Abstract
Purpose. The purpose of this study was to assess the impact of the FDA's regulatory review policy for prescription drugs approved prior to, and following the implementation of PDUFA. Theoretical framework. The integration of two theoretical models, bounded rationality and the politics and public administration dichotomy, establishes the basis for empirical research of prescription drug regulation policy. Bounded rationality provides insight on the resource and information constraints that may affect FDA's decision-making processes. The politics and public administration dichotomy model sheds light on FDA's broad discretionary power in the approval of prescription drugs. Also relevant is political control theory that suggests the FDA balances its broad discretionary powers with its accountability to protect the U.S. public health. An additional conceptual construct, referred to as the reactive model, describes the reactive nature of prescription drug regulation development in the U.S. and the FDA risk-benefit decision-making process during pharmacovigilance surveillance. Methodology. This is an ex post facto study that evaluated the access and safety of new prescription drugs submitted to the FDA prior to, and following, the implementation of PDUFA. Nonparametric techniques, analysis of variance, summary statistics, and case study methodologies were employed. Findings. PDUFA significantly decreased the mean FDA review times of prescription drugs overall and across the covariates of interest. Additionally, PDUFA did not result in an increase of postmarketing adverse events. There was a slight increase in the rate of withdrawals observed following the implementation of PDUFA (3.6% [n = 6] versus 2.1% [n = 3] pre-PDUFA). Case studies of the nine withdrawn products during the time period covered by this study revealed the adverse events responsible for the withdrawals were rare such that detection in the licensing-enabling clinical programs was extremely unlikely and emphasized the importance of postmarketing pharmacovigilance. Conclusions and recommendations. This study demonstrates that the implementation of PDUFA was successful in bringing prescription drugs to the medical community faster while not increasing risk to the public safety. Additional studies that evaluate the FDA review process, including the pharmacovigilance of marketed products, are warranted and need to be conducted in pursuit of optimizing the U.S. public health.