Competitors Dispute FDA Exclusivity For Generic Drug

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.

Expert Bio:

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.