Geoffrey S. Berman, the United States Attorney for the Southern District of New York, announced that DIALECTI VOUDOURIS, a doctor who practiced in Manhattan, pled guilty today to conspiracy to violate the Anti-Kickback Statute, in connection with a scheme to prescribe Subsys, a potent fentanyl-based spray, in exchange for bribes and kickbacks from Subsys’s manufacturer, Insys Therapeutics. VOUDOURIS pled guilty before U.S. Magistrate Judge Ona T. Wang. The case is assigned to U.S. District Judge Kimba M. Wood.
U.S. Attorney Geoffrey S. Berman said: “As she admitted today, Dialecti Voudouris, a prominent Manhattan oncologist, prescribed her patients Subsys, a powerful fentanyl drug, in exchange for over $100,000 in bribes and kickbacks from the drug’s manufacturer, Insys. Today’s guilty plea – the third in this case – once again demonstrates that when a doctor’s best medical judgment is compromised by bribes, this Office will hold that physician to account, especially when a dangerous opioid like fentanyl is involved.”
According to the allegations contained in the Indictment against VOUDOURIS and filings in related proceedings:
The Insys Speakers Bureau
Subsys, which is manufactured by Insys, is a powerful painkiller approximately 50 to 100 times more potent than morphine. The FDA approved Subsys only for the management of breakthrough pain in cancer patients. Prescriptions of Subsys typically cost thousands of dollars each month, and Medicare and Medicaid, as well as commercial insurers, reimbursed prescriptions written by VOUDOURIS.
In or about August 2012, Insys launched a “Speakers Bureau,” a roster of doctors who would conduct programs (“Speaker Programs”) purportedly aimed at educating other practitioners about Subsys. In reality, Insys used its Speakers Bureau to induce the doctors who served as speakers to prescribe large volumes of Subsys by paying them Speaker Program fees. Speakers were supposed to conduct an educational slide presentation for other health care practitioners at each Speaker Program. In reality, many of the Speaker Programs were predominantly social affairs where no educational presentation about Subsys occurred. Attendance sign-in sheets for the Speaker Programs were frequently forged by adding the names and signatures of health care practitioners who had not actually been present.
VOUDOURIS’s Participation in the Scheme
VOUDOURIS, a doctor specializing in oncology and hematology who worked at a private medical office on the Upper East Side, received approximately $119,400 in Speaker Program fees from Insys in exchange for prescribing large volumes of Subsys. During a September 2014 dinner with several Insys executives and managers, a senior Insys executive told VOUDOURIS, who had recently been nominated by Insys as a Speaker, that he wanted her to prescribe Subsys to one new patient every day, and that VOUDOURIS would be allocated Speaker Programs if she continued prescribing Subsys. In a conversation with an Insys manager and sales representative soon thereafter, VOUDOURIS was once again informed that Insys expected her to write more Subsys prescriptions. In the months that followed the dinner and this conversation, VOUDOURIS’s Subsys prescriptions rose significantly. By the end of the first quarter of 2015, VOUDOURIS – who had prescribed very minimal quantities of Subsys prior to becoming a Speaker for Insys – was approximately the 10th-highest prescriber of Subsys nationally, accounting for total net sales of Subsys of approximately $581,500 in that quarter alone.
VOUDOURIS, 48, of Queens, New York, pled guilty to one count of conspiracy to violate the Anti-Kickback Statute, which carries a maximum sentence of five years in prison. The maximum potential sentence is prescribed by Congress and is provided here for informational purposes only, as any sentencing of the defendant will be determined by the judge. VOUDOURIS is scheduled to be sentenced by Judge Wood on January 3, 2020.
Mr. Berman praised the investigative work of the Federal Bureau of Investigation, and thanked the Department of Health and Human Services’ Office of Inspector General for its participation in the investigation.
