Electronic Reporting of Adverse Event Data to the Food and Drug Administration: The Experiences of Glaxo Wellcome and Zeneca as Participants in the Adverse Event Reporting System Pilot Project

Abstract

The Food and Drug Administration (FDA) has recently initiated a pilot project for electronically submitting individual case safety reports of postmarketed drugs to the agency for upload into the Adverse Event Reporting System (AERS). The data elements and the file structure used in the submission process are those defined by the E2b and M2 Expert Working Groups. Two drug manufacturers, Glaxo Wellcome and Zeneca, have chosen to participate in the pilot. This article presents the experiences of the pilot participants including: the scope and goals of the pilot project, resources required to successfully submit data electronically, lessons learned from participation, and the steps required by industry to fully implement an electronic environment.