The Importance of Consumer Reporting Side-effects with Regulated Products: The New Consumer Friendly FDA 3500B MedWatch Form

Abstract

Copyright: © 2013 Phillips L. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. The Food and Drug Administration (FDA) has a new voluntary consumer friendly MedWatch Form 3500B [1]. The new MedWatch form uses lay friendly language with a simplified layout making it easier for consumers to report problems with drugs and other regulated products to the FDA. Consumer reports to the MedWatch system are increasing [2] and have been shown to make a difference in recognizing new and serious drug adverse events. Consumers often have the most details about what they are experiencing, and are in a unique position to identify new safety signals earlier. Every Medwatch report is important; a single report can identify a safety problem and prompt the FDA into action. Recent Consumer reports alerted scientists at the FDA to a critical health issue about the accidental exposure and harm to children from to Testosterone gel used by Men [3]. These early reports prompted the FDA to mandate stronger warning labels that required that the gel be covered after applying to the skin so other people would not be exposed [3].