People have always been concerned about the quality of the products they use—especially those products that are consumed or used for medicinal purposes. Regulation of medicinal products began with inspection of imported drugs in 1848 when Congress passed the Drug Importation Act, requiring the US Customs Service to stop entry of adulterated drugs from overseas. The Federal Food and Drugs Act introduced in 1880 and later authorized by Congress in 1906, prohibited misbranded and adulterated foods and drugs in interstate commerce. There were many shortcomings with the Federal Food and Drugs Act such as evaluating the safety and efficacy of drug products, however, and FDA did not have enough regulatory discretion to carry it out; a complete revision was recommended.
Empowering FDA and shaping regulation
Depending upon the severity of adverse health consequences, recalls are divided into three classes. Class I is the most serious, sometimes based on death; Class II is based on temporary or medically reversible health consequences; and Class III is based on low likelihood of health consequences. Instead of recalls, market withdrawal can also occur in which the firm removes the product from the market or corrects the violation (3). Numerous voluntary recalls by manufacturers have resulted from failure to produce the drug products according to quality standards. Several times, all the drug products from a manufacturer were recalled because of substandard manufacturing conditions in the firm. (4, 5).
The 1951 Durham-Humphrey Amendment ensured that a prescription drug dispensed without a prescription be treated as a "misbranding" by FDA (6). The thalidomide crisis of 1960–61 in which thousands of babies were born with phecomelia deformities, mostly in Europe because the product was not approved in the United States, led to further amendments for drug effectiveness studies. Several products were grandfathered for effectiveness studies by the sponsor, and FDA was authorized to apply the 1962 Drug Efficacy Study Implementation amendment to those drugs. The amendment to the FD&C Act, called the Kefauver-Harris Amendment, also tightened safety standards (7). Another significant act of the last 30 years was promulgated as the Hatch-Waxman Act (1984) (8). This act allowed companies to market generic versions of approved brand products. As a result, preclinical and clinical studies were waived for many generic products.
A generic product is deemed comparable to the brand product if the dosage form, strength, route of administration, quality and performance characteristics, and intended use are deemed similar. FDA's Orange Book lists all agency-approved products as new drug applications (NDAs), abbreviated new drug applications (used for generics), and nonmonograph over-the-counter products. It also indicates when or whether a product is substitutable for an NDA.