This case involves a pharmaceutical company allegedly involved in a widespread kickback scheme in which they were paying physicians to prescribe an opioid pain medication. It was suggested that the company fraudulently marketed this drug for off-label use and employed improper warning practices when promoting the drug. An expert was sought to opine on the research related to the speaker programs many big pharma companies have implemented, along with the potential relationship between the drug’s promotion and kickback programs for physicians.
Question(s) For Expert Witness
- 1. Can you speak to the research completed on speaker programs, promotions, and physician kickbacks?
- 2. Have you ever published or lectured on this topic?
Expert Witness Response E-007900
For several decades, one of my key areas of research, publication, and invited lectures has been the ethical and legal implications of healthcare’s changing economics. I have also focused on some of the ethical and legal challenges found in human clinical research. Together, those have converged periodically into an exploration of the conflicts of interest created by certain forms of marketing for drugs and devices. I have some knowledge of relevant statutory and regulatory governance regarding kickbacks, though I would not consider myself to be a legal expert in the field. I am also aware that FDA is reviewing and potentially modifying its regulations regarding advertising of off-label uses for otherwise-approved drugs and devices. In the past several decades, a number of research studies have been done exploring the effects on physicians of various forms of marketing, ranging from all-expense-paid trips to exotic destinations, to simple promotions such as modest meals, notepads, and pens. I have published and lectured on this topic, and I serve on a relevant committee at a southeastern health science center.