Recently I had the pleasure of sitting down at length with Dr. David Kessler to discuss some of the challenges in the current regulatory environment. In general, throughout the discussion, we talked about how things had changed since his time as FDA Commissioner from 1990-1997.
One of the trending changes we touched on in Part 1 of our interview was the fact that there is a great deal being demanded in general of the agency. In Part 2, we focused on the fact that, as the FDA is already regulating about one-fourth of the economy, and that there is the possibility of increased expansion into food authority with the potential passage of the Food Safety Modernization Act.
In Europe, the European Medicines Agency is focused on just that – medicine. In the U.S., the FDA regulates everything from cosmetics to veterinary products to drugs to biologics to medical devices and yes, food, for which it shares responsibility with other agencies in the federal structure. At the same time, headlines are filled with news of food recalls, greater complexities in labeling and even consideration of new genetically modified foods. Can or should FDA do it all?