In 1937, when diethylene glycol was used as a solvent in the preparation of a medicinal product, an elixir of sulfanilamide, resulting in deaths, public outcry hastened the promulgation of an act that had been in preparation in the USA for several years, but which had met with opposition from pharmaceutical companies. The 1938 Food, Drug, and Cosmetics Act, as it was known, gave greater powers to the then recently formed Food and Drug Administration (FDA) in regulating the contents of medicinal formulations. Nevertheless, although similar regulatory systems have since been established around the world, episodes of poisoning with diethylene glycol in pharmaceutical formulations, whether deliberately included adulteration or as a contaminant, continue to be reported, generally in developing countries, usually affecting children, and often causing deaths.
Food and Drug Administration (FDA), agency of the U.S. federal government authorized by Congress to inspect, test, approve, and set safety standards for foods and food additives, drugs, chemicals, cosmetics, and household and medical devices. First known as the Food, Drug, and Insecticide Administration when it was formed as a separate law enforcement agency in 1927, the FDA derives the greater part of its regulatory power from four laws: the Federal Food, Drug, and Cosmetic Act, which established safety and purity standards and provided for factory inspection and for legal remedy; the Fair Packaging and Labeling Act, which required honest,
In recent decades, U.S. and foreign biopharmaceutical companies (makers of drugs that are based on chemical compounds or biological materials, such as vaccines) and medical device manufacturers have been responsible for many cures and advances in treatment that have benefited patients’ lives. New cancer treatments, medical devices, and other medical discoveries are being made at a rapid pace.