The Food and Drug Administration's Counterfeit Drug Initiative

Abstract

There have been significant efforts by the public and private sector to further secure our nation's drug supply from counterfeit drugs. In 2004, FDA released a framework as guidance for these efforts and has been facilitating the implementation of this framework. Technology-based solutions, such as using radio-frequency identification (RFID) as a means to create an electronic pedigree that documents the movement of a drug product through the drug supply chain, is an important element of the framework. In 2005, two years after the release of the framework, FDA issued an update reporting the progress on reaching the goals of the framework, including RFID implementation, use of electronic pedigree, the pedigree requirements under the Prescription Drug Marketing Act. This article summarizes the findings of FDA's Counterfeit Drug Task Force 2006 Update. A full copy of the report can be accessed at http://www.fda.gov/oc/initiatives/counterfeit/report6_06. pdf.¹