Date of Award
Spring 2021
Degree Name
Bachelor of Arts
Department
Historical & Political Studies; College of Arts & Sciences
First Advisor
Angela Kachuyevski
Abstract
This research questions the impact that the Prescription Drug User Fee Act (PDUFA) has had on the Food and Drug Administration (FDA). The FDA is a regulatory system that was established in 1938 and created in order to manage and regulate standards related to food and drugs and to ensure that these standards are being followed by individuals and firms. The PDUFA was legislated in 1992 in order to provide more resources to the FDA through user fees. While the PDUFA was enacted in order to help the FDA process applications of new drugs and medicines and review standards more quickly, the PDUFA may have had unintentional negative effects on the role of the FDA and the way in which it operates. Using pattern matching, I operationalize concepts of responsibility, regulatory, and efficiency as indicators. By looking at and investigating academic research and governmental data, I find that the PDUFA has had negative impacts on the FDA’s responsibility, regulatory power, and efficiency.
Recommended Citation
Ravin, Gabriella, "The Impact of the Prescription Drug User Fees Act (PDUFA) on the Food and Drug Administration (FDA)" (2021). Capstone Showcase. 5.
https://scholarworks.arcadia.edu/showcase/2021/pgl/5
The Impact of the Prescription Drug User Fees Act (PDUFA) on the Food and Drug Administration (FDA)
This research questions the impact that the Prescription Drug User Fee Act (PDUFA) has had on the Food and Drug Administration (FDA). The FDA is a regulatory system that was established in 1938 and created in order to manage and regulate standards related to food and drugs and to ensure that these standards are being followed by individuals and firms. The PDUFA was legislated in 1992 in order to provide more resources to the FDA through user fees. While the PDUFA was enacted in order to help the FDA process applications of new drugs and medicines and review standards more quickly, the PDUFA may have had unintentional negative effects on the role of the FDA and the way in which it operates. Using pattern matching, I operationalize concepts of responsibility, regulatory, and efficiency as indicators. By looking at and investigating academic research and governmental data, I find that the PDUFA has had negative impacts on the FDA’s responsibility, regulatory power, and efficiency.