The FDA and the Practice of Medicine

Until recently, there has been a generally accepted difference in federally mandated labeling practices between over-the-counter drugs and physician-prescribed medications. Traditionally, the federal Food and Drug Administration (FDA) has required the labeling of only nonprescription drugs obtainable directly by the public. Responsibility for access to, and information dispensed with, potentially harmful or habit-forming drugs has been left with the individual physician by the requirement of a prescription. Implicit in this restricted access to certain drugs and devices in the "by-prescription-only" mechanism has been the assumption that this was an effective safeguard for the public health.The FDA obviously thinks otherwise . . .