Electronic Pedigrees and Counterfeit Pharmaceuticals: The U.S. Experience with RFID

Abstract

This paper describes the process of implementing an electronic pedigree (e-pedigree) system in the pharmaceutical drug supply chain. The U.S. Congress mandated such a system with the Pharmaceutical Drug Marketing Act (PDMA) of 1987. Congress amended the PDMA in 1992. The Food and Drug Administration (FDA) delayed requiring compliance with the PDMA until 2007, and even then complete compliance was not required. A small drug wholesaler sued the FDA over the order implementing PDMA compliance, and even now an injunction from a federal court has suspended part of the implementation of the PDMA. In the vacuum left by the federal court injunction, the State of California mandated an e-pedigree system to implement "track and trace" for prescription drugs; later that year California suspended the implementation of its e-pedigree law until 2011. This paper traces the "fits and starts" progress of an e-pedigree based on RFID in the pharmaceutical drug supply chain. It identifies and describes the major technical issues and the major participants in the political controversy surrounding e-pedigree systems and speculates on the likely shape of the e-pedigree system that will emerge.