Drug Development And Its Regulation Drug Regulation

The history of drug regulation in the U.S. reflects the growing involvement of governments in most countries to ensure some degree of efficacy and safety in marketed medicinal agents. The first legislation, the Federal Food and Drug Act of 1906, was concerned with the interstate transport of adulterated or misbranded foods and drugs. There were no obligations to establish drug efficacy and safety. This act was amended in 1938, after the deaths of 105 children that resulted from the marketing of a solution of sulfanilamide in diethylene glycol, an excellent but highly toxic solvent. The amended act, the enforcement of which was entrusted to the FDA, was concerned primarily with the truthful labeling and safety of drugs. Toxicity studies, as well as approval of a new drug application (NDA), were required before a drug could be promoted and distributed. However, no proof of efficacy was required, and extravagant claims for therapeutic indications were made commonly.

In this relatively relaxed atmosphere, research in basic and clinical pharmacology burgeoned in industrial and academic laboratories. The result was a flow of new drugs, called "wonder drugs" by the lay press. Because efficacy was not rigorously defined, a number of therapeutic claims could not be supported by data. The risk-to-benefit ratio was seldom mentioned but emerged dramatically early in the 1960s. At that time, thalidomide, a hypnotic with no obvious advantage over other drugs in its class, was introduced in Europe. After a short period, it became apparent that the incidence of a relatively rare birth defect, phocomelia, was increasing. It soon reached epidemic proportions, and retrospective epidemiological research firmly established the causative agent to be thalidomide taken early in the course of pregnancy. The reaction to the dramatic demonstration of the terato-genicity of a needless drug was worldwide. In the U.S., it resulted in the Harris-Kefauver Amendments to the Food, Drug, and Cosmetic Act in 1962, which require sufficient pharmacological and toxicological research in animals before a drug can be tested in human beings. The data from such studies must be submitted to the FDA in the form of an application for an investigational new drug (IND) before clinical studies can begin. Three phases of clinical testing have evolved to provide the data that are used to support an NDA. Proof of efficacy is required, as is documentation of relative safety in terms of the risk-to-benefit ratio for the disease entity to be treated.

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