신약승인체계에 대한 미연방 식품의약품청의 규제

Abstract

Before a new therapeutic drug can be commercialized in the United States, it must meet the safety and effectiveness requirements of the Food and Drug Administration (FDA). Therefore, it is virtually impossible to put a new drug on the market without FDA's review and approval. In consequence, FDA is routinely blamed for delays in the availability of useful new drugs, and is sometimes charged with preventing access altogether. The expense of the studies FDA requires before granting approval coupled with the substantial time spent conducting these studies and waiting for agency approval is among the common explanations for the cost of new drugs. Thus, the current statutory criteria and administrative procedures for approval of drugs, which have been the causes of increasing health care costs and delays of using new drugs, have become target for would-be reformers. The FDA's regulation on drugs started with the Federal Food and Drugs Act of 1906. Now, the Federal Food, Drug and Cosmetic Act(FD&C Act) plays a role in the regulation of drugs as a general statute after suffering numbers of amendments. In this article, I accept the reformers' hypothesis that legal structure has a critical bearing on the rate of new product introduction, and on the cost of those products that are introduced. According to this acceptance, I recount the evolution of these standards and procedures and, in the process, seeks to identify the activities of Congress and FDA that have influenced this evolution. In doing so, especially, I focus on the efforts of Congress and FDA that have attempted to improve the contents and problems of new drug approval in 1962 Amendment. As a consequence, I reveal that Congress has amended FD&C Act all the time in order to meet the safety and effectiveness requirements for pre-marketing and post-marketing new drugs. On top of that, FDA's effort to improve the approval procedures more efficiently would be suggested.