Track-and-trace left out of reconciled PDUFA18-Jun-2012
The track-and-trace provisions
that made it into the Senate version of the PDUFA legislation will
not make the final cut as the House and Senate versions are
reconciled, according to Bill Fletcher, serialisation specialist
and managing director of Pharma Logic Solutions.
This weekend (June 16-17) has been very active as legislators considered updates to the User Fee Acts (UFA), including how to implement a federal alternative to California Law for serialising and tracing Rx drugs.
I have been actively seeking to simplify the cost and burden to drug manufacturers and drug supply chain participants for securing the US drug supply chain with pragmatic federal legislation to preempt a patchwork of individual state laws. On June 6, I spoke in the US Capital Building to a group of legislative staff, FDA and others on how other industries secure their products and how other countries are implementing drug traceability solutions. This resulted in many reaching out to me last week and this weekend for suggestions and review of proposed legislation.
I was told this morning (June 18) by multiple very reliable sources that the reconciled text for the latest UFA Bill will NOT include any track and trace statements or requirements and that the California Law stands for now. The revised Bill is expected later today and anyone interested can write me for a copy.
Given the admirable activity from the industry participants in the Prescription Drug Security Association (PDSA), and their RxTEC labeling proposal (similar to Europe's EFPIA and Turkish encoding requirements), and the momentum they have established, the group will likely promote new proposals in the future.
The key concern from many was the lack of traceability in the PDSA proposals at the lowest traded unit. Other industries, other country drug tracking, and the extensively debated California Law, all require unit level tracking and control. A common element in requirements from other countries is the use of a state controlled central registry and authentication at the point of dispensing.
I also understand that the PDSA concerns over aggregating serialised content to container, was trumped by the notion that drug packaging is tightly controlled and procedures are validated (GMP). Some said that if a manufacturer cannot reliably track which serial numbers are in the case how can they be trusted to ensure the correct product is in the bottle (ref recent Excedrin recall).
The fact that many leading drug manufacturers and supply chain organisations, including members of the PDSA, provided written confirmation in 2008 that they would be ready for the California Law by 2015 didn't help the cost or complexity argument from the PDSA.
Another argument that did not seem to gain traction was the notion that the cost to implement unit level tracking at every step in the supply chain of custody was too expensive. The arguments against this that seemed to get the most attention were (1) that other unregulated industries track serialised units and aggregate serialisation to containers for items costing far less than most Rx drugs (i.e., integrated circuits and auto parts) and (2) that because even if the cost per line is as much as $1m per line (line costs plus amortised enterprise costs), that most Rx packaging lines produce from several hundred thousand to a few million items per year and that in that case a 1 year ROI would amount to about $1 per item (and then pennies per item for maintenance after that).
Since California Law stands for now and 2015 will be upon us in no time, those waiting for PDSA may wish to consider their options and how they will comply. Implementing serialisation and tracking to comply with California and various country requirements can be done far easier and less expensive than expected.
And finally, I remain concerned for my loved ones who depend on Rx medications and the public outrage if there is unnecessary harm or death due to a failure to act.
I hope this helps. Feel free to write email@example.com with questions.
Bill Fletcher’s background spans over 29 years in pharmaceutical, enterprise and supply chain software and healthcare systems. He is currently focused on pharmaceutical serialisation, track and trace and anti-counterfeiting for both commercial and clinical goods. He has developed serialisation and e-Pedigree strategy, requirements, vendor selection and project planning for multiple companies. In May, 2012, he completed his 13th serialisation and traceability project for global life sciences companies, including multiple top 20 pharmaceutical manufacturers. He is currently under retainer agreements with multiple leading life sciences companies to provide subject matter expertise for complying with global regulatory traceability, serialisation requirements and planning the deployment of related technical solutions.
Mr. Fletcher has spoken and published numerous times on issues within the pharmaceutical industry. He is a member of several industry advisory groups and as such has had an impact on guiding the way organisations navigate the issues driving business strategy.
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