Consumer groups around the world are increasingly alarmed at the World Trade Organizations incursion into domestic regulatory matters. While a growing number of people are becoming familiar with how the WTOs controversial dispute resolution system can directly impact domestic law and regulation, what is less understood is that the WTO-promoted mechanisms of harmonization, mutual recognition and equivalency can have an equally significant impact. This presentation will discuss FDAs experience with harmonization and mutual recognition and the implications of these activities for open, democratic and accountable governance.