” within Insys that was dedicated to obtaining preauthorization for such prescriptions directly from insurers for these off-label uses.[7]
In 2017, several doctors were convicted of or pleaded guilty to accepting kickbacks from Insys in exchange for prescribing Subsys.[8],[9]
Commenting on the conviction of Kapoor and his codefendants, U.S. attorney for the District of Massachusetts Andrew E. Lelling, whose office prosecuted the case, told The New York Times, “Just as we would street-level drug dealers, we will hold pharmaceutical executives responsible for fueling the opioid epidemic by recklessly and illegally distributing these drugs, especially while conspiring to commit racketeering along the way.”[10]
The Department of Justice (DOJ) and the many other federal agencies involved in the investigation of Insys should be applauded for aggressively pursuing the most senior company executives who led this conspiracy. These executives deserve lengthy prison sentences for recklessly endangering thousands of patients and helping fuel the epidemic of opioid overdoses across the U.S.
The DOJ must build on its successful prosecution in this case and pursue criminal cases against other pharmaceutical company executives who hatch similar schemes to illegally promote prescription drugs, including but not limited to opioids, thereby placing corporate profits before patients’ lives.
References
[1] Emanuel G, Thomas K. Top executives of Insys, an opioid company, are found guilty of racketeering. The New York Times. May 2, 2019. https://www.nytimes.com/2019/05/02/health/insys-trial-verdict-kapoor.html. Accessed May 6, 2019.
[2] U.S. Department of Justice, United States Attorney’s Office, District of Massachusetts. Founder and owner of pharmaceutical company Insys arrested and charged with racketeering. October 26, 2017. https://www.justice.gov/usao-ma/pr/founder-and-owner-pharmaceutical-company-insys-arrested-and-charged-racketeering. Accessed May 6, 2019.
[3] Insys Therapeutics. Approved products. https://www.insysrx.com/products/approved. Accessed May 6, 2019.
[4] Insys Therapeutics. Drug label: fentanyl sublingual spray (SUBSYS). December 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf. Accessed May 6, 2019.
[5] U.S. Department of Justice, United States Attorney’s Office, District of Massachusetts. Founder and owner of pharmaceutical company Insys arrested and charged with racketeering. October 26, 2017. https://www.justice.gov/usao-ma/pr/founder-and-owner-pharmaceutical-company-insys-arrested-and-charged-racketeering. Accessed May 6, 2019.
[6] Ibid.
[7] Ibid.
[8] U.S. Department of Justice, United States Attorney’s Office, Southern District of Alabama. Two Mobile pain doctors convicted after seven-week trial. March 8, 2017. https://www.justice.gov/usao-sdal/pr/two-mobile-pain-doctors-convicted-after-seven-week-trial. Accessed November 9, 2017.
[9] U.S. Department of Justice, United States Attorney’s Office, District of Rhode Island. RI doctor admits to healthcare fraud, accepting kickbacks for prescribing highly addictive version of fentanyl. October 25, 2017. https://www.justice.gov/usao-ri/pr/ri-doctor-admits-healthcare-fraud-accepting-kickbacks-prescribing-highly-addictive. Accessed November 9, 2017.
[10] Emanuel G, Thomas K. Top executives of Insys, an opioid company, are found guilty of racketeering. The New York Times. May 2, 2019. https://www.nytimes.com/2019/05/02/health/insys-trial-verdict-kapoor.html. Accessed May 6, 2019.
