Written Patient Information on Prescription Drugs: The Evolution of Government and Voluntary Programs in the United States

Abstract

This paper describes the evolution of written patient information on prescription drugs, FDA's patient package insert proposal and its revocation before its implementation in the early 1980s, the status of voluntary and government efforts since that time, and a review of current trends in this area. The burgeoning practice of direct-to-consumer advertising of prescription drugs in the lay press is viewed within the context of these efforts. This paper also reviews the current developments in certain FDA regulated consumer products—over-the-counter drug labeling and nutrition labeling. The current state of patient information in the United States is reviewed in light of programs to improve prescription drug counseling, and current research in this area is discussed.