RFID Law Blog

As growing evidence of the Federal government's interest in the use of RFID, the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources held a hearing on Tuesday, July 10 on the FDA's requirements for electronic chain of custody tools to eliminate counterfeiting.

While acknowledging that there are still technology and public policy questions to be resolved, Subcommittee Chairman Mark Souder (R-IN) and all of the witnesses said that RFID was the most promising technology known to help address the need to track drug supply chains to reduce counterfeiting.

Two significant public policy questions arose that should be of interest to both RFID vendors and pharmaceutical companies:

1) Interoperability and standards/ state government pre-emption: Several of the witnesses spoke of the fact that the FDA is pursuing these RFID--related requirements at the same time as California, Florida and other emerging states. Concerns were raised about the development of multiple incompatible requirements -- both domestically and internationally.

2) Liability: A representative from the American Pharmacists Association spoke positively about the benefits of RFID to limit counterfeiting and improve patient health, but also worried about the assignment of liabilty and costs for implementing the system. In his written testimony, he wrote:

Fairly Distributing Costs and Liability

We encourage the Subcommittee to consider that all anti-counterfeiting efforts affect the liability of supply chain participants. For pharmacists, it is important that the liability of the pharmacist equate with our liability in all other areas of practice--a standard of negligence. As health care professionals, we are (and should be) required to meet our responsibilities as that of a 'reasonable pharmacist' and our responsibilities in anticounterfeiting efforts should be the same. Should counterfeit medications reach patients despite the best efforts of the pharmacists involved, those responsible for the counterfeiting should be responsible--not the health care professionals whose efforts
were defeated by criminals. We commit to performing our roles within the health care system, but do not accept liability for the actions of others.

As noted previously, efforts to better protect our medication supply are necessary but the cost and practical implications of such efforts must be considered in identifying and implementing the right solutions. Technology advances present an opportunity to strengthen the safety of our drug supply. Pharmacists and pharmacies will bear some of the additional costs necessary to employ new anti-counterfeit technologies. Depending on the technology and the necessary equipment, this may involve a substantial financial contribution. While providing an anti-counterfeit benefit, the burdens associated with infrastructure upgrades must be taken into account as policies around anti-counterfeit technologies are developed.

I spoke with the Subcommittee staff earlier today who indicated that this is only the beginning of their foray into this issue. I would expect Congress to play an increasingly important role as the FDA's requirements move forward.

For a full report on the hearing, check out the subcommittee website.