Still, the FDA is unlikely to mandate the use of RFID because such a move would likely get tied up in the courts for years. Lutter said there is a danger that individual states will enact drug pedigree laws, forcing companies to comply with 50 different requirements (Florida and California have already enacted such laws). The federal government is discussing the issue with the states, but, he said, there is no consensus on how to move forward in a way that would not unduly burden pharmaceutical companies.

One possibility that is gaining currency among pharmaceutical distributors is for the industry to move forward voluntarily with electronic pedigrees for drugs, or at least outline a plan of adoption that would satisfy consumers, politicians and regulators that the industry is committed to securing the drug supply chain. There are several benefits to moving forward voluntarily. One is that the industry could develop a pedigree system and a timetable for deployment that makes business sense, rather than having a federal requirement enacted by Congress that would drive up costs—or worse, having more states enact conflicting laws.

Another benefit is that if industry leaders move forward in lockstep, they could agree on standards and deploy technologies in stages. RFID might be too expensive today to use on every pill bottle, but the industry could deploy RFID at the pallet and case level, and begin building a system that could eventually be used on individual items.

A third benefit is that the industry could focus more effectively on problem areas. Regulation tends to be all or nothing. A voluntary pedigree system could target the points of vulnerabilities in the supply chain. As David Vucurevich, group vice president for pharmaceutical purchasing and pharmacy programs of Rite Aid Corp., a major pharmacy operator, said during the event in Washington, if his company purchases a shipment of drugs directly from Pfizer and no one else touches it, there is very little chance that there will be counterfeit drugs in that shipment. So why waste time and money tracking such shipments? Why not focus on drugs coming through a secondary distributor or from overseas?

There is no easy and inexpensive way to secure the drug supply chain. But if companies rather than regulators drive the process, they can make sure the pedigree system not only secures the drug supply chain but also delivers business benefits. The result is that consumers get drugs that are safer, but not much more expensive.