FDA to Strengthen Fight Against Counterfeit Drug Products

June 15, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.


The US Food and Drug Administration's (Rockville, MD, www.fda.gov) CounterfeitDrug Task Force is recommending regulatory actions and theimplementation of new technologies for reducing the risk of counterfeitdrugs entering the United States. The group has followed up on itsoriginal 2004 report, in which it outlined the framework for protectingthe public from counterfeit medicines, and an updated 2005 report witha third document encouraging electronic pedigrees, improvedtraceability in the drug supply chain, and the adoption ofradio-frequency identification (RFID) tools.

Among the recommended measures, FDA plans in December to discontinueits hold on the Prescription Drug Marketing Act of 1987, thus requiringdrug distributors to provide documentation of the chain of custody ofdrug products (i.e., apedigree) throughout the distribution system. According to an FDAstatement, implementation of this Act would "provide clarity in thedrug supply chain regarding who is and is not required to pass apedigree."

FDA also plans to implement pedigree regulations concerning the use ofelectronic track-and-trace technology in the supply chain (e.g., RFID), focusing on "productsmost susceptible to counterfeiting and diversion." The agency hasstated that widespread use of these technologies would "provide anelectronic safety net for our nation's drug supply" and continues toencourage the implementation of RFID technology. FDA also plans todraft a compliance policy guide that will describe its enforcementapproach to e-predigree regulations, thereby providing guidance on thetypes of drugs that are of greatest concern and clarifying how itintends to prioritize its pedigree-related enforcement resources in2007.

The report issued by the Task Force also lists key issues on electronictrack-and-trace technologies needing resolution. These issues includethe mass serialization of marketed drugs with unique identifiersassigned to each drug package, the move toward universal drug pedigreein the United States, the protection of consumer privacy whenRFID-tagged drugs are dispensed to consumers, and consumer educationabout RFID-tagged products, including benefits and assurance of privacy.