Adverse Drug Reactions: Harnessing Experiential Data to Promote Patient Welfare

Abstract:     
Part I of this Article evaluates the pre-approval and post-approval regulatory framework governing prescription drugs, and the FDA's spontaneous reporting system for adverse events, as it contrasts that system with the regulatory mechanisms used to monitor risks associated with other products. Part II summarizes the recent series of prescription drug marketing withdrawals prompted by reports of unexpected adverse reactions. Finally, Part III offers some possible solutions designed to improve the efficiency of post-approval surveillance so that fewer patients will suffer the consequences of unexpected adverse drug reactions and interactions. This Article concludes that the existing regulatory system requires fundamental reprioritization and more substantial structural reforms in order to avoid a troubling replay of recent prescription drug withdrawals. The proposed reforms may help to enhance a physician's ability to provide quality patient care based on optimal knowledge of the safety and efficacy of pharmaceutical products.

Number of Pages in PDF File: 56

Keywords: adverse drug reactions, health law, food and drug law, health law

Accepted Paper Series