Pharmaceutical Company Allegedly Involved In Opioid Kickback Scheme

Case Overview

This case involves the alleged improper marketing of a particular opioid pain medication by a defendant pharmaceutical company. The allegations claimed that the defendant fraudulently marketed the drug in question for off-label uses and that the defendant was negligent in their warning practices. The suit further alleged that the pharmaceutical company was involved in a wide-spread kickback scheme in which they were paying physicians to prescribe the drug.

Questions to the FDA Regulations expert and their responses

Please briefly describe your experience in fraud investigation as it pertains to pharmaceutical companies.

As an FDA official, I work to identify and prevent fraudulent promotional campaigns and targeted marketing. I have a great deal of experience reviewing promotional materials, professional publications, as well as print and TV media ads related to FDA-regulated products. As a federal investigator, I also participated in joint investigations (with the FBI and Postal Service) of fraud cases related to illegal manufacture and distribution of steroids, contraception and erectile-dysfunction medications. I have also worked undercover to capture illegal marketing of silicone filler and collagen by dermatologists and plastic surgeons. I am familiar with the many ways that drugs are detailed off-label by reps, and have intercepted such sales campaigns related to Retin-A, steroids, NSAIDS, and a few other drugs. Lastly, I am very familiar with the manufacturing process and patch delivery system.

Are you able to opine on the alleged fraud committed by the defending pharmacy company?

I am familiar with the many ways that drugs are detailed off-label by reps, and have intercepted such sales campaigns related to Retin-A, steroids, NSAIDS, and a few other drugs.

About the expert

This expert has been involved in FDA regulated industries for over 25 years. A former FDA Field Investigator, she independently carried out assignments covering the full range of industries under the FDA's jurisdiction and specialized in pre-approval inspections. This expert regularly presents at national and international conferences on regulatory issues, drug development and approval, and Good Lab, Manufacturing, and Clinical Practices. She is also the author of a comprehensive textbook on compliance for pharmaceuticals, medical devices, and biologics. Currently, this expert is the president and principal of her own consulting firm, where she is an international consultant to FDA regulated industries and continues to assist in the development and successful approval and commercialization of hundreds of products.