The Dividing Line Between the Role of the FDA and the Practice of Medicine: A Historical Review and Current Analysis

Abstract

Over the years, the Food and Drug Administration ("FDA") has consistently asserted that it does not regulate the practice of medicine (the "Practice of Medicine Exception") . This prohibition has never been specifically set forth in the statutory scheme which guides the FDA's action. However, the Practice of Medicine Exception has been inferred from the Congressional intent expressed in the legislative history. Although the FDA purports to maintain this exception, the reality is that agency action certainly affects medical practice.