ABSTRACT
The research, development, and approval of a drug product is a lengthy process involving drug discovery, laboratory development, animal studies, clinical trials, and regulatory registration. This lengthy process is necessary to assure the efŒcacy and safety of the drug product. In the United States, however, no regulations were put forth until the Pure Food and Drug Act was passed by the Congress in 1906. The purpose of this Act is to prevent misbranding and adulteration of food and drugs, yet it does not give the government any authority to inspect food and drugs. The Act was amended in 1912 (the Sherley Amendment) to prohibit labeling medicines with false and fraudulent claims. In 1931, the United States Food and Drug Administration (FDA) was formed. The provisions of the FDA are intended to ensure that (1) food is safe and wholesome, (2) drugs, biological products, and medical devices are safe and effective, (3) cosmetics are unadulterated, (4) the use of radiological products does not result in unnecessary exposure to radiation, and (5) all of these products are honestly and informatively labeled (Fairweather, 1994). The concept of testing marketed drugs in human subjects did not become a public issue until the late 1930s when the Elixir Sulfanilamide disaster occurred. The disaster was a safety concern of a liquid formulation of a sulfa drug which caused more than 100 deaths. This drug had never been tested in humans before its marketing. This safety concern led to the pass of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938. The FD&C Act extended its coverage to cosmetics and therapeutic devices. More importantly, the FD&C Act requires the pharmaceutical companies to submit full reports of investigations regarding the safety of new drugs. In 1962, a signiŒcant Kefauver-Harris Drug Amendments to the FD&C Act was passed, which not only strengthened the safety requirements for new drugs but also established an efŒcacy requirement for new drugs for the Œrst time. In 1984, the Congress passed the Price Competition and Patent Term Restoration Act to provide for increased patent protection to compensate for patent life lost during the approval process. Based on this Act, the FDA was authorized to approve generic drugs through the evaluation of bioequivalency on healthy
male subjects. In addition, the FDA also has the authority for designation of prescription drugs or over-the-counter (OTC) drugs.
