In April 2012 a presentation on FDA's activities to combat counterfeit drugs from Ilisa Bernstein, Director, Office of Compliance, CDER, FDA, was published.
The document provides the definition of a counterfeit drug according to U.S. law and presents the reasons why complexity of the supply chain keeps on increasing:
- Involvement of multiple participants
- Globalization of supply chains
- Increasing of criminal activities (e.g. theft)
- Rules that vary by state
As a first-step measure to ensure patient safety Ilisa Bernstein suggests to build "Supply Chain Integrity". Moreover, the document mentions FDA's new Office of Drug Security, Integrity, and Recalls which has been equipped with additional resources. The FDA also intends to improve transparency and accountability of the supply chain. The system used currently - the Pedigree System - should be replaced in the future by a Track&Trace and Authentification system with a unique serial number on each drug package. The presentation shows where the Track and Trace system can help making the supply chain more safe.
At the Anti-Counterfeit Conference - Strategies against Falsified / Counterfeit Medicines - organised by the University of Würzburg from 7 - 8 May 2012, Dr Leigh Verbois from the new Office of Drug Security, Integrity, and Recalls, CDER, FDA, USA will present the new FDA Supply Chain Integrity Initiatives (via Video Conference). More information can be found at www.counterfeit-conference.org.
You can also find more details in the presentation "FDA Efforts: Counterfeit Drugs".
Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)