The Obama administration's proposal for a track-and-trace initiative for drugs, buried within last week's IP-protection recommendations to Congress, appears to have generated little buzz.
PhRMA has added its nod in a statement by association president, John Castellani. The government's "renewed emphasis on collaboration, information sharing, education and enforcement--as it relates to counterfeit pharmaceuticals--is warmly welcomed."
But in referencing the counterfeit-fighting recommendations, the Castellani statement includes the qualifier, "as outlined in the report." And the report is noticeably lacking in details of a track-and-trace system.
Perhaps the PhRMA qualifier comes from the same line of thinking in play at the National Association of Chain Drug Stores. After identifying the recommendations it does support, NACDS states plainly that it opposes the track-and-trace idea.
"NACDS does not support the report's proposal to mandate a track and trace system. The operational processes surrounding a mandated track and trace system are still under development and cannot achieve their desired purpose at this time, which will prove extraordinarily costly for pharmacies and other supply chain operators."
The association explains in an emailed statement that among those processes still under development and "yet to be resolved" are serialized numerical identifiers, for which FDA just issued guidance this month. "In addition, FDA only recently had a public workshop to consider the operational attributes for a track and trace system, including matters such as interoperability, data management and access models, standards and authentication."
NACDS adds that it looks forward to working with the FDA as it "provides recommendations on next steps for preserving the integrity of the pharmaceutical supply chain."
- see the PhRMA statement
- here's the NACDS statement