This case involves a Food and Drug Administration (FDA) exclusivity dispute surrounding the development of a generic drug. On the same day, 2 pharmaceutical companies submitted abbreviated new drug applications for the same generic drug. An expert in FDA regulations with experience working in the office of generic drugs was sought to discuss the approval process for generics and determine the proper eligibility for generic drug exclusivity.
Question(s) For Expert Witness
- 1. Have you ever worked for the FDA? Please explain.
- 2. Can you describe your experience with FDA approval processes?
Expert Witness Response E-159741
I was the head of the chemistry division for the office of generic drugs. I also headed up their generic drug inspection program at the FDA for a time. Since then, I have held various roles at big pharmaceutical companies where I’ve continued to consult on processes for the FDA.
This highly qualified expert is a former FDA executive with global industry experience in product development, quality management, and regulatory compliance for drugs, biologicals, and medical devices. He earned both a bachelor’s and master’s in pharmacy and his PhD in pharmaceutics. Formerly, he acted as the executive vice president and general manager for the strategic regulatory division of a health technology consulting company. He had an extensive career at a large pharmaceutical company, serving as their corporate vice president for both the corporate regulatory and quality science division and the quality and regulatory division.
Expert Witness Response E-163481
I worked at the FDA for nearly 20 years. I reviewed applications for 7 years in the office of generic drugs and lead policy development for 10 years in the office of pharmaceutical science and the center for drug evaluation and research. I have also served as an expert witness in several similar cases.
This highly qualified expert received his bachelor’s degree in chemistry from a Big Ten university and his master’s degree in chemistry from a reputable research university. He previously worked as a chemist, then went on to work as a review chemist for the Food and Drug Administration. He subsequently worked as an electronic submission expert in the FDA’s office of information management. He also served as the FDA associate director of regulatory policy for drug evaluation and research. He is currently a consultant at his own pharmaceutical consulting firm.