Concerns about the lack of a nationwide standard were communicated to the US Food and Drug Administration (FDA) after its public workshop. Without pre-emptive federal legislation companies may have to adopt track-and-trace on a state-by-state basis, beginning with California in 2015.
“In the absence of clarity regarding federal pre-emption, many companies…must begin funding their plans to develop line designs, system architecture and new business processes to meet requirements for California”, said AstraZeneca.
Other players in the biopharm supply chain, such as distributors and pharmacies, expressed similar concerns. Overall, the fear is that without pre-emptive federal legislation all parts of the supply chain will face unnecessary costs as they attempt to comply with an unworkable system.
Many respondents also commented on data ownership and visibility. “A track-and-trace system must maintain the proprietary nature of each entity’s data”, said AstraZeneca, “by appropriate security controls to limit data entry and access to relevant authorised parties”.
AstraZeneca is, to date, the only big pharma to publish a response to the FDA workshop. UPS, AmerisourceBergen and the Pharmaceutical Care Management Association (PCMA) are among the other respondents.
Allergenic exemption
Jubilant Hollister-Stier and the Allergen Products Manufacturers’ Association (APMA) both called for injectable allergenic extracts to be excluded from track-and-trace requirements.
“The allergenic product industry, as a whole, would face significantly higher technical, logistical and economic barriers in meeting any electronic track-and-trace technology…than would large mainline pharmaceutical manufacturers”, said Jubilant.
Allergenic extract facilities do short packaging runs of hundreds of products with distinct forms and container sizes. This makes it impractical and economically unviable to add numerical identifiers, said Jubilant. Also, allergenic products are unlikely to be targeted by counterfeiters.