A recent round of indictments shows the federal government is going beyond pharma company executives and sales personnel in its efforts to hold individuals accountable for their roles in contributing to the opioid epidemic.
The US Attorney’s Office for the Southern District of New York announced on March 16 an indictment against five New York physicians for allegedly soliciting and accepting bribes and kickbacks in exchange for prescribing high volumes of Subsys, a powerful and potentially addictive fentanyl spray manufactured by Insys Therapeutics. Fentanyl is a synthetic opioid that is similar to morphine but is 50 to 100 times more potent.
“Payments from pharmaceutical companies should not influence how doctors prescribe – especially when a potent and dangerous drug like Fentanyl is involved,” said the US Attorney Geoffrey Berman of the Southern District of New York in a press release.
The bribes took the form of fees paid to the physicians for giving “educational presentations” about the fentanyl spray as part of a “speakers bureau.” In fact, according to the indictment, the speaker events generally had little or no educational component but were instead social gatherings at expensive New York restaurants. Those who attended were often not even medical professionals.
Insys selected the paid “speakers” based on who was prescribing large volumes of the drug and not on medical expertise or merit. The indictment describes in detail how, as the fees paid to the physicians increased, so did their prescriptions for Subsys.
The company paid each of the five physicians tens of thousands of dollars annually – and in some cases more than $100,000 – in speaker program fees in exchange for prescribing the addictive spray, according to the indictment.
Insys also paid some of the physicians for social outings that the company didn’t bother to disguise as educational presentations, such as a Christmas party and visits to nightclubs and strip clubs.
The company carefully monitored speakers’ prescription statistics and pressured the indicted doctors to increase their Subsys prescriptions by making it clear Insys would drop them from the lucrative program if they did not prescribe high volumes of the drug.
According to media reports, all five defendant physicians pleaded not guilty to the charges, including violations of the Anti-Kickback Statute. Those indicted were Gordon Freedman, Jeffrey Goldstein, Todd Schlifstein, Dialecti Voudouris, and Alexandru Burducea.
The indictment is part of a broader government enforcement action against Insys. Last fall, the Justice Department indicted Insys founder and majority owner John Kapoor, along with other Insys executives, alleging they had participated in a nationwide scheme to bribe doctors to prescribe Subsys. A trial in that case is scheduled for January 2019.
According to DOJ, two former Insys sales employees who had been charged in connection with the scheme in 2016 pleaded guilty and became cooperating witnesses for the government.
In February, DOJ announced the creation of a new task force to fight the opioid crisis. Attorney General Jeff Sessions promised the task force would use “all available criminal and civil remedies available under federal law to hold opioid manufacturers accountable for unlawful practices.”
The indictments of physicians suggest that the government is not limiting its enforcement to pharmaceutical companies, but is taking a more comprehensive approach to target all actors who have contributed to this crisis.