Regulatory Beat: FDA and Industry Seek New Strategies to Curb Counterfeiting and Diversion - A multi-layered approach is needed to authenticate biotech therapies and provide a secure distribution


Regulatory Beat: FDA and Industry Seek New Strategies to Curb Counterfeiting and Diversion
A multi-layered approach is needed to authenticate biotech therapies and provide a secure distribution chain

BioPharm International
Volume 19, Issue 4

A number of pharma manufacturers are testing RFID tracking systems, primarily for products targeted by counterfeiters and diverters, such as Purdue Pharma's OxyContin and Pfizer's Viagra. These limited projects indicate that electronic tracking is technically feasible, but that much more needs to be done to establish a broad system that can handle thousands of products moving among multiple distribution points.

With pressure mounting to do more to protect the nation's drug supply from counterfeiting, tampering, and diversion, another stay on the PDMA pedigree requirement seems unlikely. The task force will lay out the options, examine available tracking and authentication technology, describe the multiple levels of protection needed to better secure the nation's drug supply, and provide additional policy guidance to spur all parties in the supply chain to move forward.

To this end, manufacturers are collaborating with distributors and other parties to develop e-pedigree standards for messaging, item-level tagging, serialization, RFID frequencies, and network security. A key issue in developing a broad tracking system is deciding whether all the transaction information should be stored in a single central database or throughout the distribution network.

Companies also are implementing methods to identify genuine packages and products. These include overt technologies, such as color shifting inks and holograms, and more sophisticated covert methods. Desirable technologies have minimal impact on manufacturing processes, are easy to authenticate in the field, and can be applied to multiple products and packaging components to support a corporate approach to product security across brands and regions.

A key concern for biotech manufacturers is whether any inks or colorings might cause product adulteration, and if the heat from RFID tagging systems could have thermal effects on chemical bonds in some products. FDA and manufacturers are examining whether heating and radio-frequency field strengths may affect the stability of certain liquid pharmaceuticals. Manufacturers hope that FDA's May report will contain further advice on how to develop unique identifiers for drug packages and whether any colorants or other authentication technologies are likely to impact product dissolution, stability, or identification.


While electronic track-and-trace still dominates discussions about effective prescription drug protection, there is a growing realization that RFID is primarily a supply chain management tool and not that useful in product authentication. RFID currently is the most advanced tracking technology, commented FDA's Gottlieb, but he noted a need to pursue a "multi-layered approach" that includes use of two-dimensional bar codes and other technologies.

Gottlieb also acknowledged a need for laying stiffer penalties on lawbreakers and expanded enforcement and detection efforts. He suggested that the government may look for new ways to encourage drug security methods. One idea might be to require authentication technologies on drugs purchased for the national stockpile; product tracking would be important for medicines distributed broadly during a national emergency.

RFID and authentication methods may appear too costly for all but the most vulnerable products, but these strategies may pay off for manufacturers by improving inventory management and distribution systems, reducing theft, enhancing public confidence, and avoiding lawsuits from consumers harmed by an adulterated version of the company's product. In the future, lack of internal security measures and failure to adequately monitor products through the distribution system may create legal and regulatory problems for manufacturers.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634,

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