FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam

Since the passage of PDUFA, how have user fees impacted drug review?

1. They have slowed down the review process

2. They have helped expedite the drug review and approval process

3. They have no effect on the review process

4. They have increased the cost of new drugs

The correct answer is: They have helped expedite the drug review and approval process

User fees, established under the Prescription Drug User Fee Act (PDUFA), have significantly contributed to expediting the drug review and approval process. When pharmaceutical companies submit new drug applications to the FDA, they also pay fees that provide the agency with additional resources. This funding allows the FDA to hire more staff, enhance training, and improve technology—overall increasing the efficiency and capacity of the review process. The additional resources enable the FDA to reduce the backlog of applications and shorten the time required to complete reviews. As a result, drugs can reach the market more quickly, which is particularly beneficial for patients who need access to new therapies. This swift review process reflects the intent of PDUFA, which was designed in part to address delays experienced prior to the act’s implementation. Thus, the impact of PDUFA user fees is profoundly positive in enhancing the drug development timeline, allowing for faster patient access to new treatments while maintaining necessary safety and efficacy evaluations.