“Optimizing the Interaction Between the Food and Drug Administration and the Industry” The Need for Cooperation for the “Public Good”

Abstract

It is a pleasure for me to be a speaker at this conference, to share the podium with a friend and former colleague, Merve Schumate, of the FDA and also to have the opportunity to appear for the first time with Dr. Parariello of Wyeth Laboratories. The title for this morning's session, “Optimizing the Interaction Between the Food and Drug Administration and the Industry”, is an interesting one. As I was preparing my remarks, I wondered if they would be different if I was giving this talk to an FDA seminar at the agency or at the Public Citizen Litigation Group, Nader's organization. If I was talking to Dr. Sidney Wolf of the Litigation Group, I m sure that his optimization plan between FDA and the Industry would be tied to the concept of having open files, everything in writing and memoranda for all meetings. I feel fairly certain that Dr. Wolf would wish to have the opportunity to have either himself or one of his colleagues attend any of the meetings that they thought worthy of their time and effort. Now if I was an FDA reviewer and was talking about optimizing the interaction, I would see Industry representatives submitting well researched NDA files and supplements. These Industry representives would quickly understand and appreciate the wisdom of my request for additional studies, more data for the NDA, and the use of certain terms and concepts in relationship to labeling and promotional activities. They would find my suggestion of a patient package insert to be extremely helpful. On the other hand, if I were to become one of Dr. Papariello's researchers, I'm sure that I would see optimization of the system occur when my explanation to the FDA reviewer was quickly understood, all my views on the relationship of the data to the study submitted were accepted without question, and the agency looked most favorably on everything that was submitted to support the application.