REGULATORY REQUIREMENTS FOR APPROVAL FASTTRACK DRUGS AS PER US GUIDELINES

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. AIDS, Alzheimer's, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions. Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy. Advancing the health of Americans through the development of safe and effective new drugs is an imperative at the heart of FDA's mission. The infusion of resources provided through industry user fees has enabled FDA to adapt to rapid advances in science and to dramatically cut drug review times to speed promising therapies to patients. In the 21st century, FDA is the fastest drug review agency in the world. FDA has worked effectively to implement flexible review practices without lowering the agency's standard for drug efficacy. This flexibility has translated into a historically high proportion of drug approvals on the first regulatory review cycle, increasing predictability for drug developers. These changes resulted in faster drug review times relative to other regulatory authorities and an increasing proportion of new medicines being introduced in the U.S. first, allowing for earlier access to innovative treatments. Recently, rapid advances in our understanding of human biology and the underlying mechanisms of some diseases have offered many new potential targets for medical product development. But we still have a long way to go in understanding the full range of diseases that confront Americans and in developing the scientific tools necessary to translate scientific discoveries into treatments and cures. Discussions are currently underway on how to close the gap between the discovery and delivery of innovative products. With so much progress already achieved at the product review stage, more attention is being focused on early stage development and the clinical trials process. While changes are appropriate and important, none should lower FDA's evidentiary standards, otherwise patients would be exposed to unreasonable and unnecessary risks associated with insufficient information. The agency looks forward to continuing to work with others, including Congress, industry, academia, patients and advocacy groups, on these issues. Keywords: Fast track, FDA, AIDS, Alzheimer's, heart failure