ABSTRACT
In recent years, a series of prescription drugs were pulled from the marketplace due to safety problems. Table 1.1.1 lists drugs recalled by the U.S. Food and Drug Administration (FDA) between 1993 and 2000, and their reasons for recall. As it can be seen from Table 1.1.1, the most commonly seen reasons for recalls were safety concerns regarding cardiac/ cardiovascular problems and liver toxicity/failure. This has renewed concerns that the drug development and regulatory approval process moves too quickly. In the United States, however, drug development is a lengthy and costly process. On average, it takes about 12 years to obtain regulatory approval for a new drug. The cost is estimated to be approximately 300 to 450 million U.S. dollars. In many cases (e.g., the development of drug products for severe or life-threatening diseases such as cancer and AIDS), it has been criticized that the drug development and regulatory process takes too long for a promising drug product to benefit patients with severe or life-threatening diseases. The lengthy and costly process of drug development is necessary, not only to ensure that the drug under investigation is efficacious and safe before it can be approved for use in humans, but also to assure that the drug product meets regulatory requirements for good drug characteristics of identity, strength (or potency), purity, quality, stability, and reproducibility after the drug is approved.
