6 pharma executives face criminal charges for alleged fentanyl racketeering scheme

Six pharmaceutical executives who worked for Chandler, Ariz.-based Insys Therapeutics were arrested Thursday on charges that they led a nationwide conspiracy to bribe clinicians to unnecessarily prescribe fentanyl-based pain medication, according to the Department of Justice.

The government claims the executives conspired to bribe physicians and medical practitioners in several states, many of whom worked in pain clinics, to prescribe their pain medication called Subsys. This narcotic contains fentanyl, a highly addictive synthetic opioid, and is intended to treat cancer patients suffering intense episodes of breakthrough pain.

In exchange for kickbacks and bribes, practitioners allegedly wrote large numbers of prescriptions for patients, few of whom were diagnosed with cancer. The indictment also alleges the former Insys executives conspired to defraud health insurers that showed reluctance to approve payment for Subsys when it was prescribed to non-cancer patients. The defendants allegedly did so by establishing a "reimbursement unit" that obtained prior authorization directly from insurers and pharmacy benefit managers.

Here are the names of the defendants, all of whom are no longer employed by Insys Therapeutics, along with the respective charges they face:

  • Michael Babich, former president and CEO: conspiracy to commit racketeering, conspiracy to commit wire and mail fraud and conspiracy to violate the Anti-Kickback Law
  • Alec Burlakoff, former vice president of sales: Racketeer Influence and Corrupt Organizations Act conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Richard M. Simon, former national director of sales: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Sunrise Lee, former regional sales director: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Joseph A. Rowan, former regional sales director: RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law
  • Michael J. Gurry, former vice president of managed markets: RICO conspiracy and wire fraud conspiracy

Criminal charges are rarely pressed in cases involving pharmaceutical companies, and several agents noted the severity of the charges in statements.

"As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression," said Harold H. Shaw, Special Agent in Charge of the FBI, Boston Field Division. "In doing so, they contributed to the growing opioid epidemic and placed profit before patient safety. These indictments reflect the steadfast commitment of the FBI and our law enforcement partners to confront the opioid epidemic impacting our communities, while bringing to justice those who seek to profit from fraud or other criminal acts."

“I hope that today’s charges send a clear message that we will continue to attack the opioid epidemic from all angles, whether it is corporate greed or street level dealing,” said United States Attorney Carmen M. Ortiz.

The case involved cooperation of several federal and state agencies, including the FBI, HHS, OIG, FDA Office of Criminal Investigations, Drug Enforcement Administration, Department of Labor, Office of Personnel Management, U.S. Postal Inspection Service and the Department of Veterans Affairs, among others.

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