The review programs supported by user fees have more resources, while other parts of FDA, divisions with important public health missions, often go without. FDA's budgetary statistics show that as user fees flowed into the agency, appropriations to support other activities have remained unchanged or have declined. Meanwhile, funding for other programs, from color additives in foods to post-market surveillance to manufacturer and import inspections, has drifted downward. Balancing Benefits and Costs Even in user fee-funded operations, the additional resources have come at a cost. 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.