About the Portal

Origins and Purpose of the Safety Reporting Portal

I. Background

The Federal Adverse Event Task Force, headed by Amy Patterson, Director of NIH's Office of Biotechnology Assessment, was formed in the wake of the Department of Health and Human Services Secretary's Advisory Committee on Human Subjects Protections (SACHRP) March 2004 meeting. It includes representatives of the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, U.S. Food and Drug Administration (FDA), Office of Human Research Protection (OHRP), the Department of Defense (DoD), and the Department of Veterans Affairs (VA), all of which are ex official members of SACHRP, with the goal of streamlining and coordinating the currently diverse Federal requirements for the reporting and review of adverse events.

II. Purpose

The purpose of this Safety Reporting Portal is to create greater harmonization among Federal agencies for adverse event and product problem reporting.
Furthermore, the Safety Reporting Portal will ultimately enable anyone with Internet access the ability to report a safety concern about a medical product as well as foods, cosmetics, animal feed and veterinary products.
This portal represents one of the initiatives of the Task Force, and is currently being developed in collaboration with the U.S. Food and Drug Administration (FDA), as part of their MedWatchPlus (http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIProjects/ucm083238.htm) strategic effort.