Development of Medications for Addictive Disorders

Abstract

The development of medications in the United States is regulated by the Food and Drug Administration (FDA) under the authority granted by the Federal Food Drug and Cosmetic Act (FFDCA). The regulatory powers of the FDA have evolved due to both catastrophic events and technological advances which led to amendments in the FFDCA. The original enactment of the FFDCA occurred in 1906 and prohibited adulterated food or drugs from interstate commerce. The next major development that influenced the current system was the sulfanilamide elixir tragedy in 1938. This untested medication proved fatal in 107 cases before it was removed from the market. The FFDCA was amended to authorize the FDA to require premarketing approval of a new drug product. Manufacturers were required to file New Drug Applications (NDAs) containing evidence that a drug was safe for its claimed use.