Restricting Access to Non-Psychoactive Medications: Public Health Necessity or Disabling Professional Prerogative?

An obscure regulation issued in 1938 and its codification into the law in 1951 as an amendment to the Food, Drug and Cosmetic Act are identified as the pivotal events that have allowed the Food and Drug Administration to restrict public access to non-psychoactive medications approved for human use in the United States. The assumptions of the framers of this legislation are analyzed, and the validity of these assumptions is evaluated. Moral entrepreneurs within the FDA lost faith in the capacity of private companies to serve the medicinal needs of the nation and in the ability of consumers to make informed decisions about medications and appointed physicians as the purchasing agents for consumers. The effects of this decision on the delivery of health care services and on the practice of self-medication in the United States are discussed.