FDA Overview

Slide 13 of 30  

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•In 1937, a public health disaster tragically drove home the need for a stronger federal law. Sulfanilamide, the first "wonder drug" and a popular and effective treatment for diseases like strep throat and gonorrhea, was formulated into an Elixir of Sulfanilamide and marketed for use in children. But the liquid formulation contained a poison, the same chemical used in antifreeze, and it killed 107 people, most of them children. The earlier law did not require the drug's manufacturer to test the formulation for safety before it was sold.
•Congress corrected this weakness in the law the next year when it passed the Federal Food, Drug, and Cosmetic Act. This law, for the first time, required companies to prove the safety of new drugs before putting them on the market. The new act also added the regulation of cosmetics and therapeutic devices, and generally updated the law to improve consumer protection.
•Congress has continued to give FDA new responsibilities over the years, including the requirement that drugs and medical devices be proven effective as well as safe before they can be sold.