GSK Alli Review Shows FDA Data Mining In Context
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA review of the over-thecounter switch application for the weight management therapy orlistat provides a window into agency's use of data mining, especially with its passive surveillance Adverse Event Reporting System, to identify and evaluate signals. One safety concern that did not sway FDA was colon cancer, which was the basis for Public Citizen’s citizen petition calling for withdrawal of Rx Xenical and non-approval of alli. FDA did not believe the spontaneous AE reports, or Public Citizen's biomarker, constitute a safety signal warranting further investigation