A growing number of U.S. states are formalizing electronic pedigree requirements in order to comply with the FDA's anti-counterfeiting initiatives.


A new two-phase RFID authentication platform introduced by Texas Instruments (TI) and VeriSign should make it easier for pharmaceutical manufacturers, suppliers, distributors and pharmacies to meet the FDA drug pedigree requirements. It may also make it easier for consumers to accept RFID technology in their prescription packaging.

Mikael Ahlund, director of RFID healthcare for TI, says that the platform is unique in providing two layers of protection against counterfeiting. The model enhances system security by digitally certifying the authenticity of 13.56 MHz RFID tags via a cryptographic Public Key Infrastructure (PKI) available through VeriSign. "The beauty of this approach is that because the elements for the private key are preprogrammed into the tag and the reader is preprogrammed for the public key, the authentication is actually done off-network," says Ahlund.

"We're using multiple layers of protection," says Graham Gillen, senior product manager for VeriSign. "Ultimately, it's about making the tag, and hence the product, hard to fake or reproduce."

The platform is non-proprietary and can be implemented by any RFID system and PKI provider. That can save drug manufacturers and suppliers the considerable infrastructure costs associated with deploying most RFID systems. The additional security may relieve some consumers' fears that their personal and private information may be intercepted by electronic hackers.

The idea of using RFID in the prescription drug pipeline has had consumers and pharmaceutical manufacturers/suppliers hotly at odds. The TI/Verisign model suggests that when used with care, RFID may indeed be protective without being invasive.

Sally Bacchetta is an award-winning freelance writer and sales trainer. She has published articles on a variety of topics, including RFID, selling skills, motivation, and pharmaceutical sales.

Visit her RFID blog for an exploration of the ethical and social considerations of RFID.