title: FDA Adverse Event Reporting System: Recruiting Doctors to Make Surveillance a Little Less Passive.
abstract: Within the last few decades, a shift has taken place in FDA's approach to drug development, with greater emphasis put on postmarketing data collection and less on the traditional premarketing scheme. The FDA Adverse Event Reporting System (FAERS) is the primary system for collecting Adverse Events, but has been criticized for years for the low reporting rate into the system and the poor quality of the information submitted. This paper argues that physicians need to be required to submit adverse event reports to FAERS, because such a requirement (1) would produce a greater number of the high quality reports necessary to better determine causality; (2) is merely an extension of physicians' ethical obligations; and (3) aligns with the approach in the Vaccine Adverse Event Reporting System (VAERS). Furthermore, advances in electronic health records can aid in reporting efficiency.
authors.forename: Justin M
authors.initials: JM
authors.lastname: Mann
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D006801:Humans; D019221:Mandatory Reporting; D060735:Pharmacovigilance; D010819:Physician's Role; D014481:United States; D014486:United States Food and Drug Administration