Two former pharmaceutical company salesmen have been charged with violating the Anti-Kickback Statute in connection to their participation in a scheme to pay physicians thousands of dollars prescribe millions of dollars' worth of fentanyl.
The two men, Jonathan Roper, a former district manager at the pharmaceutical company, and Fernando Serrano, a former sales representative at the company, were arrested June 9.
Fentanyl is a synthetic opioid that is classified as a Schedule II controlled substance and is approximately 100 times more potent than morphine as an analgesic. Because of the risk of misuse, abuse and addiction associated with prescription fentanyl products, only physicians who have enrolled in a mandated FDA program and completed necessary training are permitted to prescribe it.
The pharmaceutical company where the two charged men used to work gained FDA approval in January 2012 for a fentanyl spray product, which is intended to manage pain in cancer patients who are already receiving and who are tolerant to opioid therapy for persistent pain. To market the fentanyl spray, the drugmaker established a program purportedly aimed at educating healthcare professionals about the product. Physicians who were selected as speakers at the company's speaker programs were allegedly compensated for providing educational presentations to a peer-level audience of healthcare professionals using a preapproved PowerPoint presentation.
However, in reality, many of the speaker programs that Mr. Roper and Mr. Serrano organized and attended were predominantly social gatherings at high-end restaurants in Manhattan that involved no education of the fentanyl spray and no slide presentation at all. Additionally, many of the programs lacked an appropriate audience of healthcare professionals. Mr. Roper and Mr. Serrano allegedly forged sign-in sheets by adding in the names and signatures of physicians who were not present.
In 2014 alone, two physicians selected as speakers by Mr. Roper and Mr. Serrano were paid $147,000 and $112,000 in speaker fees, respectively. During this time period, those two physicians were also the two largest prescribers of the fentanyl spray in the U.S., prescribing, respectively, over $2 million and $3 million worth of the product. Approximately $1 million worth of fentanyl spray was reimbursed by Medicare.