The Drug Regulatory System of the United States Food and Drug Administration: A Defense of Current Requirements for Safety and Efficacy

Abstract

The 1962 Amendments to the Food, Drug, and Cosmetic Act have substantially increased the accountability of manufacturers of new drugs, both by raising standards for clinical testing as well as requiring, for the first time, a demonstration of proof of efficacy. Critics of the new regulatory system of the Food and Drug Administration (FDA) which imposes the requirements, have called for the repeal of the new standards on the grounds that they are stringent to the point of being counterproductive, reflect an unwarranted and excessive concern over drug safety, and have jeopardized the position of the U.S. in the worldwide development of new drugs. The author defends the regulatory system against these criticisms by demonstrating the importance of the scientific standards it has deemed essential for evaluating and approving new drug applications. Evidence of tragedy caused by inefficacious and unsafe drugs used in other countries but not in the U.S. supports FDA concern over safety and efficacy, and indicates that through its caution, the U.S. has doubtlessly been spared similar tragedy. Finally, worldwide trends in new drug development are investigated and it is shown that many factors are involved in the variation in the number and variety of drugs introduced in the marketplace of any given country which have nothing to do with its regulatory policies. It is concluded that FDA's regulatory system serves to assure the safety and efficacy of all drugs introduced into this country, while at the same time, continues to support and encourage the development of significant new drugs.