How Have User Fees Affected the FDA?

Some policy experts answer that question by arguing that budget constraints contributed to regulatory delays in the past. The reform simply relaxed those constraints by increasing the resources for new-drug review. However, there is little empirical evidence to suggest that changes in the fda’s budget influenced regulatory delays and the speed of review prior to user fees. Other policy experts claim that the adoption of user fees altered bureaucratic motivations in the fda by providing new economic rewards and creating new political pressures to accelerate review. Still others claim that politicians are using their control over agency financing to influence regulatory behavior. Those claims will receive increased attention this year as the fall deadline approaches for Congress to renew the user fee program. With the fee set at about $310,000 (in 2001) for each new-drug application and strong market demand for innovative new drugs, there is much at stake in the debate over the program’s reauthorization.