For more than three years, management at Insys Therapeutics operated a “nationwide conspiracy” to boost sales of Subsys, federal prosecutors allege in a new indictment. That scheme was said to include high-end meals, “sham” speaker events, reimbursement tactics and more as the company brass allegedly pushed the addictive painkiller for off-label uses.
The government’s 60-page indictment details an effort by Insys execs, led by former CEO Michael Babich, to home in on practitioners who ranked high on the opioid prescribing list. Its allegations are also a non-compliance manual of sorts: A rundown of what not to do if you want to follow pharma's sales rules.
Don't target doctors who prescribe for uses for which your drug isn't approved, for instance. According to the indictment, execs “continuously targeted practitioners who prescribed Transmucosal Immediate Release Fentanyl (TIRF) drugs—a class that includes Subsys—not just for breakthrough cancer pain, but for all pain.”
Subsys, approved in 2012 to treat cancer pain, brought in $329 million in sales for the company last year. Looking to boost the launch, Insys allegedly pushed the med off-label for general pain. The company also allegedly set up a “reimbursement unit” tasked with getting coverage from reluctant payers, according to the indictment.
Another no-no? A cadre of doctors whose outsized entertainment and consulting fees match up with outsized script numbers. Prosecutors presented details of 10 high-prescribing practitioners in Alabama, Michigan, Florida and elsewhere who, after being contact by an Insys representative, greatly increased their Subsys prescriptions. Many of the practitioners received more than $100,000 in “bribes and kickbacks,” prosecutors say.
And, as the scripts piled up at some of the high-prescribing offices, Insys allegedly hired “area business liaisons” to assist with the paperwork. “ABLs,” as the indictment says, often worked inside of the doctors’ offices for Insys. One was the girlfriend of a practitioner from Florida. Another was “a woman close to” the practitioner out of Michigan. None of the practitioners was named in the document.
Alec Burlakoff, who served as a regional sales manager and VP of Sales, faces charges of RICO conspiracy, mail fraud conspiracy and conspiracy to violate the Anti-Kickback Law. Babich faces charges of conspiracy to commit racketeering, conspiracy to commit wire and mail fraud, and conspiracy to violate the Anti-Kickback Law.
Throughout the indictment, prosecutors detail Insys’ alleged prescribing incentives in various forms, including speaking fees and high-end food. After a dinner meeting with the doctor out of Michigan, Burlakoff was said to email other execs that they should “expect a nice 'bump' fellas...."
Third on the what-not-to-do list: Don't forge sign-in sheets for speaker events, and when education is promised, education needs to be delivered. And listened to: In previous Insys indictments, sales managers were said to prop a laptop on the sidelines to run a program that everyone could ignore.
“Many speaker events had no attendees at all,” according to the latest indictment. “When this occurred, sales representatives were told to falsify the names of attendees and their signatures on Company sign-in sheets.”
Crazy nights on the town? Could be suspect, particularly if bragged about via text. In one instance, prosecutors said Insys execs hosted another practitioner from Florida in their Arizona headquarters to foster that relationship.