Historical Background

• The regulation of drugs in the United States began with the Import Drugs Act of 1846, enacted after Mexico sold the US Army tainted drugs to treat malaria.

• In 1906, the Food and Drug Administration (FDA) was formed, primarily to regulate commerce and to combat the then rampant adulteration (made harmful or less valuable) of foods and drugs.

• The FDA was not concerned with safety until 1938, following the unnecessary deaths of 107 children from a new drug preparation. This led to laws requiring drugs be proven as safe before they were allowed on the market.

• The last major change was the provision of the FDA in 1962 that drugs be proven to be effective as well as safe before they could be used.

• Today, the FDA continues to regulate all drugs sold in this country, both by insuring that they are safe and effective in what they do before they are released and by limiting their distribution by deciding which medications require a prescription to be sold.