ABSTRACT
The regulation of foods and drugs has had a relatively long and checkered history, leading up to the present-day rules and regulations of the Food and Drug Administration (FDA). Drugs were never regulated in the United States until 1906. In the previous year, Sinclair Lewis had published his book The Jungle, detailing abuses in food preparation and handling at the Chicago Stockyards, and the book attracted widespread public attention. The passage of the Pure Food and Drugs Act in 1906 marked the beginning of the federal regulation of drugs. However, the major emphasis in this legislation was not upon drugs, but upon the adulteration of foods. The legislation also gave the government authority to control the accurate labeling of drugs, but did not mandate controls over drug advertising, testing, or the contents of the drug. The present-day FDA was not created until 1938 (Office of Technology Assessment 1993). In 1938, Congress enacted the Food, Drug, and Cosmetic (FDC) Act, the most important provision of which was that a drug now had to be considered safe for the use that was suggested on the label before it could be marketed; and the FDA was given the authority to judge safety. The Act also increased the government’s control over the advertising and labeling of foods, drugs, and cosmetics. Because of the provisions in the Act, drug companies then began premarket testing, but the FDA did not yet specify the necessary procedures for premarket testing. The next phase in the federal regulation of drugs was the 1962
Amendments to the FDC Act of 1938. These amendments were particularly controversial because of their testing stringency (and consequently, greater monetary costs for pharmaceutical firms), compared to previous forms of federal drug regulation. First of all, the emphasis upon drug safety was accentuated by the formal establishment of safety thresholds in mandating three phases of drug testing. Second, for the first time, they required that the drug firms prove that a drug was effective in treating a condition that it said the drug was supposed to be treating. Third, the drug had to be shown to be both, safe and effective before it could be marketed, creating a very large amount of premarket testing and paperwork for drug companies. Over time and into the year 2006, these premarketing tests have become more encompassing and increasingly expensive (DiMasi, Hansen, and Grabowski 2003).
