It takes an average of 15 years from the moment a manufacturer first approaches the Food and Drug Administration (FDA) with an idea for a new drug to its final approval for marketing. For drugs and biologics that address unmet needs or serious diseases or conditions, FDA regularly uses three formal mechanisms to expedite the development and review process: Fast Track product development, Priority Review, and Accelerated Approval. Accelerated Approval involves different concerns than do the other programs designed to speed the normal process for important new products, and therefore this paper will not discuss it further. FDA's Web pages on the use of its Fast Track and Priority Review programs provide the review times for successful applications. If an application is assigned to one year in the Fast Track column and to another in the All Priority column, for example, relying on the annual median approval times could distort the comparisons. The other categories, however, overlap. For seven of the nine years, median Fast Track times were shorter than Priority Reviews, suggesting that Fast Track may have reduced time-to-market beyond the shortening of review time afforded by Priority Review.
By statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration (FDA) works with several overlapping yet distinct programs to get to market quickly new drug and biological products that address unmet needs. FDA most frequently uses three mechanisms for that purpose: Accelerated Approval, Fast Track, and Priority Review. The first two affect the development process before a sponsor submits a marketing application. Accelerated Approval allows surrogate endpoints in trials to demonstrate effectiveness and is relevant in fewer situations than the others. The Fast Track program encourages a sponsor to consult with FDA while developing a product. Unlike the others, Priority Review involves no discussions of study design or procedure; it relates only to an application's place in the review queue. Analysis of total approval time for approved applications under the Fast Track and Priority Review programs shows that for seven of the past nine years, Fast Track products have shorter median approval times than do all those applications assigned to Priority Review.