Food Additive Approval Procedures Discourage Innovation

摘要

There are many parallels between what we observe today in the Food and Drug Administration's regulatory regime for food additives and its regulation of other products, Pharmaceuticals and medical devices in particular. I will focus on the impact of legal structure on regulatory performance. By legal structure, I mean what the statutes assigning authority and responsibility to FDA say, not so much what the regulatory policies of the agency are. My point is that to an important extent, those policies are powerfully influenced by the statutory structure, so the focus of my remarks is as much on Congress and the choices it makes as it is on FDA and the choices it makes.