The Kefauver-Harris Drug Amendments
These amendments to the 1938 Food, Drug and Cosmetic Act were compelled into law in large part because of the use of Thalidomide which produced thousands of deformed new-born babies. The new law mandated efficacy as well as safety before a drug could be marketed, required FDA to assess the efficacy of all drugs introduced since 1938, instituted stricter agency control over drug trials (including a requirement that patients involved must give their informed consent), transferred from the Federal Trade Commission to the FDA regulation of prescription drug advertising, established good manufacturing practices by the drug industry, and granted the FDA greater powers to access company production and control records to verify those practices.