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.
The case is being prosecuted by the Office’s Complex Frauds
and Cybercrime Unit. Assistant U.S.
Attorneys Noah Solowiejczyk and David Abramowicz are in charge of the
prosecution.
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