Highly trained scientists and experts want to do more with their careers than crank out reviews, so many leave within three years, preventing the agency from building an institutional memory of previous reviews. Staff turnover can be disruptive for the industry as well. In addition to the current impacts of the user fee program on FDA's activities, Suydam worries about the future. Several recent studies by the University of California at San Diego, Anderson Consulting and PriceWaterhouseCoopers have tried to look into the future and predict how the drug development process will evolve and how FDA will need to respond. The studies predict that the pharmaceutical industry will quadruple the annual output of new drugs while reducing development time to market by one-third.
NMEs are chemically unique drugs that are completely different than any other drug on the market.
These compounds require additional scrutiny since there are no similar drugs to which they can be compared. For example, a fast-follower might have a similar therapeutic effect but reduced side effects. Computer technologies will improve the predictive modeling of new drugs, and computer simulations will optimize clinical trial design and increase the amount of clinical information collected. Finally, information technologies will streamline electronic submissions to the agency. To make this work, FDA reviewers will need to spend more time advising companies about protocol design and making themselves available for an ongoing dialogue throughout the drug development process.