Earlier this week, the FDA held a public workshop titled, “Determination of System Attributes for the Tracking and Tracing of Prescription Drugs.” Consistent with the Food and Drug Administration Amendments Act of 2007, the FDA seeks to protect consumers from dangerous counterfeit and adulterated drug products by implementing track and trace technology that will increase the transparency of the supply chain and hold supply chain participants accountable. To that end, the FDA organized the workshop to create a forum in which various industry stakeholders could discuss possible track and trace technologies, and the related interoperability, authentication and data management issues.
There are many questions the FDA must answer before it can efficiently implement track and trace technology. For instance, what is the best technology – bar codes, RFID, or something else entirely? Will the technology impact the composition of products, such as delicate biologics? Will it be applied across the entire industry? If it is not applied consistently, what impact will this have on pharmacies and their distribution activities? Who will absorb the cost associated with implementing this technology along the entire supply chain?
The FDA’s renewed industry interest in track and trace technology may, in part, be due to California’s stringent electronic pedigree requirements. Effective in 2015, California will mandate electronic pedigree at the smallest saleable unit.
It will be interesting to see how the federal track and trace requirements compare to California’s requirements. The industry could be facing immense – and expensive – changes. Companies may have to alter their packaging, implement new technology across product lines, and develop new processes and procedures for distributing products.