Food and Drug Administration's Drug Approval Process

Although the law provides that the Food and Drug Administration (FDA) must make a decision on a new drug application (NDA) within 180 days after an NDA is filed, a review of the process used by the FDA for approving new medical drugs for marketing in the United States showed that the 180-day review time is generally not met. The average approval time for 80 NDA's approved in fiscal year 1978 was 34 months. Some reasons for delay are: FDA guidelines are vague regarding the documentation to be submitted with an NDA; there are frequent changes of NDA reviewers before the processing of an application is completed; scientific disagreements occur between FDA and industry; and communications from FDA to industry are slow or inadequate. There was an uneven distribution of workload among FDA reviewers. A comparison of the drug approval system of the United States with systems in other countries showed major differences in: the use of expert committees; post-marketing surveillance; the use of foreign test data to support safety and effectiveness of a drug; flexibility in restricting the use of drugs; and review of marketed drugs. Also, the computer resources of FDA have not been adequately used to support FDA reviewers.